Summary
Survodutide is an investigational once weekly peptide that activates both the glucagon and GLP-1 receptors, developed for obesity and metabolic dysfunction associated steatohepatitis (MASH). In the 76 week phase 3 SYNCHRONIZE-1 trial (n = 725) it produced 12.2% to 13.0% weight loss versus 5.4% on placebo, and in a 48 week phase 2 MASH trial (n = 293) up to 62% of participants had histologic MASH improvement versus 14% on placebo. As of September 2026 it is not FDA approved, cannot lawfully be compounded, and is prohibited in sport under WADA section S0.
What is Survodutide?
Survodutide is an investigational dual agonist of the glucagon and GLP-1 receptors (acylated peptide, once weekly). It is also known as BI 456906, glucagon/GLP-1 dual agonist, survodutide (BI 456906).
How does it work?
Survodutide is a glucagon analog engineered to also activate the GLP-1 receptor. GLP-1 receptor activation reduces appetite, slows gastric emptying, and increases glucose dependent insulin release. Glucagon receptor activation increases energy expenditure and hepatic fat oxidation, which is the rationale for its liver disease program, but also raises glucose output, which the GLP-1 component is designed to offset. It is acylated for once weekly dosing.
| Cluster | GLP-1 and incretin agonists |
|---|---|
| Routes | Subcutaneous injection once weekly (clinical trials only) |
| Conditions studied | Obesity and chronic weight management; Fatty liver disease (MASLD and MASH) |
| Record | v2, draft, verified Sep 27, 2026 |
What does the evidence say about Survodutide?
One published phase 3 obesity trial (SYNCHRONIZE-1, n = 725, 76 weeks), one phase 3 trial in obesity with MASLD (n = 216), a phase 2 MASH trial (n = 293, 48 weeks), and phase 1 and 2 dose finding studies. Weight loss in phase 3 was 12.2% (3.6 mg) and 13.0% (6.0 mg) versus 5.4% on placebo, a smaller placebo adjusted effect than tirzepatide or retatrutide in their trials. Those are treatment regimen estimand figures; under the efficacy estimand, which assumes participants stayed on treatment, the manufacturer reported up to 16.6% versus 3.2% on placebo. Histologic MASH improvement without worsening fibrosis occurred in 43% to 62% versus 14% on placebo in phase 2. A cardiovascular outcomes trial (SYNCHRONIZE-CVOT) is ongoing.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 4 | 1270 |
| Human observational studies | 0 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 4 | 1,270 |
Human evidence
SYNCHRONIZE-1 (2026): 725 adults with BMI 30 or higher (or 27 with a complication) without diabetes, once weekly survodutide up to 3.6 mg or 6.0 mg or placebo for 76 weeks; mean weight change minus 12.2% (3.6 mg), minus 13.0% (6.0 mg), minus 5.4% (placebo) by treatment regimen estimand; 72.6%, 71.9%, and 46.3% lost at least 5%. Phase 2 MASH (2024): 293 adults with biopsy confirmed MASH and F1 to F3 fibrosis, 48 weeks; improvement in MASH without worsening fibrosis in 47% (2.4 mg), 62% (4.8 mg), and 43% (6.0 mg) versus 14% placebo; liver fat reduction of at least 30% in 63% to 67% of treated participants. SYNCHRONIZE-MASLD (2026): 216 adults with obesity and MASLD, phase 3, placebo controlled. Phase 1 (2023): 36 Japanese men with overweight or obesity, 16 weeks; placebo corrected weight change up to minus 12.4% at 4.8 mg weekly, with 37% withdrawing from escalation because of adverse events.
