Eli Lilly’s retatrutide, an investigational triple agonist targeting GIP, GLP-1, and glucagon receptors, remains in the TRIUMPH Phase 3 program with five positive trials reported through mid-2026 showing 20–28% mean weight loss at the 12 mg dose. No Biologics License Application has been filed, and Lilly has stated it will complete the chemistry, manufacturing, and controls package before submitting in Q1 2027. Standard FDA review for a new biologic typically requires 10–12 months, placing any possible approval in late 2027 or 2028. Trader consensus at 96.7% “No” for 2026 approval reflects this fixed sequence of data maturation, filing, and regulatory evaluation, with limited scope for acceleration absent an unforeseen priority-review designation or expedited pathway.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · ОновленоFDA затверджує ретатрутид цього року?
$579,742 Обс.
$579,742 Обс.
$579,742 Обс.
$579,742 Обс.
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.
Ринок відкрито: Jan 12, 2026, 5:52 PM ET
Вирішувач
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.
Вирішувач
0x65070BE91...Eli Lilly’s retatrutide, an investigational triple agonist targeting GIP, GLP-1, and glucagon receptors, remains in the TRIUMPH Phase 3 program with five positive trials reported through mid-2026 showing 20–28% mean weight loss at the 12 mg dose. No Biologics License Application has been filed, and Lilly has stated it will complete the chemistry, manufacturing, and controls package before submitting in Q1 2027. Standard FDA review for a new biologic typically requires 10–12 months, placing any possible approval in late 2027 or 2028. Trader consensus at 96.7% “No” for 2026 approval reflects this fixed sequence of data maturation, filing, and regulatory evaluation, with limited scope for acceleration absent an unforeseen priority-review designation or expedited pathway.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · Оновлено


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