Compounds / Survodutide
Survodutide
Also known as: BI 456906; survodutide; glucagon/GLP-1 receptor dual agonist; Boehringer Ingelheim / Zealand Pharma dual agonist
Primary research focus: Obesity and MASH (metabolic dysfunction-associated steatohepatitis), in late-stage clinical development
Last updated July 2026 · Reviewed against FDA labeling and published research.
What is Survodutide?
Survodutide (BI 456906) is an investigational once-weekly injectable glucagon/GLP-1 receptor dual agonist being developed by Boehringer Ingelheim, licensed from Zealand Pharma. Like semaglutide it activates the GLP-1 receptor, but its second target is the glucagon receptor rather than GIP, which produces a distinct metabolic profile with pronounced effects on liver fat. It is in Phase 3 for obesity and MASH and is not FDA-approved.
Survodutide activates both the GLP-1 receptor and the glucagon receptor. GLP-1 agonism decreases appetite and increases fullness and satiety while enhancing glucose-dependent insulin secretion and slowing gastric emptying. Glucagon agonism is thought to act directly on the liver to increase hepatic fat oxidation, reduce liver fat, regulate metabolic function, resolve inflammation, and improve fibrosis; it also increases overall energy expenditure. This liver-directed action is the key differentiator from GLP-1-only agents and from tirzepatide, whose second target is GIP. A fatty-acid modification extends the half-life to allow once-weekly dosing.
How it’s supplied
Investigational; not commercially available anywhere. In clinical development it is a once-weekly subcutaneous injection. Material sold under this name outside a clinical trial is gray-market research product, not FDA-reviewed for potency or sterility.
Dosage Chart
Units shown are for a U-100 insulin syringe (100 units = 1 mL), calculated from the vial size and BAC water you select. Always confirm against your prescription and your syringe markings.
| Phase | Dose | Frequency | Notes |
|---|---|---|---|
| Weeks 1-2 | 0.6mg | 1x Weekly | — |
| Weeks 3-4 | 1.2mg | 1x Weekly | — |
| Weeks 5-6 | 1.8mg | 1x Weekly | — |
| Weeks 7-8 | 2.4mg | 1x Weekly | — |
| Weeks 9-10 | 3.6mg | 1x Weekly | — |
| Weeks 11-12 | 4.8mg | 1x Weekly | — |
| Weeks 13+ | 6mg | 1x Weekly | — |
- Administer on the same day each week to maintain stable plasma levels
- Titrate slowly; gastrointestinal effects are dose-related and ease with gradual escalation
- Rotate injection sites to reduce irritation and lipohypertrophy
- Reduce dose when combined with insulin or sulfonylureas to lower hypoglycemia risk
- Discuss pausing before scheduled surgery or anesthesia (delayed gastric emptying)
- Maintain hydration to offset gastrointestinal fluid loss
- Not for use during pregnancy or breastfeeding
- Do not exceed the recommended dose to try to speed results
Potential Benefits and Side Effects
Effects reported in published research. Not a promise of results, and not medical advice.
- Reported in clinical trials; not an approved-label claim.
- Sustained weight loss averaging up to 16.6 percent at 76 weeks in the Phase III SYNCHRONIZE-1 trial, versus 3.2 percent for placebo, with up to 85.1 percent achieving at least 5 percent weight loss.
- Up to 18.7 percent weight loss at 46 weeks in Phase 2 completers, without an apparent plateau.
- Up to 62 percent MASH resolution without worsening fibrosis in Phase 2 (NEJM 2024).
- Reductions in liver fat content via direct glucagon-receptor action on the liver, a mechanism GLP-1-only drugs lack.
- Increased energy expenditure in addition to appetite reduction.
- Reported effects are primarily gastrointestinal and consistent with the GLP-1 class; no new safety concerns outside class expectations were observed in Phase III.
- Nausea.
- Vomiting.
- Diarrhea.
- Constipation.
- Gastrointestinal events were mild to moderate and temporary, occurring more frequently during dose escalation and prompting more discontinuations in that phase; heart-rate increase is a consideration with glucagon agonism.
Warnings and contraindications
Important safety information. This is not exhaustive — read the full prescribing information and consult your prescriber or pharmacist.
- No FDA-approved labeling exists; the following reflect trial observations and class effects, not an approved label.
- Survodutide is investigational and has not been approved for use; its efficacy and safety have not been established, and the full profile will be defined through regulatory review.
- Gastrointestinal events are the most common class effect, occurring more frequently during dose escalation; in Phase III they were reported as mild to moderate and temporary.
- Glucagon receptor agonism can raise heart rate and increase hepatic glucose output, which warrants attention.
- GLP-1 class considerations include pancreatitis, gallbladder events, and caution with a personal or family history of medullary thyroid carcinoma or MEN 2.
