The Oral Frontier: Clinical Developments, Competitive Dynamics, and Market Potential in Oral Obesity Therapeutics

 I. Executive Summary

The treatment landscape for obesity is undergoing a profound transformation, driven largely by the success of injectable incretin-based therapies. However, the pursuit of effective, convenient, and well-tolerated oral agents represents the next major frontier in this therapeutic area. Recent clinical trial data, particularly from Phase 3 studies, reveal that high-dose oral formulations, such as Novo Nordisk's oral semaglutide 50mg, can achieve weight loss comparable to market-leading injectables like Wegovy. Eli Lilly's orforglipron, an oral non-peptide GLP-1 receptor agonist, also shows significant promise in late-stage development, potentially offering manufacturing and cost advantages. Other companies, including Roche and Structure Therapeutics, are advancing novel oral small molecules, some employing biased agonism or targeting complementary pathways like amylin, aiming for improved efficacy or tolerability.

Despite promising efficacy, significant challenges remain. Gastrointestinal side effects are prevalent with oral GLP-1 receptor agonists, often requiring careful dose titration and potentially impacting patient adherence, as highlighted by the high discontinuation rates seen in Pfizer's discontinued danuglipron program. Safety signals, such as the liver enzyme elevations observed with danuglipron, warrant close monitoring across the class.

The global obesity drug market is projected to exceed $100 billion annually within the next decade, presenting a substantial commercial opportunity. While injectables currently dominate and are expected to retain the majority market share (~85% by 2035), oral therapies could capture a significant segment (~15% or more), driven by patient preference for convenience. Success for oral agents will hinge on demonstrating a competitive clinical profile – balancing efficacy comparable to injectables with manageable tolerability – and navigating complex payer landscapes where high costs and reimbursement hurdles persist. The potential for lower manufacturing costs associated with small molecule orals could be a key differentiator, potentially enabling broader market access if reflected in pricing strategies. Overall, the oral obesity drug space presents high potential rewards, but is characterized by significant clinical development risks, intense competition, and market access uncertainties.

II. Introduction: The Evolving Landscape of Obesity Treatment

Obesity has escalated into a global health crisis, affecting nearly a billion people worldwide in 2020, with projections suggesting this number could rise significantly by 2035. Recognized not merely as a lifestyle condition but as a complex chronic disease, obesity is a major risk factor for a spectrum of severe comorbidities, including type 2 diabetes (T2D), cardiovascular disease (CVD), hypertension, dyslipidemia, certain cancers, osteoarthritis, and sleep apnea. The economic burden is substantial, encompassing direct healthcare costs for treating obesity and its consequences, as well as indirect costs related to lost productivity and premature mortality, estimated to potentially exceed $4 trillion globally by 2035.  

Historically, treatment approaches centered on lifestyle modifications – diet and exercise. While foundational, these interventions often yield insufficient or unsustainable weight loss for many individuals facing the physiological complexities of obesity. Pharmacotherapy has long been considered an adjunct, but older medications offered modest efficacy often coupled with significant safety concerns, limiting their widespread use.  

The landscape began to shift dramatically with the advent of incretin-based therapies, particularly glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Initially developed for T2D, drugs like liraglutide and later semaglutide demonstrated significant weight loss benefits alongside glycemic control. This class works by mimicking the action of the endogenous GLP-1 hormone, which enhances glucose-dependent insulin secretion, suppresses glucagon release, slows gastric emptying, and acts on brain centers to regulate appetite and increase satiety. The approval of higher-dose semaglutide (Wegovy, Novo Nordisk) specifically for chronic weight management marked a turning point, offering unprecedented levels of pharmacologically induced weight loss, often exceeding 15%. Eli Lilly further advanced the field with tirzepatide (Mounjaro for T2D, Zepbound for obesity), a dual agonist targeting both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors, which demonstrated even greater weight loss in clinical trials, sometimes exceeding 20%. These injectable therapies have revolutionized obesity management, proving that substantial, clinically meaningful weight loss is achievable pharmacologically.  

Despite the success of injectables, challenges remain. Needle aversion, the perceived inconvenience of injections (even weekly ones), and manufacturing complexities associated with peptide-based drugs create demand for alternative formulations. Oral therapies offer the promise of greater patient convenience, potentially improving treatment initiation, adherence, and long-term persistence, which are crucial for managing a chronic condition like obesity. Furthermore, developing oral small molecules could potentially overcome the manufacturing bottlenecks and high costs associated with large peptide injectables, potentially expanding global access. The development of oral semaglutide (Rybelsus) for T2D, utilizing the SNAC absorption enhancer technology to enable gastric absorption of the peptide, demonstrated the feasibility of oral incretin delivery. This success spurred intensive research into higher-dose oral semaglutide for obesity and the development of novel oral GLP-1 RAs, including non-peptide small molecules.  

This report provides an in-depth analysis of the current state and future prospects of oral obesity drug candidates. It examines the latest clinical trial data for key molecules, maps the competitive landscape identifying leading companies and their strategies, assesses the market dynamics comparing oral versus injectable therapies, evaluates the significant market opportunity, and provides a qualitative outlook on the business potential and profitability for companies navigating this rapidly evolving and highly competitive therapeutic area.

III. Clinical Trial Snapshot: Key Oral Obesity Candidates

The development pipeline for oral obesity drugs is active, with several candidates progressing through mid-to-late-stage clinical trials. Success hinges on demonstrating efficacy comparable to established injectables while offering a favorable safety and tolerability profile, particularly concerning gastrointestinal side effects common to the GLP-1 RA class.

