PeptideAmerica

GLP-1 receptor agonists

Retatrutide

LY3437943

US status
No lawful route
Class
GLP-1 receptor agonists
Approved product
None
Route
None lawful; investigational, and sold as research-use-only material

Regulatory record

4 dated actions on record; FDA final action still open (hollow marker).
March 2026
FDA issues warning letters to two firms whose websites offered retatrutide for sale, finding the products to be unapproved new drugs; both letters state that despite labeling the products for research use only and not for human consumption, evidence from the firms' own websites establishes that the products are intended to be drugs for human use.
June 2026
FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition.
August 2026
Drugs@FDA holds no record of retatrutide as the active ingredient of any drug product, and the substance sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. It has never been nominated for one.
FDA final action
None as of August 2026.

Status verified for this index · August 2026

Definition

Retatrutide is an investigational agonist at three receptors at once — the glucose-dependent insulinotropic polypeptide receptor, the GLP-1 receptor, and the glucagon receptor. It is a further step along the line that runs from single-agonist to dual-agonist incretin drugs, and it is in active late-stage development.

It is also sold, today, as research-use-only material. This index tracks it because that combination — a real drug candidate with a real trial program and no lawful route to a person outside a trial — is the position readers most often misread.

Evidence

The trial record exists and it is the sponsor's. Across two name variants PubMed returns 178 indexed records, of which 109 carry the Humans subject heading, 8 the clinical-trial publication type, and 7 the randomized-controlled-trial type [1]. All eight were opened and read, and every one belongs to the development program: a phase 1b multiple-ascending-dose trial in type 2 diabetes, phase 2 trials in obesity and in type 2 diabetes, a phase 2a trial in metabolic dysfunction-associated steatotic liver disease, body-composition and lipid substudies, and a phase 3 trial [1].

The phase 2 obesity trial is the result the market reacted to and the one most often quoted secondhand [2]; a phase 3 trial in people with type 2 diabetes and inadequate glycemic control on diet and exercise has since been published [3]. Reporting either as evidence of approval is the error this page exists to prevent, and the distinction is not subtle: a trial establishes what a compound does under study conditions, and an approval establishes that a specific product may be sold to be used.

The eight trial-type records are also the reason a count alone tells a reader nothing about legality. Ipamorelin has two and no route; retatrutide has eight and no route; semaglutide has hundreds and an approval. The number that decides the legal question is not in the literature at all.

Lawful access

There is no lawful United States supply route outside a clinical trial. No approved product containing retatrutide exists: a query of Drugs@FDA by active ingredient returns no records for it, in the same run in which the same query returned records for bremelanotide and for liraglutide and returned none for a deliberately invented ingredient name [4].

FDA has stated the compounding position in its own words rather than leaving it to inference: retatrutide and cagrilintide cannot be used in compounding under federal law, they are not components of FDA-approved drugs, and they have not been found safe and effective for any condition [5]. The substance appears in no category of the section 503A bulks list published on May 14, 2026, and it has never been nominated for one [6].

The agency has also acted on research-use-only sales. In March 2026 it issued warning letters to two firms whose websites offered retatrutide, finding the products to be unapproved new drugs; both letters state that despite labeling marketing the products for research use only and not for human consumption, evidence obtained from the firms' own websites establishes that the products are intended to be drugs for human use [7][8]. This index records those letters as disclosure of what FDA has stated and adjudicates no business. The research-only page explains what the labeling posture is and is not.

Elsewhere in this index

Filed under

Reference tables

Same class

References

  1. PubMed, National Library of Medicine. Census run 2026-08-31 across two name variants — "retatrutide" OR "LY3437943" — returning 178 indexed records, 109 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 7 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved and read individually; all belong to the sponsor's development program, spanning phase 1b through phase 3. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
  2. Jastreboff AM, Kaplan LM, Frías JP, et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial. N Engl J Med. 2023;389(6):514–526. PMID 37366315
  3. Bajaj HS, Welch M, Shah P, et al. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. 2026;407(10546):2402–2413. PMID 42250575
  4. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run 2026-08-31: a search by active-ingredient name returned no records for retatrutide. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. Source
  5. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of June 15, 2026. Read 2026-08-31. Source
  6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full 2026-08-31: retatrutide appears in none of Category 1, Category 2, or Category 3. Source
  7. US Food and Drug Administration. Warning letter, MARCS-CMS 721806, March 31, 2026. Read 2026-08-31. Source
  8. US Food and Drug Administration. Warning letter, MARCS-CMS 721600, March 31, 2026. Read 2026-08-31. Source