The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.

Start Date02 Mar 2026

Sponsor / Collaborator

University Medical Center Groningen

NCT07221591

/ Not yet recruitingPhase 1

Relative Bioavailability of Two Survodutide (BI 456906) Formulations When Administered Subcutaneously Via Pre-filled Syringe Over 28 Weeks (an Open-label, Randomised, Multiple Dose, Parallel Group Trial)

This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2.
The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body.
Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months.
Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.

Start Date05 Nov 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07071974

/ Active, not recruitingPhase 1

Relative Bioavailability of Two BI 456906 Formulations After Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).

Start Date28 Jul 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Survodutide

100 Translational Medicine associated with Survodutide

100 Patents (Medical) associated with Survodutide

Literatures (Medical) associated with Survodutide

16 Sep 2025·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Efficacy of GLP-1-based Therapies on Metabolic Dysfunction-associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis: A Systematic Review and Meta-analysis

Review

Author: Wang, Qinghua ; Prud'homme, Gerald J ; Ni, Yunzhi ; Wang, Zhihong ; Wang, Yahao ; Zhou, Yue

Abstract:

Objective:

New therapies are urgently needed for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). We conducted this systematic review and meta-analysis to evaluate the therapeutic effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on MASLD/MASH.

Methods:

We searched PubMed, Embase, and Cochrane Library databases to identify randomized controlled trials (RCTs) that compared GLP-1RAs with placebo or active agents with respect to the efficacy in patients with MASLD/MASH. The effects of GLP-1RAs on liver fat content (LFC) by imaging, liver histology, serum liver enzymes, and noninvasive fibrosis indexes [Fibrosis-4, nonalcoholic fatty liver disease fibrosis score, cytokeratin 18, procollagen III, and liver stiffness) were evaluated. Mean differences and risk ratios with 95% confidence intervals were pooled using a random-effect model.

Results:

Twenty-five RCTs involving 2600 patients who used GLP-1RAs including liraglutide, exenatide, dulaglutide, semaglutide, tirzepatide, efinopegdutide, survodutide, and retatrutide were included. Overall, GLP-1RAs treatment for a median of 24 weeks demonstrated a significant reduction in LFC by 5.21%, with retatrutide displaying the most obvious treatment effects. GLP-1RAs treatment induced significant histological improvements in steatosis, hepatocellular ballooning, and lobular inflammation but nonsignificantly improved fibrosis, with the evidence for tirzepatide more robust than that for semaglutide and liraglutide. GLP-1RAs treatment significantly decreased serum alanine aminotransferase, aspartate aminotransferase, and γ-glutamyl transferase compared with control. GLP-1RAs also significantly improved liver stiffness, with semaglutide displaying the most obvious treatment effect. No drug-related adverse effects involving the liver were observed.

Conclusion:

GLP-1RAs decreased liver fat deposition and improved histological steatosis, hepatocellular ballooning, and lobular inflammation, without worsening of fibrosis in MASLD and MASH.

08 Sep 2025·DIABETES OBESITY & METABOLISM

Efficacy and safety of survodutide on glycemic control and weight loss in adults: A systematic review and meta‐analysis

Article

Author: Zhang, Yan‐Ling ; Sun, Chang‐Feng ; Yu, Shan ; Xiao, Ya‐Jun ; Chen, Jiao ; Liu, Xiao‐Ling ; Deng, Cun‐Liang ; Liu, Yan‐Qun

Abstract:

Aim:

This meta‐analysis aimed to evaluate the efficacy and safety of survodutide on glycemic control and weight loss in adults.

Methods:

We systematically searched PubMed, Embase, the Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov for randomized controlled trials (RCTs) evaluating the efficacy and safety of survodutide up to 12 July 2025. The primary outcomes were changes in glycated haemoglobin (HbA1c), fasting glucagon levels, body weight, waist circumference, along with the incidence of adverse events (AEs). Secondary outcomes included body mass index (BMI), lipid profiles, and blood pressure.

