This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroBo Pharmaceuticals (NRBO).
Over the past two years, NeuroBo Pharmaceuticals 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.
DA-1241 - FDA Regulatory Timeline and Events
DA-1241 is a drug developed by NeuroBo Pharmaceuticals 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:
- June 21, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced the presentation of pre-clinical data on DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, demonstrating additive hepatoprotective effects in combination with Efruxifermin, a fibroblast growth factor 21 (FGF21) analogue, in a metabolic dysfunction-associated steatohepatitis (MASH) mouse model.
AI Summary
MetaVia Inc. recently presented pre-clinical data at the American Diabetes Association Scientific Sessions highlighting the promising effects of its novel drug, DA-1241. DA-1241 is a G-Protein-Coupled Receptor 119 (GPR119) agonist that, when combined with Efruxifermin—a fibroblast growth factor 21 (FGF21) analogue—showed additive hepatoprotective benefits in a mouse model of metabolic dysfunction-associated steatohepatitis (MASH).
The study demonstrated that the combination therapy reduced liver fat, inflammation, and fibrosis more effectively than either treatment alone. These improvements point to enhanced liver protection and a potential new treatment strategy for MASH. The findings support the idea that targeting different pathways simultaneously can lead to better outcomes, reinforcing the promise of DA-1241 as part of a combination therapy for liver disease associated with metabolic dysfunction.
Read Announcement - Drug:
- DA-1241
- Announced Date:
- June 4, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced that an abstract highlighting pre-clinical data on DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, has been accepted for a poster presentation at the American Diabetes Association's 85th Scientific Sessions, taking place June 20-23, 2025 at the McCormick Place Convention Center in Chicago, Illinois.
AI Summary
MetaVia Inc., a clinical-stage biotechnology company, announced that an abstract featuring pre-clinical data on DA-1241 has been accepted for a poster presentation at the American Diabetes Association’s 85th Scientific Sessions. The event will be held from June 20-23, 2025 at the McCormick Place Convention Center in Chicago, Illinois.
The poster, titled "Additive Hepatoprotective Effects of DA-1241, a GPR119 Agonist, in Combination with Efruxifermin in a Diet-Induced Obese and Biopsy-Confirmed Mouse Model of MASH," will highlight the promising effects of DA-1241. As a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, DA-1241 is being developed for potential use in treating Metabolic Dysfunction-Associated Steatohepatitis and type 2 diabetes by promoting the release of key gut peptides that help regulate glucose, lipid metabolism, and inflammation.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- May 7, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced that data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), demonstrates both hepatoprotective and glucose-regulating effects.
AI Summary
MetaVia Inc. announced data from its Phase 2a clinical trial of DA-1241, a new GPR119 agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). The study showed that a 100 mg dose of DA-1241 led to a significant drop in liver enzyme levels (ALT decreased by 22.8 U/L) after 16 weeks, indicating strong hepatoprotective effects. The trial also found improvements in liver fat content, as measured by a better CAP score (23.0 dB/m reduction), and improvements in non-invasive tests that monitor liver inflammation and fibrosis.
Additionally, DA-1241 demonstrated a positive impact on glucose regulation, as it helped lower HbA1c levels in both non-diabetic patients and those with type 2 diabetes. These encouraging results suggest that DA-1241 may serve as a promising standalone or combination therapy for addressing both liver health and metabolic issues in MASH patients.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- April 23, 2025
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
MetaVia Inc. announced that an abstract highlighting data from its Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH), has been accepted as a late-breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place May 7-10, 2025 in Amsterdam, the Netherlands.
AI Summary
MetaVia Inc. recently announced that an abstract from its Phase 2a clinical trial of DA-1241 has been accepted as a late-breaking poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025. DA-1241 is a novel GPR119 agonist designed to treat Metabolic Dysfunction-Associated Steatohepatitis (MASH) by improving liver health and glucose regulation. The study is focused on patients with presumed MASH and shows promising results in its ability to reduce liver inflammation and improve metabolic functions.
The poster session is scheduled for May 7-10, 2025 in Amsterdam, the Netherlands. This presentation underlines MetaVia’s commitment to developing new treatments for metabolic liver diseases and could have significant implications for patients facing both liver issues and related metabolic disorders.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- May 22, 2024
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
NeuroBo Pharmaceuticals, announced that pre-clinical data suggests that DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in combination with semaglutide (Wegovy®), improves liver fibrosis and demonstrates additive hepatoprotective effects in pre-clinical metabolic dysfunction-associated steatohepatitis (MASH) models compared to either treatment alone.
