Upcoming FDA Events for Optimi Health
Optimi Health (OPTH) has upcoming FDA regulatory milestones for psilocybin-assisted therapy. The table below outlines estimated target dates and event types for these pending regulatory actions.
Optimi Health's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Optimi Health (OPTH).
Over the past two years, Optimi Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
psilocybin-assisted. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Psilocybin-assisted therapy FDA Regulatory Timeline and Events
Psilocybin-assisted therapy is a drug developed by Optimi Health for the following indication: for Major Depressive Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- psilocybin-assisted therapy
- Announced Date:
- September 10, 2026
- Target Action Date:
- H1 2027
- Estimated Target Date Range:
- January 1, 2027 - June 30, 2027
- Indication:
- for Major Depressive Disorder
Announcement
Optimi Health Corp announced that the trial is planned to be initiated in the first half of 2027
Read Announcement- Drug:
- psilocybin-assisted therapy
- Announced Date:
- September 10, 2026
- Target Action Date:
- LATE 2027
- Estimated Target Date Range:
- October 1, 2027 - December 31, 2027
- Indication:
- for Major Depressive Disorder
Announcement
Optimi Health Corp. announced that the dosing expected to be complete by the end of 2027.
Read Announcement- Drug:
- psilocybin-assisted therapy
- Announced Date:
- September 10, 2026
- Indication:
- for Major Depressive Disorder
Announcement
Optimi Health Corp announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD").
Read Announcement
Optimi Health FDA Events - Frequently Asked Questions
As of now, Optimi Health (OPTH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Optimi Health (OPTH) has reported FDA regulatory activity for psilocybin-assisted therapy.
The most recent FDA-related event for Optimi Health occurred on September 10, 2026, involving psilocybin-assisted therapy. The update was categorized as "Trial Initiation," with the company reporting: "Optimi Health Corp announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocybin-assisted therapy for individuals with major depressive disorder ("MDD")."
Currently, Optimi Health has one therapy (psilocybin-assisted therapy) targeting the following condition: for Major Depressive Disorder.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:OPTH last updated on 9/10/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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