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-1241 and DA-1726. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
DA-1241 FDA Regulatory Timeline and Events
DA-1241 is a drug developed by MetaVia for the following indication: G-Protein-Coupled Receptor 119.
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-1241
- Announced Date:
- May 20, 2026
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc announced the publication of new preclinical research supporting the anti-fibrotic potential of vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in the peer-reviewed, international journal, Biomolecules & Therapeutics.
AI Summary
MetaVia Inc. announced new preclinical research on vanoglipel (DA-1241), a novel GPR119 agonist, published in the peer-reviewed journal Biomolecules & Therapeutics. The study supports the drug’s possible anti-fibrotic effects, meaning it may help reduce the buildup of scar tissue in the liver. Researchers also pointed to a differentiated mechanism of GPR119 activation, which may affect both metabolic problems and fibrotic progression.
According to the authors, these combined metabolic and anti-fibrotic actions could make GPR119 agonism a promising treatment approach for liver fibrosis and metabolic dysfunction-associated steatohepatitis, or MASH. MetaVia said the findings add to the scientific case for vanoglipel as a potential therapy in liver disease.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- November 7, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced the presentation of positive new data from its Phase 2a clinical trial evaluating vanoglipel (DA-1241), a potent and selective G protein-coupled receptor 119 (GPR119) agonist, as a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH).
AI Summary
MetaVia presented positive Phase 2a results for vanoglipel (DA-1241), an oral GPR119 agonist being studied as a treatment for metabolic dysfunction‑associated steatohepatitis (MASH). The randomized, placebo‑controlled trial enrolled 109 patients with presumed MASH and tested vanoglipel 50 mg, 100 mg, and 100 mg plus a DPP4 inhibitor once daily for 16 weeks. The drug showed a differentiated dual effect on liver and metabolic pathways, supporting its development as both a standalone and combination therapy.
Vanoglipel produced meaningful glucose and liver benefits: HbA1c fell starting at Week 4 and at Week 16 decreased by about 0.54% with monotherapy and 0.66% with combination therapy. Liver markers improved—ALT declined in those with elevated baseline ALT, steatosis and stiffness improved by CAP and VCTE, and noninvasive scores (FAST, NIS‑4) moved favorably. Biomarkers of cell death, inflammation, and fibrosis fell, and plasma lipidomics showed reductions in pathogenic glycerolipids and glycerophospholipids. The treatment was well tolerated with no treatment‑related discontinuations. Findings were presented at AASLD 2025.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- October 27, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced that an abstract highlighting data on Vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, has been accepted for a poster presentation at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting 2025, taking place November 7-11, 2025 in Washington, D.C.
AI Summary
MetaVia Inc. (NASDAQ: MTVA), a clinical-stage biotech company focused on cardiometabolic diseases, announced that an abstract on Vanoglipel (DA-1241) has been accepted for a poster presentation at the AASLD Liver Meeting 2025 in Washington, D.C., on November 10 from 1:00–2:00 pm ET in Hall DE (Poster 4012).
Titled “Vanoglipel (DA-1241), a GPR119 Agonist, Demonstrates Hepatoprotective Effects Through Improving Inflammation and Metabolism in the Liver,” the data come from a 16-week randomized, placebo-controlled trial in presumed MASH patients. The poster will be presented by Rohit Loomba, M.D., MHSc, Professor of Medicine and Chief of Gastroenterology and Hepatology at UC San Diego. A copy will be available afterward in the Posters section of MetaVia’s website.
Vanoglipel is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist that boosts release of gut peptides GLP-1, GIP, and PYY, which support glucose and lipid metabolism. Preclinical studies and Phase 1a/1b/2a trials have shown it reduces liver steatosis, inflammation, fibrosis, and improves glucose control with good tolerability.
For more information, visit www.metaviatx.com.
Read Announcement
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:
- April 10, 2026
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced that the first patient has been dosed in Part 3 of its Phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors.
AI Summary
MetaVia Inc. announced that the first patient has been dosed in Part 3 of its Phase 1 clinical trial of DA-1726, a new dual oxyntomodulin (OXM) analog that targets both GLP-1 and glucagon receptors. The company is testing the safety, tolerability, and activity of this molecule, which is designed to act on two key pathways involved in appetite and metabolism. Dosing the first patient in Part 3 marks a step forward in early human testing and helps gather more data on how the drug works in people.
The 16-week study will enroll obese but otherwise healthy adults and compares two titration strategies: a one-step dose titration to 48 mg and a two-step titration to 64 mg. For more details on the trial, see clinicaltrials.gov identifier NCT06252220 or visit metaviatx.com.Read Announcement
- Drug:
- DA-1726
- Announced Date:
- March 18, 2026
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced that the Institutional Review Board (IRB) at Clinical Pharmacology of Miami has approved the Company's Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors.
