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Weight loss · Evidence tier A

Survodutide

BI 456906 (Boehringer Ingelheim development code)

Survodutide is an experimental weekly weight-loss injection from Boehringer Ingelheim. In a 76-week trial, adults with obesity or overweight and no diabetes lost 12.2% to 13.0% of their weight, versus 5.4% on placebo1. It is not approved anywhere23.

Last reviewed · First published · 32 sources · 24 min read · By the Pinc Peptide editors

Illustration: a glass vial with a pink label reading Survodutide
Illustration, not a real product: an empty glass vial (photo: Missouri Historical Society, public domain) with our label. See every vial.

Quick answers

What is it?
An experimental weekly weight-loss injection from Boehringer Ingelheim, which licensed it from Zealand Pharma2. This lab-made peptide acts like two hormones at once, GLP-1 and glucagon24. It is not approved anywhere23.
Does it work?
Yes, in large trials. In a 76-week trial, adults with overweight or obesity and no diabetes lost 12.2% to 13.0% of their weight, versus 5.4% on placebo1. In a second 76-week trial, adults with type 2 diabetes lost 8.2% to 9.8%, versus 3.9% on placebo5.
Is it safe?
Not fully known. In a 76-week trial, gut side effects affected 80.9% to 89.7% of people on it, versus 47.9% on placebo1. In that trial, 17.8% to 20.2% stopped because of them, versus 2.9% on placebo3. Heart-safety trial results are expected later in 20262.
Is it legal?
It is not approved anywhere23. By our reading, US pharmacies may not make it67. FDA has warned companies that sold it falsely labeled “for research purposes”8. In sport, it is likely banned under a catch-all rule910.
What is in the vials?
Half of the completed tests failed. Of 27 tests that Finnrick, an independent testing service, listed from April 2025 to April 2026, 13 failed and 1 was incomplete11. A pass needs at least 99.5% purity and a dose within 35% of the label11.

What it is

Survodutide (development code BI 456906) is a lab-made peptide of 29 amino acids derived from glucagon, with added activity at the receptor for GLP-1 (glucagon-like peptide-1), the target of semaglutide412. It mimics oxyntomodulin, a natural gut hormone that activates both receptors and lowers body weight in humans by raising energy expenditure and reducing food intake412, and the KEGG drug database classes it as an oxyntomodulin analog13. The glucagon receptor activity is meant to add weight loss by raising energy expenditure, on top of the appetite-curbing effect of GLP-1 drugs4. Zealand Pharma, which licensed it to Boehringer Ingelheim, says it was deliberately designed with a strong bias toward the GLP-1 receptor, and that glucagon reduces liver fat14. In obese mice it cut body weight by up to 32% in 28 days, versus 25% to 27% on semaglutide, but the difference was significant only against the lower semaglutide dose12. A C18 fatty acid binds it to albumin in the blood, which prolongs its half-life enough for once-weekly injection4.

In June 2011 Zealand Pharma and Boehringer Ingelheim (BI) signed a license, research and development agreement to advance dual glucagon/GLP-1 peptides, and BI obtained global rights to the lead candidate, survodutide14. BI funds all development and is solely responsible for developing and selling it worldwide214. Its design and animal data were published in 2022 and the first human studies in 20231215. As of 31 December 2025, Zealand was eligible for up to EUR 315 million in milestone payments plus royalties on sales14. BI’s Phase 3 program in obesity is called SYNCHRONIZE14. In October 2024 BI started two Phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, in MASH (metabolic dysfunction-associated steatohepatitis, fatty liver disease with inflammation) with liver scarring or cirrhosis1416.

