Retatrutide, Eli Lilly’s investigational triple-hormone receptor agonist targeting GLP-1, GIP, and glucagon, remains in multiple Phase 3 trials under the TRIUMPH program. As of mid-2026, the company has not yet submitted a New Drug Application to the FDA, with pivotal data readouts from several studies still scheduled for later this year. The March 2026 release of positive topline results from the TRANSCEND-T2D-1 diabetes trial demonstrated strong A1C reductions and weight loss, but these findings alone do not complete the required efficacy and safety package. Standard FDA review timelines following submission—typically ten months or longer—place any potential approval well into 2027, supporting the market’s strong consensus against approval by year-end.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · AggiornatoLa FDA approva la Retatrutide quest' anno?
Sì
$564,321 Vol.
$564,321 Vol.
Sì
$564,321 Vol.
$564,321 Vol.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for Eli Lilly’s for a drug product whose active ingredient is Eli Lilly’s retatrutide (including any brand name or identifier such as LY3437943) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Mercato aperto: Jan 12, 2026, 5:52 PM ET
Resolver
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for Eli Lilly’s for a drug product whose active ingredient is Eli Lilly’s retatrutide (including any brand name or identifier such as LY3437943) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Resolver
0x65070BE91...Retatrutide, Eli Lilly’s investigational triple-hormone receptor agonist targeting GLP-1, GIP, and glucagon, remains in multiple Phase 3 trials under the TRIUMPH program. As of mid-2026, the company has not yet submitted a New Drug Application to the FDA, with pivotal data readouts from several studies still scheduled for later this year. The March 2026 release of positive topline results from the TRANSCEND-T2D-1 diabetes trial demonstrated strong A1C reductions and weight loss, but these findings alone do not complete the required efficacy and safety package. Standard FDA review timelines following submission—typically ten months or longer—place any potential approval well into 2027, supporting the market’s strong consensus against approval by year-end.
Riepilogo sperimentale generato dall'AI con riferimento ai dati di Polymarket. Questo non è un consiglio di trading e non ha alcun ruolo nella risoluzione di questo mercato. · Aggiornato
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