Survodutide
Also sold as: BI 456906, BI456906
Survodutide (BI 456906) is not approved by FDA for any indication — it returns no match in Drugs@FDA on any query field, and in a December 2024 warning letter FDA stated that 'No FDA-approved applications pursuant to section 505 of the FD&C Act … are in effect for these products' after finding a seller offering 'SURVODUTIDE' among products it called unapproved new drugs, holding that 'FOR RESEARCH USE ONLY' labeling did not defeat evidence of intended human use. It is in active clinical development by Boehringer Ingelheim, with Phase 3 trials still recruiting. Its human evidence is nonetheless real: two Phase 3 randomised, double-blind, placebo-controlled trials of once-weekly subcutaneous survodutide were published on 7 June 2026 — SYNCHRONIZE-1 in the New England Journal of Medicine (725 adults with obesity, 76 weeks) and SYNCHRONIZE-MASLD in Nature Medicine (216 adults, 48 weeks) — and both met their primary endpoints. Those trials used the sponsor's investigational material, gastrointestinal adverse events were the most common in both, and the largest survodutide trial conducted, a cardiovascular safety study of 5,531 participants, completed on 30 June 2026 with no results posted as of 2 August 2026.
Which molecule this is. A single investigational peptide that agonises two receptors — the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R) — described as a 'glucagon receptor/glucagon-like peptide-1 receptor dual agonist' in the Nature Medicine Phase 3 report and as 'an investigational glucagon receptor-GLP-1 receptor dual agonist' in the NEJM Phase 3 report. 'Survodutide' and 'BI 456906' denote one molecule; the trial registrations use both names interchangeably, and there is no fragment-versus-full-length ambiguity of the kind that makes TB-500 records unreadable. The ambiguity is somewhere else entirely: nothing verifies that a vial sold as 'survodutide' by a research-chemical vendor contains that molecule, at that purity, at any stated content. Survodutide is not an ingredient in any FDA-approved drug product (recorded, sourced, under FDA findings), so no vial of it originates from an approved supply.
FDA status
This is in active clinical development with an identifiable sponsor and registered trials. It is not approved, and being in trials is not evidence that it works.
In active clinical development with an identifiable sponsor and registered trials. Not approved. Being in trials is not evidence that it works. THE ACTIVE-DEVELOPMENT TEST WAS RUN, NOT ASSUMED, because a terminated programme is not investigational — it is a programme that failed, and this vertical routinely sells 'in clinical trials' on the strength of a trial that stopped years ago. Queried against the ClinicalTrials.gov API on 2026-08-02: totalCount 24 survodutide registrations, of which 23 name Boehringer Ingelheim as lead sponsor and one is an investigator-initiated Phase 2 study at University Medical Center Groningen (NCT07206290, not yet recruiting). None of the 24 is terminated, withdrawn or suspended. Two Phase 3 trials are RECRUITING right now — LIVERAGE (NCT06632444, estimated 1,800 participants, estimated primary completion 2031-12-27) and LIVERAGE-Cirrhosis (NCT06632457, estimated 1,590) — and a Phase 1 study (NCT07407348) began recruiting 2026-03-11. Nothing in the programme reads as terminated or withdrawn. THE NOT-APPROVED HALF is carried separately and sourced separately: Drugs@FDA returns no match for survodutide on any of four query fields (see FDA findings). SCOPE LIMIT, stated because the alternative is to imply knowledge this record does not have: 'investigational' describes the development programme, not any marketing application. This record makes no claim about whether a new drug application for survodutide has been submitted, accepted or is pending. FDA does not publish that, and no primary document establishing it was located on 2026-08-02.
Evidence
Efficacy established by adequate, well-controlled trials in humans.