Benefits: what the research shows

Survodutide has been tested in large placebo-controlled trials. In SYNCHRONIZE-1, 725 adults with obesity or overweight and no diabetes lost 12.2% (3.6 mg) and 13.0% (6.0 mg) of body weight at 76 weeks, versus 5.4% on placebo, counting people who stopped treatment or took other weight-loss drugs1; by the efficacy estimand, which assumes everyone stayed on treatment, the figures were 15.3% and 16.6% versus 3.2%3. In SYNCHRONIZE-2, 752 adults with obesity or overweight and type 2 diabetes lost 8.2% and 9.8% versus 3.9% at 76 weeks, and HbA1c (average blood sugar) fell 0.9 and 0.8 points versus 0.2 from a baseline of 7.4%5; BI’s headline figure, by the efficacy estimand, was up to 13.1% versus 3.1%2. In SYNCHRONIZE-MASLD, 216 adults with obesity and fatty liver disease received 6.0 mg or placebo for 48 weeks: liver fat fell by at least 30% in 68.5% versus 28.6%, and weight fell 8.7% versus 1.4%, counting people who stopped; by the efficacy estimand the figures were 84.2% versus 24.3% and 12.2% versus 1.0%19. In a 48-week Phase 2 trial in 293 adults with biopsy-confirmed MASH and liver scarring (fibrosis stages F1 to F3), MASH improved without worse scarring in 47%, 62% and 43% on 2.4, 4.8 and 6.0 mg, versus 14% on placebo16. There are important limits. BI sponsored all of the trials described here1516192021. In SYNCHRONIZE-1 the placebo group lost 5.4%, more than the 2% to 3% assumed when the trial was planned, and more than 16% of that group reported using a prohibited GLP-1-based medicine while still enrolled3. The heart-safety trial, SYNCHRONIZE-CVOT, enrolled 5,531 people and was completed on 30 June 2026, but no results had been posted as of 7 October 202622; BI expects to present them later in 20262. In the 46-week Phase 2 obesity trial (387 adults), weight fell by up to 14.9% versus 2.8% on placebo when people were analyzed by the dose they were assigned, and only 60.4% completed treatment, with similar rates on survodutide and placebo20. Zealand’s widely quoted figure of up to 18.7% comes from an analysis by the dose people actually reached while on treatment2023. LIVERAGE, the Phase 3 trial in MASH with moderate or advanced scarring, aims to enroll about 1,800 people, with primary completion estimated for 27 December 203124. The only comparison with semaglutide is a 16-week Phase 2 trial in type 2 diabetes, in which weight fell by up to 8.7% (1.8 mg twice weekly) versus 5.3% on open-label semaglutide up to 1.0 mg weekly21.

Key human studies

StudyDesignPeopleDose and routeResult
le Roux et al., N Engl J Med 2026 (SYNCHRONIZE-1)1PubMed · DOI · NCT06066515 Phase 3 randomized, double-blind, placebo-controlled trial (1:1:1), 76 weeks; adults with BMI 30 or more (27 or more with a weight-related condition), without diabetes; 116 sites in 14 countries 725 Dose adjusted up to 3.6 mg or 6.0 mg, subcutaneous once weekly, or placebo, with diet and activity counseling Body weight -12.2% (3.6 mg) and -13.0% (6.0 mg) vs -5.4% with placebo (treatment-regimen estimand)1; -15.3% and -16.6% vs -3.2% (efficacy estimand)3. Gastrointestinal adverse events 80.9% and 89.7% vs 47.9%1; they led 17.8% and 20.2% vs 2.9% to stop3.
Wharton et al., N Engl J Med 2026 (SYNCHRONIZE-2)5PubMed · DOI · NCT06066528 Phase 3 randomized, double-blind, placebo-controlled multinational trial (1:1:1), 76 weeks; adults with type 2 diabetes and BMI 27 or more 752 3.6 mg or 6.0 mg subcutaneous once weekly, or placebo Body weight -8.2% and -9.8% vs -3.9% with placebo (treatment-regimen estimand); HbA1c -0.9 and -0.8 points vs -0.2 from a baseline of 7.4%; gastrointestinal adverse events 72.8% and 77.7% vs 38.6%5. By the efficacy estimand, BI reported weight loss of up to 13.1% vs 3.1%2.
Kaplan et al., Nat Med 2026 (SYNCHRONIZE-MASLD)19PubMed · DOI · NCT06309992 Phase 3 randomized, double-blind, placebo-controlled trial (2:1), 48 weeks; adults with obesity and fatty liver disease with signs of inflammation or scarring (at-risk MASLD), with or without type 2 diabetes; sites in the US and Spain 216 6.0 mg subcutaneous once weekly, or placebo Liver fat down 30% or more in 68.5% vs 28.6% (treatment-regimen estimand) and 84.2% vs 24.3% (efficacy estimand); body weight -8.7% vs -1.4% and -12.2% vs -1.0%. Gastrointestinal adverse events led 19.9% vs 4.3% to stop19.
Sanyal et al., N Engl J Med 202416PubMed · DOI · NCT04771273 Phase 2 randomized, placebo-controlled trial (1:1:1:1), 48 weeks (24 weeks of rapid dose escalation, 24 of maintenance); adults with biopsy-confirmed MASH and fibrosis stages F1 to F3 293 2.4, 4.8 or 6.0 mg subcutaneous once weekly, or placebo Improvement in MASH without worsening of fibrosis 47%, 62% and 43% vs 14%; liver fat down 30% or more 63%, 67% and 57% vs 14%; fibrosis better by at least one stage 34%, 36% and 34% vs 22%. Nausea 66% vs 23%, vomiting 41% vs 4%; serious adverse events 8% vs 7%16.
le Roux et al., Lancet Diabetes Endocrinol 202420PubMed · DOI · NCT04667377 Phase 2 randomized, double-blind, placebo-controlled dose-finding trial, 46 weeks (20 weeks of dose escalation, 26 of maintenance); adults with BMI 27 or more without diabetes, at 43 centers in 12 countries 387 0.6, 2.4, 3.6 or 4.8 mg subcutaneous once weekly, or placebo Body weight -6.2%, -12.5%, -13.2% and -14.9% vs -2.8% with placebo (by assigned dose). Gastrointestinal adverse events 75% vs 42%. 60.4% of treated participants completed the 46 weeks20.
Blüher et al., Diabetologia 202421PubMed · DOI · NCT04153929 Phase 2 randomized trial, 16 weeks; adults with type 2 diabetes on metformin; survodutide and placebo double-blind, semaglutide open-label 413 Survodutide up to 0.3, 0.9, 1.8 or 2.7 mg once weekly or 1.2 or 1.8 mg twice weekly, subcutaneous; placebo; or semaglutide up to 1.0 mg once weekly HbA1c down by up to 1.71 points. Body weight down by up to 8.7% (1.8 mg twice weekly) vs 5.3% with semaglutide. Adverse events 77.8% on survodutide, 52.5% on placebo and 52.0% on semaglutide21.

