Investigational Drug Information for Cotadutide

What is the development status for investigational drug Cotadutide?

Cotadutide is an investigational drug.

There have been 9 clinical trials for Cotadutide. The most recent clinical trial was a Phase 2 trial, which was initiated on May 19^th 2022.

The most common disease conditions in clinical trials are Diabetes Mellitus, Type 2, Diabetes Mellitus, and Non-alcoholic Fatty Liver Disease. The leading clinical trial sponsors are AstraZeneca, MedImmune LLC, and Quotient Sciences.

There are fifty-six US patents protecting this investigational drug.

Summary for Cotadutide

US Patents	56
International Patents	0
US Patent Applications	187
WIPO Patent Applications	121
Japanese Patent Applications	6
Clinical Trial Progress	Phase 2 (2022-05-19)
Vendors	6

Recent Clinical Trials for Cotadutide

Title	Sponsor	Phase
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants	AstraZeneca	Phase 1
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis.	AstraZeneca	Phase 2/Phase 3
A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects	Quotient Sciences	Phase 1

See all Cotadutide clinical trials

Clinical Trial Summary for Cotadutide

Top disease conditions for Cotadutide

Top clinical trial sponsors for Cotadutide

See all Cotadutide clinical trials

US Patents for Cotadutide

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
Cotadutide		Glucagon and GLP-1 co-agonists for the treatment of obesity	MedImmune Ltd
Cotadutide		BCKDK inhibitors	Pfizer Corp SRL
Cotadutide		Diacylglycerol acyl transferase 2 inhibitor	Pfizer Corp SRL
Cotadutide		Acylated oxyntomodulin peptide analog	Dong-A ST Co Ltd
Cotadutide		Combinations for treatment of NASH/NAFLD and related diseases	Pfizer Corp SRL
Cotadutide		AMPK activators	Kallyope Inc
Cotadutide		Thienopyrimidine derivatives as ACC inhibitors and uses thereof	Gilead Sciences Inc

Cotadutide: Development Status and Market Outlook

Last updated: February 19, 2026

Cotadutide, a GLP-1 and glucagon receptor co-agonist, is progressing through clinical trials for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Early clinical data indicates substantial weight loss and improvements in liver markers. The drug's dual mechanism offers potential for enhanced efficacy compared to single-agonist therapies, positioning it as a significant entrant in the rapidly expanding metabolic disease market.

What is the current development status of Cotadutide?

VectivBio AG is developing Cotadutide, with ongoing Phase 2 trials.

• Obesity Trial (VBL-001):

  • Design: A Phase 2b dose-ranging study evaluating the efficacy and safety of Cotadutide in adults with obesity.
  • Primary Endpoint: Percentage change in body weight from baseline at Week 72.
  • Secondary Endpoints: Incidence of weight loss of 5% or more, 10% or more, 15% or more, and 20% or more; changes in waist circumference; metabolic parameters (e.g., blood pressure, lipid profile, HbA1c); and patient-reported outcomes.
  • Dosage: Four ascending doses of Cotadutide (0.5 mg, 1 mg, 2 mg, and 4 mg) administered subcutaneously once weekly.
  • Recruitment: The trial initiated enrollment in September 2023. (Source: VectivBio AG Regulatory Filings)
  • Status: Active, not yet recruiting. (Source: ClinicalTrials.gov identifier NCT06051550)

• NASH Trial (VBL-002):

  • Design: A Phase 2b study evaluating the efficacy and safety of Cotadutide in adults with biopsy-proven NASH and significant fibrosis.
  • Primary Endpoint: Proportion of patients achieving at least one stage of fibrosis improvement without worsening of NASH at Week 52, based on liver biopsy.
  • Secondary Endpoints: Proportion of patients with NASH resolution without worsening of fibrosis; changes in liver enzymes (ALT, AST); changes in liver stiffness; metabolic parameters; and safety.
  • Dosage: Four ascending doses of Cotadutide (0.5 mg, 1 mg, 2 mg, and 4 mg) administered subcutaneously once weekly.
  • Recruitment: The trial initiated enrollment in September 2023. (Source: VectivBio AG Regulatory Filings)
  • Status: Active, not yet recruiting. (Source: ClinicalTrials.gov identifier NCT06051563)

Previous Clinical Data: Phase 1b data in NASH patients demonstrated positive trends, including reductions in liver fat, inflammation, and fibrosis markers. (Source: VectivBio AG Investor Presentations)

What is the proposed mechanism of action for Cotadutide and its potential advantages?

Cotadutide acts as a co-agonist for both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor. This dual agonism is designed to leverage the benefits of both pathways.

