**The market's 97.7% implied probability that the FDA will not approve retatrutide in 2026 reflects the drug's current regulatory status and standard timelines.** Retatrutide (LY3437943), Eli Lilly's investigational once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors, remains an unapproved investigational therapy as of late August 2026. Lilly has not submitted a Biologics License Application (BLA) or New Drug Application. On July 23, 2026, Lilly reported positive topline Phase 3 results from the TRIUMPH-2 and TRIUMPH-3 trials (part of a program now backed by five successful late-stage studies). These showed mean weight reductions of 20.8–22.6% at the 12 mg dose over 80 weeks in adults with obesity plus type 2 diabetes or established cardiovascular disease, alongside A1C improvements. The company explicitly stated it is completing the Chemistry, Manufacturing, and Controls (CMC) package and plans to submit the BLA in Q1 2027. FDA review of a BLA typically requires 10–12 months (potentially shorter with priority review), placing any potential approval in late 2027 or 2028. This timeline—confirmed across Lilly announcements, regulatory trackers, and independent analyses—makes approval by December 31, 2026, effectively impossible under normal processes. No emergency-use authorization pathway or accelerated submission has been indicated. Realistic scenarios that could theoretically shift the outcome remain low-probability: an unforeseen regulatory fast-track or manufacturing breakthrough enabling an earlier filing is unlikely given the explicit Q1 2027 target and ongoing CMC work. Conversely, any CMC delays, additional data requirements, or classification disputes (Lilly is appealing whether retatrutide qualifies as a biologic) would only push timelines later. The market consensus accurately aggregates these verifiable development and regulatory facts.
Resumen experimental generado por IA con datos de Polymarket. Esto no es asesoramiento de trading y no influye en cómo se resuelve este mercado. · ActualizadoSí
2% probabilidad
$578,993 Vol.
$578,993 Vol.
30 dic 2026
Sí
2% probabilidad
$578,993 Vol.
$578,993 Vol.
30 dic 2026
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.**The market's 97.7% implied probability that the FDA will not approve retatrutide in 2026 reflects the drug's current regulatory status and standard timelines.** Retatrutide (LY3437943), Eli Lilly's investigational once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors, remains an unapproved investigational therapy as of late August 2026. Lilly has not submitted a Biologics License Application (BLA) or New Drug Application.
On July 23, 2026, Lilly reported positive topline Phase 3 results from the TRIUMPH-2 and TRIUMPH-3 trials (part of a program now backed by five successful late-stage studies). These showed mean weight reductions of 20.8–22.6% at the 12 mg dose over 80 weeks in adults with obesity plus type 2 diabetes or established cardiovascular disease, alongside A1C improvements. The company explicitly stated it is completing the Chemistry, Manufacturing, and Controls (CMC) package and plans to submit the BLA in Q1 2027. FDA review of a BLA typically requires 10–12 months (potentially shorter with priority review), placing any potential approval in late 2027 or 2028.
This timeline—confirmed across Lilly announcements, regulatory trackers, and independent analyses—makes approval by December 31, 2026, effectively impossible under normal processes. No emergency-use authorization pathway or accelerated submission has been indicated.
Realistic scenarios that could theoretically shift the outcome remain low-probability: an unforeseen regulatory fast-track or manufacturing breakthrough enabling an earlier filing is unlikely given the explicit Q1 2027 target and ongoing CMC work. Conversely, any CMC delays, additional data requirements, or classification disputes (Lilly is appealing whether retatrutide qualifies as a biologic) would only push timelines later. The market consensus accurately aggregates these verifiable development and regulatory facts.
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.
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.
Mercado abierto: Jan 12, 2026, 5:52 PM ET
Volumen
$578,993Fecha de finalización
31 dic 2026Mercado abierto
Jan 12, 2026, 5:52 PM ETResolver
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.**The market's 97.7% implied probability that the FDA will not approve retatrutide in 2026 reflects the drug's current regulatory status and standard timelines.** Retatrutide (LY3437943), Eli Lilly's investigational once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors, remains an unapproved investigational therapy as of late August 2026. Lilly has not submitted a Biologics License Application (BLA) or New Drug Application.
On July 23, 2026, Lilly reported positive topline Phase 3 results from the TRIUMPH-2 and TRIUMPH-3 trials (part of a program now backed by five successful late-stage studies). These showed mean weight reductions of 20.8–22.6% at the 12 mg dose over 80 weeks in adults with obesity plus type 2 diabetes or established cardiovascular disease, alongside A1C improvements. The company explicitly stated it is completing the Chemistry, Manufacturing, and Controls (CMC) package and plans to submit the BLA in Q1 2027. FDA review of a BLA typically requires 10–12 months (potentially shorter with priority review), placing any potential approval in late 2027 or 2028.
This timeline—confirmed across Lilly announcements, regulatory trackers, and independent analyses—makes approval by December 31, 2026, effectively impossible under normal processes. No emergency-use authorization pathway or accelerated submission has been indicated.
Realistic scenarios that could theoretically shift the outcome remain low-probability: an unforeseen regulatory fast-track or manufacturing breakthrough enabling an earlier filing is unlikely given the explicit Q1 2027 target and ongoing CMC work. Conversely, any CMC delays, additional data requirements, or classification disputes (Lilly is appealing whether retatrutide qualifies as a biologic) would only push timelines later. The market consensus accurately aggregates these verifiable development and regulatory facts.
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.
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.
Volumen
$578,993Fecha de finalización
31 dic 2026Mercado abierto
Jan 12, 2026, 5:52 PM ETResolver
0x65070BE91...**The market's 97.7% implied probability that the FDA will not approve retatrutide in 2026 reflects the drug's current regulatory status and standard timelines.** Retatrutide (LY3437943), Eli Lilly's investigational once-weekly triple agonist targeting GIP, GLP-1, and glucagon receptors, remains an unapproved investigational therapy as of late August 2026. Lilly has not submitted a Biologics License Application (BLA) or New Drug Application. On July 23, 2026, Lilly reported positive topline Phase 3 results from the TRIUMPH-2 and TRIUMPH-3 trials (part of a program now backed by five successful late-stage studies). These showed mean weight reductions of 20.8–22.6% at the 12 mg dose over 80 weeks in adults with obesity plus type 2 diabetes or established cardiovascular disease, alongside A1C improvements. The company explicitly stated it is completing the Chemistry, Manufacturing, and Controls (CMC) package and plans to submit the BLA in Q1 2027. FDA review of a BLA typically requires 10–12 months (potentially shorter with priority review), placing any potential approval in late 2027 or 2028. This timeline—confirmed across Lilly announcements, regulatory trackers, and independent analyses—makes approval by December 31, 2026, effectively impossible under normal processes. No emergency-use authorization pathway or accelerated submission has been indicated. Realistic scenarios that could theoretically shift the outcome remain low-probability: an unforeseen regulatory fast-track or manufacturing breakthrough enabling an earlier filing is unlikely given the explicit Q1 2027 target and ongoing CMC work. Conversely, any CMC delays, additional data requirements, or classification disputes (Lilly is appealing whether retatrutide qualifies as a biologic) would only push timelines later. The market consensus accurately aggregates these verifiable development and regulatory facts.
Resumen experimental generado por IA con datos de Polymarket. Esto no es asesoramiento de trading y no influye en cómo se resuelve este mercado. · Actualizado
Cuidado con los enlaces externos.
Cuidado con los enlaces externos.
Preguntas frecuentes