Eli Lilly plans to submit its Biologics License Application for retatrutide—a triple agonist targeting GLP-1, GIP, and glucagon receptors—only in the first quarter of 2027, after completing additional Phase 3 TRIUMPH trials and gathering manufacturing data. FDA review of such submissions typically requires 10–12 months, placing any potential approval well into 2028. With the filing deadline already past the 2026 calendar year and no accelerated pathway indicated for full marketing authorization, traders assign just 2.5% probability to approval this year. An expanded-access program allows limited pre-approval use under FDA guidance but does not substitute for completed review or agency approval. Unexpected fast-track designation or submission acceleration would be required to alter this timeline.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhậtCó
$578,572 KL.
$578,572 KL.
Có
$578,572 KL.
$578,572 KL.
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.
Thị trường mở: 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 plans to submit its Biologics License Application for retatrutide—a triple agonist targeting GLP-1, GIP, and glucagon receptors—only in the first quarter of 2027, after completing additional Phase 3 TRIUMPH trials and gathering manufacturing data. FDA review of such submissions typically requires 10–12 months, placing any potential approval well into 2028. With the filing deadline already past the 2026 calendar year and no accelerated pathway indicated for full marketing authorization, traders assign just 2.5% probability to approval this year. An expanded-access program allows limited pre-approval use under FDA guidance but does not substitute for completed review or agency approval. Unexpected fast-track designation or submission acceleration would be required to alter this timeline.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhật


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