A. Oral Semaglutide (Novo Nordisk)

• Background: Novo Nordisk pioneered the oral delivery of a peptide GLP-1 RA with Rybelsus, approved for T2D in 3mg, 7mg, and 14mg doses. This formulation utilizes the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino)caprylate (SNAC) to protect the semaglutide peptide from gastric degradation and facilitate its absorption. Building on this platform, Novo Nordisk investigated higher doses (25mg and 50mg) specifically for obesity in the OASIS program.  
• OASIS 1 (Phase 3a - 50mg): This pivotal 68-week trial enrolled 667 adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with comorbidities, but without T2D, comparing once-daily oral semaglutide 50mg against placebo, both alongside lifestyle intervention.
  • Efficacy: The trial met its primary endpoints, demonstrating statistically significant and superior weight loss for oral semaglutide 50mg. Using the treatment policy estimand (an intent-to-treat analysis regardless of treatment adherence or discontinuation), the mean weight loss from baseline at week 68 was -15.1% (SE 0.5) for the semaglutide group versus -2.4% (SE 0.5) for placebo, yielding an estimated treatment difference of -12.7 percentage points (95% CI -14.2 to -11.3; $p<0.0001$). An alternative analysis estimating the effect if all participants adhered to treatment showed an even greater weight loss of -17.4% for semaglutide versus -1.8% for placebo. A high proportion of participants receiving oral semaglutide 50mg achieved clinically significant weight loss thresholds compared to placebo: ≥5% weight loss (85% vs 26%), ≥10% (69% vs 12%), ≥15% (54% vs 6%), and ≥20% (34% vs 3%) (all $p<0.0001$). This level of efficacy positions the 50mg oral dose firmly in the range of its injectable counterpart, Wegovy (semaglutide 2.4mg), establishing a high benchmark for other oral contenders.  
  • Safety/Tolerability: The safety profile appeared consistent with the known profile of the GLP-1 RA class. Adverse events (AEs) were more frequent with semaglutide (92%) than placebo (86%). Gastrointestinal AEs were the most common, reported by 80% of participants on semaglutide compared to 46% on placebo. These events were predominantly mild to moderate in severity and tended to diminish over time, occurring most frequently during the dose escalation phase. While efficacy rivals injectables, this high incidence of GI side effects underscores a potential tolerability challenge for the oral formulation, which might affect real-world adherence compared to less frequent injectables.  
   
• OASIS 4 (Phase 3b - 25mg): This trial evaluated the 25mg once-daily dose in 300 adults with obesity or overweight. Results indicated significant weight loss, also comparable to Wegovy, suggesting the 25mg dose is also a viable therapeutic option.  
• Other Studies: A dedicated study (NCT05236517) showed that oral semaglutide 50mg reduced energy intake, appetite, and food cravings, and improved eating control at 20 weeks, supporting its mechanism of action beyond glycemic control. The extensive PIONEER program previously established the efficacy of lower doses (up to 14mg) for T2D, demonstrating superiority over placebo and active comparators like empagliflozin and liraglutide in reducing HbA1c and body weight.  
• Approval Status: Rybelsus (up to 14mg) is approved for T2D. Following the positive OASIS 1 results, Novo Nordisk stated its intention to file for regulatory approval for the 50mg dose for obesity in the US and EU in 2023. A potential launch is anticipated around 2026, though contingent on portfolio prioritization and manufacturing capacity. The 25mg and 50mg doses are not yet FDA-approved for either T2D or obesity.  

B. Orforglipron (Eli Lilly)

• Background: Orforglipron (LY3502970) represents a different approach as a once-daily, oral, non-peptide small molecule GLP-1 RA. This structural difference potentially offers advantages in manufacturing simplicity, scalability, and cost compared to peptide-based drugs. Lilly licensed the compound from Chugai Pharmaceutical in 2018.  
• Phase 2 (Obesity): A 36-week Phase 2 trial evaluated orforglipron (12mg, 24mg, 36mg, 45mg doses) for chronic weight management in adults with obesity or overweight but without T2D.
  • Efficacy: The study demonstrated statistically significant, dose-dependent weight loss across all doses compared to placebo. At 36 weeks, mean weight loss ranged from 9.4% (at 12mg) to 14.7% (at 45mg), compared to 2.3% for placebo. Notably, weight loss appeared to continue throughout the 36 weeks without reaching a plateau, suggesting potential for further reduction with longer treatment durations. While promising, this 14.7% at 36 weeks appears numerically slightly lower than the 15.1% seen with oral semaglutide 50mg at 68 weeks in Phase 3 , highlighting the need for longer-term Phase 3 data for a clearer comparison.  
  • Safety/Tolerability: The safety profile was reported as comparable to the incretin class. Gastrointestinal AEs (nausea, vomiting, diarrhea) were the most frequently reported, primarily mild to moderate and occurring during dose escalation. Specific discontinuation rates for this Phase 2 obesity study were not provided in the available sources.  
   
• ACHIEVE-1 (Phase 3 - T2D): This 40-week trial compared orforglipron (3mg, 12mg, 36mg doses) as monotherapy against placebo in 559 adults with T2D and inadequate glycemic control.
  • Efficacy: The trial successfully met its primary endpoint, showing superior A1C reduction versus placebo across all doses (mean reduction of -1.3% to -1.6%). It also met key secondary endpoints, including significant weight loss. At the highest dose (36mg), participants achieved an average weight loss of 16 lbs (approximately 7.9%) compared to placebo at 40 weeks. Furthermore, 65% of participants on the highest dose reached an A1C level of ≤ 6.5%.  
  • Safety/Tolerability: The safety profile remained consistent with the injectable GLP-1 class. The most common AEs were GI-related (diarrhea, nausea, dyspepsia, constipation, vomiting). In this T2D trial, the discontinuation rate due to AEs at the highest dose was reported as 8% , which appears lower than rates seen in some other oral GLP-1 trials.  
   
• Development Status: Orforglipron is advancing through a comprehensive Phase 3 program, encompassing the ACHIEVE trials for T2D and the ATTAIN trials for obesity/overweight. Lilly anticipates submitting orforglipron for regulatory approval for weight management by the end of 2025, with a T2D submission planned for 2026. This timeline suggests a potential market launch starting in 2026. The non-peptide nature could be a significant advantage in terms of manufacturing scale and cost if clinical performance holds up in the larger, longer-term Phase 3 obesity trials.  

