FDA approves a psychedelic for medical use in 2026?

Prediction market · Polymarket

Overview

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.

Ticker

fda-approves-a-psychedelic-for-medical-use-in-2026

Volume

1.2K

24h volume

775

1w volume

1.2K

Open interest

650

Liquidity

15.4K

Liquidity CLOB

15.4K

Start

Apr 16, 2026

End

Dec 31, 2026

Status

Active

Access

Restricted

Created

Apr 16, 2026

Event ID

382447

Slug

fda-approves-a-psychedelic-for-medical-use-in-2026

Markets

1

Tags

MushroomsPoliticsdrugFDAPsilocybinFood and Drug AdministrationLSD
Raw event data
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    "context_description": "President Trump's April 18 executive order directing the FDA to expedite reviews of breakthrough therapy-designated psychedelics like psilocybin and MDMA for PTSD and treatment-resistant depression has fueled trader optimism, with priority review vouchers and compressed timelines potentially enabling approvals by year-end. Compass Pathways' successful Phase 3 trials for COMP360 psilocybin in February, including an IND acceptance for PTSD in January, position it for a rolling new drug application submission soon, bolstering the case amid increased DEA production quotas. Yet, lingering caution from the 2024-2025 MDMA rejection by Lykos Therapeutics keeps odds balanced at 54.5% Yes, as FDA advisory committee scrutiny and safety data demands could delay resolutions; positive agency meetings or voucher awards might tip toward Yes, while trial flaws or holds could swing to No.",
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