FDA Events for MetaVia (MTVA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MetaVia (MTVA).
Over the past two years, MetaVia has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DA-1726. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DA-1726 - FDA Regulatory Timeline and Events
DA-1726 is a drug developed by MetaVia for the following indication: For The Treatment Of Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DA-1726
- Announced Date:
- July 9, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025
AI Summary
MetaVia Inc. recently announced an important update regarding its ongoing clinical trial for DA-1726, a novel dual oxyntomodulin analog for treating obesity. The company revealed that top-line data from its Phase 1 trial is expected in the fourth quarter of 2025. In this study, a new dosing cohort of 48 mg has begun, following promising results from an earlier 32 mg dose. This advancement is part of a multiple ascending dose trial aimed at identifying the maximum tolerated dose while assessing safety, tolerability, and key metabolic benefits. Early findings from the 32 mg cohort showed meaningful weight loss, improved glucose levels, and positive trends in waist circumferences, supporting the drug’s potential as a strong alternative to current obesity treatments. MetaVia looks forward to further substantiating DA-1726’s capabilities with the upcoming data release later this year.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- July 9, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced dosing of the first patient in the 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
AI Summary
MetaVia Inc. has started the dosing of the first patient in the 48 mg multiple ascending dose cohort for its Phase 1 clinical trial of DA-1726, a new obesity treatment. DA-1726 is a dual oxyntomodulin analog that works by activating both the GLP-1 and glucagon receptors to help reduce appetite and increase energy expenditure. This new dosing cohort aims to define the maximum tolerated dose while further exploring the drug’s potential. Previous results from lower doses showed promising outcomes, including dose-dependent weight loss, improvements in fasting glucose levels, and mild, transient side effects. The trial, which focuses on safety and tolerability, will continue to monitor these effects along with overall metabolic improvements. Top-line data from the 48 mg cohort are expected to be released in the fourth quarter of 2025.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- April 22, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. reported additional top-line results from the multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), further demonstrating its potential as a best-in-class obesity drug.
AI Summary
MetaVia Inc. has announced additional top-line results from Part 2 of its Phase 1 multiple ascending dose (MAD) trial of DA-1726, a novel dual oxyntomodulin (OXM) analog agonist. DA-1726 works by activating both glucagon-like peptide-1 (GLP1R) and glucagon receptors (GCGR) and is being developed as a best-in-class obesity treatment. In the 28-day study with doses ranging from 8 mg to 32 mg, a clear dose-dependent response was observed. Subjects treated with higher doses experienced greater reductions in body weight and body mass index (BMI) compared to the placebo group, indicating the drug’s potential for enhanced efficacy with higher and longer dosing. Importantly, the trial showed no significant drug-induced cardiovascular effects, supporting the safety profile of DA-1726 and its promise for future obesity treatments.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- April 15, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced positive results from the 4-week multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
AI Summary
MetaVia Inc. announced positive results from the 4-week multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial for DA-1726. DA-1726 is a new dual oxyntomodulin analog that activates both GLP-1 and glucagon receptors, targeting obesity through reduced appetite and increased energy expenditure. In the trial, subjects receiving a 32 mg dose without titration experienced a maximum weight loss of 6.3% and an average loss of 4.3% by Day 26. The study also noted a notable drop in fasting glucose levels and a reduction in waist circumference, accompanied by early satiety in most patients.
The results demonstrated excellent safety and tolerability with only mild gastrointestinal effects that resolved quickly, and no significant adverse events led to treatment discontinuation. MetaVia plans further studies to explore higher doses and compare safety and effectiveness, underscoring DA-1726’s potential as a promising new obesity treatment.
Read Announcement
MetaVia FDA Events - Frequently Asked Questions
As of now, MetaVia (MTVA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MetaVia (MTVA) has reported FDA regulatory activity for DA-1726.
The most recent FDA-related event for MetaVia occurred on July 9, 2025, involving DA-1726. The update was categorized as "Top-line data," with the company reporting: "MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025"
Currently, MetaVia has one therapy (DA-1726) targeting the following condition: For The Treatment Of Obesity.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MTVA) was last updated on 7/13/2025 by MarketBeat.com Staff
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