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icon for FDA zatwierdza Retatrutide w tym roku?
Technologia·Drug

FDA zatwierdza Retatrutide w tym roku?

icon for FDA zatwierdza Retatrutide w tym roku?
Technologia·Drug

FDA zatwierdza Retatrutide w tym roku?

Tak

2% szansa
Polymarket

$578,572 Wol.

Tak

2% szansa
Polymarket

$578,572 Wol.

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.Eli Lilly’s July 2026 announcement that it will submit a Biologics License Application for retatrutide, its investigational GIP/GLP-1/glucagon triple agonist, in the first quarter of 2027 drives the near-certain market consensus against 2026 FDA approval. Positive topline Phase 3 TRIUMPH trial results, including up to 22.6% average weight loss at 80 weeks in patients with obesity and cardiovascular disease, confirm strong efficacy and safety data but arrive too late for a 2026 filing and the standard 10–12-month FDA review cycle. Historical precedent shows novel biologics rarely receive approval without a completed submission, and no accelerated pathway or priority review has been indicated. While an unexpected early filing or breakthrough designation could theoretically compress timelines, current manufacturing data collection and regulatory scheduling make approval this year highly improbable.

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.
Wolumen
$578,572
Data zakończenia
Dec 31, 2026
Rynek otwarty
Jan 12, 2026, 5:52 PM ET

Resolver

0x65070BE91...
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.
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.Eli Lilly’s July 2026 announcement that it will submit a Biologics License Application for retatrutide, its investigational GIP/GLP-1/glucagon triple agonist, in the first quarter of 2027 drives the near-certain market consensus against 2026 FDA approval. Positive topline Phase 3 TRIUMPH trial results, including up to 22.6% average weight loss at 80 weeks in patients with obesity and cardiovascular disease, confirm strong efficacy and safety data but arrive too late for a 2026 filing and the standard 10–12-month FDA review cycle. Historical precedent shows novel biologics rarely receive approval without a completed submission, and no accelerated pathway or priority review has been indicated. While an unexpected early filing or breakthrough designation could theoretically compress timelines, current manufacturing data collection and regulatory scheduling make approval this year highly improbable.

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.
Wolumen
$578,572
Data zakończenia
Dec 31, 2026
Rynek otwarty
Jan 12, 2026, 5:52 PM ET

Resolver

0x65070BE91...
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.

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