Results:

Six RCTs involving 1272 participants were included in this meta‐analysis. Compared with placebo, survodutide significantly reduced HbA1c (weighted mean difference [WMD]: −0.66%, 95% confidence interval [CI] [−1.08, −0.23], p = 0.002) and fasting glucagon levels (WMD: −7 pmol/L, 95% CI [−10.3, −3.69], p = 0.016). Greater reductions were observed in the subgroup receiving a total weekly dose of >2.4 mg compared with the subgroup receiving ≤2.4 mg weekly. Survodutide also significantly decreased body weight (WMD: −6.7 kg, 95% CI [−10.0, −3.4], p < 0.001) and waist circumference (WMD: −7.09 cm, 95% CI [−9.44, −4.47], p < 0.001), with enhanced effects observed at higher total weekly doses (>2.4 mg) and longer treatment durations (>16 weeks). Additionally, significant reductions were observed in BMI, and modest reductions were noted in total cholesterol, triglycerides, and blood pressure. However, survodutide was associated with a higher risk of treatment discontinuation due to AEs, with gastrointestinal AEs being the most common, although there was no significant increase in the incidence of serious AEs.

Conclusions:

Survodutide significantly reduced HbA1c, body weight, and waist circumference. A greater reduction in HbA1c was specifically associated with a higher total weekly dose (>2.4 mg), while more pronounced effects on body weight and waist circumference were observed with both higher doses and longer treatment durations (>16 weeks). However, it is crucial to highlight the significant increase in gastrointestinal AEs and the associated risk of treatment discontinuation. Further large‐scale, multicentre, long‐term, and high‐quality RCTs are necessary to validate these results in diverse populations.

01 Sep 2025·Molecular Metabolism

Novel NPY2R agonist BI 1820237 provides synergistic anti-obesity efficacy when combined with the GCGR/GLP-1R dual agonist survodutide

Article

Author: Oldenburger, Anouk ; Grube, Achim ; Baljuls, Angela ; Krawczyk, Bartlomiej ; Hecksher-Sørensen, Jacob ; Zimmermann, Tina ; Brennauer, Albert ; Borghardt, Jens ; Baader-Pagler, Tamara ; Haebel, Peter ; Reindl, Wolfgang ; Martel, Eric ; Rudkjaer, Lise Biehl ; Peters, Stefan ; Augustin, Robert

OBJECTIVE:

Nutrient-stimulated gut hormone peptide YY3-36 (PYY3-36) selectively activates the neuropeptide Y2 receptor (NPY2R) and reduces energy intake in humans. We describe the discovery and pharmacology of the long-acting NPY2R agonist BI 1820237 and its potential bodyweight-lowering efficacy alone and in combination with the glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist survodutide.

METHODS & RESULTS:

BI 1820237 dose-dependently reduced food intake and gastric emptying in lean mice. Significant bodyweight reductions were not observed with BI 1820237 alone in diet-induced obese mice, however combination with survodutide led to bodyweight reduction of 22% which was significantly (p < 0.01) greater than the 17% bodyweight reduction with survodutide alone. Regression-based interaction analysis demonstrated that BI 1820237 increased the efficacy of survodutide by 265% at an ED50 of 11.7 nmol/kg over a range of dose combinations.

CONCLUSION:

Synergistic NPY2R and GCGR/GLP-1R agonism provides an attractive mode of action for clinically relevant weight loss in patients with obesity.

130

News (Medical) associated with Survodutide

04 Nov 2025

·www.prnewswire.com

MetaVia to Present New Phase 1 and Pre-Clinical Data on DA-1726 at ObesityWeek® 2025

