Survodutide: what the trials show, status and safety
Summary
Survodutide is an experimental injection that switches on two receptors at once: the GLP-1 receptor, which curbs appetite, and the glucagon receptor, which raises energy expenditure. In the largest published trial, people lost 12.2 to 13.0 per cent of their body weight over 76 weeks, against 5.4 per cent on placebo. Stomach and bowel side effects reached almost 90 per cent in one group, and no country has approved it. The American medicines agency names it among the substances sold illegally under a research label.
Key findings at a glance
- The published weight result is 12.2 and 13.0 per cent over 76 weeks. SYNCHRONIZE-1 randomised 725 adults with obesity and without diabetes to two dose levels or placebo, which reached 5.4 per cent. At least 5 per cent of body weight was lost by 72.6, 71.9 and 46.3 per cent of participants (p < 0.001) [1].
- A second, higher figure from the same trial circulates widely. The 16.6 against 3.2 per cent in the developer announcement comes from a different statistical rule, which estimates the effect had everyone stayed on treatment [1], [2].
- The clearest effect is on liver fat. In 216 adults with obesity and fatty liver disease, 68.5 per cent reached a liver fat reduction of at least 30 per cent over 48 weeks, against 28.6 per cent on placebo (p < 0.0001) [3].
- More was not better in the liver tissue trial. Across 293 people with liver inflammation and fibrosis, the middle dose level improved the tissue in 62 per cent, the highest in only 43, the lowest in 47 and placebo in 14 [4].
- Tolerability is the recurring problem. Stomach and bowel symptoms affected 80.9 and 89.7 per cent of the treated groups in phase 3, against 47.9 on placebo, and only 60.4 per cent completed the 46-week phase 2 obesity trial [1], [5].
- The decisive safety trial has no published result. SYNCHRONIZE-CVOT, with 5,531 participants, finished in June 2026 with nothing posted and nothing published [6].
- American regulators name the substance in an enforcement context. The medicines agency lists survodutide among the compounds sold illegally under a research label and warned one company by name in August 2026 [7], [8].
- It is prohibited in sport at all times under the catch-all class for substances with no approval anywhere [9].
What it is
Survodutide is a synthetic peptide of 29 amino acids with a fatty-acid chain attached to the side of the molecule. That chain is what allows long gaps between injections: it binds to blood proteins and slows the removal of the peptide from the body [10], [11], [13].
The Danish company Zealand Pharma discovered it and licensed it to Boehringer Ingelheim, which runs the development programme. It carries no brand name, because it is sold nowhere [3], [6].
Quick facts
| Field | Value | Ref |
|---|---|---|
| Name | Survodutide; development code BI 456906 | [11] |
| Class | Dual glucagon and GLP-1 receptor agonist; acylated peptide of the oxyntomodulin type | [11], [13] |
| Structure | 29 amino acids with a C-terminal amide, a synthetic building block at position 2 and a fatty-acid side chain on a short linker | [11] |
| Formula and mass | C192H289N47O61, 4232 g/mol | [10] |
| Half-life | Never published as a number; the molecule is built for a long interval between injections | [13] |
| Route in trials | Subcutaneous injection, once weekly in almost all groups | [1] |
| Status | Not approved in any market; phase 3 | [6] |
| Developer | Zealand Pharma, licensed to Boehringer Ingelheim | [3] |
| CAS registry number | 2805997-46-8 | [10] |
| PubChem CID | 171378821, and a second entry 168429725 | [10] |
| UNII | 2ALA66NS64 | [11] |
| ChEMBL | CHEMBL5314776 | [12] |
| ATC code | None assigned | [14] |
How it works
The design idea is to pull two levers at once: eat less, and burn a little more.
- The GLP-1 half reduces appetite. It slows the emptying of the stomach and prompts insulin release only when blood sugar is high. Early trials used a delayed uptake of paracetamol in week one as a measurable sign of the slowing [15].
- The glucagon half raises energy expenditure. Glucagon signalling increases the energy the body burns and mobilises fat stored in the liver. Falling levels of certain amino acids in the blood served as an indirect marker that this receptor was being hit [13], [15].
