Vital Kauaʻi

Iboga in the United States

Federal

Ibogaine and Tabernanthe iboga remain Schedule I. Executive Order 14401 (2026-04-18; 91 FR 21709) directs FDA priority vouchers, an FDA/DEA Right to Try pathway naming ibogaine compounds, and at least $50M via ARPA-H for state-federal research. FDA accepted the first US ibogaine-derivative IND (DemeRx noribogaine, 2026-04-22) and on 2026-10-05 opened Docket FDA-2026-N-10429 on ibogaine trial design and safety for opioid use disorder and PTSD, with comments due 2026-11-20. NIDA is funding a Mass General Brigham ibogaine study, ARPA-H's ASCENT-IBO solution summaries were due 2026-10-15, and HHS and VA signed a five-year psychedelic therapy partnership that covers ibogaine. Congress has H.R. 9559 and House-passed FY2027 NDAA amendments. No iboga-specific federal court ruling was found.

Last checked: October 26, 2026

  1. FDA

    FDA requests public input on design and safety of ibogaine clinical trials

    FDA opened Docket No. FDA-2026-N-10429 (Federal Register document 2026-20427, published 2026-10-06 at 91 FR 63563) asking for comments, data and information on early-phase ibogaine trial protocols: dose selection and escalation, care setting, safety monitoring for cardiac and neurologic adverse events, eligibility criteria, stopping rules and safety oversight. HHS is prioritizing adults with opioid use disorder and adults with PTSD for federally supported ibogaine research. FDA asked that comments leave aside scheduling, legalization, religious use and the merits of any specific ibogaine product. Comments are due 2026-11-20.

    Source: FDA press announcement

  2. Federal

    Psyence BioMed partners with DEA-registered Benuvia for US ibogaine manufacture

    Texas Ibogaine Research Corporation, Psyence BioMed's Texas subsidiary, entered a manufacturing partnership with Benuvia Operations, which runs a DEA-registered controlled-substance facility in Round Rock, Texas, for planned US manufacture of pharmaceutical-grade ibogaine API. The PsyLabs licence term sheet is to be replaced by a definitive agreement on or before 2026-11-30 (private-sector milestone).

    Source: GlobeNewswire

  3. Federal

    Psyence BioMed announces exclusive US ibogaine licence term sheet for Texas subsidiary

    Psyence BioMed's Texas Ibogaine Research Corporation signed a binding term sheet for exclusive US development, supply and distribution rights to PsyLabs pharmaceutical-grade ibogaine (private-sector milestone).

    Source: GlobeNewswire via Manila Times

  4. Federal

    GAO finds DEA and FDA lack written drug-scheduling procedures

    GAO report GAO-26-108623 found that DEA lacks policies setting out staff roles and procedures for drug scheduling and that FDA lacks written procedures for scheduling evaluations and recommendations, and recommended both agencies write them. The process it reviewed is the one any ibogaine rescheduling would go through.

    Source: U.S. GAO

  5. NIH

    ARPA-H holds ASCENT-IBO Proposers' Day

    ARPA-H held a Proposers' Day in the Washington, D.C. area for ASCENT-IBO (Special Notice ARPA-H-SN-26-158 under Proactive Health Office ISO ARPA-H-SOL-24-106), which funds accelerated combined Phase 1/2 ibogaine trials in opioid use disorder. Solution summaries of up to six pages were due 2026-10-15 at 9:00 p.m. ET; full-proposal deadlines are set in each team's solution-summary feedback letter. The notice publishes no dollar ceiling or award count.

    Source: BW&CO funding guide

  6. Federal

    MAPS comments on University of Miami gift of 1994 ibogaine IND to HHS

    MAPS published commentary on the University of Miami's gift of its original 1994 ibogaine IND to HHS and called for open science.

    Source: MAPS

  7. White House

    Trump announces University of Miami gift of 1994 ibogaine IND to HHS

    President Trump announced on Truth Social that HHS Secretary Kennedy received the University of Miami's original 1994 ibogaine Investigational New Drug application, giving access to foundational FDA documents.

    Source: Just the News

  8. Congress

    House passes FY2027 NDAA with psychedelics amendments

    By voice vote in an en bloc package, the House adopted amendments extending a DoD psychedelic research program to 2033 and codifying parts of EO 14401, including a VA official for emerging therapies (ibogaine named by sponsors). NDAA passed 216-212.

    Source: Marijuana Moment

  9. NIH

    ARPA-H special notice on ibogaine for opioid use disorder (SN-26-156)

    ARPA-H's Proactive Health Office issued Special Notice ARPA-H-SN-26-156 under ISO ARPA-H-SOL-24-106, responding to EO 14401. It invited solution summaries for plans to develop and submit an ibogaine IND for people with treatment-resistant opioid use disorder or a raised risk of death after a nonfatal overdose, with an FDA regulatory strategy and a plan to reduce cardiac risk. Responses were due 2026-08-09. ASCENT-IBO (ARPA-H-SN-26-158, posted 2026-08-05) is a separate follow-on notice that builds on it.

