Boehringer Ingelheim × Zealand Pharma GLP-1 / glucagon dual agonist in Phase 3 development. Strong Phase 2 NEJM MASH signal (62% MASH improvement at 4.8 mg) and FDA Breakthrough Therapy Designation for non-cirrhotic MASH (Sept 2024). Not yet approved anywhere.
Survodutide (development code BI 456906) is a peptide GLP-1 + glucagon receptor dual agonist, co-developed by Boehringer Ingelheim and Zealand Pharma and originally optimized in the Zealand discovery program. It's a mechanism-class twin with mazdutide — both are GLP-1 + glucagon dual agonists, distinct from tirzepatide (GLP-1 + GIP) and retatrutide (triple GLP-1 + GIP + glucagon).
Same dual mechanism as mazdutide. The GLP-1R arm produces glucose-dependent insulin secretion, glucagon suppression in hyperglycemia, delayed gastric emptying, and central appetite suppression. The glucagon receptor (GCGR) arm increases hepatic energy expenditure and fatty-acid oxidation in liver, reduces hepatic lipid accumulation (the source of the strong MASH signal), and produces dose-dependent FGF-21 elevation — a hepatic metabolic-flexibility hormone — per Zimmermann et al. Mol Metab 2022 (PMID 36356832).
The Zimmermann preclinical paper showed BI 456906 at 30 nmol/kg outperformed semaglutide at 20 nmol/kg on body weight in DIO mice over 4 weeks, with mechanism-consistent FGF-21 elevation and cholesterol / triglyceride reduction.
The headline Phase 2 MASH study is Sanyal et al. NEJM 2024 (PMID 38847460). Biopsy-confirmed non-cirrhotic MASH with F1–F3 fibrosis, 48 weeks. The 4.8 mg dose produced histologic MASH improvement without fibrosis worsening in 62% of participants vs 14% on placebo — among the largest signals reported for any incretin in MASH. Phase 2 obesity dose-finding came from le Roux et al. Lancet Diabetes Endocrinol 2024 (PMID 38330987); Phase 2 T2DM from Blüher et al. Diabetologia 2024 (PMID 38095657, with a semaglutide open-label reference arm); Phase 1b cirrhosis PK from Lawitz et al. J Hepatol 2024 (PMID 38857788, showing no PK-driven dose adjustment needed in hepatic impairment — clinically important for the MASH program).
The Phase 3 SYNCHRONIZE program is in progress. SYNCHRONIZE-1 (obesity, 76 weeks) topline: −16.6% body weight on the higher dose (baseline paper PMID 41187967; topline disclosed in Boehringer press materials). SYNCHRONIZE-2 (obesity in T2DM, baseline PMID 41216778). SYNCHRONIZE-CVOT (cardiovascular outcomes, design paper PMID 39453356).
Some sources have stated "approaching 20% weight loss" — the Phase 3 SYNCHRONIZE-1 topline is −16.6%, not 20%. The 20% figure traces to small Phase 1 high-dose data, not pivotal trials. Notably, the Phase 2 MASH dose-response is quadratic: 4.8 mg outperformed 6.0 mg, suggesting a GI-tolerability ceiling. Phase 3 CVOT hedges with both 3.6 mg and 6.0 mg arms.
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Start Tracking FreeSurvodutide and mazdutide share receptor pharmacology (GLP-1 + glucagon). The differences:
| Feature | Survodutide | Mazdutide |
|---|---|---|
| Sponsor | Boehringer Ingelheim × Zealand Pharma | Eli Lilly → Innovent (China rights) |
| Approval | None as of May 2026 | NMPA Jun 2025 (obesity), Sept 2025 (T2DM) — China only |
| FDA Breakthrough Designation | Yes — non-cirrhotic MASH (Sept 2024) | No |
| Phase 3 weight loss | −16.6% (SYNCHRONIZE-1 topline) | −18.55% (GLORY-2 9 mg, 60 wk) |
| MASH evidence | 62% improvement at 4.8 mg (NEJM Phase 2) | −71.9% liver fat (GLORY-2 subgroup) |
| Availability | Investigational only | China retail; gray-market in US |
Survodutide is investigational. The dosing reflects published clinical-trial protocols, not an approved label.
| Parameter | Range |
|---|---|
| Starting dose | 0.3 mg weekly SC, escalating |
| Phase 2 obesity | 0.6 / 2.4 / 3.6 / 4.8 mg weekly (le Roux 2024) |
| Phase 2 MASH | 2.4 / 4.8 / 6.0 mg weekly; 4.8 mg outperformed 6.0 mg on MASH endpoint |
| Phase 3 SYNCHRONIZE | Up to 6.0 mg weekly |
| Route | Subcutaneous, once weekly |
The quadratic dose-response in MASH — 4.8 mg better than 6.0 mg — reflects a GI tolerability ceiling. Phase 3 CVOT hedges with both 3.6 mg and 6.0 mg arms.
