Eli Lilly's investigational triple agonist retatrutide, targeting GLP-1, GIP, and glucagon receptors for obesity and type 2 diabetes, continues in phase 3 trials, driving trader consensus to a 73.5% implied probability against FDA approval in 2026. March 19 topline results from the TRANSCEND-T2D-1 trial showed superior A1C reductions of 1.7–2.0% and 16.8% mean weight loss at 40 weeks versus comparators, bolstering efficacy data alongside prior TRIUMPH obesity studies reporting up to 28% weight loss. However, no New Drug Application has been filed with the FDA, with remaining trials in the six-study program slated to complete by mid-2026 and NDA submission projected for late 2026 or early 2027. Standard 6–10 month review periods, even with potential priority review, render year-end approval improbable per official timelines from ClinicalTrials.gov and Lilly updates, as traders anticipate confirmatory safety and efficacy integration.
Resumo experimental gerado por IA com dados do Polymarket · AtualizadoA FDA aprova o Retatrutide este ano?
A FDA aprova o Retatrutide este ano?
Sim
$543,959 Vol.
$543,959 Vol.
Sim
$543,959 Vol.
$543,959 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.
Mercado Aberto: 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...Eli Lilly's investigational triple agonist retatrutide, targeting GLP-1, GIP, and glucagon receptors for obesity and type 2 diabetes, continues in phase 3 trials, driving trader consensus to a 73.5% implied probability against FDA approval in 2026. March 19 topline results from the TRANSCEND-T2D-1 trial showed superior A1C reductions of 1.7–2.0% and 16.8% mean weight loss at 40 weeks versus comparators, bolstering efficacy data alongside prior TRIUMPH obesity studies reporting up to 28% weight loss. However, no New Drug Application has been filed with the FDA, with remaining trials in the six-study program slated to complete by mid-2026 and NDA submission projected for late 2026 or early 2027. Standard 6–10 month review periods, even with potential priority review, render year-end approval improbable per official timelines from ClinicalTrials.gov and Lilly updates, as traders anticipate confirmatory safety and efficacy integration.
Resumo experimental gerado por IA com dados do Polymarket · Atualizado
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