    Source: ARPA-H special notice (EverGlade copy)

  10. FDA

    FDA finalizes guidance on clinical investigations of psychedelic drugs

    FDA announced the final guidance 'Psychedelic Drugs: Considerations for Clinical Investigations' (Federal Register document 2026-14158, published 2026-07-14 at 91 FR 43101, Docket FDA-2023-D-1987), finalizing the June 2023 draft. The nonbinding guidance covers manufacturing, nonclinical work, clinical pharmacology, trial design, abuse potential and participant safety monitoring for psychedelic drug development, the general framework behind FDA's ibogaine-specific request for information of 2026-10-05.

    Source: Federal Register (public inspection)

  11. VA and DoD

    HHS and VA sign five-year psychedelic therapy partnership

    HHS and VA signed a five-year memorandum of understanding to coordinate research, clinician training and health-system readiness for rapid-acting psychedelic therapies, ibogaine among them, for veterans with serious mental illness, contingent on FDA approval. The announcement came with a separate FDA-VA agreement and new NIH and ARPA-H ibogaine funding for opioid use disorder.

    Source: HHS press release

  12. Congress

    IBOGAINE Act (H.R. 9559) introduced

    Rep. Morgan Luttrell introduced the bill with cosponsors Reps. McCaul, Bergman and Correa. It would codify EO 14401, direct the Attorney General to decide within 60 days whether to move ibogaine from Schedule I to Schedule II, clarify Right to Try exemptions and set up federal-state research partnerships. It would also create a special DEA registration for physicians to give Schedule I investigational drugs under Right to Try, with the Attorney General acting on a complete application within 45 days, and require DEA rulemaking within 240 days. It was referred to Energy and Commerce, Judiciary and Veterans' Affairs, and on 2026-07-17 to the Subcommittee on Health; no further action has been reported.

    Source: Congress.gov

  13. NIH

    NIDA funds Mass General Brigham ibogaine study for opioid use disorder

    NIDA awarded a UG3/UH3 cooperative agreement (about $2.3M for June 2026 to May 2028, up to roughly $11M if it advances) to Brigham and Women's Hospital, led by Joji Suzuki, to seek IND clearance and run a single-ascending-dose Phase 1 of pharmaceutical-grade ibogaine in healthy volunteers, then people with opioid use disorder. Dosing stops if QTc exceeds 500 ms or rises 20 percent over baseline.

    Source: Psychedelic Alpha

  14. FDA

    FDA issues priority vouchers and announces psychedelic regulatory actions

    FDA issued Commissioner's National Priority Vouchers to three psilocybin/methylone programs, announced forthcoming trial-design guidance for serotonin-2A agonists, and cleared the first US study of an ibogaine derivative (noribogaine HCl) for alcohol use disorder.

    Source: FDA press announcement

  15. FDA

    DemeRx announces FDA acceptance of IND for DMX-1001 (noribogaine)

    FDA accepted DemeRx's IND for oral noribogaine for alcohol use disorder, described as the first FDA-authorized US trial of an ibogaine derivative. DemeRx anticipates Phase 2 in 2027.

    Source: BioSpace (DemeRx press release)

  16. Federal

    AP coverage: order signed, ibogaine remains Schedule I

    News coverage confirms the order did not reschedule ibogaine; all covered psychedelics remain Schedule I outside clinical settings.

    Source: Hawaii Tribune-Herald (AP)

  17. White House

    Executive Order 14401: Accelerating Medical Treatments for Serious Mental Illness

    FDA to issue priority vouchers to breakthrough psychedelics; FDA and DEA to build a Right to Try pathway including ibogaine compounds and needed Schedule I handling authorizations; at least $50M via ARPA-H to match state investment; AG to start rescheduling review after Phase 3. Published at 91 FR 21709 (Vol. 91, No. 77).

    Source: The White House (EO 14401 PDF)

  18. Federal

    Texas awards $50M ibogaine trial funding to UTHealth Houston and UTMB

    Under Texas SB 2308 (signed June 2025), UTMB with UTHealth Houston leads FDA-supervised ibogaine trials; study starts after required federal approvals. State action relevant to federal IND pathway.

    Source: UTMB Health

  19. NIH

    NIDA awards Gilgamesh $14M for ibogaine analog GM-3009

    The National Institute on Drug Abuse awarded a multi-year grant for IND-enabling work and Phase 1/1b trials of a cardiac-safe ibogaine analog for opioid use disorder.

    Source: BioSpace

  20. Courts

    Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418

    Supreme Court unanimously held that under RFRA the government must show a compelling interest and least restrictive means before applying the Controlled Substances Act to a church's sacramental hoasca (DMT-containing tea). Plant-sacrament precedent; not iboga-specific.

    Source: Cornell LII

How this tracker is kept

  • Each state is checked against legislature records, agency releases and published reporting, and carries the date it was last checked. Every development links to its source.
  • “No known activity” means the state was checked on the date shown and no ibogaine-specific law, bill, funding or task force was found.
  • The directory lists organizations and public offices with their own websites. Listing points readers to them and does not endorse them.
  • This tracker is offered for education and does not constitute legal or medical advice. Ibogaine and iboga remain Schedule I substances under federal law. See the medical disclaimer.
  • To share a development or request a correction, write to aloha@vitalkauai.com. For daily coverage, see Iboga Worldwide.