Retatrutide, Eli Lilly's investigational triple agonist targeting GLP-1, GIP, and glucagon receptors for obesity and type 2 diabetes, remains unapproved by the FDA with no New Drug Application submitted as of mid-April 2026, driving the market's 83% implied probability for "No" approval this year. Positive Phase 3 data from the TRANSCEND-T2D-1 trial released March 19 showed average A1C reductions of 1.7–2.0% and substantial weight loss at 40 weeks across doses, alongside earlier TRIUMPH-4 results indicating up to 28.7% body weight loss over 68 weeks. However, multiple ongoing Phase 3 trials require full data readouts before NDA filing, projected for late 2026 at earliest, followed by a 10–12 month FDA review—precluding 2026 approval per trader consensus on regulatory timelines. Additional trial results expected later this year could shift sentiment if accelerating submission plans.
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?
FDA zatwierdza Retatrutide w tym roku?
$560,784 Wol.
$560,784 Wol.
$560,784 Wol.
$560,784 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, Eli Lilly's investigational triple agonist targeting GLP-1, GIP, and glucagon receptors for obesity and type 2 diabetes, remains unapproved by the FDA with no New Drug Application submitted as of mid-April 2026, driving the market's 83% implied probability for "No" approval this year. Positive Phase 3 data from the TRANSCEND-T2D-1 trial released March 19 showed average A1C reductions of 1.7–2.0% and substantial weight loss at 40 weeks across doses, alongside earlier TRIUMPH-4 results indicating up to 28.7% body weight loss over 68 weeks. However, multiple ongoing Phase 3 trials require full data readouts before NDA filing, projected for late 2026 at earliest, followed by a 10–12 month FDA review—precluding 2026 approval per trader consensus on regulatory timelines. Additional trial results expected later this year could shift sentiment if accelerating submission plans.
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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