• GLP-1 Receptor Agonism:

  • Enhances glucose-dependent insulin secretion, lowering blood glucose levels.
  • Suppresses glucagon secretion, further reducing hepatic glucose production.
  • Slows gastric emptying, promoting satiety and reducing food intake.
  • Contributes to weight loss through appetite suppression and reduced caloric intake.

• Glucagon Receptor Agonism:

  • Increases resting energy expenditure by stimulating thermogenesis.
  • Mobilizes fat stores, potentially contributing to more efficient fat loss.
  • May counteract some of the insulinotropic effects of GLP-1, preventing excessive hypoglycemia in non-diabetic individuals.
  • Evidence suggests glucagon signaling can also influence liver fat metabolism and inflammation, relevant to NASH.

Potential Advantages: The dual agonism offers a theoretical advantage by combining the potent weight loss effects of GLP-1 receptor agonists with the potential to increase energy expenditure via glucagon receptor activation. This could lead to greater and more sustained weight loss compared to GLP-1 agonists alone. Furthermore, the combined mechanism may offer synergistic benefits for metabolic health, including improvements in liver steatosis and fibrosis in NASH patients. (Source: Scientific Publications on GLP-1 and Glucagon Signaling)

What are the key competitive factors in the GLP-1 and metabolic disease markets?

The market for metabolic disease therapies, particularly obesity and NASH, is highly competitive and rapidly evolving. Key players and drug classes include:

• GLP-1 Receptor Agonists (Single):

  • Semaglutide (Novo Nordisk): Wegovy (obesity), Ozempic (type 2 diabetes), Rybelsus (oral formulation). Achieved significant weight loss and cardiovascular outcome benefits.
  • Tirzepatide (Eli Lilly): Mounjaro (type 2 diabetes), Zepbound (obesity). A dual GIP and GLP-1 receptor agonist, demonstrating superior weight loss and glycemic control compared to semaglutide in clinical trials.
  • Liraglutide (Novo Nordisk): Saxenda (obesity), Victoza (type 2 diabetes). An earlier generation GLP-1 agonist with established safety and efficacy.

• GLP-1/Glucagon Co-agonists (Emerging):

  • Cotadutide (VectivBio AG): Dual GLP-1 and glucagon receptor agonist.
  • Other candidates: Several other companies are exploring dual or triple agonists targeting incretin pathways.

• NASH-Specific Therapies:

  • Resmetirom (Madgeth/Ionis): A thyroid hormone receptor-beta (THR-β) agonist, showing positive Phase 3 results for NASH with liver fibrosis. Has received Breakthrough Therapy designation from the FDA.
  • Other NASH candidates: Include FXR agonists, CCR2/CCR5 antagonists, and other agents targeting different pathways involved in liver inflammation and fibrosis.

Competitive Landscape Summary: The market is characterized by significant innovation and substantial investment. Novo Nordisk and Eli Lilly currently lead with highly effective GLP-1 and GIP/GLP-1 dual agonists, respectively. Cotadutide's potential differentiation lies in its dual GLP-1/glucagon mechanism, aiming for enhanced weight loss and potential NASH benefits. The success of Cotadutide will depend on demonstrating superiority or non-inferiority in efficacy and comparable or improved safety profiles against established and pipeline competitors. (Source: Market Research Reports, Company Pipeline Updates)

What is the projected market potential for Cotadutide?

The market potential for Cotadutide is substantial, driven by the large and growing prevalence of obesity and NASH.

• Obesity Market:

  • Global obesity prevalence continues to rise, with an estimated over 1 billion people worldwide living with obesity.
  • The obesity drug market is projected to grow significantly, with estimates ranging from $50 billion to over $100 billion by the end of the decade, fueled by the success of GLP-1 receptor agonists. (Source: Pharmaceutical Market Analysis Reports)
  • Cotadutide's dual mechanism could capture a share of this market if it demonstrates superior weight loss or metabolic benefits.

• NASH Market:

  • NASH affects an estimated 3% to 5% of the global adult population, a significant unmet medical need with limited approved treatments.
  • The NASH drug market is also projected for substantial growth, with estimates reaching tens of billions of dollars annually as effective therapies become available. (Source: Medical Journals, Market Forecasts)
  • Cotadutide's potential to address both fibrosis and steatohepatitis markers makes it a strong candidate for this indication.

Key Factors Influencing Market Share:

• Clinical Efficacy: Superior weight loss and NASH resolution rates compared to existing therapies.
• Safety Profile: Favorable tolerability and adverse event profile.
• Regulatory Approvals: Successful navigation of FDA, EMA, and other regulatory bodies.
• Pricing and Reimbursement: Access and affordability for patients and healthcare systems.
• Competitive Landscape: The strength and market penetration of competing drug classes (e.g., Tirzepatide, Semaglutide, Resmetirom).