ADMINISTRATION CHECK PASSED, EXPLICITLY AND PER-STUDY. Survodutide is a synthetic investigational drug, not an endogenous peptide, so the biomarker trap that empties MOTS-c's and TB-500's apparent trial counts cannot apply — but the check was run anyway rather than assumed, because assuming it is the failure this schema exists to catch. TRIAL 1 — SYNCHRONIZE-1 (NCT06066515), Phase 3, randomised, quadruple-masked, placebo-controlled, 76 weeks, enrolment 726 ACTUAL, lead sponsor Boehringer Ingelheim, status COMPLETED (primary completion 2025-12-02 ACTUAL, completion 2026-02-20 ACTUAL). The ClinicalTrials.gov intervention records read 'once weekly subcutaneous injection' for both survodutide and placebo. In the NEJM report, investigators randomised 725 adults with obesity, or with overweight and at least one obesity-related complication and without diabetes, 1:1:1 to subcutaneous survodutide or placebo, and reported that at week 76 the mean change in body weight by the treatment-regimen estimand was substantially greater in both survodutide groups than in the placebo group, with both primary end points met (P<0.001 for all comparisons with placebo). TRIAL 2 — SYNCHRONIZE-MASLD, Phase 3, randomised 2:1, double-blind, placebo-controlled, 48 weeks, 216 adults, reported in Nature Medicine the same day. Participants were 'treated with once-weekly subcutaneous injections of survodutide … or placebo'; both co-primary endpoints — reduction in MRI-PDFF-assessed liver fat content and percentage change in body weight — were met. The drug was ADMINISTERED in both. Neither measures an endogenous peptide. WHAT THE TIER MEANS AND DOES NOT MEAN. It means efficacy on the endpoints those two trials measured — body weight, and MRI-assessed liver fat content — is established by adequate, well-controlled human trials. It does NOT mean approved: survodutide is approved by FDA for nothing, and FDA has stated in a warning letter that products sold under this name 'are not generally recognized as safe and effective'. It does not mean the outcomes that matter longest are known — the cardiovascular safety trial (NCT06077864, n=5,531 ACTUAL, Boehringer Ingelheim, Phase 3) completed 2026-06-30 and had posted no results on 2026-08-02, and the two Phase 3 MASH trials do not estimate primary completion until 2031. And it does not transfer to grey-market product: both published trials used the sponsor's investigational material under trial conditions. PER-ARM FIGURES ARE LEFT TO THE CITED PAPERS. An amount beside a frequency reconstructs a regimen, and this record does not publish one in any field.
“In this phase 3, double-blind trial, we randomly assigned adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher, or 27 or higher with at least one obesity-related complication (excluding diabetes), in a 1:1:1 ratio to receive once-weekly survodutide administered subcutaneously […] or placebo, in addition to counseling for lifestyle modification.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
In a warning letter of 10 December 2024 to Xcel Research LLC, FDA found that products the firm offered for sale under the name 'SURVODUTIDE', among others, are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.
This is the document that makes survodutide unusual on this site: FDA has named it, in capitals, in an enforcement letter, alongside retatrutide and semaglutide. Read the scope precisely and in both directions. It is a finding about ONE FIRM'S PRODUCTS — Xcel Research LLC, at xcelpeptides.com, reviewed by FDA in October 2024. It is not a finding about survodutide's pharmacology, it is not a finding that the Boehringer Ingelheim trials are wrong, and it is not a statement about any other vendor. What it does establish, and what the market reading of 'it's just a research peptide' does not survive, is FDA's legal characterisation of survodutide sold this way.
Warning Letter — Xcel Research LLC (MARCS-CMS 694608) — FDA, 10 December 2024“As described below, your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).”
Checked against the source on .In the same letter, FDA held that labeling survodutide and the other products 'FOR RESEARCH USE ONLY' and 'NOT INTENDED FOR HUMAN USE' did not prevent them from being drugs, because evidence obtained from the firm's website established that the products were intended to be drugs for human use.
The research-use-only theory, tested against survodutide specifically rather than borrowed from another compound's record. FDA's method is worth reading because it is evidentiary rather than rhetorical: intended use is established from the seller's own marketing copy, and a disclaimer contradicted by that copy is not a defence. The survodutide claims FDA quoted back at this firm are structure/function and disease claims dressed in research language — that the substance 'can help regulate blood glucose levels more effectively than targeting either receptor alone' and 'has shown promise in stabilizing blood sugar levels, which is crucial for managing conditions like diabetes'. That construction — a benefit asserted of the compound, hedged with 'in research subjects' — is the exhibit, not the shield. It is also precisely the construction this site's editorial policy refuses.
Warning Letter — Xcel Research LLC (MARCS-CMS 694608) — FDA, 10 December 2024“Despite statements on your product labeling marketing your products, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes that your products are intended to be drugs for human use.”
Checked against the source on .FDA stated in the same letter that the products, including 'SURVODUTIDE', are not generally recognized as safe and effective for the referenced uses and are therefore new drugs, and that no FDA-approved applications under section 505 of the FD&C Act are in effect for these products.
