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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-10429

FDA Requests Input on Ibogaine Clinical Trial Design for Opioid Use Disorder and PTSD

💬 Comments close in 18 days (Nov 20)

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Timeline

  1. Proposed / opened

    FDA Requests Input on Ibogaine Clinical Trial Design for Opioid Use Disorder and PTSD

  2. Related document

    Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information

Briefs in this proceeding

Notable FDA HHS 💬 Comments close in 18 days (Nov 20)

FDA Requests Input on Ibogaine Clinical Trial Design for Opioid Use Disorder and PTSD

FDA seeks public comments on safety and design elements for early-phase ibogaine trials as HHS-funded studies in opioid use disorder and PTSD prepare to launch. The FDA is issuing a Request for Information (RFI) to gather public input on the design and safety considerations for early-phase...

Sources

Health and Human Services Department, Food and Drug Administration · Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information · Oct 6