New Phase 1 PK Data Support Once-Weekly Dosing; Clinically Meaningful Weight Loss Observed Without Dose Titration DA-1726 Achieves Superior Lipid-Lowering Effects and Comparable Weight Loss to Pemvidutide in Pre-clinical Models CAMBRIDGE, Mass., Nov. 4, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today 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. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy. "These Phase 1 results continue to reinforce DA-1726's potential as a differentiated dual agonist for the treatment of obesity," said Hyung Heon Kim, Chief Executive Officer of MetaVia. "The favorable safety profile observed, even without titration, together with potentially best-in-class early weight loss, waist circumference reduction and clean cardiovascular findings, is highly encouraging. The newly reported PK data demonstrating linear, dose-proportional exposure and an approximate 80-hour half-life, further support the convenience and consistency of once-weekly dosing. Based on these results, we have extended the Phase 1 study to a 48 mg dose for a total of 8 weeks to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose. We expect to read out the results from the 48 mg cohort later this year." At the highest tested dose of 32 mg, presented in the poster, participants achieved a body-weight reduction of up to 6.3% from baseline, with an average reduction of 4.3% at Day 26. Waist circumference decreased by as much as 3.9 inches, with effects sustained for two weeks after dosing ended. The 32 mg PK data, presented for the first time, shows linear, dose-proportional exposure and a mean half-life of approximately 80 hours, confirming the feasibility of once-weekly dosing. DA-1726 was well tolerated across all dose levels, with no serious adverse events or treatment discontinuations. Reported gastrointestinal events were mild and transient, and no clinically meaningful changes were observed in cardiovascular parameters, including heart rate or QTcF interval. The Phase 1 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45 kg/m². Each of the 4 cohorts presented in the poster included nine participants randomized 6:3 to receive four once-weekly subcutaneous doses of DA-1726 or placebo. The primary objective was to assess safety and tolerability based on adverse events (AEs), serious adverse events (SAEs), treatment-emergent events (TAEs), and discontinuations. Secondary endpoints evaluated PK parameters, including serum concentration and metabolite profiling at higher doses, while exploratory assessments measured metabolic, cardiovascular, and lipid parameters, as well as changes in body weight, waist circumference, and BMI. For more information on this clinical trial, please visit: NCT06252220. Presentation Details: Title: Safety, Tolerability, and Pharmacokinetics of DA-1726, an Oxyntomodulin Analogue in a Phase 1 Study Presenting Author: Chris Fang, M.D., Consulting Chief Medical Officer of MetaVia Poster Number: P-209 Poster Date: Tuesday, November 4, 2025 Poster Time: 7:30-8:30 pm ET Poster Location: Exhibit Hall A1 Mr. Kim added "The pre-clinical data presented highlighted the differentiated metabolic profile of DA-1726 compared with other dual agonists. DA-1726 demonstrated comparable weight-loss efficacy to pemvidutide while delivering superior lipid-lowering effects, including greater reductions in total cholesterol and LDL-C. In addition, DA-1726 produced greater weight loss than tirzepatide despite similar food intake, driven by enhanced energy expenditure not associated with increased physical activity. These findings support DA-1726's potential to deliver broader and more durable metabolic benefits for patients with obesity." In preclinical studies, DA-1726 promoted weight reduction by suppressing appetite and increasing energy expenditure in DIO mice. Comparative analyses focused on energy expenditure relative to tirzepatide and on body composition relative to pemvidutide, along with assessments of body weight and lipid metabolism in both treatment groups. Compared to tirzepatide, DA-1726 produced greater weight loss despite similar food intake, accompanied by enhanced energy expenditure not attributable to increased locomotor activity. DA-1726 also led to greater reductions in total cholesterol (T-CHO) and LDL-C, demonstrating a distinct glucagon-mediated metabolic mechanism. When compared with pemvidutide, DA-1726 achieved similar body-weight reductions and improvements in body composition, including decreased fat mass and relatively preserved lean mass. Notably, DA-1726 delivered superior lipid-lowering benefits, showing greater reductions in total cholesterol, LDL-C, and triglycerides across treatment groups. Presentation Details: Title: DA-1726, an Oxyntomodulin Analogue: A Promising Therapy for Obesity and Related Metabolic Disorders Presenting Author: Tae-Hyoung Kim, M.S., Lead Research Scientist of Dong-A ST Poster Number: P-154 Poster Date: Tuesday, November 4, 2025 Poster Time: 7:30-8:30 pm ET Poster Location: Exhibit Hall A1 A copy of the posters are available on the Posters section of the MetaVia website. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE MetaVia Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 1Phase 2

06 Aug 2025

·www.prnewswire.com

MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity to 8 Weeks and Announces Fifth Weekly Dose in First Patient

Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose Top-Line Data Expected in the Fourth Quarter of 2025 CAMBRIDGE, Mass., Aug. 6, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has extended to 8 weeks from 4 weeks, the 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, and has administered a fifth weekly dose to the first patient. DA-1726 is 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. The extension is designed to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Top-line data is expected in the fourth quarter of 2025. "Extending DA-1726 administration by an additional 4 weeks—for a total of 8 weeks—in the 48 mg cohort represents a meaningful step forward as we seek to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "After reviewing the original trial design and previous results, we feel confident that the 4-week extension can potentially provide more robust data, which we believe may position DA-1726 more strongly against current treatments and those in late-stage clinical trials. By extending exposure to the drug, we aim to more fully evaluate DA-1726's therapeutic profile across primary, secondary and exploratory endpoints—including safety, tolerability, body weight, waist circumference, and body mass index (BMI), among others—and to further unlock its full therapeutic potential. Previously reported data from the 32 mg dose demonstrated strong weight loss effects (mean: 4.3%, max: 6.3% by Day 26), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. These findings, along with favorable glycemic and cardiovascular safety and a mild, transient GI profile, suggest that DA-1726-may offer a superior tolerability profile compared to existing GLP-1 therapies." Mr. Kim added, "We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20–30% within the first month and up to 70% within a year. We look forward to reporting top-line data from the extended 48 mg cohort later this year, which may further validate DA-1726's longer-term safety, early efficacy and differentiated tolerability profile compared to current GLP-1 therapies." The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index (BMI) between 30 – 45 kg/m2. Nine subjects in each cohort are randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort will add 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE MetaVia Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Phase 2

24 Jul 2025

·www.fiercebiotech.com

\'Crossing fingers\': Boehringer awaits key FDA decisions to spearhead \'maturing\' pipeline

