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FDA approves a psychedelic for medical use in 2026?

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FDA approves a psychedelic for medical use in 2026?

19% probabilidad
Polymarket
NUEVO
19% probabilidad
Polymarket
NUEVO
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 on Polymarket heavily favors "No" at 81.5% implied probability for FDA approval of any psychedelic—such as psilocybin, MDMA, or LSD—for medical use in 2026, driven by the agency's rigorous standards and extended timelines. No such approvals appear on the FDA's 2026 novel drug list to date, echoing the 2024 rejection of Lykos Therapeutics' MDMA for PTSD, which prompted demands for additional Phase 3 trials. Recent setbacks include the February 2026 denial of fast-track status for a psilocybin depression treatment and mixed signals from FDA officials amid Compass Pathways' plans for a Q4 2026 rolling NDA submission for COMP360 psilocybin, with decisions likely extending into 2027. State pilot expansions, like Virginia's automatic legalization post-approval, underscore anticipation but highlight federal caution on safety and efficacy data.

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.
Volumen
$383
Fecha de finalización
31 dic 2026
Mercado abierto
Apr 16, 2026, 10:42 AM ET
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.
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 on Polymarket heavily favors "No" at 81.5% implied probability for FDA approval of any psychedelic—such as psilocybin, MDMA, or LSD—for medical use in 2026, driven by the agency's rigorous standards and extended timelines. No such approvals appear on the FDA's 2026 novel drug list to date, echoing the 2024 rejection of Lykos Therapeutics' MDMA for PTSD, which prompted demands for additional Phase 3 trials. Recent setbacks include the February 2026 denial of fast-track status for a psilocybin depression treatment and mixed signals from FDA officials amid Compass Pathways' plans for a Q4 2026 rolling NDA submission for COMP360 psilocybin, with decisions likely extending into 2027. State pilot expansions, like Virginia's automatic legalization post-approval, underscore anticipation but highlight federal caution on safety and efficacy data.

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.
Volumen
$383
Fecha de finalización
31 dic 2026
Mercado abierto
Apr 16, 2026, 10:42 AM ET
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.

Cuidado con los enlaces externos.

Preguntas frecuentes

"FDA approves a psychedelic for medical use in 2026?" es un mercado de predicción en Polymarket donde los operadores compran y venden acciones de "Sí" o "No" según si creen que este evento ocurrirá. La probabilidad actual según la comunidad es 19% para "Yes". Por ejemplo, si "Sí" se cotiza a 19¢, el mercado colectivamente asigna una probabilidad de 19% de que este evento ocurra. Estas probabilidades cambian continuamente a medida que los operadores reaccionan a nuevos desarrollos e información. Las acciones del resultado correcto son canjeables por $1 cada una tras la resolución del mercado.

"FDA approves a psychedelic for medical use in 2026?" es un mercado recién creado en Polymarket, lanzado el Apr 16, 2026. Como mercado nuevo, esta es tu oportunidad de ser uno de los primeros operadores en establecer las probabilidades y las señales de precio iniciales del mercado. También puedes guardar esta página en marcadores para seguir el volumen y la actividad de trading a medida que el mercado gana tracción.

Para operar en "FDA approves a psychedelic for medical use in 2026?", simplemente elige si crees que la respuesta es "Sí" o "No". Cada lado tiene un precio actual que refleja la probabilidad implícita del mercado. Introduce tu cantidad y haz clic en "Operar". Si compras acciones de "Sí" y el resultado se resuelve como "Sí", cada acción paga $1. Si se resuelve como "No", tus acciones de "Sí" pagan $0. También puedes vender tus acciones en cualquier momento antes de la resolución para asegurar ganancias o limitar pérdidas.

La probabilidad actual para "FDA approves a psychedelic for medical use in 2026?" es 19% para "Yes". Esto significa que la comunidad de Polymarket actualmente cree que hay una probabilidad de 19% de que este evento ocurra. Estas probabilidades se actualizan en tiempo real basándose en operaciones reales, proporcionando una señal continuamente actualizada de lo que el mercado espera.

Las reglas de resolución para "FDA approves a psychedelic for medical use in 2026?" definen exactamente qué debe ocurrir para que cada resultado sea declarado ganador, incluyendo las fuentes de datos oficiales utilizadas para determinar el resultado. Puedes revisar los criterios de resolución completos en la sección "Reglas" en esta página sobre los comentarios. Recomendamos leer las reglas cuidadosamente antes de operar, ya que especifican las condiciones exactas, casos especiales y fuentes.