Doses studied

Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.

In human studies

No dose is approved. In the Phase 3 SYNCHRONIZE-1 and SYNCHRONIZE-2 trials, the dose was raised gradually to a target of 3.6 mg or 6.0 mg once weekly, injected under the skin, for 76 weeks in total15. SYNCHRONIZE-MASLD used 6.0 mg weekly for 48 weeks19. The Phase 2 obesity trial tested 0.6, 2.4, 3.6 and 4.8 mg weekly over 46 weeks20, and the Phase 2 MASH trial tested 2.4, 4.8 and 6.0 mg weekly over 48 weeks16. A 16-week Phase 2 trial in type 2 diabetes tested doses up to 2.7 mg weekly or 1.8 mg twice weekly21.

In animal studies

Mice: diet-induced obese male mice received daily injections under the skin of 3, 10, 20 or 30 nmol/kg for 30 days, compared with semaglutide at 20 or 100 nmol/kg12. These are research doses in animals, not human doses.

What users report

No community dosing page was cited for this compound.

Routes
  • Subcutaneous injection once weekly (one Phase 2 trial also tested twice weekly); the only route in the human studies we found
  • No human data found for any other route

Every dose studied for Survodutide, with sources →

Quality and the gray market

What testing finds

Finnrick, an independent testing service, listed 27 survodutide tests dated 25 April 2025 to 23 April 2026: 13 passed, 13 failed and 1 was incomplete, so half of the completed tests failed (as displayed on 7 October 2026)11. Its default “Purity focus” standard requires purity of at least 99.5% and a measured dose within 35% of the label11. A Finnrick correction dated 1 August 2025 says one vendor’s survodutide results were under review11. Finnrick also offers free mail-in testing to US users, so by our reading its results may not represent the whole market11.

How it is sold

Survodutide is sold online as vials labeled for research use. FDA says companies have illegally sold unapproved drugs containing survodutide and other GLP-1 drugs, falsely labeled “for research purposes” or “not for human consumption”, directly to consumers for human use with dosing instructions (page current 1 October 2026)8. As of 7 October 2026, FDA’s warning-letter database listed two letters naming survodutide26. In the first, dated 10 December 2024, FDA said Xcel Research LLC’s website, reviewed in October 2024, offered products including “MAZDUTIDE” and “SURVODUTIDE”, and that despite “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE” labels its products were intended as drugs for human use27. In the second, dated 24 August 2026, FDA told NuScience Peptides LLC, after a website review in July 2026, that its “Survodutide” and “Mazdutide” products were unapproved new drugs despite labels saying they were “not intended for human or veterinary use”28. We found no verified price or demand data.