AI Summary
NeuroBo Pharmaceuticals announced promising pre-clinical results for its novel G-Protein-Coupled Receptor 119 (GPR119) agonist, DA-1241, when used in combination with semaglutide (Wegovy®). According to the study, this drug combination significantly improved liver fibrosis and showed additive hepatoprotective effects in pre-clinical models of metabolic dysfunction-associated steatohepatitis (MASH) compared to when either treatment was given alone. The data, presented in a poster at the EASL Congress 2024, suggest that the combination therapy works by reducing liver inflammation, fat buildup, and fibrogenesis more effectively than monotherapies. These findings are seen as an important step in developing new treatments for MASH, as they highlight the potential of targeting both GPR119 and GLP1R pathways to offer improved benefits in liver health and metabolic control.
Read Announcement- Drug:
- DA-1241
- Announced Date:
- May 22, 2024
- Indication:
- G-Protein-Coupled Receptor 119
Announcement
NeuroBo Pharmaceuticals announced that Data Will be Presented in Two Posters at the EASL Congress 2024
AI Summary
NeuroBo Pharmaceuticals announced that pre-clinical data will be featured in two poster presentations at the upcoming EASL Congress 2024 in Milan, Italy, from June 5-8. The presentations, led by researchers from Dong-A ST Research Center and Gubra, focus on DA-1241, a novel GPR119 agonist. The data shows that when DA-1241 is combined with semaglutide (Wegovy®), the treatment produces additive hepatoprotective effects in pre-clinical models of metabolic dysfunction-associated steatohepatitis (MASH). This combination appears promising, as it significantly reduces liver fibrosis, steatosis, and inflammation compared to when each agent is used alone. The posters will provide detailed insights into these effects, highlighting potential improvements in liver health and metabolic control. Attendees can view the posters both at the congress and online through NeuroBo’s website.
Read Announcement
DA-1726 - FDA Regulatory Timeline and Events
DA-1726 is a drug developed by NeuroBo Pharmaceuticals 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:
- March 20, 2025
- Indication:
- For The Treatment Of Obesity
Announcement
MetaVia Inc. Provides Corporate Update
AI Summary
MetaVia Inc. provided a corporate update outlining their latest progress in the clinical development of cardiometabolic therapies. The company is advancing DA-1726, a novel dual agonist targeting both GLP-1 and glucagon receptors, for obesity treatment. They reported strong safety data from the initial parts of the Phase 1 study and are adding more cohorts in the MAD Part 2 trial to better determine the maximum tolerated dose. Top-line data from these additional cohorts is expected by April 2025, which will offer an early look at the clinical efficacy of DA-1726. MetaVia believes that DA-1726 could become a best-in-class obesity drug, potentially providing improved tolerability over current GLP-1 agonists. Additionally, the update noted that the company’s cash position of $16 million at the end of Q4 2024 is expected to support operations into the third quarter of 2025.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- September 30, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025
AI Summary
NeuroBo Pharmaceuticals announced that their multiple ascending dose (MAD) study is making progress, and the top-line data readout for MAD Part 2 is expected in the first quarter of 2025. This upcoming data release will provide early insights into the clinical efficacy of DA-1726, a novel dual agonist designed to act on both GLP-1 and glucagon receptors to target obesity. The MAD Part 2 study will involve approximately 36 obese, yet otherwise healthy, participants enrolled in a randomized, placebo-controlled, double-blind trial. Participants will receive weekly doses of DA-1726 over four weeks, allowing the company to evaluate the drug’s safety, tolerability, and pharmacokinetic profile. NeuroBo’s emphasis on achieving a balanced activation of these receptors aims to boost energy expenditure and improve weight loss while maintaining a strong safety profile.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- September 30, 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced positive top-line safety, tolerability, and dose-linear pharmacokinetics (PK) data from the single ascending dose (SAD) Part 1 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
NeuroBo Pharmaceuticals announced encouraging results from the first part of its Phase 1 trial evaluating DA-1726, a novel treatment for obesity. In the single ascending dose (SAD) study, 45 obese but otherwise healthy participants received either DA-1726 or a placebo. The data revealed that DA-1726 was safe and well tolerated, with no serious adverse events reported. Only a few subjects experienced mild adverse events in comparison to those on placebo. Additionally, the trial showed a dose-linear pharmacokinetics (PK) profile, meaning the drug’s concentration in the blood increased predictably with higher doses. This finding supports the drug’s potential for precise dosing, which could be crucial for managing obesity. The positive safety, tolerability, and PK results pave the way for further investigation in subsequent trial phases aimed at confirming the clinical efficacy of DA-1726.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- August 13, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Top Line Data Readout from SAD Part 1 Expected in the Third Quarter of 2024
AI Summary
NeuroBo Pharmaceuticals announced a key milestone in their Phase 1 clinical trial for the obesity treatment candidate DA‐1726. The single ascending dose (SAD) study completed enrollment with 45 participants and encountered no significant issues. As a result, NeuroBo is on track to report top-line data readout for the SAD Part 1 portion of the trial in the third quarter of 2024. This data is critical in assessing the safety, tolerability, and overall early promise of the dual agonist, which targets both GLP-1 and glucagon receptors.