C. Danuglipron (Pfizer) - Development Discontinued

• Background: Danuglipron (PF-06882961) was another oral, small molecule GLP-1 RA candidate pursued by Pfizer. Development included both twice-daily (BID) and once-daily (QD) formulations.  
• Phase 2b (Twice-Daily - Obesity): This trial evaluated the BID formulation in adults with obesity but without T2D.
  • Efficacy: The study met its primary endpoint, demonstrating statistically significant, placebo-adjusted weight loss ranging from 5% to 9.5% at 26 weeks and 8% to 13% at 32 weeks, depending on the dose.  
  • Safety/Tolerability: Despite the efficacy, the BID formulation was plagued by poor tolerability. High rates of GI AEs were observed, including nausea (up to 73%), vomiting (up to 47%), and diarrhea (up to 25%). These side effects led to exceptionally high treatment discontinuation rates, exceeding 50% across all danuglipron doses compared to approximately 40% for placebo. Consequently, Pfizer announced in December 2023 that it would not advance the BID formulation into Phase 3 trials. This outcome starkly illustrates that achieving efficacy with oral GLP-1s is insufficient if patients cannot tolerate the required doses long-term.  
   
• Phase 1/2 (Once-Daily - Obesity): Pfizer subsequently focused on developing a modified-release, once-daily formulation, hoping to improve tolerability. Dose-optimization studies (NCT06567327, NCT06568731) were conducted.
  • Efficacy/PK: These studies reportedly met key pharmacokinetic objectives, identifying a QD formulation and dose with the potential for a competitive profile in Phase 3, based on the efficacy seen in earlier BID studies.  
  • Safety/Tolerability: Pfizer stated that the overall frequency of elevated liver enzymes across the entire danuglipron program (involving over 1,400 participants) was generally in line with approved drugs in the GLP-1 class. However, a critical safety issue emerged in one of the QD dose-optimization studies: an asymptomatic participant experienced potential drug-induced liver injury (DILI), which resolved upon stopping the drug. This followed the discontinuation of Pfizer's earlier GLP-1 candidate, lotiglipron, also due to liver enzyme elevations.  
   
• Development Status: In April 2025, Pfizer announced the discontinuation of the entire danuglipron development program, including for obesity and T2D. The decision was based on a review of the total data package, the observed potential DILI case, and input from regulators. This marks a significant setback for Pfizer in the oral GLP-1 space. The company is now pivoting focus towards other mechanisms in its metabolic pipeline, notably the oral GIPR antagonist PF-07976016 (currently in Phase 2) and potentially an oral version of VK-2735 (GLP-1/GIP) from Viking Therapeutics. The repeated liver safety signals encountered by Pfizer raise important questions about the challenges of developing safe oral GLP-1 small molecules and will likely intensify regulatory scrutiny on liver safety for all candidates in this class.  

D. Oral Amycretin (Novo Nordisk)

• Background: Amycretin is a novel unimolecular co-agonist targeting both the GLP-1 and amylin receptors. Amylin is another hormone involved in glucose control and appetite regulation, potentially offering synergistic effects with GLP-1 for weight loss and perhaps better tolerability. Novo Nordisk is developing both a once-weekly subcutaneous injection and a once-daily oral formulation.  
• Phase 1 (Oral): Early data from the oral formulation trial was presented in March 2024.
  • Efficacy: The oral version demonstrated a 13.1% reduction in body weight after just 12 weeks of treatment. This rapid and substantial early weight loss is highly encouraging for an oral agent and suggests the dual mechanism translates effectively.  
  • Safety/Tolerability: Specific safety data for the oral formulation from the Phase 1 trial were not detailed in the reviewed snippets. However, the subcutaneous formulation tested in a Phase 1b/2a trial showed a safety profile consistent with incretin-based therapies, with GI AEs being the most common and mostly mild-to-moderate.  
• Phase 1b/2a (Subcutaneous): While not oral, the results inform the potential of the mechanism. This trial showed dose-dependent weight loss, reaching up to 22.0% at 36 weeks with the highest dose tested (20mg weekly). These results strongly support the potential of the dual GLP-1/amylin agonism approach.  
• Development Status: Phase 1 data for the oral formulation is available. Novo Nordisk has stated plans for further clinical development of amycretin (subcutaneous) based on the Phase 1b/2a results. The specific timeline and plans for advancing the oral formulation into Phase 2 or 3 trials for obesity are not explicitly mentioned in the provided sources but are anticipated given the promising early oral data and Novo's strategy to compete across modalities. The potential for superior efficacy compared to GLP-1 monotherapies makes oral amycretin a key pipeline candidate to monitor.  

E. CT-996 (Roche/Carmot Therapeutics)

• Background: CT-996 is a once-daily, oral, small molecule GLP-1 RA acquired by Roche through its $2.7 billion acquisition of Carmot Therapeutics in December 2023. A key differentiating feature is its design as a biased agonist, intended to preferentially activate the efficacy-related cAMP signaling pathway with minimal recruitment of β-arrestin, a pathway linked to receptor internalization and potentially some side effects.  
• Phase 1 (Obesity/Overweight without T2D): Roche reported positive topline results from the initial parts of the multi-part Phase 1 trial (CT-996-201, NCT05814107) in July 2024.
  • Efficacy: Treatment resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within just 4 weeks. This rapid onset of significant weight loss is noteworthy for an oral agent in early development. Full data is expected at a future medical meeting.  
  • Safety/Tolerability: CT-996 was reported as well-tolerated. Most AEs were mild or moderate GI issues, consistent with the incretin class. Importantly, there were no treatment discontinuations related to the study drug in these initial cohorts. This early tolerability profile, potentially linked to its biased agonism, is a positive signal, especially given the rapid efficacy observed. Pharmacokinetic data also suggested that CT-996's absorption was not significantly affected by food, potentially allowing for more flexible dosing without strict fasting requirements.  
   