Side effects and risks

  • Gut side effects are very common: in SYNCHRONIZE-1, 80.9% and 89.7% of people on 3.6 mg and 6.0 mg had gastrointestinal adverse events, versus 47.9% on placebo1, and 17.8% and 20.2% stopped treatment because of them, versus 2.9%3. They were most common while the dose was being raised3.
  • Heart rate rose by 3.2 to 3.5 beats per minute at week 76 in SYNCHRONIZE-13, and by 3.6 versus 0.8 beats per minute on placebo at week 52 in SYNCHRONIZE-MASLD19.
  • In an early study that raised the dose over 6 weeks, 10 of 80 people (12.5%) stopped survodutide, most often because of a heart or blood-vessel adverse event (6 people)15.
  • Symptomless rises in pancreatic enzymes were slightly more common on survodutide than on placebo in SYNCHRONIZE-1; no acute pancreatitis was confirmed3.
  • Long-term effects are unknown: the longest published trials ran 76 weeks, and the heart-safety trial (5,531 people, completed 30 June 2026) had not reported as of 7 October 20261222.
  • Gray-market products are of unknown quality: half of the completed Finnrick tests of survodutide failed11.
  • Legal and sport risk: FDA has warned sellers over survodutide sold for human use828, and athletes risk an S0 anti-doping violation, by our reading of the WADA List9.

Questions people ask

Is survodutide FDA approved?

No. Boehringer Ingelheim said on 1 October 2026 that survodutide has not been approved for use, and Drugs@FDA lists no product containing it225. FDA has granted it Fast Track and Breakthrough Therapy designations for MASH, a fatty liver disease, but these are not approvals2.

How much weight do people lose on survodutide?

In SYNCHRONIZE-1, adults with obesity or overweight and no diabetes lost 12.2% to 13.0% of their weight over 76 weeks, versus 5.4% on placebo, counting people who stopped treatment1. By the efficacy estimand, which assumes everyone stayed on treatment, the figures were 15.3% and 16.6% versus 3.2%3. People with type 2 diabetes lost less: 8.2% to 9.8% versus 3.9%5.

Does survodutide help fatty liver disease?

In a 48-week trial in adults with obesity and fatty liver disease, liver fat fell by at least 30% in 68.5% of people on 6.0 mg versus 28.6% on placebo, counting people who stopped19. In a 48-week Phase 2 trial in MASH with liver scarring, MASH improved in up to 62% of people versus 14% on placebo16. A larger Phase 3 trial in MASH is still running24.

What are the side effects of survodutide?

Mostly gut effects such as nausea, vomiting, diarrhea and constipation, most often while the dose is being raised3. In SYNCHRONIZE-1 they affected 80.9% to 89.7% of people on survodutide versus 47.9% on placebo, and heart rate rose by 3.2 to 3.5 beats per minute13.

When will survodutide be available?

No date has been announced. Zealand Pharma said in February 2026 that Phase 3 results could pave the way for regulatory submission in 202614. BI’s release of 1 October 2026 named no filing date and said heart-safety results are expected later in 20262.

Is survodutide banned in sport?

It is not named on WADA’s 2026 or 2027 Prohibited List910. Because no regulator has approved it, by our reading it falls under S0, WADA’s ban on non-approved substances9. WADA warns that unnamed peptides may still be prohibited31.

Survodutide vs semaglutide: what’s the difference?

Semaglutide, an approved drug, acts on the GLP-1 receptor; survodutide also acts on the glucagon receptor, which is meant to raise energy expenditure, and is not approved24. The only head-to-head data come from a 16-week trial in type 2 diabetes, where weight fell by up to 8.7% on survodutide versus 5.3% on open-label semaglutide up to 1.0 mg21.

What is still unknown

  • Results of SYNCHRONIZE-CVOT, the heart-safety trial (completed 30 June 2026; BI expects to present results later in 2026).
  • Human half-life: the Phase 1 abstracts we read give no value, and their full texts were not accessible to us.
  • When, and to which regulators, Boehringer Ingelheim will apply for approval.
  • Phase 3 results in MASH with liver scarring (LIVERAGE; primary completion estimated 27 December 2031).
  • How much the placebo group’s use of other GLP-1 drugs (more than 16%) narrowed the measured difference in SYNCHRONIZE-1.
  • Effects beyond 76 weeks, including whether weight returns after stopping, and effects on lean mass.
  • Whether survodutide has a USP or NF monograph (not checked).
  • UK, EU, Canadian and wider Australian rules (not verified).
  • WADA has not ruled on survodutide by name; the S0 status is our reading of the List.