- In animals the combination outperformed a GLP-1 drug alone. The discovery paper reports greater weight reduction than with semaglutide, attributed to both higher energy expenditure and lower food intake. Whether that explanation holds in people is not established [13].
- Part of the liver effect may not run through weight loss. In the phase 2 liver trial, weight loss carried 71.8 per cent of the effect on liver inflammation but only 36.3 per cent of the effect on fibrosis. The authors read the rest as a direct action on the liver [16].
What the trials found
Twenty-six trials are registered, twenty-five of them run by the developer, from the first human study in 2017 to the two phase 3 trials published in 2026 [6].
Weight
Phase 3 RCT SYNCHRONIZE-1 randomised 725 adults of average age 47.1 years, average body mass index 37.9 and average starting weight 108.8 kg. After 76 weeks, average weight was 12.2 per cent below baseline at the lower dose level and 13.0 per cent below at the higher one, against 5.4 per cent on placebo [1].
Phase 3 trial, 725 adults with obesity and without diabetes, 76 weeks, treatment-regimen estimand. Group sizes 241, 242 and 242. Source [1].
Phase 3 RCT Those figures come from the treatment-regimen estimand, which counts every participant as randomised, including people who stopped early. The efficacy estimand instead estimates what would have happened had everyone continued: 16.6 against 3.2 per cent, with 85.1 against 38.8 per cent losing at least 5 per cent (p < 0.0001). This page leads with the lower figure, because it describes the whole group [1], [2].
Phase 2 RCT The earlier dose-finding trial ran 46 weeks in 386 treated adults across four dose levels. Average weight fell 6.2 per cent below baseline at the lowest, then 12.5, 13.2 and 14.9 per cent, against 2.8 per cent on placebo. Only 233 of the 386 finished [5].
Liver fat
Phase 3 RCT SYNCHRONIZE-MASLD treated 216 adults with obesity and fatty liver disease for 48 weeks. A liver fat reduction of at least 30 per cent, measured by magnetic resonance imaging, was reached by 68.5 against 28.6 per cent (p < 0.0001). Weight fell by 8.7 against 1.4 per cent. Both co-primary endpoints were met [3].
Phase 3 RCT Under the efficacy estimand the same trial gives 84.2 against 24.3 per cent for liver fat and 12.2 against 1.0 per cent for weight. The authors name two limits: 48 weeks is short for a liver disease, and recruitment covered only the United States and Spain [3].
Liver tissue, where more was not better
Phase 2 RCT In 293 adults with biopsy-confirmed liver inflammation and fibrosis, the primary endpoint after 48 weeks was improvement of the inflammation without worsening of the scarring. It was reached by 47 per cent at the lowest dose level, 62 at the middle one and 43 at the highest, against 14 per cent on placebo [4].
Phase 2 trial, 293 treated adults with biopsy-confirmed liver inflammation and fibrosis, 48 weeks. The best-fitting model was a curve rather than a straight line (p < 0.001), so the highest dose level performed worse than the middle one. Source [4].
Phase 2 RCT Improvement of the fibrosis by at least one stage reached 34, 36 and 34 per cent against 22 on placebo — a much smaller gap, and not a primary endpoint [4].
Blood sugar
Phase 2 RCT A 16-week trial in 411 adults with type 2 diabetes tested six dose groups against placebo and an open semaglutide arm. From a starting value of 64.7 plus or minus 9.2 mmol/mol (8.07 plus or minus 0.84 per cent), long-term blood sugar fell by between 9.92 mmol/mol (0.91 per cent) and 18.72 mmol/mol (1.71 per cent) [17].
Phase 2 RCT At the lower dose levels that fall matched semaglutide, 15.95 against 16.07 mmol/mol, or 1.46 against 1.47 per cent. At the higher levels weight fell further with survodutide, by 8.7 per cent (95 per cent CI 10.1 to 7.3) against 5.3 (95 per cent CI 6.6 to 4.1) [17].