The successful completion of the SAD study has also allowed the company to start the multiple ascending dose (MAD) study ahead of schedule. NeuroBo’s progress in this early clinical phase supports their commitment to transforming the treatment of obesity and cardiometabolic diseases, with additional data from later trial stages anticipated in early 2025.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- August 13, 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced the completion of enrollment of the single ascending dose (SAD) Part 1 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
NeuroBo Pharmaceuticals announced the successful completion of enrollment for the single ascending dose (SAD) part of its Phase 1 clinical trial for DA-1726, a new dual oxyntomodulin analog agonist that activates both GLP-1 and glucagon receptors. This treatment is designed for obesity management. In the SAD study, 45 participants were enrolled and randomized into five cohorts in a 6:3 ratio of DA-1726 to placebo, with no significant issues encountered during the trial. This smooth progress has allowed the company to initiate the multiple ascending dose (MAD) study ahead of schedule. Top-line data from the SAD portion is expected in the third quarter of 2024, with MAD results anticipated in the first quarter of 2025, marking important milestones in NeuroBo’s quest to transform obesity treatment with a potentially best-in-class agent.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- August 13, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Top Line Data from the MAD Part 2 in the First Quarter of 2025
AI Summary
NeuroBo Pharmaceuticals is moving forward with its Phase 1 clinical trial testing DA-1726 for obesity treatment. In the study, researchers are examining both a Single Ascending Dose (SAD) and a Multiple Ascending Dose (MAD) approach. No significant issues were encountered during the SAD portion, which allowed the MAD study to start earlier than planned. The company has announced that it expects to release top-line data from the MAD Part 2 segment in the first quarter of 2025. This upcoming data readout is key as it will help assess the safety, tolerability, and drug behavior in the body. NeuroBo’s progress with DA-1726 supports their goal of transforming treatments for cardiometabolic diseases and could mark an important step toward introducing a best-in-class obesity drug with a favorable tolerability profile.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced dosing of the first patient in 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), for the treatment of obesity.
AI Summary
NeuroBo Pharmaceuticals has advanced its Phase 1 clinical trial for DA-1726 by dosing the first patient in the multiple ascending dose (MAD) Part 2 study, ahead of schedule. DA-1726 is a novel dual oxyntomodulin analog agonist that activates both the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) to assist in treating obesity. This early dosing phase is a key milestone in evaluating the drug’s safety, tolerability, and dosing effects in obese individuals. Preclinical studies have shown that DA-1726 may offer improved weight loss compared to some established obesity treatments while helping to preserve lean body mass and lower glucose levels. The ongoing Phase 1 trial is designed to yield important data on DA-1726’s pharmacokinetics and pharmacodynamics, information that could support its potential as a best-in-class therapy for obesity.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- June 26, 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024
AI Summary
NeuroBo Pharmaceuticals, a clinical-stage biotechnology company, announced that top-line data from Part 1 of its Phase 1 single ascending dose trial for DA-1726 is expected in the third quarter of 2024. The trial is focused on determining the safety and initial response of DA-1726, a dual agonist targeting both GLP-1 and glucagon receptors, which may lead to weight loss by reducing appetite and increasing energy expenditure.
