FDA approves Retatrutide this year?

Retatrutide is a triple agonist hormone/peptide drug developed by Eli Lilly and currently in trial to treat obesity, fatty liver disease, type-2 diabetes, knee osteoarthritis, and more.

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.