Recorded separately from the violation finding above because it answers a different question — 'has FDA approved anything containing survodutide?' — and because the two get merged everywhere else. Note the sentence is scoped to 'these products', i.e. the firm's, which is why the general not-approved claim on this record rests on Drugs@FDA below rather than on this sentence alone. Two independent documents, one conclusion.
Warning Letter — Xcel Research LLC (MARCS-CMS 694608) — FDA, 10 December 2024“No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products.”
Checked against the source on .Survodutide does not appear in Drugs@FDA. Queried through the openFDA drug/drugsfda endpoint on 2026-08-02 across four fields — generic name, brand name, active-ingredient name and unfielded full text — every query returned NOT_FOUND, as did the drug/label endpoint.
A NOT_FOUND is only as good as the query that produced it, so the query was controlled. In the same session, on the same endpoint, `products.active_ingredients.name:"TIRZEPATIDE"` returned 2 results — the field name and syntax are correct, and the absence is about survodutide, not about the request. This is the correction of a real failure mode in this library: a false 'sermorelin is not in Drugs@FDA' claim was produced by querying a field whose openFDA block was empty. WHAT THIS ABSENCE MEANS. Drugs@FDA lists approved applications. Survodutide is in neither an approved application nor, therefore, an approved product, which is the not-approved half of its status. WHAT IT DOES NOT MEAN: Drugs@FDA does not list investigational drugs at all, so absence from it is not evidence about the development programme in either direction. The development programme is sourced separately, to the trial registrations.
Drugs@FDA (openFDA drug/drugsfda) — query for active ingredient SURVODUTIDE — FDA, 31 July 2026Checked against the source on .Survodutide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.
Recorded to close a misreading, not to assert a status — which is why this record carries no compoundingStatus field at all. Verified first-hand on 2026-08-02 by fetching the PDF with a browser user-agent and extracting its text locally: zero hits for 'survodutide' across all seven pages. Absence from this list cannot by itself distinguish 'nominated then withdrawn' from 'never nominated' from 'never on the nomination track at all', and no document was located that resolves which of those applies to survodutide. So the absence is recorded and the status is left blank. Two of the three statutory 503A conditions for a bulk drug substance are verifiable from this record's own sources and both fail: survodutide does not appear on the 503A bulks list (this finding), and it is not a component of an FDA-approved drug product (the Drugs@FDA finding above). The third condition — whether an applicable USP or NF monograph exists — was NOT verified against a primary document and is therefore not asserted here in either direction. Unlike retatrutide, survodutide has no FDA letter walking through all three prongs, and this record does not manufacture one by analogy.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .
Documented safety signals
In the Phase 3 SYNCHRONIZE-1 trial (n=725), investigators reported that the most common adverse events were gastrointestinal symptoms, typically mild to moderate, occurring in 80.9% of participants in the lower-dose survodutide group and 89.7% in the higher-dose survodutide group, versus 47.9% in the placebo group. No deaths were reported.
Attributed to the trial, and scoped to it. Read the placebo column before reading the survodutide columns: 47.9% of participants on placebo also reported gastrointestinal adverse events, so the arithmetic difference is the signal, not the raw incidence. Read the gradient too — the higher-dose arm reported a higher incidence than the lower-dose arm, which is the pattern that matters most for anyone self-administering an unapproved vial with no titration schedule and no prescriber. Bounds: 725 participants over 76 weeks cannot characterise uncommon or long-latency harms, and 'no deaths were reported' is a statement about this trial, not about the molecule.
Survodutide Once Weekly for the Treatment of Adults with Obesity — The New England Journal of Medicine, 7 June 2026“The most common adverse events were gastrointestinal symptoms (typically mild to moderate), which occurred in 80.9% of the participants in the [lower-dose] group, in 89.7% of those in the [higher-dose] group, and in 47.9% of those in the placebo group. No deaths were reported.”
Checked against the source on .In the Phase 3 SYNCHRONIZE-MASLD trial (n=216), investigators reported that the most frequently reported adverse events with survodutide were gastrointestinal, commonly occurring during dose escalation, and generally of mild-to-moderate severity.