Boehringer Ingelheim\'s chief medical officer told Fierce that the FDA’s decision on zongertinib could come at “any moment.”\n It\'s shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. The German drugmaker is awaiting the agency\'s decision on approving key therapies for lung cancer and idiopathic pulmonary fibrosis (IPF) with the aim of launching both meds before the end of 2025.The privately owned company’s top oncology prospect is zongertinib, a HER2-selective tyrosine kinase inhibitor that earlier this year was tied to an objective response rate of 71% among patients with advanced non-small cell lung cancer.If the FDA gives zongertinib the green light in the coming months, the drug would be the first orally administered targeted therapy available for patients with previously treated HER2-mutated lung cancer.“Zongertinib selectively inhibits HER2 while sparing EGFR, which is critical,” Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., told Fierce Biotech in an interview ahead of the company’s first-half earnings results. “So it has the potential to be the first oral and also, as far as we can see, potential to be a best-in-class treatment with a very benign safety and tolerability profile.”For now, the company is “really excited” and “crossing fingers” while it waits for the FDA’s verdict, which could come at “any moment,” Hinsch Gylvin said. Another FDA decision Boehringer is “eagerly waiting” this year is for its PDE4B inhibitor nerandomilast in IPF. Phase 3 data posted in May were considered by analysts to be a step up from Boehringer’s approved IPF drug Ofev, but not a game changer.Still, Hinsch Gylvin argued that nerandomilast has “got the potential to really revolutionize care” for the chronic lung disease.Just days after the nerandomilast readout, PureTech reaffirmed a phase 2b trial success for its own IPF candidate deupirfenidone. Hinsch Gylvin wouldn’t be drawn on whether this meant nerandomilast could soon have a tough battle on its hands, instead pointing out that the aim of Boehringer’s option is to create “a solution for patients that hopefully will change this condition, which is actually fatal.”The CMO also didn’t commit herself to a ballpark figure for sales of Boehringer’s two prospective approvals, but did point out that more than one million patients worldwide have the condition.Another late-stage asset that Hinsch Gylvin is keen to raise awareness of is a DPP1/CatC inhibitor called verducatib, which Boehringer is now evaluating in a late-stage study of non-cystic fibrosis bronchiectasis.“This is part of our maturing pipeline,” she said. “We have over 10 more late-stage trials coming within the next 12 to 18 months.”It seems like any Big Pharma worth the name has a contestant in the obesity race, and Boehringer is no exception. The company’s glucagon/GLP-1 receptor dual agonist survodutide is in late-stage development for both weight loss and metabolic dysfunction-associated steatohepatitis (MASH). Phase 2 readouts for the Zealand Pharma-partnered drug have already demonstrated a placebo-adjusted 64.8% improvement in the fatty liver disease as well as almost 19% weight loss at 46 weeks.But with everyone from Novo Nordisk’s weight loss mainstay Wegovy to up-and-comer candidates from the likes of Rivus Pharmaceuticals showing promise in both obesity and MASH, does Boehringer still think it can stand out in such a crowded space?“We expect a lot from survodutide,” said Hinsch Gylvin, who pointed to the fact that weight loss hadn’t plateaued in the phase 2 trial by the 46-week readout. “In MASH, we had very strong data in phase 2 that helped us to really accelerate.”The company’s MASH ambitions aren’t limited to survodutide, however. There’s also a SIRPα antagonist in a midstage trial that Boehringer “expects a lot from.” Another red-hot space Boehringer has been dabbling in is T-cell engagers. The DLL3/CD3 T-cell engager obrixtamig is being evaluated in midstage trials in both extrapulmonary neuroendocrine carcinoma and small-cell lung cancer.“That\'s definitely also one to look out for,” Hinsch Gylvin said.Further back in development, Boehringer has a B7-H6/CD3 T-cell engager that is tasked with “turn[ing] cold tumors hot.” Another phase 1-stage cancer drug name-checked by Hinsch Gylvin is a CD137/FAP bispecific agonist being aimed at head and neck cancer.In April, Boehringer committed more than $30 million to a new R&D facility specifically focused on antibody-drug conjugates. The site is run by the company’s Swiss subsidiary NBE Therapeutics, which Boehringer bought for $1.5 billion in 2020 in a deal centered around a ROR1-directed ADC. More recently, Boehringer has continued to seek out partners in the ADC arena, kicking off 2025 with a $1.3 billion biobucks licensing deal with Synaffix.Announcing the site in Basel in April, Boehringer said the location will “contribute to building a broad pipeline of ADCs, addressing novel tumor target space to develop next-generation cancer treatments.”Hinsch Gylvin placed this ADC work in the broader context of the company’s “very robust oncology pipeline.”“Apart from small molecule inhibitors, we\'re also exploring T cell engagers, protein degraders, ADCs, cancer vaccines [and] oncolytic viruses,” she continued. “So we really do have a robust pipeline, and we continue to look to strengthen it even further.”One disease area for which Boehringer is less well known is eye health, but the company has been working to change that in recent years—including by licensing a bispecific antibody from Surrozen and a geographic-atrophy-focused pact with RetinAI.Hinsch Glyvin said this ophthalmology work is “fairly new for Boehringer” but has already been “recognized by clinicians as something to look out for.” Boehringer’s Human Pharma business grew 5.7% in the first half of 2025, reaching 11.3 billion euros ($13.2 million) in net sales. This growth was credited to the likes of Jardiance for diabetes, heart failure and kidney disease as well as IPF drug Ofev.According to Hinsch Glyvin, Boehringer invests around 28% of this Human Pharma revenue back into its innovation pipeline—a ratio at the top end of its Big Pharma peers.So, is the company eyeing some of this cash to seek out new drugs to plug any remaining gaps in its portfolio?“About 50% of our pipeline is already anchored in partnerships, and so we continue to always look outside, whether it is for actual partnerships on our current pipeline, or anywhere else to invest,” Hinsch Glyvin said.“I would say we are very fortunate also with this maturing pipeline and the outlook we have to potentially launch up to 20 indications in the coming years,” she added.

