is ibogaine on track for fda approval before mdma or psilocybin?
“Ibagane, the one psychedelic that no one's would even want to use recreationally, is going to get there first.”
a host said on Huberman Lab, 2026-09-28, at 1:47:42. hear it in context →
first, the part that holds
ibogaine does have real federal momentum. an april 2026 executive order names "ibogaine compounds" twice, and on october 5, 2026 the fda put out a formal request for input on how ibogaine trials should be run, alongside early-phase trials funded by arpa-h and nida.
what we found when we went and looked
we read the fda's october 5, 2026 ibogaine notice. it asks the public how to design early-phase ibogaine trials, covering starting dose, cardiac and neurologic monitoring, and stopping rules. comments are due november 20, 2026. the only ibogaine-class study the fda says it has cleared is an early-phase trial of noribogaine, a derivative, for alcohol use disorder. psilocybin for treatment-resistant depression is much further along: the developer's august 2026 sec filing reports two positive phase 3 trials (p<0.001 in each), a commissioner's national priority voucher issued in april 2026, and an fda rolling review of its new drug application that is "ongoing". mdma has already been through a full fda review. the fda turned down that application on august 8, 2024 and asked for a new trial. on the primary record, ibogaine is the furthest of the three from approval.
assertion by assertion
| assertion | verdict | what the record says |
|---|---|---|
| ibogaine is on track to be fda-approved before psilocybin | false | psilocybin (treatment-resistant depression) has two positive phase 3 trials, a national priority voucher (april 2026) and an fda rolling review of its new drug application, which the developer's 10-q for the period ending june 30, 2026 describes as "ongoing". ibogaine is at the stage where the fda is still asking the public how early-phase trials should be designed (comments due november 20, 2026). limitation: approval is never guaranteed, and the 10-q gives no approval date. [1][2] |
| ibogaine is on track to be fda-approved before mdma | false | mdma (midomafetamine) for ptsd reached a full fda review as nda 215455 and received a complete response letter on august 8, 2024. the letter asked for a new trial with blinded long-term follow-up and an independent data audit. ibogaine has never had an application reviewed and has no phase 3 program that the fda acknowledges. limitation: we found no primary-source record of mdma's status after 2024, so its current timeline is unverified. even so, it started from a later stage than ibogaine is at now. [1][3] |
| ibogaine has federal policy support behind its development | confirmed | executive order 14401 (signed april 18, 2026; published in the federal register april 22, 2026) names "ibogaine compounds" among psychedelics showing "potential in clinical studies". it directs a right to try pathway for them and directs arpa-h to put at least $50 million toward state psychedelic programs. the fda's october 2026 notice says hhs, through arpa-h, and nida are funding early-phase ibogaine research. limitation: the order's priority vouchers go only to drugs with breakthrough therapy designation. the order does not say ibogaine has one, and support for research is not support for approval. [1][4] |
both directions
for the speaker: the federal record singles out ibogaine. the executive order names it specifically, the fda's request for input is about ibogaine alone, and arpa-h and nida are paying for early-phase studies. a separate fda clearance let an early-phase noribogaine study go ahead. the order also creates a right to try route that could let some patients get ibogaine compounds before any approval. if "get there first" means first to legal patient access through right to try, not fda approval, that is a different question, and the order makes it at least possible. it is still unproven.
against: fda approval of a new drug needs adequate and well-controlled trials, usually phase 3, and then a reviewed new drug application. on october 5, 2026 the fda was still asking for public comment on the basic design of early-phase ibogaine trials: starting dose (proposed maximum 10 mg/kg), cardiac and neurologic monitoring, eligibility and stopping rules. that is the starting line. psilocybin has finished two phase 3 trials and its application is under rolling review with a priority voucher, which the program is designed to move faster. mdma has already been through one full review. the safety work the fda flags for ibogaine, cardiac and neurologic monitoring, is the kind of question that tends to slow early development down.
what this cannot say
this is a forecast, and no primary record can settle a forecast. our verdict compares where each drug stands today in fda and sec documents. it does not predict outcomes: psilocybin could still be turned down, and mdma's path since 2024 is not in any primary source we could read. the developer's sec filing is a company statement, not an fda decision. we did not use news reports of ibogaine phase 2/3 programs or abstinence rates, because we could not find them in a primary record. the speaker named no source, so we could not check what timeline they had in mind.
sources, each one fetched and read
- U.S. Food and Drug Administration, "FDA Seeks Public Input to Support Ibogaine Research," press announcement, October 5, 2026 What we read there: announces a request for information on the design of early-phase clinical trials of ibogaine drug products, covering dose selection and escalation (proposed maximum starting dose 10 mg/kg), care setting, monitoring for cardiac and neurologic adverse events, eligibility, stopping rules and safety oversight. comments are due november 20, 2026. it notes fda clearance for an early-phase study of noribogaine hydrochloride for alcohol use disorder, and early-phase work funded by arpa-h and nida. Fetched 2026-10-06 (HTTP 200). https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research
- COMPASS Pathways plc, Form 10-Q for the period ended June 30, 2026, U.S. Securities and Exchange Commission, EDGAR What we read there: "In April 2026, the FDA issued a National Priority Voucher for COMP360 psilocybin treatment in TRD"; phase 3 trials comp005 and comp006 each showed a reduction in symptom severity with p<0.001; "the FDA granted our request for a rolling review of our NDA, which is ongoing." no approval date is given. Fetched 2026-10-06 (HTTP 200). https://www.sec.gov/Archives/edgar/data/0001816590/000181659026000058/cmps-20260630.htm
- U.S. Food and Drug Administration, openFDA complete response letter database, NDA 215455 (midomafetamine), letter dated August 8, 2024 What we read there: the fda found the application "does not provide substantial evidence of effectiveness or establish the safety" of midomafetamine for ptsd. it cited underreported adverse events, a single-visit durability follow-up, and about 40% of participants having used the drug before, and recommended a new trial with blinded long-term follow-up and an independent third-party data audit. Fetched 2026-10-06 (HTTP 200). https://api.fda.gov/transparency/crl.json?search=midomafetamine
- Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness," signed April 18, 2026, Federal Register Doc. 2026-07907 (publication date April 22, 2026) What we read there: "Psychedelic drugs, including ibogaine compounds, show potential in clinical studies..."; it directs priority vouchers for psychedelics with breakthrough therapy designation, a right to try pathway that includes ibogaine compounds, at least $50 million through arpa-h for state psychedelic programs, and prompt rescheduling review for schedule i products that complete phase 3. Fetched 2026-10-06 (HTTP 200). https://public-inspection.federalregister.gov/2026-07907.pdf
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