**Retatrutide remains in Phase 3 trials under Eli Lilly’s TRIUMPH program, with the New Drug Application (NDA) not expected until Q4 2026 at the earliest.** Recent positive topline data from TRIUMPH-1 (May 2026) demonstrated up to 28.3% mean weight loss at 80 weeks on the 12 mg dose, alongside improvements in cardiometabolic markers, but this is only one of multiple pivotal studies. Other trials, including those in diabetes and osteoarthritis, continue to read out through 2026, and full data packages are required before submission. The FDA’s standard 10–12 month review timeline means that even a late-2026 filing would place any potential approval decision in 2027. No accelerated review designation or breakthrough therapy status has been confirmed to shorten this process, and historical precedents for similar GLP-1 agonists show that complete Phase 3 datasets across indications are typically needed. These factors underpin traders’ strong consensus against 2026 approval.
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?
$569,797 Обс.
$569,797 Обс.
$569,797 Обс.
$569,797 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
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 in Phase 3 trials under Eli Lilly’s TRIUMPH program, with the New Drug Application (NDA) not expected until Q4 2026 at the earliest.** Recent positive topline data from TRIUMPH-1 (May 2026) demonstrated up to 28.3% mean weight loss at 80 weeks on the 12 mg dose, alongside improvements in cardiometabolic markers, but this is only one of multiple pivotal studies. Other trials, including those in diabetes and osteoarthritis, continue to read out through 2026, and full data packages are required before submission. The FDA’s standard 10–12 month review timeline means that even a late-2026 filing would place any potential approval decision in 2027. No accelerated review designation or breakthrough therapy status has been confirmed to shorten this process, and historical precedents for similar GLP-1 agonists show that complete Phase 3 datasets across indications are typically needed. These factors underpin traders’ strong consensus against 2026 approval.
Експериментальне резюме, згенероване ШІ з посиланням на дані Polymarket. Це не торгова порада і не впливає на вирішення цього ринку. · Оновлено
Обережно з зовнішніми посиланнями.
Обережно з зовнішніми посиланнями.
Часті запитання