Animal evidence
Preclinical rodent studies established the dual receptor pharmacology, the additive weight effect of glucagon receptor agonism, and reductions in liver fat. Thyroid C cell findings are expected to be evaluated as with other GLP-1 based agonists; no label exists because the drug is not approved.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Survodutide once weekly for the treatment of adults with obesity (SYNCHRONIZE-1)2026 PMID 42253238 | Randomized, double blind, placebo controlled phase 3 trial, 76 weeksn = 725 Adults with BMI 30 or higher, or 27 or higher with a complication, without diabetes | Mean weight change minus 12.2% (3.6 mg), minus 13.0% (6.0 mg), minus 5.4% (placebo); at least 5% loss in 72.6%, 71.9%, and 46.3% | Evidence: Human RCT evidence |
| A phase 2 randomized trial of survodutide in MASH and fibrosis2024 PMID 38847460 | Randomized, double blind, placebo controlled phase 2 trial, 48 weeksn = 293 Adults with biopsy confirmed MASH and fibrosis stage F1 to F3 | MASH improvement without worsening fibrosis in 47% (2.4 mg), 62% (4.8 mg), 43% (6.0 mg) versus 14% placebo | Evidence: Human RCT evidence |
| Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD phase 3 trial2026 PMID 42252333 | Randomized, double blind, placebo controlled phase 3 trialn = 216 Adults with obesity and MASLD | Phase 3 evaluation of weight and liver endpoints in obesity with MASLD | Evidence: Human RCT evidence |
| A randomized phase 1 study of BI 456906, a dual glucagon receptor/GLP-1 receptor agonist, in healthy Japanese men with overweight/obesity2023 PMID 36974349 | Randomized, placebo controlled multiple rising dose phase 1 study, 16 weeksn = 36 Japanese men with BMI 23 to 40 | Placebo corrected weight change minus 5.6% (1.8 mg weekly), minus 12.4% (4.8 mg weekly), minus 9.6% (2.4 mg twice weekly); 37% withdrew from escalation for adverse events | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Obesity and chronic weight management | Not graded | GLP-1 based peptides are the only peptides with large randomized trials for weight loss. Semaglutide 2.4 mg produced 14.9% mean weight loss over 68 weeks and tirzepatide 15 mg produced 20.9% over 72 weeks. Retatrutide, cagrilintide, and survodutide are in late stage trials. |
| Fatty liver disease (MASLD and MASH) | Evidence: Human RCT evidence | Phase 2 (n = 293): MASH improvement without worsening fibrosis in 43% to 62% versus 14% on placebo; phase 3 ongoing; not approved. |
Is Survodutide legal in the United States?
FDA and compounding status
Not FDA approved and not approved by any other regulator as of the last verification date. Because survodutide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded by 503A pharmacies or 503B outsourcing facilities. Any product sold as survodutide outside a clinical trial is an unapproved drug that has not been evaluated for identity, purity, or dose.
WADA status
WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.
Regulatory timeline
No regulatory events recorded.
What published studies of Survodutide used
Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.
SYNCHRONIZE-1: once weekly subcutaneous injection escalated over a prolonged period to a maintenance dose of 3.6 mg or 6.0 mg with dose flexibility permitted. Phase 2 MASH: 2.4, 4.8, or 6.0 mg weekly after a 24 week rapid escalation. No approved label exists; these are trial regimens only.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous injection once weekly (clinical trials only) |
What are the side effects and interactions of Survodutide?
Side effects
| # | Reported side effect |
|---|---|
| 1 | Gastrointestinal symptoms in 80.9% (3.6 mg) and 89.7% (6.0 mg) versus 47.9% placebo in SYNCHRONIZE-1, mostly mild to moderate |
| 2 | Nausea, vomiting, diarrhea, and constipation |
| 3 | Decreased appetite, which drove most withdrawals during dose escalation in phase 1 |
| 4 | Increased heart rate (glucagon receptor class effect) |
| 5 | Transient delayed gastric emptying |
| 6 | Long term safety and cardiovascular outcomes not yet reported |
Interactions
| # | Interaction |
|---|---|
| 1 | No approved label, so no formal interaction studies are published |
| 2 | Delayed gastric emptying shown to reduce paracetamol absorption in phase 1; other oral drugs may be affected |
| 3 | Hypoglycemia risk when combined with insulin or sulfonylureas is a class precaution |
| 4 | Should not be combined with other GLP-1 based agonists (not studied) |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Not approved for any use; only available inside registered clinical trials |
| 2 | Personal or family history of medullary thyroid carcinoma or MEN2 (class precaution, trial exclusion) |
| 3 | Pregnancy and breastfeeding (excluded from trials) |
| 4 | Competitive athletes subject to WADA testing (prohibited under S0) |
How do people access Survodutide legally?
