Digestive & weight GLP-1 / glucagon dual agonist
Survodutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Survodutide is an investigational GLP-1 and glucagon dual-receptor agonist, developed by Boehringer Ingelheim with Zealand Pharma, given as a once-weekly injection for obesity and liver disease (MASH). In a Phase 2 trial and a Phase 3 liver trial, it improved liver disease and reduced body weight, with a positive Phase 3 obesity topline also reported. As of 2026 it is not approved anywhere.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or any regulator
- What it is
- GLP-1 and glucagon receptor dual agonist given as a once-weekly injection
- Research
- Positive Phase 2 and Phase 3 results in liver disease and a positive Phase 3 obesity topline
- How it works
- Glucagon component intended to add direct liver-fat effects
- Evidence strength
- Deep research
Summary
Survodutide is an investigational GLP-1 and glucagon dual agonist studied for obesity and liver disease. Learn how it works, what trials show, and its status.
What is survodutide?
Survodutide is an experimental dual-receptor agonist that activates the glucagon and GLP-1 receptors, discovered by Zealand Pharma and developed by Boehringer Ingelheim under the code BI 456906. It is given as a once-weekly injection and is in development for obesity and for metabolic dysfunction-associated steatohepatitis (MASH). It is investigational and not approved.
How does it work?
Survodutide combines two hormone actions. The glucagon receptor arm is intended to increase energy expenditure and promote fat breakdown in the liver, while the GLP-1 receptor arm reduces appetite and supports weight loss. The combination is designed to pair weight loss with direct liver-fat reduction, which is the rationale for its use in MASH. This describes the proposed mechanism rather than a proven outcome.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or any regulator
Category: In clinical trials · Primary body area: Digestive & weight
No. Survodutide is investigational and not approved by the FDA or EMA. According to the developers, Phase 3 programs in obesity and in MASH are active, and a positive Phase 3 obesity topline has been reported via press release.
What does the research show?
Editor’s note
Evidence strength: Deep research (3 human · 0 animal/cell studies)
It has a positive Phase 2 and a positive Phase 3 in liver disease, plus a positive Phase 3 obesity topline, representing consistent, peer-reviewed RCT evidence, though it is not FDA-approved.
The evidence spans Phase 2 and Phase 3:
| Trial | Population | Result |
|---|---|---|
| Phase 2 trial, according to PubMed | Biopsy-confirmed MASH | Met its primary goal of histologic improvement without worsening fibrosis compared with placebo over 48 weeks |
| Phase 3 trial (SYNCHRONIZE-MASLD) | Adults with obesity and fatty liver | Far more participants on survodutide achieved a large reduction in liver fat than on placebo, with a mean weight change of about −12% versus −1% |
| Phase 3 obesity trial | Obesity | Topline mean weight loss of about 17%, reported via company press release, with full peer-reviewed results pending |
These are consistent, replicated results, though the drug is not approved.
Sources: the Phase 2 MASH trial (Sanyal et al., New England Journal of Medicine, 2024, DOI: 10.1056/NEJMoa2401755) and the Phase 3 SYNCHRONIZE-MASLD trial (Kaplan et al., Nature Medicine, 2026, DOI: 10.1038/s41591-026-04479-3), both indexed on PubMed; and Boehringer Ingelheim / Zealand Pharma obesity trial announcements. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
3 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
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