• Development Status: The initial single and multiple ascending dose parts in participants without T2D are complete. A third part enrolling participants with T2D was planned to start in Q4 2024. Based on the positive Phase 1 data, Roche intends to advance CT-996 into Phase 2 clinical development. Roche executives have expressed optimism about CT-996, highlighting its potential as a best-in-class oral option and the manufacturing advantages of a small molecule. The combination of rapid efficacy, good early tolerability, and dosing convenience positions CT-996 as a strong contender if these attributes hold in larger, longer trials.  

F. GSBR-1290 (Structure Therapeutics)

• Background: GSBR-1290 is another once-daily, oral, non-peptide small molecule GLP-1 RA being developed by Structure Therapeutics. Like CT-996, it is also designed as a biased agonist.  
• Phase 2a (Obesity): A 12-week, double-blind, placebo-controlled trial evaluated GSBR-1290 (120mg QD with titration) in 64 healthy overweight or obese participants.
  • Efficacy: The trial met its objectives, showing a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 6.2% at 12 weeks ($p<0.0001$). A high proportion of participants achieved significant weight loss: 67% achieved ≥6% loss, and 33% achieved ≥10% loss, compared to 0% for placebo. A separate capsule-to-tablet PK study demonstrated similar or slightly better efficacy, with up to 6.9% placebo-adjusted weight loss at 12 weeks using the tablet formulation.  
  • Safety/Tolerability: GSBR-1290 demonstrated a generally favorable safety and tolerability profile. As expected for the class, the leading AEs were GI-related (nausea, vomiting), typically occurring early in treatment and lessening after titration was complete. AE-related study discontinuation rates were reported as relatively low, ranging from 5% in the main Phase 2a obesity study to 11% in the capsule-to-tablet PK study. An earlier update mentioned a 0% discontinuation rate due to AEs in the obesity cohort. No treatment-related serious AEs were reported over 12 weeks , and importantly, no liver safety signals were observed. This tolerability profile appears competitive compared to some other oral agents.  
   
• Phase 2a (T2D): A parallel cohort in T2D patients showed significant reductions in both HbA1c (-1.01% to -1.02% placebo-adjusted) and weight (-3.26% to -3.51% placebo-adjusted) at 12 weeks, with a low AE-related discontinuation rate of 2.8%.  
• Development Status: Structure Therapeutics initiated dosing in its Phase 2b ACCESS study in November 2024. This is a larger (approx. 220 participants), longer (36 weeks) trial evaluating multiple doses (up to 120mg) with an optimized titration schedule. A second Phase 2b study, ACCESS II, is planned to evaluate even higher doses (180mg and 240mg) in about 82 participants, also over 36 weeks, with dosing expected to start by end of 2024. Topline data from both ACCESS studies are anticipated in Q4 2025. Structure is positioning GSBR-1290 as a potential best-in-class oral small molecule GLP-1RA and a backbone for future combinations with its own pipeline assets targeting amylin and GIPR.  

G. Other Oral Candidates

While Novo Nordisk, Eli Lilly, Roche, and Structure Therapeutics have some of the most prominent oral candidates in mid-to-late development, other companies are also active:

• Merck: Entered the oral GLP-1 space by acquiring rights to MK-6024 (efinopegdutide) from Hanmi and, more recently, licensing an oral GLP-1 candidate (HRS-9531, Phase 3) from China's Jiangsu Hengrui Pharmaceuticals.  
• Viking Therapeutics: Primarily known for its injectable dual GLP-1/GIP agonist VK-2735, the company is also developing an oral formulation which entered Phase 1 trials.  
• Shionogi: Has an oral candidate, S-309309, mentioned as having completed Phase 2.  

Table 1: Summary of Key Oral Obesity Drug Clinical Trial Results

Drug Name (Company)	Mechanism	Phase (Obesity Indication)	Population (Obesity Trials)	Duration	Efficacy: Mean % Weight Loss vs Placebo (Placebo-Adjusted)	Key Safety/Tolerability Notes	Development Status/Timeline
Oral Semaglutide 50mg (Novo)	GLP-1 RA (Peptide)	Phase 3a (OASIS 1)	Overweight/Obese (no T2D)	68 weeks	-15.1% (-12.7% adjusted)	GI AEs (80% vs 46%), mild-moderate, common during titration	Filed for US/EU approval in 2023; potential launch 2026+
Oral Semaglutide 25mg (Novo)	GLP-1 RA (Peptide)	Phase 3b (OASIS 4)	Overweight/Obese (with comorbidities)	64 weeks	Significant weight loss reported, comparable to Wegovy	Profile consistent with class	Trial completed; part of overall oral semaglutide program
Orforglipron (Lilly)	GLP-1 RA (Small Mol)	Phase 2	Overweight/Obese (no T2D)	36 weeks	Up to -14.7% (-12.4% adjusted)	GI AEs most common, mild-moderate. Discontinuation rate not specified.	Phase 3 (ATTAIN) ongoing; submission planned end 2025; potential launch 2026+
Danuglipron (Pfizer)	GLP-1 RA (Small Mol)	Phase 2 (BID) / Phase 1/2 (QD)	Overweight/Obese (no T2D)	26-32w (BID)	BID: -5% to -13% adjusted. QD: PK met, efficacy inferred	BID: High GI AEs (>73% Nausea), >50% discontinuation. QD: Potential DILI signal	Development Discontinued (April 2025)
Oral Amycretin (Novo)	GLP-1/Amylin	Phase 1	Overweight/Obese (BMI 27-39.9)	12 weeks	-13.1% (placebo-adjusted not stated)	SubQ version: GI AEs common, mild-moderate. Oral data limited.	Phase 1 completed. Further development plans for oral version not specified
CT-996 (Roche)	GLP-1 RA (Biased SM)	Phase 1	Overweight/Obese (no T2D)	4 weeks	-6.1% adjusted	Well-tolerated, mild/mod GI AEs, 0% discontinuation. No food effect.	Phase 1 completed; Phase 2 planned.
GSBR-1290 (Structure)	GLP-1 RA (Biased SM)	Phase 2a	Healthy Overweight/Obese (BMI 27-40)	12 weeks	-6.2% to -6.9% adjusted (tablet)	Favorable profile, mild/mod GI AEs, low discontinuation (0-11%). No liver signals.	Phase 2b (ACCESS I & II) ongoing; Topline data Q4 2025.
HRS-9531 (Jiangsu Hengrui/Merck)	GLP-1/GIP (Oral)	Phase 3	T2D/Obesity? (Not specified in snippets)	Not specified	Not specified	Not specified	Phase 3 ongoing. Merck licensed rights.

