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Investigational / not FDA-approved

Survodutide

Dual glucagon / GLP-1 receptor agonist (BI 456906) — investigational; not FDA-approved.

Editorial review:
What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. Survodutide (developmental code BI 456906) is a dual glucagon receptor / GLP-1 receptor agonist. PubChem CID 171378821; formula C192H289N47O61 / MW ~4232; CAS 2805997-46-8. It has no approved drug indication in the jurisdictions this drawer treats as labeled (US/EU). Off-label does not apply. There is no label to be off of. It is not mazdutide (also dual GLP-1/glucagon, different molecule / different CID/CAS/codes), not retatrutide (triple agonist), and not dulaglutide, semaglutide, or tirzepatide.

Bottom line

PubMed holds discovery/preclinical pharmacology, phase 2 obesity and type 2 diabetes programs, and a phase 2 MASH-with-fibrosis trial. Those are investigational human objects. Post-hoc blood-pressure and subgroup analyses stay inside the parent trial object. They do not create a labeled cardiometabolic indication.

Papers

Investigational — discovery / preclinical

PMID 36356832 — Zimmermann 2022

Tested: discovery and preclinical pharmacology of BI 456906 as a GCGR/GLP-1R dual agonist with anti-obesity efficacy in laboratory models.

Does not show: a controlled human obesity or MASH result, or a labeled indication.

Investigational — obesity (phase 2)

PMID 38330987 — le Roux 2024

Tested: once-weekly injectable survodutide versus placebo for body weight in adults with obesity (randomized, double-blind, placebo-controlled, dose-finding phase 2).

Does not show: a labeled obesity indication, a type 2 diabetes primary claim (see Blüher), or equivalence to mazdutide or retatrutide.

PMID 39821928 — le Roux 2025

Tested: sex and baseline-BMI subgroup analysis inside the phase 2 obesity trial of survodutide (BMI ≥27 kg/m² enrollment frame).

Does not show: a new independent pivotal trial, or a labeled claim.

PMID 39582349 — le Roux 2025

Tested: post-hoc blood-pressure outcomes from the randomized phase 2 obesity program of survodutide.

Does not show: a dedicated cardiovascular-outcomes trial, or a labeled hypertension indication.

Investigational — type 2 diabetes (phase 2)

PMID 38095657 — Blüher 2024

Tested: dose-response effects of survodutide versus placebo and versus open-label semaglutide on HbA1c and body weight in people with type 2 diabetes (phase 2).

Does not show: a labeled T2D indication, that survodutide equals semaglutide, or an obesity-without-diabetes result as the primary object.

Investigational — MASH / fibrosis (phase 2)

PMID 38847460 — Sanyal 2024

Tested: once-weekly injectable survodutide versus placebo for metabolic dysfunction–associated steatohepatitis with fibrosis (randomized phase 2).

Does not show: a labeled MASH indication, or a substitute for the obesity or T2D phase 2 objects.

Secondary / context

PMID 40963161 — Arun 2025

Tested: narrative review of survodutide as an emerging dual GLP-1/glucagon agonist in cardiometabolic care.

Does not show: a new primary randomized result, or an approved indication.

What is not established

An approved obesity, type 2 diabetes, or MASH indication. Phase 3 confirmatory labeled claims. Interchangeability with mazdutide, retatrutide, dulaglutide, semaglutide, or tirzepatide. That post-hoc BP or subgroup analyses equal a CVOT. A non-trial preparation is not BI 456906 trial material.

Selected sources

36356832 38330987 38095657 38847460 39821928 39582349 40963161

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