AI Summary
MetaVia Inc. announced that the Institutional Review Board (IRB) at Clinical Pharmacology of Miami has approved the company's Phase 1 Part 3 clinical trial of its lead asset, DA-1726. The study is a 16-week trial in obese, otherwise healthy adults that will test two dosing strategies: a one-step dose titration to 48 mg and a two-step dose titration to 64 mg. The approval clears the site to begin enrolling participants and running the planned dosing schedules under the study protocol.
DA-1726 is a novel, dual oxyntomodulin (OXM) analog designed to activate both GLP-1 (GLP1R) and glucagon (GCGR) receptors, aiming to combine effects on appetite and metabolism. This Phase 1 Part 3 study will primarily assess safety, tolerability, and how the body responds to these dose escalations as MetaVia moves DA-1726 through early clinical development.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- February 13, 2026
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced a strong global intellectual property portfolio supporting lead asset 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 and related metabolic disorders.
AI Summary
MetaVia Inc. announced a strong global intellectual property portfolio backing its lead drug candidate, DA-1726. The portfolio includes 39 granted and pending patents in the United States and other countries, giving the company protection for DA-1726 into 2041 unless patent terms are extended. This patent coverage is intended to secure the company’s technology and support further development and commercialization efforts worldwide.
DA-1726 is a novel, dual oxyntomodulin (OXM) analog that activates both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). By targeting these two receptors, the therapy is designed to treat obesity and related metabolic disorders through combined effects on appetite, metabolism, and energy balance. For more information, visit www.metaviatx.com.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- January 5, 2026
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 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 announced positive, statistically significant results from the 8-week non-titrated 48 mg multiple ascending dose (MAD) cohort of its Phase 1 trial of DA-1726, a dual oxyntomodulin analogue that activates GLP-1 and glucagon receptors for obesity. By Day 26 participants had 6.1% weight loss (14.6 lb; p=0.003) and a 5.8 cm waist reduction (p=0.006). By Day 54 weight loss deepened to 9.1% (21.2 lb) and waist circumference fell 9.8 cm (p=0.022). Fasting glucose improved by 12.3 mg/dL from a baseline of 105.3 mg/dL, and vibration-controlled transient elastography (VCTE) showed a 23.7% reduction in liver stiffness, indicating direct hepatic activity.
DA-1726 was well tolerated with no treatment-related discontinuations and only mild-to-moderate gastrointestinal events. An individual prediabetic subject’s HbA1c fell from 6.0% to 5.5% by Day 54. MetaVia believes the glucagon component could drive deeper visceral fat loss versus GLP-1-only drugs, supporting further development and planned longer titration studies.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- November 4, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced that it will present new Phase 1 and pre-clinical data on DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), in two poster presentations at ObesityWeek® 2025, taking place in-person and virtually November 4-7, 2025 in Atlanta, GA.
AI Summary
MetaVia Inc. will present new Phase 1 and pre-clinical data on DA-1726, a dual oxyntomodulin analog that activates GLP-1 and glucagon receptors, at ObesityWeek® 2025 in Atlanta (November 4–7). The Phase 1 study showed DA-1726 was safe and well tolerated without dose titration, supporting once-weekly subcutaneous dosing thanks to a mean half-life of approximately 80 hours.
After four weeks of treatment, participants achieved up to 6.3% body-weight reduction (average 4.3%) and waist circumference decreases of up to 3.9 inches. No serious adverse events occurred, and gastrointestinal side effects were mild and transient. The trial has been extended to explore an 8-week, 48 mg cohort for longer-term efficacy and maximum tolerated dose.
In diet-induced obesity mouse models, DA-1726 matched pemvidutide’s weight-loss efficacy while delivering superior lipid-lowering effects, including greater reductions in total cholesterol and LDL-C, highlighting its potential for broader metabolic benefits.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- October 20, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. announced that two abstracts highlighting data on DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), have been accepted for poster presentations at ObesityWeek® 2025, taking place in-person and virtually November 4-7, 2025 in Atlanta, GA.
AI Summary
MetaVia Inc., a clinical-stage biotechnology company, announced that two abstracts on DA-1726—a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors—have been accepted for poster presentations at ObesityWeek® 2025. The meeting will take place November 4-7, 2025, in Atlanta, GA, with virtual access offered.
The first poster, “Safety, Tolerability, and Pharmacokinetics of DA-1726, an Oxyntomodulin Analogue in a Phase 1 Study” (P-209), will be presented by Chris Fang, M.D., Consulting CMO of MetaVia. The second, “DA-1726, an Oxyntomodulin Analogue: A Promising Therapy for Obesity and Related Metabolic Disorders” (P-154), will be presented by Tae-Hyoung Kim, M.S., Lead Research Scientist at Dong-A ST. Both sessions are scheduled for Tuesday, November 4, 7:30–8:30 pm ET in Exhibit Hall A1.
A copy of each poster will be available in the Posters section of MetaVia’s website after the presentations.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- July 9, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 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