Recorded as its own entry rather than folded into the SYNCHRONIZE-1 note, because it is a second trial, a different population and a different journal reaching the same characterisation — which is worth more than one trial saying it twice. The clause 'commonly occurring during dose escalation' is the load-bearing one and it describes a condition that only exists inside a trial: escalation there is protocol-defined, monitored, and reversible by an investigator. The authors also state the trial's own limitations verbatim — 'short trial duration (48 weeks) and limited global reach (participants recruited in the United States and Spain)'.
Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial — Nature Medicine, 7 June 2026“The most frequently reported adverse events with survodutide were gastrointestinal, commonly occurring during dose escalation, and were generally of mild-to-moderate severity.”
Checked against the source on .The largest survodutide trial conducted — a Phase 3, randomised, double-blind, event-driven cardiovascular safety study in participants with overweight or obesity, enrolment 5,531 ACTUAL, lead sponsor Boehringer Ingelheim — completed on 2026-06-30 and had no results posted on ClinicalTrials.gov as of 2026-08-02.
Recorded as a safety signal because an unreported cardiovascular safety trial IS the safety position, and the alternative — saying nothing — reads as though the question were settled. Verified against the ClinicalTrials.gov API on 2026-08-02: overall status COMPLETED, primary completion 2026-06-01 ACTUAL, completion 2026-06-30 ACTUAL, hasResults false, no results-first-submitted date. State only what the registry states. This is NOT a claim that the trial found a problem, and it is NOT a claim that it found none. It is a claim that the largest body of cardiovascular safety data on this molecule is not yet public, one month after the trial closed. Any source telling you survodutide's cardiovascular safety is established is not reading this registration.
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity — ClinicalTrials.gov, 23 July 2026Checked against the source on .FDA stated that products sold under the name 'SURVODUTIDE', among others, are not generally recognized as safe and effective for the uses claimed on the seller's website.
Placed under safety signals as well as FDA findings because of how it is misread. 'Not generally recognized as safe and effective' is a term of art describing the ABSENCE of an approval finding — it is the statutory test that makes something a 'new drug' requiring an approved application. It is not a finding that the Phase 3 trials failed; they did not. Both readings are live in this vertical and both are wrong: sellers cite the trials as though they were an approval, and critics cite this sentence as though it were a negative efficacy finding. The honest position is that no FDA safety and effectiveness determination for survodutide exists, and an unapproved vial has had no FDA review of its identity, purity or content at all.
Warning Letter — Xcel Research LLC (MARCS-CMS 694608) — FDA, 10 December 2024“Your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is survodutide FDA-approved in 2026?
No. Survodutide is not approved by FDA for any indication, in any population, by any route. Drugs@FDA, queried through the openFDA drug/drugsfda endpoint on 2 August 2026, returns no match for survodutide on generic name, brand name, active-ingredient name or unfielded full text, and the drug/label endpoint returns no match either — while the same endpoint returns results for tirzepatide on the same field in the same session, so the absence is about survodutide and not about the query. FDA said the same thing in different words in a warning letter of 10 December 2024, writing of a seller's survodutide and other products that 'No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products.' Survodutide is an investigational Boehringer Ingelheim molecule still in Phase 3 development; this record makes no claim about whether a marketing application has been submitted, because FDA does not publish that and no primary document establishing it was located.
Drugs@FDA (openFDA drug/drugsfda) — query for active ingredient SURVODUTIDE — FDA, 31 July 2026Checked against the source on .- Is it legal to buy survodutide sold 'for research use only'?
No — FDA has addressed that exact labeling, on survodutide by name. In a warning letter of 10 December 2024 to Xcel Research LLC, FDA wrote that 'Despite statements on your product labeling marketing your products, "FOR RESEARCH USE ONLY" and "NOT INTENDED FOR HUMAN USE," evidence obtained from your website establishes that your products are intended to be drugs for human use.' FDA found the firm's 'SURVODUTIDE' product, among others, to be an unapproved new drug whose introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The mechanism is what matters: intended use is established from the seller's own marketing copy, so a disclaimer contradicted by that copy is not a defence. Scope, stated honestly — this letter concerns one firm's products, reviewed by FDA in October 2024. It is cited as evidence of FDA's legal position on survodutide sold this way, not as a finding about any other vendor.
Warning Letter — Xcel Research LLC (MARCS-CMS 694608) — FDA, 10 December 2024“Despite statements on your product labeling marketing your products, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes that your products are intended to be drugs for human use.”