The company plans to advance its program by evaluating multiple ascending doses, with further top-line results anticipated in the first quarter of 2025. With recent financing of up to $70 million, NeuroBo aims to support ongoing clinical development and expand testing in future trial parts to assess overall weight loss and other key outcomes. These developments could help establish DA-1726 as a potentially best-in-class treatment for obesity.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- H1 2026
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026
AI Summary
NeuroBo Pharmaceuticals, Inc. has outlined key upcoming milestones in the clinical development of its obesity drug candidate, DA-1726. The company plans to begin dosing patients for Part 3 of its Phase 1 trial in the third quarter of 2025, following clearance of an updated IND application from the FDA. Part 3 is designed to assess total weight loss, maximum-tolerated individualized dosing, dietary changes, and other exploratory endpoints at 24 weeks. Importantly, NeuroBo expects an interim data readout around mid-2026, with top-line results to be released in the second half of 2026. These milestones are crucial steps in evaluating DA-1726’s potential as a best-in-class dual agonist for obesity, supported by recent financing of up to $70 million that will help further advance its clinical program.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that the Multiple Ascending Dose Part 2 in the First Quarter of 2025
AI Summary
NeuroBo Pharmaceuticals announced major progress in its Phase 1 clinical trial for DA-1726, an investigational obesity treatment. The company revealed that top-line data from the Multiple Ascending Dose (MAD) Part 2 will be available in the first quarter of 2025. In this phase, participants receive multiple doses of DA-1726—a dual agonist that targets both GLP1R and glucagon receptors—to evaluate its safety, tolerability, and pharmacokinetics, as well as its impact on weight loss.
The advancement of MAD Part 2 highlights NeuroBo’s strong commitment to moving quickly through clinical milestones and exploring DA-1726’s potential as a best-in-class obesity therapy. With recent financing bolstering its efforts, the company is focused on further refining dosing strategies and gathering crucial data to support the development of this innovative treatment in the fight against obesity.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- April 17, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024
AI Summary
NeuroBo Pharmaceuticals announced an important milestone for its Phase 1 clinical trial of DA-1726, a new dual agonist targeting obesity. The company now expects the top-line data from the Single Ascending Dose (SAD) Part 1 to be available in the third quarter of 2024. This data will provide initial insights into the safety and tolerability of DA-1726, which acts on both the GLP-1 and glucagon receptors, offering a potential new approach to weight loss by reducing food intake and increasing energy expenditure.
The trial will enroll approximately 45 obese but otherwise healthy participants across several cohorts. The upcoming data readout is a significant step forward in assessing the novel treatment’s potential benefits compared to existing therapies in the fight against obesity. NeuroBo's accelerated timelines underline its commitment to advancing innovative treatments for cardiometabolic diseases.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- April 17, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals, announced that First Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024
AI Summary
NeuroBo Pharmaceuticals announced that the first patient in the Multiple Ascending Dose (MAD) Part 2 of its Phase 1 trial for DA-1726 is expected to be dosed in the third quarter of 2024. DA-1726 is a novel dual oxyntomodulin (OXM) analog agonist that targets both GLP-1 and glucagon receptors, aiming to treat obesity by reducing food intake and increasing energy expenditure. The company has accelerated the trial timelines, with top-line data from the Single Ascending Dose (SAD) Part 1 also expected in the third quarter of 2024, and additional MAD data anticipated in the first quarter of 2025. This trial, conducted in obese yet otherwise healthy subjects, will evaluate the safety, tolerability, and pharmacokinetic profile of DA-1726, bringing the novel treatment one step closer to potentially offering improved weight loss benefits compared to current options.
Read Announcement- Drug:
- DA-1726
- Announced Date:
- April 17, 2024
- Indication:
- For The Treatment Of Obesity
Announcement
NeuroBo Pharmaceuticals announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part 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
NeuroBo Pharmaceuticals has begun dosing the first patient in Part 1 of its Phase 1 trial for DA-1726, a new treatment for obesity. DA-1726 is a dual oxyntomodulin analog agonist that activates both GLP-1 and glucagon receptors. This dual action is designed to reduce appetite and increase energy expenditure, and early studies suggest it may offer better tolerability than current GLP-1 agonists. The study, based on a single ascending dose approach, focuses on assessing the safety and tolerability of DA-1726. Future trial phases will evaluate multiple doses. NeuroBo plans to share initial results in the third quarter of 2024, with additional dosing expected later this year. The dosing marks a significant milestone in advancing DA-1726 into human studies and may pave the way for improved obesity management.
Read Announcement