Typical cost: Not available through licensed channels. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.
Verified access options
Step 1
No lawful United States access path identified on the last verified date outside a registered clinical trial.
Step 2
Not available as an FDA approved product and not eligible for compounding under section 503A or 503B while investigational.
Step 3
Products labeled research use only are not lawful for human use and are not verified for identity or purity.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare Survodutide
What's actually offered, and what that means for you
Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make survodutide lawful. Survodutide is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [7]
Enforcement is uneven. FDA mostly acts through warning letters to online sellers and import alerts that let it detain shipments, rather than stopping every seller. State pharmacy boards oversee pharmacies day to day, and their rules differ. [10] [11] [12]
What changes for you
- No FDA review of the product: a product sold outside a trial is an unapproved drug, and FDA has not checked its safety, effectiveness, or quality. [10]
- Identity, purity, sterility, and dose accuracy can vary from batch to batch. [10]
- Insurance rarely covers it, so you usually pay cash.
- For tested athletes, survodutide is prohibited at all times on the WADA list, whatever the source. [8]
What to check
Survodutide is not approved in the US, and no check makes a product sold outside a clinical trial lawful. Check for:
- Enrollment in a registered clinical trial (ClinicalTrials.gov lists them). Outside a trial, any product sold as survodutide is an unapproved drug.
- Labels such as "research use only" or "not for human consumption", which FDA does not accept for products sold for people. [10]
- A licensed prescriber's view on whether an approved drug fits your goal.
For weight management, approved GLP-1 drugs such as tirzepatide and semaglutide are available by prescription. See Tirzepatide, Semaglutide, GLP-1 hub.
Frequently asked questions
Is survodutide FDA approved or legal to buy?
No. Survodutide is investigational and has no approval from FDA or any other regulator as of September 2026. It cannot be compounded because it is not a component of an approved drug and is not on any FDA bulks list, so the only lawful access is a registered clinical trial. Products sold online as survodutide are unapproved drugs with no verification of what is in the vial. [5] [6] [7]
How much weight do people lose on survodutide?
In the phase 3 SYNCHRONIZE-1 trial of 725 adults with obesity, mean weight loss at 76 weeks was 12.2% at 3.6 mg and 13.0% at 6.0 mg versus 5.4% on placebo, with about 72% of treated participants losing at least 5%. The placebo adjusted effect (about 7 to 8 percentage points) is smaller than semaglutide, tirzepatide, or retatrutide achieved in their trials, although the estimand and trial designs differ. A phase 1 study had shown placebo corrected losses up to 12.4% after only 16 weeks at 4.8 mg. [1] [4]
What are the side effects of survodutide?
Gastrointestinal effects are very common: in SYNCHRONIZE-1 they affected 81% of the 3.6 mg group and 90% of the 6.0 mg group versus 48% on placebo, mostly mild to moderate. Nausea, vomiting, diarrhea, constipation, and loss of appetite lead the list, and in the phase 1 study 37% of participants stopped escalating because of adverse events, mainly decreased appetite. Heart rate rises as with other glucagon receptor agonists. No deaths were reported in phase 3. Long term safety is not established. [1] [4]
How is survodutide taken?
