{
  "$schema": "https://retatrutidestatus.com/status.json",
  "compound": "Retatrutide",
  "alsoKnownAs": [
    "LY3437943"
  ],
  "sponsor": "Eli Lilly and Company",
  "regulatoryStatus": "Investigational",
  "fdaApproved": false,
  "approvedByAnyRegulator": false,
  "label": "Not FDA approved",
  "severity": "amber",
  "summary": "Retatrutide remains an investigational drug. It has not been approved by the FDA or by any other regulator, and no FDA decision date has been announced. Lilly has said it plans to submit a Biologics License Application in Q1 2027. A submission would begin the regulatory process; it would not itself make retatrutide an approved medicine.",
  "approvalDate": null,
  "pdufaDate": null,
  "submissionMade": false,
  "submissionAcceptedByFda": false,
  "nextMilestone": {
    "name": "Planned regulatory submission window",
    "window": "Q1 2027",
    "start": "2027-01-01",
    "end": "2027-03-31",
    "precision": "quarter",
    "isApprovalDate": false,
    "isCompanyProjection": true,
    "source": "https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional"
  },
  "confirmed": [
    "Retatrutide is investigational. It has no approval record in Drugs@FDA.",
    "Lilly has disclosed positive topline results from five Phase 3 studies.",
    "One of those five, TRANSCEND-T2D-1, has been published in a peer-reviewed journal.",
    "Lilly has stated it plans to submit a BLA to the FDA in Q1 2027."
  ],
  "notConfirmed": [
    "That a submission has been made — as of the last check, it has not.",
    "Any FDA approval date.",
    "Any FDA decision (PDUFA) date.",
    "A commercial launch date.",
    "A U.S. brand name.",
    "A U.S. list price.",
    "Insurance or Medicare coverage."
  ],
  "phase3": {
    "registeredTrials": 14,
    "completed": 5,
    "resultsDisclosed": 5,
    "peerReviewedPublications": 1
  },
  "lastVerified": "2026-07-31T02:56:00Z",
  "officialSource": {
    "name": "Drugs@FDA: FDA-Approved Drugs",
    "publisher": "U.S. Food and Drug Administration",
    "url": "https://www.accessdata.fda.gov/scripts/cder/daf/"
  },
  "sponsorSource": {
    "name": "Lilly's triple agonist retatrutide successful in two additional Phase 3 obesity trials",
    "publisher": "Eli Lilly and Company",
    "url": "https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional",
    "date": "2026-07-23"
  },
  "latestEvent": {
    "date": "2026-07-23",
    "headline": "Lilly states a Q1 2027 BLA submission plan",
    "source": "https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional"
  },
  "disclaimer": "Independent tracker. Not affiliated with Eli Lilly and Company, the FDA, or any regulatory agency. Not medical advice.",
  "attribution": "Retatrutide Status — https://retatrutidestatus.com",
  "documentation": "https://retatrutidestatus.com/widget"
}