Sources

  1. 1Survodutide Once Weekly for the Treatment of Adults with Obesity New England Journal of Medicine, 20 Aug 2026. pubmed.ncbi.nlm.nih.gov
  2. 2Boehringer Ingelheim’s survodutide achieves up to 13.1% weight loss in new Phase III trial, alongside significant improvements in glycemic control in people with obesity and type 2 diabetes Boehringer Ingelheim (GlobeNewswire), 1 Oct 2026. globenewswire.com
  3. 3Survodutide Phase 3 Data Signal Metabolic Gains Beyond Weight Loss AJMC (The American Journal of Managed Care), 8 Jun 2026. ajmc.com
  4. 4Perspectives in weight control in diabetes - Survodutide Diabetes Research and Clinical Practice, Jan 2024. pubmed.ncbi.nlm.nih.gov
  5. 5Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes New England Journal of Medicine, 1 Oct 2026. pubmed.ncbi.nlm.nih.gov
  6. 6Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act U.S. Food and Drug Administration, 14 May 2026. fda.gov
  7. 7Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
  8. 8FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss U.S. Food and Drug Administration, 1 Oct 2026. fda.gov
  9. 9World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
  10. 10World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
  11. 11Survodutide Safety Testing Results & Vendor Ratings Finnrick, accessed 7 Oct 2026. finnrick.com
  12. 12BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy Molecular Metabolism, Dec 2022. pubmed.ncbi.nlm.nih.gov
  13. 13KEGG DRUG: Survodutide (D12898) KEGG, Kanehisa Laboratories, accessed 7 Oct 2026. kegg.jp
  14. 14Zealand Pharma Annual Report 2025 Zealand Pharma A/S, 19 Feb 2026. zealandpharma.com
  15. 15Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906 Diabetes, Obesity and Metabolism, Apr 2023. pubmed.ncbi.nlm.nih.gov
  16. 16A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis New England Journal of Medicine, 25 Jul 2024. pubmed.ncbi.nlm.nih.gov
  17. 17Proposed International Nonproprietary Names: List 128 (WHO Drug Information, Vol. 36, No. 4) World Health Organization, 2022. cdn.who.int
  18. 18PubChem Compound Summary: CID 171378821 (synonyms include survodutide) PubChem, U.S. National Library of Medicine, accessed 7 Oct 2026. pubchem.ncbi.nlm.nih.gov
  19. 19Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial Nature Medicine, Aug 2026. pubmed.ncbi.nlm.nih.gov
  20. 20Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial The Lancet Diabetes & Endocrinology, Mar 2024. pubmed.ncbi.nlm.nih.gov
  21. 21Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial Diabetologia, Mar 2024. pubmed.ncbi.nlm.nih.gov
  22. 22A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) (NCT06077864) ClinicalTrials.gov, 30 Sep 2026. clinicaltrials.gov
  23. 23Transforming the future of metabolic health: J.P. Morgan 44th Healthcare Conference 2026 Zealand Pharma A/S, 14 Jan 2026. zealandpharma.com
  24. 24LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis (NCT06632444) ClinicalTrials.gov, 1 Oct 2026. clinicaltrials.gov
  25. 25Drugs@FDA via openFDA: search for active ingredient survodutide (no matches) U.S. Food and Drug Administration (openFDA), 6 Oct 2026. api.fda.gov · data query
  26. 26Warning Letters (database search for survodutide) U.S. Food and Drug Administration, accessed 7 Oct 2026. fda.gov
  27. 27Warning letter to Xcel Research LLC (MARCS-CMS 694608) U.S. Food and Drug Administration, 10 Dec 2024. fda.gov
  28. 28Warning letter to NuScience Peptides LLC (MARCS-CMS 733652) U.S. Food and Drug Administration, 24 Aug 2026. fda.gov
  29. 2921 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A (eCFR, as of 25 September 2026) Electronic Code of Federal Regulations (eCFR), 25 Sep 2026. ecfr.gov
  30. 30Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
  31. 31Summary of Major Modifications and Explanatory Notes: 2027 Prohibited List World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
  32. 32WADA publishes 2027 Prohibited List World Anti-Doping Agency, 21 Sep 2026. wada-ama.org

Not medical advice. This page reports what studies and regulators say; it does not recommend using any product. How we grade evidence · Report an error.