**Retatrutide remains an investigational triple agonist (GLP-1/GIP/glucagon) from Eli Lilly that has not yet completed its full Phase 3 program or received an NDA submission.** As of mid-June 2026, multiple TRIUMPH obesity and TRANSCEND diabetes trials are ongoing or recently reported topline data, with full completion and data analysis projected for late 2026 or early 2027. Positive May 2026 TRIUMPH-1 results showed up to 28.3% mean weight loss at 80 weeks (and 30.3% at 104 weeks in an extension) on the 12 mg dose, meeting primary and key secondary endpoints, yet these are intermediate readouts rather than the complete dataset required for regulatory filing. Standard FDA review timelines of 10–12 months after NDA submission make a 2026 approval highly unlikely under current conditions. Analysts and company commentary consistently project NDA filing no earlier than Q4 2026 or Q1 2027, pushing any potential PDUFA date into 2027 or later. Recent positive efficacy signals have not accelerated the timeline enough to overcome these structural constraints, supporting the market-implied 88.5% probability against approval this year. Upcoming full trial readouts and any Lilly guidance on filing plans will be the next key catalysts.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · ZaktualizowanoFDA zatwierdza Retatrutide w tym roku?
Tak
$569,574 Wol.
$569,574 Wol.
Tak
$569,574 Wol.
$569,574 Wol.
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.
Rynek otwarty: 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 remains an investigational triple agonist (GLP-1/GIP/glucagon) from Eli Lilly that has not yet completed its full Phase 3 program or received an NDA submission.** As of mid-June 2026, multiple TRIUMPH obesity and TRANSCEND diabetes trials are ongoing or recently reported topline data, with full completion and data analysis projected for late 2026 or early 2027. Positive May 2026 TRIUMPH-1 results showed up to 28.3% mean weight loss at 80 weeks (and 30.3% at 104 weeks in an extension) on the 12 mg dose, meeting primary and key secondary endpoints, yet these are intermediate readouts rather than the complete dataset required for regulatory filing. Standard FDA review timelines of 10–12 months after NDA submission make a 2026 approval highly unlikely under current conditions. Analysts and company commentary consistently project NDA filing no earlier than Q4 2026 or Q1 2027, pushing any potential PDUFA date into 2027 or later. Recent positive efficacy signals have not accelerated the timeline enough to overcome these structural constraints, supporting the market-implied 88.5% probability against approval this year. Upcoming full trial readouts and any Lilly guidance on filing plans will be the next key catalysts.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · Zaktualizowano
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