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Survodutide

Also known as BI 456906.

Not approved by the FDA or the EMA. Its Phase 3 program is still running, and its Breakthrough Therapy status does not mean approval.

HisAc4GlnGlyThrPheThrSerAspTyrSerLysTyrLeuAspGluArgAlaAlaLysAspPheIleLysTrpLeuGluSerAla
29 amino acids, in order. A double ring marks a mirror-image, modified or non-standard one. End caps, bridges and anything attached to the chain are not drawn. Source: FDA substance registry.
Human evidence
Grade B

Some trials

Completed randomized trials
4
Approved?
No

Not approved in the US or the EU

Sport (WADA)
Not named

Not named on WADA's list. That is not clearance.

Checked on .

How we count a trial
Short answer

As of September 2026, the FDA and the EMA have not approved survodutide for any use. It holds an FDA Breakthrough Therapy designation for MASH, a serious fatty liver disease. That status does not mean approval. Its Phase 3 program is still running. No trial on this page tested a vial sold as survodutide. If one reached you, nothing on the outside tells you what is in it.

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What is survodutide?

Survodutide is a lab-made, long-acting drug that switches on two gut-hormone receptors at once, GLP-1 and glucagon. Boehringer Ingelheim makes it and is developing it for obesity and for MASH, a serious fatty liver disease. The FDA and the EMA have not approved it for any use.

Does survodutide work?

Neither the FDA nor the EMA has approved it for any use. Two published trials reported weight loss, and two more trials on this record are listed as ongoing.

What we found. 4 completed randomized trials counted on the record. The 4 study rows below show 2 published trials and 2 listed as ongoing, so the count and the list do not match.

Studies on the survodutide record: each study, what it was tested in, its status and what it shows.
Phase 2 trial (2024)PeoplePublishedSignificant weight loss compared with placebo
Phase 3 trial in obesity (NEJM)PeoplePublishedSubstantial weight loss in adults with obesity
SYNCHRONIZE-MASLD, NCT06309992 on ClinicalTrials.gov (opens in new tab)PeopleOngoing or reported. The record gives both wordsIt tests the effect on liver fat and weight in people with steatohepatitis, a fatty liver disease. No finding is listed
Weight-loss trial in type 2 diabetes, NCT06066528 on ClinicalTrials.gov (opens in new tab)PeopleOngoingIt tests weight loss in people with overweight or obesity and type 2 diabetes. No finding is listed

The record's summary also says trials showed less liver fat in people with MASH. Its study list gives no liver result to back that.

How we count a trial

Is survodutide safe?

The record says only that common side effects mirror those of other GLP-1-class drugs. It names none. Long-term heart and liver outcome data, beyond the length of the current trials, are still pending. Past that point, nobody knows. That is the picture for the drug as the trials on this record gave it. A vial with survodutide on the label is outside that picture, as the vial section explains.

What is in a vial sold as survodutide?

The trials above tested Boehringer Ingelheim's own product. This record holds no sign that survodutide is on sale. If a vial with this name reached you, none of those trials tested it, and the checklist lists what to ask the seller.

What don't we know?

  • Whether the FDA or the EMA will approve it. The Phase 3 program is still running.
  • What long-term use does to the heart and the liver. Those outcome data are still pending.
  • What the two trials listed as ongoing will show.
  • What is in any vial sold as survodutide.

The other side

Survodutide has published randomized trials, one of them in the New England Journal of Medicine. The FDA also gave it a status meant to speed development, because of its potential in MASH. Neither fact is an approval, and the Phase 3 program is still running.

What would change this record?

  • An approval decision from the FDA or the EMA, after the SYNCHRONIZE Phase 3 program is complete.

Change log

  • Record checked. No change logged yet.
Every change on the Table

Three questions to ask next

Ask better questions.

More questions about survodutide

Is survodutide FDA approved?

No. As of September 2026 neither the FDA nor the EMA has approved survodutide for any use.

What does Breakthrough Therapy designation mean for survodutide?

It is an FDA status meant to speed development, granted here for MASH. The record says it is not the same as approval.

Has survodutide been tested in people?

Yes. The record lists two published trials that reported weight loss. Two more, in fatty liver disease and in type 2 diabetes, are listed as ongoing.

Are trials of survodutide still running?

Yes. The Phase 3 SYNCHRONIZE program is ongoing. The record lists SYNCHRONIZE-MASLD (NCT06309992 on ClinicalTrials.gov (opens in new tab)) and a type 2 diabetes trial (NCT06066528 on ClinicalTrials.gov (opens in new tab)) as ongoing.

Is survodutide banned in sport?

It is not named on WADA's list. That is not clearance.
Sources

Record checked on . Each source shows the date it was checked.

Metabolic and weight

In the same group

All 12 in this group
Still curious

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