Observational A later analysis pooled 800 participants from both phase 2 trials. In people with diabetes, markers of insulin production rose and markers of insulin resistance fell; in people without diabetes the production marker did not move, while resistance, glucagon, C-peptide and fasting insulin fell. Whether that lasts after treatment stops is unknown [18].
Pooled results across the early trials
Meta-analysis Six randomised trials with 1,272 participants were pooled before the phase 3 results appeared. Against placebo, fasting glucagon fell by 7 pmol/l (95 per cent CI 10.3 to 3.69; p = 0.016), body weight by 6.7 kg (95 per cent CI 10.0 to 3.4; p < 0.001) and waist circumference by 7.09 cm (95 per cent CI 9.44 to 4.47; p < 0.001). The same analysis found a higher risk of stopping treatment because of side effects [19].
Cardiovascular outcomes, still missing
No result SYNCHRONIZE-CVOT enrolled 5,531 adults with overweight or obesity and measured the time to the first cardiovascular death, stroke, heart attack or ischaemia-driven procedure, to week 114. It finished on 30 June 2026. Nothing is posted in the registry and nothing is published; only the design and the starting characteristics have appeared [6], [20].
The first human studies
Phase 1 The first-in-human work began in 2017 with 24 men. The largest placebo-corrected weight change in the early studies was 5.79 per cent at week 6 and 13.8 per cent at week 16. Reduced appetite was the most common drug-related event, in 9 of 18 participants, or 50.0 per cent, and two, or 8.3 per cent, stopped because of nausea and vomiting [15].
Phase 1 A parallel 16-week study in 36 healthy Japanese men gave placebo-corrected weight changes of 5.57, 12.37 and 9.62 per cent below baseline, against a placebo group that gained 1.06 per cent. Drug-related events occurred in every treated participant [21].
Phase 1 A separate study looked at people with liver cirrhosis. The amount measured in the blood matched that of healthy controls at every severity grade, the confidence intervals around the ratios including 1. Drug-related events affected 82.4 and 87.5 per cent of participants over 28 weeks [22].
What is still unknown
- Three further phase 3 trials. SYNCHRONIZE-2 in 755 people with diabetes, SYNCHRONIZE-CN in 307 Chinese adults and SYNCHRONIZE-JP in 274 Japanese adults have all ended; only design papers exist [6], [23], [24].
- The liver disease endpoints that matter. LIVERAGE, with 1,800 participants, and LIVERAGE-Cirrhosis, with 1,590, are still recruiting; LIVERAGE is due to finish in 2031 [6].
- Long-term safety, immune reactions and pregnancy. Nothing is published on antibodies against the drug, on pregnancy, breastfeeding or children [6].
- Any head-to-head phase 3 comparison. The only direct comparison is an open-label arm in a 16-week phase 2 trial [17].
Side effects and safety
No approved product information exists anywhere, so everything below comes from trial publications rather than a regulator-reviewed label. The pattern is the same in every trial: the stomach and the bowel, worst in the weeks when the amount is raised [1].
- Stomach and bowel symptoms dominate. In the 76-week phase 3 trial they affected 80.9 and 89.7 per cent of the two treated groups, against 47.9 per cent on placebo. Most were mild or moderate, and no deaths were reported [1].
- The individual symptoms are common. In the phase 2 liver trial, nausea affected 66 against 23 per cent, diarrhoea 49 against 23 and vomiting 41 against 4. Serious events occurred in 8 per cent against 7 [4].
- Overall event rates are high. In the phase 2 obesity trial, 281 of 309 treated participants, or 91 per cent, had at least one adverse event, against 58 of 77, or 75 per cent, on placebo [5].
- Many people stopped. Only 233 of 386 participants, or 60.4 per cent, completed the 46-week phase 2 obesity trial. In the Japanese phase 1 study 10 of 27 treated participants, or 37.0 per cent, stopped early, and in the group with the highest dose level tested it was 6 of 9 [5], [21].
- Heart and vessel events led the reasons for stopping in one early study. In part A of the first multiple-dose study, 10 of 80 participants, or 12.5 per cent, withdrew, most often after a cardiac or vascular event, in 6, or 7.5 per cent [15].
- A modest rise in heart rate is described. A 2026 review names it alongside stomach and bowel intolerance as a reason for higher dropout than with comparator drugs, though no figures in the primary trial reports back this up [25].
- One participant stopped for a rising pancreatic enzyme. An amylase increase was the reason for one withdrawal in the Japanese phase 1 study [21].
Two structural gaps matter more than any single number: no regulator has ever assessed this substance, so no risk management plan exists, and the cardiovascular outcome trial that is the standard safety test for this class has produced no public result [6].
The wider class of GLP-1 receptor agonists carries known risks, among them pancreatitis and gallbladder signals and a raised aspiration risk during anaesthesia; whether they apply here cannot be settled without an assessment dossier. The added glucagon component brings theoretical risks of its own, on blood pressure, heart rate and liver metabolism, and no long-term data cover them [6].
Why this page lists no doses
This page gives no amounts for survodutide in any unit, and no escalation schedules or injection intervals. The substance is investigational, approved nowhere, and there is no lawful setting for its use outside a clinical trial; no authority has ever reviewed what amount a person tolerates [6]. The trials show why a figure would mislead: in the liver tissue trial the highest of the three levels tested performed worse than the middle one [4].
This matters because the substance is traded. The American medicines agency names survodutide among the compounds sold to consumers under a false research label, with dosing instructions attached, and calls these products of unknown quality and potentially harmful to health [7].
That is not an abstract warning. In a letter dated 24 August 2026 and published on 1 September, the agency told a peptide seller that its listed products, survodutide among them, are unapproved new drugs: the seller's own website showed they were meant for people, despite the research-use wording [8].
Anything traded under this name comes from elsewhere than the trial manufacturing. Identity, content and sterility are unverified, and no published laboratory analysis of grey-market survodutide exists [7].
Development and approval status
Survodutide is approved in no market in the world. On 17 September 2026 it was in late phase 3 development for obesity, type 2 diabetes and liver disease [6].
From a discovery paper to an unfinished phase 3 programme
- 2017First human studyA single-dose escalation in 24 men opens the clinical programme, ref [15]
- 2022The chemistry is publishedThe discovery paper describes the dual receptor design and the fatty-acid chain, ref [13]
- 2023Accepted into the European support schemeThe code BI 456906 enters the PRIME list for liver disease in November, refs [28], [33]
- 2024Three phase 2 results appearObesity, type 2 diabetes and liver tissue results are published within months of each other, refs [5], [17], [4]
- 2024American designation for liver diseaseThe medicines agency grants an accelerated-development designation in September and two large liver trials start, ref [34]
- 2026Two phase 3 trials publishedSYNCHRONIZE-1 in August and SYNCHRONIZE-MASLD report their results, refs [1], [3]
- 2026The safety trial ends without a resultSYNCHRONIZE-CVOT with 5531 participants finishes on 30 June, nothing posted, ref [6]
- 2031The liver endpoint trial is dueLIVERAGE with 1800 participants is estimated to finish, ref [6]
| Market | Status | Since or note |
|---|---|---|
| United States | Unapproved | Investigational only |
| European Union | Unapproved | No assessment report |
| Germany | Unapproved | Trials only |
| United Kingdom | Unapproved | Unlicensed |
| Australia | Unapproved | Not scheduled |
| Canada | Unapproved | No product entry |
| Switzerland | Unapproved | None found |
Six of these entries rest on register queries run on 17 September 2026, each alongside a control substance in the same database, so a blank result means absence rather than a broken query [26], [27], [29], [30], [31], [32]. The German entry follows from the European one, because this drug class is approved centrally [27].
Two things are easy to misread as approvals. The European PRIME scheme, entered in November 2023, and the American Breakthrough Therapy designation of September 2024 for non-cirrhotic liver disease with moderate to advanced fibrosis are programmes that speed development up. Neither is an approval, and neither says anything about whether one will follow. The developer puts it plainly in its own announcements: the substance is investigational and has not been approved for use [28], [33], [34].
