Trader consensus favors no FDA approval of a psychedelic for medical use in 2026 at 64%, reflecting the agency's cautious approach following the 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD and the absence of any new drug application filings to date. Compass Pathways' COMP360 psilocybin met its Phase 3 primary endpoint for treatment-resistant depression in February 2026, earning breakthrough therapy designation, yet NDA submission remains pending with a potential review timeline extending into 2027. Recent Trump administration signals, including a halted fast-track in February and an expected executive order on April 17 to boost psychedelic research like ibogaine for PTSD, introduce policy momentum but underscore regulatory hurdles and historical precedents limiting near-term approvals. State-level preparations in Connecticut and Virginia anticipate future shifts, but federal timelines dominate trader skepticism.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · ОбновленоНОВОЕ
НОВОЕ
31 дек. 2026 г.
НОВОЕ
НОВОЕ
31 дек. 2026 г.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) approves any psychedelic substance for medical use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.Trader consensus favors no FDA approval of a psychedelic for medical use in 2026 at 64%, reflecting the agency's cautious approach following the 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD and the absence of any new drug application filings to date. Compass Pathways' COMP360 psilocybin met its Phase 3 primary endpoint for treatment-resistant depression in February 2026, earning breakthrough therapy designation, yet NDA submission remains pending with a potential review timeline extending into 2027. Recent Trump administration signals, including a halted fast-track in February and an expected executive order on April 17 to boost psychedelic research like ibogaine for PTSD, introduce policy momentum but underscore regulatory hurdles and historical precedents limiting near-term approvals. State-level preparations in Connecticut and Virginia anticipate future shifts, but federal timelines dominate trader skepticism.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) approves any psychedelic substance for medical use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.
Открытие рынка: Apr 16, 2026, 10:42 AM ET
Объем
$988Дата окончания
31 дек. 2026 г.Открытие рынка
Apr 16, 2026, 10:42 AM ETResolver
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) approves any psychedelic substance for medical use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.Trader consensus favors no FDA approval of a psychedelic for medical use in 2026 at 64%, reflecting the agency's cautious approach following the 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD and the absence of any new drug application filings to date. Compass Pathways' COMP360 psilocybin met its Phase 3 primary endpoint for treatment-resistant depression in February 2026, earning breakthrough therapy designation, yet NDA submission remains pending with a potential review timeline extending into 2027. Recent Trump administration signals, including a halted fast-track in February and an expected executive order on April 17 to boost psychedelic research like ibogaine for PTSD, introduce policy momentum but underscore regulatory hurdles and historical precedents limiting near-term approvals. State-level preparations in Connecticut and Virginia anticipate future shifts, but federal timelines dominate trader skepticism.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) approves any psychedelic substance for medical use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.
Psychedelic substances include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
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.
Объем
$988Дата окончания
31 дек. 2026 г.Открытие рынка
Apr 16, 2026, 10:42 AM ETResolver
0x65070BE91...Trader consensus favors no FDA approval of a psychedelic for medical use in 2026 at 64%, reflecting the agency's cautious approach following the 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD and the absence of any new drug application filings to date. Compass Pathways' COMP360 psilocybin met its Phase 3 primary endpoint for treatment-resistant depression in February 2026, earning breakthrough therapy designation, yet NDA submission remains pending with a potential review timeline extending into 2027. Recent Trump administration signals, including a halted fast-track in February and an expected executive order on April 17 to boost psychedelic research like ibogaine for PTSD, introduce policy momentum but underscore regulatory hurdles and historical precedents limiting near-term approvals. State-level preparations in Connecticut and Virginia anticipate future shifts, but federal timelines dominate trader skepticism.
Экспериментальная сводка, созданная ИИ на основе данных Polymarket. Это не является торговой рекомендацией и не влияет на то, как разрешается этот рынок. · Обновлено
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