Phase 2AcquisitionLicense out/in

100 Deals associated with Survodutide

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis, Liver	Phase 3	United States	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	China	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Japan	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Argentina	Boehringer Ingelheim (China) Investment Co., Ltd.	14 Oct 2024
Fibrosis, Liver	Phase 3	Argentina	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Australia	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Austria	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Belgium	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Brazil	Boehringer Ingelheim GmbH	14 Oct 2024
Fibrosis, Liver	Phase 3	Bulgaria	Boehringer Ingelheim GmbH	14 Oct 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04771273 (1404-0043, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	295	Survodutide (Survodutide 2.4 mg - Planned Maintenance Treatment)	cikmszpmcp = vjwjbeojwx msgtsvmvmg (srxsibyxlj, lbwabimijz - rdoexitaug) View more	-	03 Dec 2024
				Survodutide (Survodutide 4.8 mg - Planned Maintenance Treatment)	cikmszpmcp = odrenzhhub msgtsvmvmg (srxsibyxlj, qcmupnolqf - wyacvqfoqy) View more
ESC2024	Phase 2	Obesity	387	Survodutide 4.8 mg	tpyxhjknbu(loiuzmtelr) = mhnutlfrky dwswvlapjb (eweodfkmbk )	Positive	01 Sep 2024
NCT04153929 \| NCT04667377 \| NCT03591718 (1665-P, ADA2024)	Phase 1/2	Diabetes Mellitus, Type 2 \| Obesity HbA1c \| insulin sensitivity \| glucose biomarkers ... View more	-	Survodutide	bziwwvrqsx(inltkyxeal) = 0.4 vs 0.0 kcxyuwrfiu (cqjhpjeuto ) View more	Positive	14 Jun 2024
				Placebo
NCT04771273 (1404-0043, Pubmed)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	293	Survodutide 2.4 mg	camvrvtfgl(hwbuakstsk) = zylhergqls pomeckwaqv (iuypdfyyvk ) View more	Positive	07 Jun 2024
				Survodutide 4.8 mg	camvrvtfgl(hwbuakstsk) = qlqblnlzpi pomeckwaqv (iuypdfyyvk ) View more
NCT04667377 (Phase II Trial, ENDO2024)	Phase 2	Overweight \| Obesity	384	Survodutide 4.8 mg	ypdwqarjfw(qsejfvllqi) = pnzwwhmtus kwyeuvhndn (djkowywcry )	Positive	01 Jun 2024
				Placebo	ypdwqarjfw(qsejfvllqi) = ixtlnqnqpn kwyeuvhndn (djkowywcry )
NCT04771273 (Corporate Publications) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	295	Survodutide	xatoonmvij(orhoszkezl) = hxmtpgyguh bgcyihwtai (cllesbobiq ) Met	Positive	26 Feb 2024
				placebo	xatoonmvij(orhoszkezl) = mhqmbrreav bgcyihwtai (cllesbobiq ) Met
NCT04771273 (GlobeNewswire) Manual	Phase 3	Metabolic Dysfunction Associated Steatohepatitis	-	survodutide	yufhykokma(qgxegfykto) = uwfsuardjo rwvyabofcx (bjznloxgiu ) Met	Positive	26 Feb 2024
				Placebo	yufhykokma(qgxegfykto) = xrxvnqozrm rwvyabofcx (bjznloxgiu ) Met
NCT04667377 (Phase II Trial, CTgov)	Phase 2	Obesity	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	aaksgzlrsn(iydpdtelax) = dkzatcjzxk grakbmmczv (ynikradczw, 1.07) View more	-	02 Nov 2023
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	aaksgzlrsn(iydpdtelax) = ckmogtyazc grakbmmczv (ynikradczw, 1.01) View more
NCT04667377 (ADA2023) Manual	Phase 2	Overweight \| Obesity	387	BI 456906 0.6 mg	vjnuaitduv(uusxmgqciv) = pbyfftafeq huxjqhfkld (vtagrclrsa ) View more	Positive	23 Jun 2023
				BI 456906 2.4 mg	vjnuaitduv(uusxmgqciv) = orarmmilvn huxjqhfkld (vtagrclrsa ) View more
NCT04153929 (Phase II, CTgov)	Phase 2	Diabetes Mellitus, Type 2	413	Placebo (Placebo)	lipfjqjxsc(hvbjbmweec) = dxvylcgxwz bhaehnyjrw (yxwvwdhnap, 0.81) View more	-	29 Nov 2022
				BI 456906 (BI 456906 0.3 mg)	lipfjqjxsc(hvbjbmweec) = wbzyjbkcyr bhaehnyjrw (yxwvwdhnap, 0.71) View more

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