 

Note: SM = Small Molecule; BID = Twice Daily; QD = Once Daily. Efficacy data are mean % weight loss from baseline unless stated as placebo-adjusted. Discontinuation rates are due to AEs related to study drug where specified. Cross-trial comparisons should be made with caution due to differences in study design, population, duration, and analysis methods.

IV. Competitive Landscape: Leading Companies and Pipelines

The race to develop and commercialize effective oral obesity therapies involves established leaders in the incretin space, large pharmaceutical companies entering through acquisitions or internal development, and smaller biotechnology firms focused on novel small molecules.

• Dominant Players (Injectables & Orals):

  • Novo Nordisk: As the pioneer of injectable semaglutide (Wegovy for obesity, Ozempic for T2D), Novo Nordisk holds a commanding position. Their strategy clearly involves extending this dominance into the oral space. Rybelsus, their oral semaglutide for T2D, provided the technological platform (SNAC). The successful Phase 3 OASIS trials for higher-dose (25mg, 50mg) oral semaglutide specifically for obesity demonstrate their commitment. Beyond GLP-1 monotherapy, Novo is advancing oral amycretin, a dual GLP-1/amylin agonist, which showed highly promising Phase 1 weight loss results. Their deep pipeline also includes the injectable dual agonist CagriSema (semaglutide + cagrilintide), aiming for potentially higher efficacy than Wegovy. Novo's established commercial infrastructure, regulatory experience, and multi-pronged pipeline across mechanisms and modalities solidify their leadership role, aiming to capture patients preferring either injectable or oral routes.  
  • Eli Lilly: Lilly emerged as Novo's primary competitor with the highly effective dual GLP-1/GIP agonist injectable tirzepatide (Zepbound for obesity, Mounjaro for T2D). Lilly is aggressively pursuing the oral market, leading the non-peptide small molecule race with orforglipron, currently in extensive Phase 3 trials (ATTAIN and ACHIEVE) for both obesity and T2D. The potential manufacturing and cost advantages of this small molecule are a key strategic element. Lilly's pipeline is also broad, featuring the next-generation injectable triple agonist retatrutide (GLP-1/GIP/Glucagon) and other mechanisms like bimagrumab. Lilly's strategy mirrors Novo's in aiming for leadership across different drug types and patient needs.  

• Major Pharma Pursuing Orals:

  • Pfizer: Pfizer aimed to be a major player with its oral small molecule GLP-1 RA, danuglipron. However, the program's discontinuation in April 2025 due to tolerability issues with the BID formulation and a liver safety signal with the QD formulation represents a significant setback. This highlights the inherent risks in developing oral GLP-1s. Pfizer's focus now shifts to earlier-stage assets, including an oral GIPR antagonist (PF-07976016, Phase 2) and potentially an oral version of Viking's VK-2735 (GLP-1/GIP, Phase 1). Their experience underscores the difficulty in translating the success of injectables to the oral route safely and effectively.  
  • Roche: Roche strategically entered the obesity field through the $2.7 billion acquisition of Carmot Therapeutics in late 2023. This provided a portfolio including the oral, biased small molecule GLP-1 RA CT-996, which showed promising Phase 1 results (rapid weight loss, good tolerability) and is advancing to Phase 2. Roche also gained injectable dual GLP-1/GIP agonists (CT-388, CT-868). Further diversifying, Roche recently licensed Zealand Pharma's long-acting amylin analog, petrelintide, for $1.65 billion, with plans to explore combinations, likely with its GLP-1/GIP assets. Roche's strategy appears focused on combining different mechanisms to potentially achieve superior outcomes or target specific patient populations, leveraging both oral and injectable modalities.  
  • Amgen: While a major player in biologics, Amgen's most prominent obesity candidate is MariTide (maridebart cafraglutide), an injectable GLP-1 agonist and GIPR antagonist. Its key differentiation is less frequent dosing (monthly or potentially longer). Phase 2 data showed significant weight loss (~17-20% at 52 weeks) without plateauing, leading to the initiation of a Phase 3 program (MARITIME). While MariTide itself is not oral, its development reflects the broader trend of seeking convenient dosing regimens. Amgen's presence in the oral obesity space seems less defined based on the provided information.  
  • Boehringer Ingelheim (with Zealand Pharma): Their collaboration focuses on survodutide, an injectable dual GLP-1/glucagon receptor agonist, currently in Phase 3 for obesity. An oral candidate from this partnership is not highlighted in the snippets.  

• Emerging Players (Oral Focus):

  • Structure Therapeutics: This clinical-stage company is specifically focused on developing novel oral small molecule therapeutics for metabolic diseases. Their lead asset, GSBR-1290 (oral biased GLP-1 RA), demonstrated competitive efficacy and favorable tolerability in Phase 2a trials and is now progressing into larger Phase 2b studies (ACCESS I & II) with data expected in Q4 2025. Their strategy emphasizes the potential advantages of small molecules (scalability, cost) and includes building a pipeline for combinations, with oral amylin and GIPR programs in discovery. Structure represents a focused challenger leveraging structure-based drug design for oral incretins.  
  • Viking Therapeutics: Known primarily for its injectable GLP-1/GIP agonist VK-2735, Viking is also developing an oral formulation of the same candidate, currently in Phase 1 clinical trials. Success with the oral version would position them to compete across both administration routes.  
  • Jiangsu Hengrui (China): This Chinese company has an oral dual GLP-1/GIP agonist, HRS-9531, already in Phase 3 development. Merck has licensed rights to this compound, indicating interest from major pharma in late-stage oral assets developed elsewhere. This highlights the globalization of the obesity drug pipeline.  