Checked against the source on .- Is there human evidence that survodutide works?
Yes — survodutide is one of the few compounds sold on the peptide market with published, peer-reviewed Phase 3 randomised trials. In SYNCHRONIZE-1 (NCT06066515), a 76-week phase 3 double-blind trial reported in the New England Journal of Medicine on 7 June 2026, investigators randomised 725 adults with obesity — or with overweight and at least one obesity-related complication, excluding diabetes — in a 1:1:1 ratio to once-weekly subcutaneous survodutide or placebo, and reported that both primary end points were met, with substantially greater reduction in body weight at week 76 in both survodutide groups than with placebo (P<0.001 for all comparisons with placebo). A second phase 3 trial, SYNCHRONIZE-MASLD, published in Nature Medicine the same day, randomised 216 adults with obesity and at-risk metabolic dysfunction-associated steatotic liver disease 2:1 to once-weekly subcutaneous survodutide or placebo and met both co-primary endpoints — liver fat content by MRI-PDFF and percentage change in body weight. Both trials were funded by Boehringer Ingelheim and used the sponsor's investigational material. That evidence describes the molecule under trial conditions. It says nothing about the contents, purity or identity of a vial sold as 'survodutide' by a research-chemical vendor, and survodutide is not an ingredient in any FDA-approved drug product, so no such vial comes from an approved supply.
Survodutide Once Weekly for the Treatment of Adults with Obesity — The New England Journal of Medicine, 7 June 2026“In this phase 3, double-blind trial, we randomly assigned adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher, or 27 or higher with at least one obesity-related complication (excluding diabetes), in a 1:1:1 ratio to receive once-weekly survodutide administered subcutaneously […] or placebo, in addition to counseling for lifestyle modification.”
Checked against the source on .- Why do different sources report different weight-loss numbers for survodutide?
Because the same trial can be analysed under more than one estimand, and the two answer different questions. The Nature Medicine report of SYNCHRONIZE-MASLD publishes both in the same abstract, which makes the gap checkable rather than arguable: 84.2% of survodutide-treated patients versus 24.3% on placebo had at least a 30% reduction in liver fat content 'using the efficacy estimand', while the treatment regimen estimand for the same endpoint was 68.5% versus 28.6%; mean percentage change in body weight was -12.2% with survodutide and -1.0% with placebo using the efficacy estimand, and -8.7% versus -1.4% using the treatment regimen estimand. An efficacy estimand describes what happened in participants who stayed on treatment as intended; a treatment-regimen estimand incorporates early discontinuation and protocol deviations, so it is closer to what happens in practice and it is consistently the smaller number. In SYNCHRONIZE-1, the New England Journal of Medicine reports that 'The primary efficacy analysis was conducted according to the treatment-regimen estimand'. Neither figure is wrong; a figure quoted without saying which estimand produced it is unusable. Check which one any number you are given comes from.
Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial — Nature Medicine, 7 June 2026“In total, 84.2% of survodutide-treated patients versus 24.3% of placebo-treated patients had ≥30% reduction in LFC using the efficacy estimand (P < 0.0001; treatment regimen estimand: 68.5% versus 28.6%, respectively; P < 0.0001). Mean percentage change in body weight was -12.2% with survodutide and -1.0% with placebo using the efficacy estimand (P < 0.0001; treatment regimen estimand: -8.7% versus -1.4%, respectively; P < 0.0001).”
Checked against the source on .- Can a compounding pharmacy make survodutide?
Not on the strength of anything this record can document, and the honest answer names what was checked and what was not. Section 503A permits compounding from a bulk drug substance only if it meets one of three conditions: it is the subject of an applicable USP or NF monograph, or it is a component of an FDA-approved drug product, or it appears on FDA's 503A bulks list. Two of the three were verified against primary documents on 2 August 2026 and both fail. Survodutide appears nowhere in FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 14 May 2026 — verified by fetching the PDF and extracting its text locally, with zero hits across all seven pages. And survodutide is not a component of any FDA-approved drug product, since Drugs@FDA returns no match for it at all. The third condition, whether an applicable USP or NF monograph exists, was not verified against a primary document and is not asserted here in either direction. Note also what does NOT apply: FDA's statement that retatrutide and cagrilintide 'cannot be used in compounding under federal law' appears on a page that does not mention survodutide anywhere, and it is not repeated here as though it did.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .