home / compounds / Survodutide
Survodutide
BI 456906
REC PPT-SURVODUTIDE // REV 2026-10-04 // assessment changes are logged, never silent
A glucagon/GLP-1 dual receptor agonist with a genuine late-stage randomised programme in obesity and MASH, and no marketing authorisation from any regulator as of August 2026.
What it is
Survodutide (BI 456906) is a lipidated synthetic peptide developed by Boehringer Ingelheim with Zealand Pharma that activates both the GLP-1 receptor and the glucagon receptor. The glucagon arm is what separates it structurally from single-target GLP-1 agonists such as semaglutide.
What it does
Studied for chronic weight management in adults with overweight or obesity, and for metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis. Type 2 diabetes and cardiovascular outcome trials are also running.
Does it work?
Evidence measured 2026-08-25: 397 indexed publications, 14 randomised controlled trials and 26 interventional ClinicalTrials.gov records. The counts are small in absolute terms but unusually clean — there is essentially no query collision, so almost every hit is about this compound. A 48-week phase 2 trial in 293 adults with biopsy-confirmed MASH reported histological improvement without worsening of fibrosis in 47-62% of survodutide arms versus 14% on placebo (NEJM, 2024). The phase 3 obesity trial SYNCHRONIZE-1 (n=726) completed in December 2025 and the sponsors reported mean weight reduction of up to 16.6% at 76 weeks versus 3.2% on placebo in April 2026; the phase 3 MASH outcome trials LIVERAGE and LIVERAGE-Cirrhosis are still recruiting and are not scheduled to read out for years.
Claims vs data
Each marketing claim, tagged by what the evidence actually supports.
| Produced double-digit mean body-weight reduction over 76 weeks in a phase 3 randomised trial | supported |
| Improves MASH histology without worsening fibrosis | partially true |
| The glucagon arm raises energy expenditure more than GLP-1-only agents do | weak evidence |
| An approved prescription obesity treatment | overreach |
Reference figures
Quoted from published reference material. These are not Peptuity recommendations.
molecular data — PubChem CID 171378821
The evidence, counted
Live counts from Europe PMC and ClinicalTrials.gov.
482 publications indexed, but only 14 randomised controlled trials and 29 registered interventional studies. Human evidence exists but is thin.
SRC // EUROPE PMC + CTGOV // "Survodutide" // FETCHED 2026-10-04 // 482 RECORDS
Most-cited literature
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[01]
Type 2 diabetes mellitus in adults: pathogenesis, prevention and therapy
Lu X, Xie Q, Pan X, Zhang R, Zhang X, Peng G, Zhang Y, Shen S, Tong N. · Signal Transduct Target Ther 2024 · 475 citations · DOI 10.1038/s41392-024-01951-9
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[02]
A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis
Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, An · N Engl J Med 2024 · 426 citations · DOI 10.1056/nejmoa2401755
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[03]
Efficacy and Safety of GLP-1 Medicines for Type 2 Diabetes and Obesity
Drucker DJ. · Diabetes Care 2024 · 292 citations · DOI 10.2337/dci24-0003
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[04]
What is the pipeline for future medications for obesity?
Melson E, Ashraf U, Papamargaritis D, Davies MJ. · Int J Obes (Lond) 2025 · 214 citations · DOI 10.1038/s41366-024-01473-y
Regulatory status
Formal, dated regulatory actions.
US FDA 2026-08
Not approved. Survodutide returns no record in the FDA Drugs@FDA approved-products database and remains investigational; the phase 3 MASH trial LIVERAGE (NCT06632444, 1,800 participants, Boehringer Ingelheim) was still recruiting as of August 2026 with estimated primary completion in 2031.
Common questions
Is survodutide approved anywhere?
No. As of August 2026 it does not appear in the FDA Drugs@FDA approved-products database and no marketing authorisation has been confirmed from any other major regulator. It is an investigational compound in phase 3 trials.
How does it differ from semaglutide or tirzepatide?
Semaglutide targets the GLP-1 receptor alone; tirzepatide targets GLP-1 and GIP. Survodutide targets GLP-1 and the glucagon receptor. Whether that third combination produces clinically different outcomes has not been settled by head-to-head randomised trials.
What is the strongest single piece of human evidence?
The 48-week phase 2 MASH trial published in the New England Journal of Medicine in 2024, which used liver biopsy as its endpoint rather than a surrogate marker. Biopsy endpoints are the hardest evidence available in liver disease, but this was a phase 2 trial of 293 people and the confirmatory phase 3 trials have not reported.
Is it prohibited in sport?
Survodutide is not named on the WADA 2026 Prohibited List. GLP-1 receptor agonists as a class are not prohibited; WADA placed markers of semaglutide and tirzepatide on its Monitoring Program from 1 January 2026, which imposes no sanction. Athletes should confirm current status directly with WADA or their national anti-doping organisation.
Related compounds
Retatrutide
Triple agonist with the strongest phase 2 weight results yet — but not approved anywhere.
Tirzepatide
Dual GIP/GLP-1 agonist. Approved, and outperformed semaglutide in head-to-head trials.
Semaglutide
GLP-1 agonist. Approved, trial-backed, and genuinely effective for weight and glycaemic control.
Mazdutide
A glucagon/GLP-1 dual receptor agonist approved in China by the NMPA for weight management and for type 2 diabetes — a Chinese approval, not a US FDA one; it has no US or EU marketing authorisation.