It also appears on no American list of bulk substances for pharmacy compounding, consistent with it not being part of any approved product [36].
The wider legal picture is under are peptides legal and FDA-approved peptides.
Anti-doping
Survodutide is prohibited at all times, in and out of competition. It is not named on the 2026 prohibited list, but falls under class S0, which covers any pharmacological substance with no current approval by any government health authority for human therapeutic use and names drugs under clinical development as an example [9].
That is a different reason from the one that applies to approved incretin drugs: semaglutide is approved, so S0 does not catch it and it does not appear on the list at all. If survodutide were ever approved, its classification would change [9].
Substances in class S0 count as specified substances, which affects how a sanction is measured but not the ban itself. The annex to the German anti-doping statute lists neither survodutide nor any glucagon or GLP-1 receptor agonist — a gap in a closed list, not a permission, since medicines law applies regardless [9], [35].
The full picture is at peptides banned in sport.
Compared with related peptides
| Substance | Receptors | Status | Strongest published weight result | Ref |
|---|---|---|---|---|
| Survodutide | Glucagon and GLP-1 | Phase 3, approved nowhere | 13.0 per cent over 76 weeks, phase 3 | [1] |
| Mazdutide | Glucagon and GLP-1 | Approved in China | See its own page | — |
| Retatrutide | GIP, GLP-1 and glucagon | Phase 3, approved nowhere | See its own page | — |
| Tirzepatide | GIP and GLP-1 | Approved medicine | See its own page | — |
| Semaglutide | GLP-1 only | Approved medicine | See its own page | — |
Survodutide sits in the middle of this field: one receptor more than semaglutide, the same receptor pair as mazdutide, which reached approval in China first [3]. The distance to the approved drugs is evidential as well as regulatory. Tirzepatide and semaglutide have completed cardiovascular outcome trials behind them; survodutide has one that finished in June 2026 and published nothing [6].
Its distinguishing feature is the liver. The glucagon component appears to act on liver fat partly independently of weight loss, which is why two of the three large trials still running are liver trials [6], [16].
Common misconceptions
- "Survodutide is a GLP-1 drug like the approved ones." It activates two receptors, not one, which is why only 36.3 per cent of its effect on liver scarring in the phase 2 analysis ran through weight loss [16].
- "It is a twincretin like tirzepatide." Tirzepatide combines two gut hormones. The glucagon receptor is not a gut hormone receptor, so the mechanisms are not interchangeable [13].
- "Survodutide and mazdutide are the same thing." Both pair glucagon with GLP-1, but they are different molecules from different companies: mazdutide is approved in China, survodutide nowhere [6].
- "Weight loss with survodutide was 16.6 per cent." That figure describes people who stay on treatment. The published main analysis of the whole randomised group reports 12.2 and 13.0 per cent against 5.4 per cent on placebo [1], [2].
- "The support designations mean approval is close." The European PRIME scheme and the American Breakthrough Therapy designation speed development up and say nothing about whether an approval follows. The developer states that the substance has not been approved for use [33], [34].
- "Research-labelled material is the same substance as in the trials." There is no lawful route to survodutide outside a trial, and the American agency has formally warned a company that listed it among its products [7], [8].
Frequently asked questions
What is survodutide?
It is an experimental injectable peptide that activates two receptors at once: the GLP-1 receptor, which reduces appetite and slows the stomach, and the glucagon receptor, which raises the energy the body burns and mobilises fat in the liver. Zealand Pharma discovered it and Boehringer Ingelheim is developing it. It is a medicine in no country.
How much weight did people lose with survodutide?
In the phase 3 trial SYNCHRONIZE-1, 725 adults with obesity and no diabetes were followed for 76 weeks. The published main analysis reports an average change of 12.2 and 13.0 per cent for the two dose levels, against 5.4 per cent on placebo. A second way of analysing the same trial gives 16.6 against 3.2 per cent; both are correct and answer different questions.
Why do two different weight figures for survodutide circulate?
Because the trial was analysed with two statistical rules, called estimands. The treatment-regimen estimand counts everyone as randomised, including people who stopped early, and gives 12.2 and 13.0 per cent. The efficacy estimand estimates the effect if everyone had stayed on treatment, and gives 16.6 per cent. The published paper leads with the first, which is the more conservative.
Is survodutide approved anywhere?
No. Register checks on 17 September 2026 found no approval in the United States, the European Union, Germany, the United Kingdom, Australia, Canada or Switzerland, and none is documented for China or Japan. Each search ran alongside a control substance that was found, so a blank result means absence rather than a broken query. The developer states in its own announcements that the substance has not been approved for use.
What are the side effects of survodutide in the trials?
They are dominated by the stomach and bowel. In the 76-week phase 3 trial, such symptoms affected 80.9 and 89.7 per cent of the two treated groups against 47.9 per cent on placebo. In the phase 2 liver trial, nausea affected 66 against 23 per cent, diarrhoea 49 against 23 and vomiting 41 against 4. Most were mild or moderate.
How many people stopped taking survodutide?
A lot, and this is the central caveat of the programme. In the 46-week phase 2 obesity trial only 233 of 386 participants, or 60.4 per cent, completed the treatment phase. In an early Japanese study, 10 of 27 treated participants, or 37.0 per cent, stopped early; in the group with the highest dose level tested it was 6 of 9.
Did higher doses of survodutide work better in the liver trial?
No, and that is unusual. In the 48-week phase 2 trial in 293 people with liver inflammation and scarring, the middle dose level improved the liver tissue in 62 per cent of participants, the highest in only 43 per cent, the lowest in 47 and placebo in 14. The best-fitting statistical model was a curve, not a straight line.
Is survodutide the same as tirzepatide, retatrutide or mazdutide?
No. Tirzepatide combines GIP and GLP-1, two gut hormones. Retatrutide adds glucagon to those two, making three receptors. Mazdutide combines glucagon and GLP-1 like survodutide, but it is a different molecule from a different company and is approved in China. Survodutide is approved nowhere.
Is survodutide banned in sport?
Yes, at all times, in and out of competition. It is not listed by name on the 2026 prohibited list but falls under class S0, the catch-all for any pharmacological substance with no current approval from a government health authority, which explicitly includes drugs under clinical development. Substances in that class count as specified substances, which affects how a sanction is measured but not the ban.
Why is survodutide sold online if it is not approved?
It is sold illegally. The American medicines agency names survodutide among the substances sold to consumers under a false research label, calls such products of unknown quality and warns people not to buy them. In August 2026 it formally warned one company that listed survodutide among its products. Nothing traded that way comes from the trial manufacturing.
Sources
- le Roux CW, Wharton S, Startseva E, et al.; SYNCHRONIZE-1 Investigators (2026). Survodutide Once Weekly for the Treatment of Adults with Obesity. New England Journal of Medicine 395(8):776-787. PMID 42253238. DOI 10.1056/NEJMoa2600751.
- Zealand Pharma A/S. Company announcement of 28 April 2026 on the topline results of SYNCHRONIZE-1, distributed via GlobeNewswire. Reports 16.6 against 3.2 per cent and 85.1 against 38.8 per cent responders under the efficacy estimand.
- Kaplan LM, Startseva E, le Roux CW, et al.; SYNCHRONIZE-MASLD Investigators (2026). Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease. Nature Medicine 32(8):2948-2958. PMID 42252333. DOI 10.1038/s41591-026-04479-3. Author correction of 25 August 2026, PMID 42642663. Contains the licence statement naming Zealand Pharma and Boehringer Ingelheim.
- Sanyal AJ, Bedossa P, Fraessdorf M, et al.; 1404-0043 Trial Investigators (2024). A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. New England Journal of Medicine 391(4):311-319. PMID 38847460. DOI 10.1056/NEJMoa2401755.
- le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM (2024). Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes & Endocrinology 12(3):162-173. PMID 38330987. DOI 10.1016/S2213-8587(23)00356-X. Erratum 2026;14(2):e2.