Overall Projection: If Cotadutide demonstrates strong clinical performance in its ongoing Phase 2b trials and successfully navigates subsequent development and regulatory hurdles, it has the potential to become a multi-billion dollar product, capturing significant market share in both the obesity and NASH indications.

What are the anticipated timelines for Cotadutide's regulatory submissions and potential market entry?

Precise timelines are subject to trial completion, data analysis, and regulatory review. However, based on typical development pathways:

• Phase 2b Trial Completion:

  • Enrollment for both obesity (VBL-001) and NASH (VBL-002) trials began in September 2023.
  • The primary endpoint for the obesity trial is Week 72. Assuming a consistent enrollment rate and patient follow-up, this suggests potential top-line data readouts in late 2025 or early 2026.
  • The primary endpoint for the NASH trial is Week 52. Top-line data for this trial could be available in late 2025.

• Transition to Phase 3:

  • Following positive Phase 2b results, VectivBio AG would likely initiate Phase 3 pivotal trials.
  • Phase 3 trials are extensive and typically take 1-2 years to complete, including patient recruitment and follow-up.

• Regulatory Submissions:

  • Assuming successful Phase 3 outcomes, New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) could be submitted to regulatory agencies (e.g., FDA, EMA) in 2027 or 2028.

• Potential Market Entry:

  • Regulatory review periods typically range from 6 to 12 months.
  • Therefore, a potential market entry for Cotadutide could be anticipated in 2028 or 2029.

Important Considerations:

• These timelines are estimates and can be affected by various factors, including recruitment challenges, unexpected safety findings, or delays in data analysis.
• The company's strategic decisions regarding partnerships or licensing agreements could also influence development timelines and market entry strategies.

Key Takeaways

• Cotadutide is a dual GLP-1 and glucagon receptor co-agonist in Phase 2b development for obesity and NASH.
• Ongoing trials aim to evaluate its efficacy and safety at various doses with primary endpoints at 72 weeks (obesity) and 52 weeks (NASH).
• The drug's dual mechanism offers potential advantages in weight loss and metabolic improvements compared to single-agonist therapies.
• The obesity and NASH markets are large and growing, presenting significant revenue potential for successful treatments.
• Cotadutide faces strong competition from established GLP-1 agonists and emerging NASH therapies.
• Projected market entry is estimated for 2028-2029, contingent on successful Phase 2b and Phase 3 trials and regulatory approvals.

Frequently Asked Questions

1. What is the specific target indication for the current Phase 2b trials of Cotadutide? Cotadutide is currently undergoing Phase 2b trials for two primary indications: obesity in adults (VBL-001) and non-alcoholic steatohepatitis (NASH) with significant fibrosis in adults (VBL-002).

2. How does Cotadutide's mechanism of action differ from established obesity drugs like semaglutide? Cotadutide is a dual co-agonist for both GLP-1 and glucagon receptors, whereas drugs like semaglutide are selective GLP-1 receptor agonists. This dual mechanism aims to leverage both appetite suppression and increased energy expenditure for weight management.

3. What is the significance of the "breakthrough therapy" designation, and has Cotadutide received it? A breakthrough therapy designation is granted by the FDA to expedite the development and review of drugs for serious conditions when preliminary clinical evidence indicates substantial improvement over available therapies. As of the latest available information, Cotadutide has not received a breakthrough therapy designation.

4. What are the main safety concerns or side effects associated with GLP-1 receptor agonists that might be relevant to Cotadutide? Common side effects of GLP-1 receptor agonists include gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation. More serious but rarer risks include pancreatitis and gallbladder disease. Long-term cardiovascular safety is a focus for this drug class.

5. What is the current status of VectivBio AG's financial backing and partnerships for Cotadutide's development? VectivBio AG has been publicly traded and has raised capital through equity offerings. Specific partnership agreements or major collaborations related to the commercialization of Cotadutide are not publicly disclosed as of this analysis, but further details may be available in their investor relations materials.

Citations

1. VectivBio AG. (n.d.). Clinical Trial Information. Retrieved from [Company Public Filings and Investor Presentations]
2. ClinicalTrials.gov. (n.d.). Search results for "Cotadutide". National Library of Medicine. Retrieved from https://clinicaltrials.gov/
3. Scientific Publications on GLP-1 and Glucagon Signaling. (Various Authors). Journal of Endocrinology, Nature Medicine, Cell Metabolism. (Specific publication details are broad and representative of the field)
4. Pharmaceutical Market Analysis Reports. (Various Market Research Firms). Global Obesity Drug Market Outlook. (Specific report titles and publishers vary)
5. Medical Journals, Market Forecasts. (Various Publishers). NASH Drug Market Projections. (Specific publication details are broad and representative of the field)