The competitive landscape shows a clear pattern: the incumbent leaders (Novo, Lilly) are leveraging their existing platforms while aggressively developing oral alternatives. Other large pharma players (Roche, Pfizer post-setback, Merck via licensing) are entering or re-strategizing, often targeting differentiated mechanisms or combinations. Smaller, specialized companies like Structure Therapeutics are betting heavily on the advantages of oral small molecules. This intense competition across multiple modalities and mechanisms suggests a dynamic market evolution in the coming years.

Table 2: Leading Companies & Oral Obesity Pipeline Status

Company	Lead Oral Candidate(s)	Mechanism(s)	Highest Phase (Obesity)	Estimated Key Data/Filing Timeline
Novo Nordisk	Oral Semaglutide (25mg, 50mg)	GLP-1 RA (Peptide)	Phase 3 (Completed)	Filed 2023; Potential Launch 2026+
	Oral Amycretin	GLP-1 / Amylin	Phase 1	Phase 1 data reported; Further plans TBD
Eli Lilly	Orforglipron	GLP-1 RA (Small Mol)	Phase 3	Phase 3 ongoing; Submission end 2025; Launch 2026+
Pfizer	Danuglipron	GLP-1 RA (Small Mol)	Phase 1/2	Development Discontinued (Apr 2025)
	PF-07976016	GIPR Antagonist	Phase 2	Phase 2 ongoing; Initial completion Dec 2025
	VK-2735 (Oral)	GLP-1 / GIP	Phase 1	Phase 1 ongoing
Roche (Carmot)	CT-996	GLP-1 RA (Biased SM)	Phase 1	Phase 1 data reported; Phase 2 planned
Structure Therapeutics	GSBR-1290	GLP-1 RA (Biased SM)	Phase 2b	Phase 2b ongoing; Topline data Q4 2025
Viking Therapeutics	VK-2735 (Oral)	GLP-1 / GIP	Phase 1	Phase 1 ongoing
Jiangsu Hengrui / Merck	HRS-9531	GLP-1 / GIP	Phase 3	Phase 3 ongoing

 

Note: Phase indicates highest stage reached specifically for obesity/weight management indication based on snippets. Timelines are estimates based on company statements or analyst reports.

V. Market Opportunity Assessment

The market for anti-obesity medications (AOMs) is poised for explosive growth, transforming it into one of the largest therapeutic categories in the pharmaceutical industry. Understanding the overall market size and the specific dynamics between oral and injectable formulations is crucial for assessing the opportunity.

• Overall Obesity Drug Market Size: Driven by the high global prevalence of obesity (over 200 million in 7MM alone, growing at 0.7% annually ) and the proven efficacy of new incretin-based therapies, market forecasts project staggering growth. Estimates consistently point towards a market exceeding $100 billion in annual sales within the next decade. Specific projections include:  

  • $104.9 billion by 2035 (Global, CAGR 21.1%)  
  • $173.5 billion by 2031 (7MM*, CAGR 32.3%)  
  • $126 billion by 2030 (GLP-1Rs specifically)  
  • The overall GLP-1 market (including diabetes) is projected to reach $157.5 billion by 2035 (CAGR 11.1%). North America, particularly the US, is expected to remain the dominant market, likely accounting for around 60% of global sales by 2035.  

• Oral vs. Injectable Market Dynamics:

  • Current State: The market is overwhelmingly dominated by injectable therapies. Parenteral formulations captured approximately 82% to 93% of the revenue share in 2024. This reflects the established efficacy, bioavailability, and market presence of weekly injectables like Wegovy and Zepbound.  
  • Patient Preference & Convenience: A significant driver for oral drug development is patient preference. Many patients prefer pills over injections due to factors like needle phobia, ease of use, discretion, and the perceived lower burden for chronic therapy. Oral administration eliminates the need for injection devices and potentially simplifies storage and travel. Some newer oral candidates like CT-996 may also offer dosing flexibility independent of meals, unlike oral semaglutide which requires specific administration conditions (fasting, limited water).  
  • Efficacy: The primary challenge for oral therapies has been achieving efficacy comparable to injectables. High-dose oral semaglutide (50mg) has demonstrated weight loss (~15%) similar to its injectable counterpart in Phase 3. Early data for other orals like orforglipron (~15% at 36 weeks Phase 2) , oral amycretin (~13% at 12 weeks Phase 1) , CT-996 (~6% at 4 weeks Phase 1) , and GSBR-1290 (~6-7% at 12 weeks Phase 2a) are promising but require confirmation in longer, larger trials. Some analysts remain skeptical that orals will consistently match the peak efficacy of the best injectables, particularly dual/triple agonists. Differentiation might emerge in the quality of weight loss (e.g., preserving lean muscle mass).  
  • Safety & Tolerability: This remains a critical hurdle. Achieving high efficacy with oral GLP-1 RAs often involves high doses, which can exacerbate GI side effects (nausea, vomiting, diarrhea). While these are also seen with injectables, the daily dosing and potentially different absorption profiles of orals might make them harder to manage for some patients. The >50% discontinuation rate for Pfizer's twice-daily danuglipron starkly highlighted this issue. Conversely, the low discontinuation rates reported for CT-996 (0%) and GSBR-1290 (0-11%) in early trials offer hope that newer mechanisms (biased agonism) or formulations might improve tolerability. The liver safety signals seen with Pfizer's candidates necessitate careful monitoring for all oral agents.  
  • Manufacturing & Cost: Injectable peptides are biologically complex, requiring specialized manufacturing processes that are difficult and expensive to scale, contributing to supply shortages and high prices. Oral small molecules (like orforglipron, CT-996, GSBR-1290) generally offer simpler chemistry, easier scalability, and potentially significantly lower cost of goods sold (COGS). Oral peptides like semaglutide still face peptide manufacturing challenges but avoid the cost and complexity of autoinjector devices. This cost differential could be a major factor in pricing and market access.  
  • Payer Perspective & Pricing: The high price of current GLP-1 injectables (list prices >$1,000/monthintheUS[74,75])createssignificantaffordabilityandaccessbarriers.[67,74,76]Payers,includingcommercialinsurersandgovernmentprograms,aregrapplingwiththepotentialbudgetimpactofcoveringthesedrugsforalargeeligiblepopulation.[74,77]Coverageisoftenrestricted,requiringpriorauthorizationsorsteptherapy.[76]Medicarecurrentlydoesnotcoverdrugssolelyforobesity,althoughcoverageispossibleifapprovedforrelatedconditionslikeCVD.[18,77]Oraldrugs\ast could\ast potentiallybepricedlowerduetomanufacturingefficiencies,whichmightimprovepayeracceptanceandbroadenaccess.[18]However,cost-effectivenessanalysescomparingoralstoinjectablesandlifestyleinterventionswillbecriticalforreimbursementdecisions.[78,79]Theemergenceofdirect-to-consumerplatformsandcash-payoptionsoffersanalternativeaccessroutebutraisesequityconcerns.[71,74]\ast \ast \ast MarketSharePotentialforOrals:\ast \ast Whiletheconvenienceofpillsisastrongdraw,currentmarketforecastssuggestinjectableswillmaintaintheirdominance.Projectionsindicatetheparenteralroutewillstillaccountforapproximately\ast \ast 85Thepursuitoforalobesitydrugsisdrivenbythecleardesireforgreaterpatientconvenienceandthepotentialforbroadermarketaccesscomparedtoinjectables.However,theclinicalrealitypresentsacomplextrade-off.Achievinginjectable-levelefficacyoftennecessitateshighoraldoses,which,asseenwithoralsemaglutid{e}^{\prime }shighGIAErates[23]anddanuglipro{n}^{\prime }sfailure[36],cansignificantlycompromisetolerability.Thisfundamentalchallengemaylimittheoveralldisplacementofinjectablesunlessneweroralagentswithimprovedmechanisms,likebiasedagonism(CT-996,GSBR-1290)[49,58]ordualagonism(oralamycretin)[40],cansuccessfullydecouplehighefficacyfromseveresideeffects.Furthermore,thepotentialmanufacturingandcostadvantagesoforalsmallmoleculesrepresentapowerfullever.[17,18]Currentinjectabletherapiesfacesignificantcostandreimbursementhurdles.[74,76]Iforalsmallmoleculescanbeproducedandpricedsubstantiallylowerwhileofferingcompetitiveclinicalbenefits,theycouldunlockamuchlargerpatientvolumebyimprovingaffordabilityandpayeracceptance.Thispricingflexibilitycouldprovemoredecisiveincapturingmarketsharethanincrementaldifferencesinconvenienceorevenpeakefficacyforsomepatientsegments.Despitethesepotentialadvantages,themarketforecastpredictingcontinueddominanceofinjectables(85\ast \ast Table3:Comparison:Oralvs.InjectableObesityDrugs(GLP-1Based)\ast \ast |Feature|OralDrugs(GLP-1based)|InjectableDrugs(GLP-1based)||:----------------------------|:----------------------------------------------------------------------------------------------------------------------|:-------------------------------------------------------------------------------------------------------------------------||\ast \ast Efficacy(|\ast \ast DosingFrequency\ast \ast |TypicallyOnce-Daily[23,27,52,54]|TypicallyOnce-Weekly(Wegovy,Zepbound)[10];Monthlyemerging(MariTide)[65]||\ast \ast Convenience/PatientPref.\ast \ast |Generallypreferred(noneedles)[5,17];Somerequirespecificdosingconditions(e.g.,fastingforRybelsus).[6]|Lessfrequentdosingisconvenient;Needleaversionisabarrierforsome.[5,11]||\ast \ast Tolerability(CommonAEs)\ast \ast |GIsideeffects(nausea,vomiting,diarrhea)common,potentiallydose-limiting;Liversignalsaconcernforsome.[23,39]|GIsideeffectscommon,oftentransient,managedbytitration.[23]||\ast \ast Manufacturing/Cost\ast \ast |Peptides(Semaglutide):Complex,costly.[17]SmallMolecules(Orforglipron,CT-996,GSBR-1290):Potentiallysimpler,cheaperCOGS.[17,18]|Peptides:Complex,highcapitalcost,supplyconstraintsexperienced.[17,71]||\ast \ast PayerAccess/Pricing\ast \ast |Potentialforlowerpricing(esp.smallmols)mayimproveaccess[18];Stillfacesreimbursementhurdles.[74]|Highlistprices($>1000/mo) limit access; Significant payer resistance and restrictions. | | Market Share | Minority share currently; Projected ~15% by 2035. | Dominant share currently; Projected ~85% by 2035. |  

VI. Business Potential and Profitability Outlook

Assessing the business potential for companies developing oral obesity drugs requires synthesizing the vast market opportunity with clinical trial prospects, competitive positioning, and economic factors like manufacturing costs and pricing power.

• Peak Sales Forecasts: The sheer scale of the obesity market translates into blockbuster peak sales potential for successful therapies. Analyst consensus and market reports project:

  • The overall GLP-1 market (T2D + Obesity) could reach $157.5 billion by 2035.  
  • The dedicated obesity market is forecast to hit $105 billion to $174 billion between 2031 and 2035.  
  • Individual oral drug forecasts highlight significant potential:
    • Orforglipron (Lilly): Consensus estimates project sales climbing rapidly post-launch (expected 2026), potentially reaching $19 billion by 2035. GlobalData forecasts $11.8 billion as early as 2030. These figures place it in the upper echelon of drug sales potential, rivaling many established injectable blockbusters, contingent on Phase 3 success.  
    • Oral Semaglutide (Novo): While the approved Rybelsus (T2D) has peak sales projected around $6.2 billion , the potential for the higher 25mg/50mg obesity doses is less clearly defined in forecasts but is expected to contribute significantly to Novo's overall semaglutide franchise revenue, which includes the multi-billion dollar injectable Ozempic/Wegovy.  
  • For context, leading injectables like Wegovy and Zepbound have peak sales forecasts in the $20-30 billion range each. Next-generation injectables like CagriSema also carry peak estimates exceeding $20 billion.  

