FDA approves a psychedelic for medical use in 2026?
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THE FOOD AND DRUG ADMINISTRATION SAYS IT WILL OFFER ULTRA-FAST REVIEW TO THREE PSYCHEDELIC DRUGS BEING STUDIED FOR HARD-TO-TREAT MENTAL HEALTH CONDITIONS, INCLUDING DEPRESSION, PER AP ...
FDA Fast-Tracks Review of Some Psychedelic Drugs. This Stock Is Set to Benefit.
FDA Fast-Tracks Review of Some Psychedelic Drugs. This Stock Is Set to Benefit. -- Barrons.com
The U.S. Food and Drug Administration on Friday announced a series of measures aimed at accelerating the development of psychedelic treatments for serious mental illness. • • That comes after President Donald Trump signed an executive order on Saturday directing federal health agencies to expand access to emerging therapies. • • Full details:
FDA moves to fast-track review of psilocybin and methylone for mental health
Psychedelic Drug Developers Rise After US FDA Moves to Fast-Track Drugs After Trump Order
Kennedy calls psychedelic drug ‘the most promising treatment’ for depression
What is this event about?
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.