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Política·Cogumelos

FDA approves a psychedelic for medical use in 2026?

Market icon
Política·Cogumelos

FDA approves a psychedelic for medical use in 2026?

18% chance
Polymarket
NOVO
18% chance
Polymarket
NOVO
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 reflects an 82% implied probability against FDA approval of any psychedelic for medical use in 2026, anchored by the agency's rigorous standards following its 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD, which required additional phase 3 trials. Recent hurdles include the February 2026 denial of breakthrough therapy fast-track status for a psilocybin depression candidate, underscoring ongoing concerns over trial design and safety data. While Compass Pathways announced positive phase 3 results for its psilocybin formulation that month—previously granted breakthrough designation—new drug application review processes typically take 10-12 months, compressing timelines for year-end resolution. State-level psilocybin access expands amid federal caution, with late-2026 data readouts potentially shifting odds.

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.
Volume
$253
Data de Término
31 dez 2026
Mercado Aberto
Apr 16, 2026, 10:42 AM ET

Resolver

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.
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 reflects an 82% implied probability against FDA approval of any psychedelic for medical use in 2026, anchored by the agency's rigorous standards following its 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD, which required additional phase 3 trials. Recent hurdles include the February 2026 denial of breakthrough therapy fast-track status for a psilocybin depression candidate, underscoring ongoing concerns over trial design and safety data. While Compass Pathways announced positive phase 3 results for its psilocybin formulation that month—previously granted breakthrough designation—new drug application review processes typically take 10-12 months, compressing timelines for year-end resolution. State-level psilocybin access expands amid federal caution, with late-2026 data readouts potentially shifting odds.

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.
Volume
$253
Data de Término
31 dez 2026
Mercado Aberto
Apr 16, 2026, 10:42 AM ET

Resolver

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.

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Frequently Asked Questions

"FDA approves a psychedelic for medical use in 2026?" is a prediction market on Polymarket where traders buy and sell "Yes" or "No" shares based on whether they believe this event will happen. The current crowd-sourced probability is 18% for "Yes." For example, if "Yes" is priced at 18¢, the market collectively assigns a 18% chance that this event will occur. These odds shift continuously as traders react to new developments and information. Shares in the correct outcome are redeemable for $1 each upon market resolution.

"FDA approves a psychedelic for medical use in 2026?" is a newly created market on Polymarket, launched on Apr 16, 2026. As an early market, this is your opportunity to be among the first traders to set the odds and establish the market's initial price signals. You can also bookmark this page to track volume and trading activity as the market gains traction over time.

To trade on "FDA approves a psychedelic for medical use in 2026?," simply choose whether you believe the answer is "Yes" or "No." Each side has a current price that reflects the market's implied probability. Enter your amount and click "Trade." If you buy "Yes" shares and the outcome resolves as "Yes," each share pays out $1. If it resolves as "No," your "Yes" shares pay $0. You can also sell your shares at any time before resolution if you want to lock in a profit or cut a loss.

The current probability for "FDA approves a psychedelic for medical use in 2026?" is 18% for "Yes." This means the Polymarket crowd currently believes there is a 18% chance that this event will occur. These odds update in real-time based on actual trades, providing a continuously updated signal of what the market expects to happen.

The resolution rules for "FDA approves a psychedelic for medical use in 2026?" define exactly what needs to happen for each outcome to be declared a winner — including the official data sources used to determine the result. You can review the complete resolution criteria in the "Rules" section on this page above the comments. We recommend reading the rules carefully before trading, as they specify the precise conditions, edge cases, and sources that govern how this market is settled.