Trader consensus on Polymarket heavily favors "No" at 77% implied probability for FDA approval of retatrutide in 2026, driven by Eli Lilly's confirmed timeline placing New Drug Application (NDA) submission in Q4 2026 after completing ongoing Phase 3 TRIUMPH and TRANSCEND trials. Recent positive data from March 2026's TRANSCEND-T2D-1 trial showed retatrutide, an investigational triple GLP-1/GIP/glucagon agonist, reducing A1C by 1.7–2.0% and enabling 16.8% average weight loss at 40 weeks in type 2 diabetes patients, building on prior obesity results up to 28.7% weight reduction. However, standard FDA review takes 10–12 months post-filing, or 6 months under priority review—leaving insufficient time before year-end resolution. Lilly's Q1 2026 earnings reaffirmed this outlook, with additional Phase 3 readouts expected later this year amid inherent regulatory uncertainties.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated$562,923 Vol.
$562,923 Vol.
$562,923 Vol.
$562,923 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.
Market Opened: 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...Trader consensus on Polymarket heavily favors "No" at 77% implied probability for FDA approval of retatrutide in 2026, driven by Eli Lilly's confirmed timeline placing New Drug Application (NDA) submission in Q4 2026 after completing ongoing Phase 3 TRIUMPH and TRANSCEND trials. Recent positive data from March 2026's TRANSCEND-T2D-1 trial showed retatrutide, an investigational triple GLP-1/GIP/glucagon agonist, reducing A1C by 1.7–2.0% and enabling 16.8% average weight loss at 40 weeks in type 2 diabetes patients, building on prior obesity results up to 28.7% weight reduction. However, standard FDA review takes 10–12 months post-filing, or 6 months under priority review—leaving insufficient time before year-end resolution. Lilly's Q1 2026 earnings reaffirmed this outlook, with additional Phase 3 readouts expected later this year amid inherent regulatory uncertainties.
Experimental AI-generated summary referencing Polymarket data. This is not trading advice and plays no role in how this market resolves. · Updated



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