• Profitability Assessment (Qualitative):

  • High Potential Revenue: The enormous market size ($100B+) undeniably offers the potential for substantial revenue generation for any company successfully bringing an effective and safe oral obesity drug to market.  
  • Clinical Risk Dependency: This potential is entirely dependent on navigating the significant risks of late-stage clinical development. Demonstrating not just efficacy comparable to injectables, but also a manageable and safe long-term tolerability profile is paramount. As Pfizer's experience with danuglipron showed, clinical setbacks (tolerability, safety signals) can derail even promising candidates, erasing potential value.  
  • Manufacturing Costs and Margins: The underlying nature of the drug molecule significantly impacts profitability. Oral small molecules, pursued by Lilly (orforglipron), Roche (CT-996), and Structure (GSBR-1290), offer a potential advantage through lower manufacturing costs (COGS) compared to the complex biological manufacturing required for peptides, whether oral (Novo's semaglutide) or injectable (Novo's semaglutide, Lilly's tirzepatide). This lower COGS could translate into higher gross margins or allow for more competitive pricing strategies while maintaining profitability. If oral small molecules achieve clinical success, this manufacturing cost advantage could become a critical factor in long-term profitability, especially as price competition intensifies.  
  • Market Access and Net Pricing: Achieving broad market access and favorable reimbursement is a major determinant of realized revenue and profitability. Payers are already pushing back on the high prices of injectable GLP-1s due to the large patient population and budget impact. While oral drugs might be priced lower than injectables, they will still face intense scrutiny regarding cost-effectiveness. Companies will likely need to offer substantial rebates and discounts to secure preferred formulary placement, meaning net prices could be significantly lower than list prices, impacting overall profitability. The ability to negotiate effectively with payers will be crucial.  
  • Competitive Dynamics: The obesity market is rapidly becoming crowded, with Novo Nordisk and Eli Lilly leading, but numerous other players developing candidates with diverse mechanisms and administration routes. This intense competition will inevitably lead to price erosion over time. Profitability will depend on establishing clear points of differentiation – whether through superior efficacy, better tolerability, improved convenience (e.g., dosing frequency, food independence), or addressing specific comorbidities – that can justify premium pricing or capture specific patient segments.  
  • Overall Outlook: The profitability outlook for companies succeeding with oral obesity drugs is potentially very high but carries significant uncertainty. Success requires clearing high clinical hurdles (efficacy, safety, tolerability). Companies with differentiated oral small molecules (Lilly, potentially Roche, Structure) may hold a long-term profitability advantage due to lower COGS, provided their clinical profiles are competitive. However, intense competition and payer pressure will constrain pricing power for all players. Significant investment in R&D and commercialization is required, and failure carries substantial financial risk.

The forecasts projecting peak sales in the range of $10-20 billion for a leading oral candidate like orforglipron are striking. Achieving such figures would place it among the best-selling drugs globally. However, this potential must be viewed alongside the market share forecasts suggesting orals might only capture ~15% of the total obesity market value by 2035. This implies that while one or two oral agents could achieve massive individual success, the overall market structure is expected to remain dominated by injectables. It suggests the $100B+ market will likely support multiple blockbuster therapies, both oral and injectable, rather than a single oral drug displacing the established injectable leaders entirely. The profitability for any single oral agent will depend not just on its own merits but on the number of successful competitors (both oral and injectable) it faces and the resulting price dynamics.  

VII. Conclusion: The Future of Oral Obesity Therapies

The development of oral therapies marks a pivotal evolution in the pharmacological management of obesity, driven by the desire for enhanced patient convenience and broader accessibility. Clinical advancements, particularly with high-dose oral semaglutide and the non-peptide orforglipron, demonstrate that oral formulations can achieve substantial weight loss, potentially rivaling the efficacy of market-leading injectables. Novel approaches, including dual GLP-1/amylin agonism (oral amycretin) and biased GLP-1 agonism (CT-996, GSBR-1290), offer promise for further efficacy gains or improved tolerability profiles.

However, the path to market for oral agents is fraught with challenges. Tolerability, primarily gastrointestinal side effects, remains a significant hurdle, potentially limiting adherence and real-world effectiveness compared to less frequently administered injectables. The discontinuation of Pfizer's danuglipron due to both tolerability and liver safety concerns underscores the substantial clinical development risks and the high bar set by regulators.

Eli Lilly and Novo Nordisk, the current leaders in the injectable space, are strategically positioned with late-stage oral candidates (orforglipron and oral semaglutide/amycretin, respectively), aiming to capture patient preference for pills and potentially ease manufacturing pressures. Challengers like Roche (leveraging the Carmot acquisition) and Structure Therapeutics are focusing on differentiated small molecules, betting on potential advantages in tolerability or manufacturing cost.

While offering undeniable convenience, oral drugs are unlikely to completely supplant injectables in the near future. Forecasts suggest injectables will retain the dominant market share, likely due to their established efficacy track record and the emergence of even more potent or less frequently dosed injectable options. Nonetheless, successful oral therapies are poised to capture a significant market segment, estimated around 15-20% or potentially $15-30 billion+ annually within the next decade. Their success will depend critically on achieving a compelling balance of efficacy, safety, tolerability, and crucially, navigating the complex payer landscape through competitive pricing, potentially enabled by the lower manufacturing costs of small molecules. The future likely involves a segmented market where both oral and injectable therapies coexist, offering tailored options based on individual patient needs, preferences, and access considerations. Continued innovation in mechanisms, formulations, and combination therapies will further shape this dynamic and promising field.

VIII. Disclaimer

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