- ClinicalTrials.gov, API v2, queried 17 September 2026. Overall query for the substance returns 26 trials, 25 sponsored by Boehringer Ingelheim and one by University Medical Center Groningen. Individual records read: NCT06066528 (SYNCHRONIZE-2), NCT06077864 (SYNCHRONIZE-CVOT), NCT06214741 (SYNCHRONIZE-CN), NCT06176365 (SYNCHRONIZE-JP), NCT06632444 (LIVERAGE), NCT06632457 (LIVERAGE-Cirrhosis). All four completed phase 3 trials show hasResults false.
- US Food and Drug Administration. "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", content current as of 1 September 2026, retrieved 17 September 2026. Names survodutide among the substances sold under a false research label and calls the products of unknown quality. https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- US Food and Drug Administration. Warning letter to NuScience Peptides LLC, reference 733652, dated 24 August 2026, published 1 September 2026. Lists "Survodutide" among the unapproved new drugs and states that website evidence shows the products are intended for human use despite the research-use labelling. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026
- World Anti-Doping Agency. The 2026 Prohibited List, in force 1 January 2026. Class S0 read in full on 17 September 2026; no match for the substance name or the development code, and classes S2 and S4.4 checked individually.
- PubChem, PUG-REST, queried 17 September 2026. CID 171378821 and CID 168429725, both with formula C192H289N47O61 and mass 4232, differing only in the stereochemistry block of the InChIKey. CAS 2805997-46-8.
- FDA/NCATS Global Substance Registration System, UNII 2ALA66NS64, queried 17 September 2026. Peptide sequence of both subunits, the side-chain acylation, the C-terminal amide and the substitution at position 2.
- ChEMBL, CHEMBL5314776, molecule type protein, maximum phase 3, first approval null, queried 17 September 2026.
- Zimmermann T, Thomas L, Baader-Pagler T, et al. (2022). BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy. Molecular Metabolism 66:101633. PMID 36356832. DOI 10.1016/j.molmet.2022.101633.
- WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2026, queried 17 September 2026: no match, against A10BJ06 for the control substance semaglutide.
- Jungnik A, Arrubla Martinez J, Plum-Mörschel L, et al. (2023). Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/GLP-1 receptor agonist BI 456906. Diabetes, Obesity and Metabolism 25(4):1011-1023. PMID 36527386. DOI 10.1111/dom.14948.
- Noureddin M, Sanyal AJ, Bedossa P, et al. (2026). Weight reduction-dependent and -independent effects of survodutide on liver endpoints: mediation analysis of a phase 2 trial in MASH. Hepatology, online ahead of print. PMID 42545725. DOI 10.1097/HEP.0000000000001825. 170 participants with fibrosis stage 2 or 3 and paired biopsies.
- Blüher M, Rosenstock J, Hoefler J, Manuel R, Hennige AM (2024). Dose-response effects on HbA1c and bodyweight reduction of survodutide compared with placebo and open-label semaglutide in people with type 2 diabetes. Diabetologia 67(3):470-482. PMID 38095657. DOI 10.1007/s00125-023-06053-9. Correction 2024;67(4):758.
- Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C (2026). Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity. Diabetes, Obesity and Metabolism 28(9):8242-8253. PMID 42331726. DOI 10.1111/dom.70861.
- Xiao YJ, Yu S, Zhang YL, et al. (2025). Efficacy and safety of survodutide on glycemic control and weight loss in adults: a systematic review and meta-analysis. Diabetes, Obesity and Metabolism 27(12):7062-7074. PMID 40922121. DOI 10.1111/dom.70105.
- Platz E, Kaplan LM, le Roux CW, et al. (2026). Survodutide for the Treatment of Obesity: Baseline Characteristics of the SYNCHRONIZE Cardiovascular Outcomes Trial. JACC: Heart Failure 14(5):102780. PMID 41329105. DOI 10.1016/j.jchf.2025.102780.
- Yazawa R, Ishida M, Balavarca Y, Hennige AM (2023). A randomized Phase I study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 456906 in healthy Japanese men with overweight or obesity. Diabetes, Obesity and Metabolism 25(7):1973-1984. PMID 36974349. DOI 10.1111/dom.15064.
