**Lilly has not yet submitted a biologics license application (BLA) for retatrutide, its investigational triple agonist (GLP-1/GIP/glucagon) for obesity and related conditions, and explicitly plans to file only in Q1 2027.** Positive Phase 3 TRIUMPH trial readouts through July 2026 (including up to 28.3% mean weight loss at 80 weeks in TRIUMPH-1 and strong results in diabetes and cardiovascular populations) confirm robust efficacy data, yet the chemistry, manufacturing, and controls package and full submission remain incomplete. Standard FDA review timelines of 10–12 months after filing place any potential approval in late 2027 or 2028 at the earliest. This timeline underpins the 94.3% market-implied probability of no approval in 2026. Traders recognize that even breakthrough or priority review designations cannot compress the process enough for a 2026 decision when the application itself is scheduled for next year. Historical precedent for similar cardiometabolic drugs reinforces that regulators require the complete dossier before starting the clock. Realistic scenarios that could shift odds include an unexpectedly accelerated filing (for instance, if remaining data packages close ahead of schedule) or an unprecedented expedited pathway, though neither appears supported by current Lilly guidance or agency norms. New safety signals or manufacturing issues could further delay progress, while positive late-2026 data releases would mainly inform the 2027 submission rather than enable immediate approval.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhậtCó
6% khả năng
$583,125 KL.
$583,125 KL.
Dec 30, 2026
Có
6% khả năng
$583,125 KL.
$583,125 KL.
Dec 30, 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.**Lilly has not yet submitted a biologics license application (BLA) for retatrutide, its investigational triple agonist (GLP-1/GIP/glucagon) for obesity and related conditions, and explicitly plans to file only in Q1 2027.** Positive Phase 3 TRIUMPH trial readouts through July 2026 (including up to 28.3% mean weight loss at 80 weeks in TRIUMPH-1 and strong results in diabetes and cardiovascular populations) confirm robust efficacy data, yet the chemistry, manufacturing, and controls package and full submission remain incomplete. Standard FDA review timelines of 10–12 months after filing place any potential approval in late 2027 or 2028 at the earliest.
This timeline underpins the 94.3% market-implied probability of no approval in 2026. Traders recognize that even breakthrough or priority review designations cannot compress the process enough for a 2026 decision when the application itself is scheduled for next year. Historical precedent for similar cardiometabolic drugs reinforces that regulators require the complete dossier before starting the clock.
Realistic scenarios that could shift odds include an unexpectedly accelerated filing (for instance, if remaining data packages close ahead of schedule) or an unprecedented expedited pathway, though neither appears supported by current Lilly guidance or agency norms. New safety signals or manufacturing issues could further delay progress, while positive late-2026 data releases would mainly inform the 2027 submission rather than enable immediate approval.
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.
Thị trường mở: Jan 12, 2026, 5:52 PM ET
Khối lượng
$583,125Ngày kết thúc
Dec 31, 2026Thị trường mở
Jan 12, 2026, 5:52 PM ETNgười giải quyết
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.**Lilly has not yet submitted a biologics license application (BLA) for retatrutide, its investigational triple agonist (GLP-1/GIP/glucagon) for obesity and related conditions, and explicitly plans to file only in Q1 2027.** Positive Phase 3 TRIUMPH trial readouts through July 2026 (including up to 28.3% mean weight loss at 80 weeks in TRIUMPH-1 and strong results in diabetes and cardiovascular populations) confirm robust efficacy data, yet the chemistry, manufacturing, and controls package and full submission remain incomplete. Standard FDA review timelines of 10–12 months after filing place any potential approval in late 2027 or 2028 at the earliest.
This timeline underpins the 94.3% market-implied probability of no approval in 2026. Traders recognize that even breakthrough or priority review designations cannot compress the process enough for a 2026 decision when the application itself is scheduled for next year. Historical precedent for similar cardiometabolic drugs reinforces that regulators require the complete dossier before starting the clock.
Realistic scenarios that could shift odds include an unexpectedly accelerated filing (for instance, if remaining data packages close ahead of schedule) or an unprecedented expedited pathway, though neither appears supported by current Lilly guidance or agency norms. New safety signals or manufacturing issues could further delay progress, while positive late-2026 data releases would mainly inform the 2027 submission rather than enable immediate approval.
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.
Khối lượng
$583,125Ngày kết thúc
Dec 31, 2026Thị trường mở
Jan 12, 2026, 5:52 PM ETNgười giải quyết
0x65070BE91...**Lilly has not yet submitted a biologics license application (BLA) for retatrutide, its investigational triple agonist (GLP-1/GIP/glucagon) for obesity and related conditions, and explicitly plans to file only in Q1 2027.** Positive Phase 3 TRIUMPH trial readouts through July 2026 (including up to 28.3% mean weight loss at 80 weeks in TRIUMPH-1 and strong results in diabetes and cardiovascular populations) confirm robust efficacy data, yet the chemistry, manufacturing, and controls package and full submission remain incomplete. Standard FDA review timelines of 10–12 months after filing place any potential approval in late 2027 or 2028 at the earliest. This timeline underpins the 94.3% market-implied probability of no approval in 2026. Traders recognize that even breakthrough or priority review designations cannot compress the process enough for a 2026 decision when the application itself is scheduled for next year. Historical precedent for similar cardiometabolic drugs reinforces that regulators require the complete dossier before starting the clock. Realistic scenarios that could shift odds include an unexpectedly accelerated filing (for instance, if remaining data packages close ahead of schedule) or an unprecedented expedited pathway, though neither appears supported by current Lilly guidance or agency norms. New safety signals or manufacturing issues could further delay progress, while positive late-2026 data releases would mainly inform the 2027 submission rather than enable immediate approval.
Tóm tắt AI thử nghiệm tham chiếu dữ liệu Polymarket. Đây không phải tư vấn giao dịch và không ảnh hưởng đến cách thị trường này được giải quyết. · Cập nhật
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