Pre-filled with a typical Survodutide setup. Edit any field — the draw updates live.
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Survodutide's safety profile in published trials is broadly similar to other incretin-class drugs.
Common incretin-class effects: GI (nausea, vomiting, diarrhea, constipation, most pronounced during escalation), decreased appetite (on-target), injection-site reactions, hypoglycemia uncommon as monotherapy and rising with concurrent insulin or sulfonylureas.
Class concerns: pancreatitis, thyroid C-cell tumors (class boxed warning for GLP-1 RAs based on rodent data), gallbladder disease (class concern with rapid weight loss).
Glucagon-arm-specific: possible cardiovascular effects from glucagon-receptor activation, characterized in published trial reports. Counter-regulatory glucose effects are mostly compensated by the GLP-1R arm.
Mazdutide — mechanism-class twin (same GLP-1/glucagon receptors). Approved in China.
Semaglutide — pure GLP-1R; smaller liver-fat reduction.
Tirzepatide — GLP-1 + GIP (not glucagon). Different receptor combination.
Retatrutide — triple GLP-1 + GIP + glucagon. Different mechanism.
Cotadutide — AstraZeneca GLP-1/glucagon dual agonist; same receptor profile as survodutide; development stalled.
Resmetirom — thyroid hormone receptor β agonist for MASH, FDA-approved 2024. Different mechanism (not an incretin); the only FDA-approved MASH drug.
Survodutide is a research peptide not approved by the FDA for human use. It is sold only as a research chemical, and StackTrax does not endorse or facilitate personal use.
Quality varies enormously among research-chemical suppliers. At minimum, look for:
StackTrax’s preferred partner NextGen Peptides does not currently carry Survodutidein their catalog, which is why you don’t see a direct purchase link here. Other major research-chemical suppliers carry it; we don’t specifically recommend one for this compound.
Build your protocol, log every dose, monitor your body's response, and get reminders so you never miss a dose.
Start Tracking FreeNo. Survodutide (BI 456906) is in Phase 3 development by Boehringer Ingelheim and Zealand Pharma — not approved by the FDA, EMA, or any other regulatory authority as of May 2026. The SYNCHRONIZE Phase 3 program (obesity, T2DM, MASH/NASH) is enrolling and reading out through 2026–2027. NDA filing has not been guided publicly. Sold in the US only as a research chemical.
Survodutide is a synthetic peptide engineered by Zealand Pharma and developed clinically by Boehringer Ingelheim. It is a long-acting dual agonist at the GLP-1 receptor and the glucagon receptor (GCGR) — same dual-mechanism class as mazdutide, both derived from the gut hormone oxyntomodulin. It uses C18 fatty-acid acylation with a glycine-serine spacer for albumin binding, giving an ~6-day plasma half-life and supporting once-weekly subcutaneous dosing.
Trial-validated maintenance doses: 2.4 mg, 3.6 mg, 4.8 mg, and 6 mg once weekly subcutaneously. Phase 2 titration: stepwise from 0.3 → 0.6 → 0.9 → 1.8 → 2.7 → 3.6 → 4.8 mg every 2 weeks. Maximum dose in Phase 3 is 6 mg. Most trials report the 4.8 mg arm as the best efficacy/tolerability point.
For a 10 mg lyophilized vial, a typical reconstitution is 10 mg + 2 mL of bacteriostatic water, yielding 5 mg/mL. A 2.4 mg dose draws to 0.48 mL (48 units on a 100-unit insulin syringe), 4.8 mg = 0.96 mL (96 units), 6 mg = 1.20 mL (use 3 mL syringe).
Survodutide and mazdutide are both GLP-1 + GCG dual agonists with broadly similar mechanism — survodutide is the Western/Boehringer development program, mazdutide is the Chinese/Innovent program (already NMPA-approved). Retatrutide adds a third arm (GIP) for triple agonism and has produced the largest reported weight-loss numbers (~28.7% in TRIUMPH-4). Tirzepatide is dual GLP-1 + GIP. Of these four, only tirzepatide is FDA approved in the US.
Appetite suppression typically noticeable within the first 1–2 weeks. Weight loss accumulates over months as the dose titrates. In Phase 2 obesity (Le Roux 2024 Lancet), survodutide produced mean weight loss of approximately 14.9% at 46 weeks on the 4.8 mg maintenance dose. Final Phase 3 numbers from SYNCHRONIZE-1 are pending.
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StackTrax guides cover peptides and compounds that are not FDA-approved for the uses discussed. The dosing, reconstitution, and safety information is compiled from published research and community protocols for educational purposes only.
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