- Lawitz EJ, Fraessdorf M, Neff GW, et al. (2024). Efficacy, tolerability and pharmacokinetics of survodutide in cirrhosis. Journal of Hepatology 81(5):837-846. PMID 38857788. DOI 10.1016/j.jhep.2024.06.003.
- Ji L, Chen L, Cheng Z, et al. (2026). Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline Characteristics (SYNCHRONIZE-CN). Diabetes Therapy, online ahead of print. PMID 42599381. DOI 10.1007/s13300-026-01908-x.
- Yokote K, Yamauchi T, Fukushima Y, et al.; SYNCHRONIZE-JP Trial Investigators (2026). Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics. Diabetes, Obesity and Metabolism 28(8):6595-6606. PMID 42219222. DOI 10.1111/dom.70862.
- Arun AJ, Darji B, Baig M, Frishman WH, Aronow WS (2025). Survodutide: A Dual GLP-1/Glucagon Agonist Reshaping Cardiometabolic Care. Cardiology in Review, online ahead of print. PMID 40963161. DOI 10.1097/CRD.0000000000001062.
- openFDA, queried 17 September 2026: the approvals, label and enforcement endpoints each returned no record for the substance, while the control query for semaglutide returned records in all three.
- European Medicines Agency, dataset of European public assessment reports, downloaded and searched 17 September 2026: no entry for the substance name or the development code, against a hit for the control substance semaglutide in the same file.
- European Medicines Agency, list of medicines currently in the PRIME scheme, EMA/521657/2016, version of 10 August 2026: the development code BI 456906 is listed under gastroenterology and hepatology for the treatment of fatty liver disease with fibrosis. PRIME is a development support scheme, not an approval.
- Electronic Medicines Compendium, United Kingdom, queried 17 September 2026: no result for the substance, against 20 results for the control substance semaglutide. The regulator's own product register could not be queried, because it loads results dynamically.
- Federal Register of Legislation, Australia. Therapeutic Goods (Poisons Standard, June 2026) Instrument 2026, full text searched 17 September 2026: no match for the substance, against entries for semaglutide and tirzepatide. The register of therapeutic goods itself was unreachable that day, so this entry rests on the Poisons Standard alone.
- Health Canada, Drug Product Database, active ingredient endpoint, queried 17 September 2026: empty result, against multiple records for the control substance semaglutide.
- Swissmedic, extended list of authorised human medicines with active ingredients and the list of authorised products, both searched 17 September 2026: no match for the substance or the development code, against entries for the control substances.
- Zealand Pharma A/S. Company announcement of 7 June 2026 via GlobeNewswire on the body composition data from SYNCHRONIZE-1. Contains the statement that survodutide is an investigational agent that has not been approved for use, and lists the development designations including the European PRIME entry of November 2023.
- Zealand Pharma A/S and Boehringer Ingelheim. Company announcement of 8 October 2024 via GlobeNewswire on the American Breakthrough Therapy designation of September 2024 for non-cirrhotic liver disease with moderate to advanced fibrosis, and on the start of the two phase 3 liver trials.
- Annex to section 2(3) of the German anti-doping act, official citation BGBl. 2023 I no. 67, sections I to III read in full on 17 September 2026: no entry for the substance, the development code, or glucagon and GLP-1 receptor agonists as a group.
- US Food and Drug Administration. Bulk drug substances used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act, content current as of 14 May 2026, retrieved 17 September 2026: survodutide is not named.
Cite this page
The facts on this page were checked on 17 September 2026, and every register behind the status table was queried that day. Two things could move quickly: the cardiovascular outcome trial could report, and three further phase 3 trials could publish.
myPeptides Research & Editing. (2026). Survodutide: what the trials show, status and safety. Version 1.0, 17 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/survodutide
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-17 | Initial publication |
Last verified: 17 September 2026. Next review: on publication of the cardiovascular outcome trial, on any approval decision, or on any change to the anti-doping classification.