- Possession or use of investigational drugs outside an authorized clinical trial may be unlawful.
- Gray-market material varies in identity and purity; safety in pregnancy and breastfeeding has not been established.
- Not established as an approved product; contraindications will be defined at any approval. Class-based cautions for GLP-1-containing agents include personal or family history of medullary thyroid carcinoma, MEN 2, and known hypersensitivity.
Reconstitution Steps
How to prepare the lyophilized vial. Confirm specifics with your pharmacist or prescriber.
- Confirm the amount of peptide in the vial and the volume of diluent you intend to use before starting.
- Wash your hands and gather supplies: the lyophilized vial, the diluent (typically bacteriostatic water), an alcohol swab, and a sterile syringe.
- Let the vial and diluent reach room temperature if they were refrigerated or frozen.
- Wipe the rubber stopper of both the peptide vial and the diluent vial with a fresh alcohol swab and let them air dry.
- Draw the intended diluent volume into the syringe.
- Insert the needle into the vial and slowly release the diluent down the inside wall rather than directly onto the powder, to avoid foaming.
- Do not shake. Gently swirl or roll the vial until fully dissolved.
- Inspect the solution: it should be clear and colorless with no visible particles. Do not use if cloudy or containing particles.
- Note the resulting concentration (amount divided by diluent volume) so it matches the reconstitution calculator on this page.
- Label the vial with the reconstitution date and store as directed under reconstituted storage.
US regulatory status
Classifications are public record but can change. For reference only, not legal advice.
Development: Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer Ingelheim solely responsible for global development and commercialization. Phase 2 results were substantial: up to 18.7 percent weight loss at 46 weeks in completers, with weight loss still trending downward without a plateau, and up to 62 percent of patients achieving MASH resolution without worsening fibrosis (New England Journal of Medicine, 2024). On April 28, 2026 Boehringer Ingelheim announced positive topline Phase III results from SYNCHRONIZE-1, which met its co-primary endpoints: adults with obesity or overweight without type 2 diabetes achieved sustained weight loss averaging up to 16.6 percent at 76 weeks (approximately 17.8 kg) versus 3.2 percent for placebo (p less than 0.0001), with up to 85.1 percent achieving at least 5 percent weight loss. It is the first glucagon/GLP-1 dual agonist to deliver a Phase 3 obesity readout, landing between semaglutide and tirzepatide on efficacy. Full data were slated for presentation at the American Diabetes Association 2026 Scientific Sessions in June, with additional SYNCHRONIZE readouts during 2026. The broader program includes SYNCHRONIZE-2 (obesity with type 2 diabetes) and the LIVERAGE studies in MASH and fibrosis. Regulatory designations include FDA Breakthrough Therapy for MASH (September 2024), FDA Fast Track for NASH, and EMA PRIME. No FDA submission had been announced as of mid-2026, with approval generally anticipated no earlier than 2027 to 2028.
Notes: Survodutide is investigational and not approved by the FDA or any other regulator; its efficacy and safety have not been established. It holds FDA Breakthrough Therapy designation for MASH with moderate or advanced fibrosis (stages 2 or 3), FDA Fast Track for NASH, and EMA PRIME designation, but these accelerate review rather than confer approval. Because it is investigational, there is no legal prescriber or compounding pathway outside a clinical trial; it is not on the FDA 503A bulk drug substances list and is not eligible for 503A or 503B compounding. Products sold under this name are unregulated. It is not a controlled substance. (Status current as of mid-2026.)
International status
Pharmacokinetics
Storage and handling
Important Notes
Practical considerations for consistency and safety.
- Survodutide is investigational and NOT approved anywhere; approval is generally anticipated no earlier than 2027 to 2028 pending Phase 3 readouts and filing.
- Its second target is the glucagon receptor, not GIP; that distinguishes it from tirzepatide and drives its liver-fat effects.
- Phase III SYNCHRONIZE-1 (April 2026) reported 16.6 percent weight loss at 76 weeks, positioning it between semaglutide and tirzepatide.
- Its MASH data (up to 62 percent resolution in Phase 2) and Breakthrough Therapy designation are a meaningful differentiator for patients with obesity plus liver disease.
- Possession or use outside an authorized clinical trial may be unlawful, and gray-market material is unregulated.
Lifestyle Factors
- Studied together with diet and physical activity for weight management.
- Adequate hydration can reduce dehydration-related complications during gastrointestinal side effects.
References
Related compounds
Important disclaimer
This page is an educational reference, not medical advice, a diagnosis, or a treatment recommendation, and not a substitute for your prescriber or pharmacist. Approval and regulatory status varies by compound and can change. Always confirm against current prescribing information and consult a qualified healthcare professional before making any decision about a medication.