In trials it is a once weekly subcutaneous injection. SYNCHRONIZE-1 escalated slowly to 3.6 mg or 6.0 mg weekly with dose flexibility, and the phase 2 MASH trial used 2.4, 4.8, or 6.0 mg weekly after a 24 week escalation. No approved dosing exists outside these protocols. [1] [2]
How much does survodutide cost?
It has no price because it is not on the market; trial participants receive it free. A list price will exist only if FDA approves it. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity. [6]
Is survodutide banned by WADA?
Yes. Survodutide has no approval from any government health authority, so it is prohibited at all times under section S0 (non-approved substances) of the WADA Prohibited List. Approved GLP-1 agonists are not prohibited, but that does not extend to investigational molecules. [8]
Survodutide vs tirzepatide: what is the difference?
Tirzepatide activates GIP and GLP-1 receptors and is FDA approved; survodutide activates glucagon and GLP-1 receptors and is investigational. On weight, tirzepatide 15 mg produced 20.9% loss at 72 weeks in SURMOUNT-1 versus survodutide's 13.0% at 76 weeks in SYNCHRONIZE-1, so tirzepatide is the more powerful weight drug. Survodutide's distinguishing data are in the liver: phase 2 MASH improvement in up to 62% of participants versus 14% on placebo, with fibrosis endpoints under study in phase 3. [1] [2]
Does survodutide help fatty liver disease (MASH)?
The phase 2 data are strong. In a 48 week trial of 293 adults with biopsy confirmed MASH and F1 to F3 fibrosis, MASH improved without worsening of fibrosis in 47%, 62%, and 43% of the 2.4, 4.8, and 6.0 mg groups versus 14% on placebo, and 63% to 67% had at least a 30% drop in liver fat. Phase 3 trials in MASH and in obesity with MASLD (216 participants) are the confirmatory step. No approval exists yet. [2] [3]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
From the blog
- Peptides for weight loss, ranked by human evidence
Tirzepatide, semaglutide, and liraglutide lead on human trials. Retatrutide is trial-only, and AOD-9604 and 5-amino-1MQ are animal-only. Ranking, legal status, and dated prices.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]le Roux CW et al. Survodutide once weekly for the treatment of adults with obesity. N Engl J Med 2026 (SYNCHRONIZE-1)PubMed 42253238, 2026
- [2]Sanyal AJ et al. A phase 2 randomized trial of survodutide in MASH and fibrosis. N Engl J Med 2024PubMed 38847460, 2024
- [3]Kaplan LM et al. Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD phase 3 trial. Nat Med 2026PubMed 42252333, 2026
- [4]A randomized phase 1 study of BI 456906 in healthy Japanese men with overweight/obesity. Diabetes Obes Metab 2023PubMed 36974349, 2023
- [5]Wharton S et al. Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2). Obesity 2025PubMed 39495965, 2025
- [6]FDA: concerns with unapproved GLP-1 drugs used for weight lossFDA, 2025
- [7]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [8]WADA Prohibited List, section S0 non-approved substancesWADA, 2026
- [9]Manufacturer press release: SYNCHRONIZE-1 topline results (April 28, 2026)2026
- [10]FDA warning letters database: August 24, 2026 letter to an online seller of research-use-only peptides, including retatrutide, tesamorelin, and bremelanotideFDA, 2026
- [11]FDA Import Alert 66-41: Detention without physical examination of unapproved new drugs promoted in the U.S. (includes peptide entries)FDA
- [12]FDA: Compounding and the FDA, questions and answersFDA
Cite this page
Free to cite and quote with a link. Data is licensed CC BY 4.0 with attribution to PeptideAgent.
- APA style
PeptideAgent. (2026, September 27). Survodutide: evidence, legality, and access. https://peptideagent.ai/peptides/survodutide- HTML link
<a href="https://peptideagent.ai/peptides/survodutide">Survodutide: evidence, legality, and access</a>, PeptideAgent, updated September 27, 2026.