RESEARCH · THE DMT ATLAS
DMT Regulation & Law
The legal and regulatory record of the molecule — how it is scheduled, how the medicines built on it move through the FDA, and the religious-liberty cases that decided whether a church may drink ayahuasca. Cited to the primary government and court record. Legal literacy, not legal advice.
✦Drug-development milestones
FDA/EMA designations and clinical filings for the DMT and 5-MeO-DMT therapeutic programs.
| Program | Sponsor | Molecule | Type | Status | Date |
|---|---|---|---|---|---|
| SPL026 (intravenous DMT) for major depressive disorder ↗ | Small Pharma (acquired by Cybin Inc., 2024) | N,N-DMT | IND | Phase 2a completed and positive; program subsequently restructured following the Cybin acquisition. No FDA designation confirmed for SPL026. | 2023-09 |
| VLS-01 (buccal transmucosal film DMT), 'Elumina' Phase 2 for treatment-resistant depression ↗ | atai Life Sciences (Viridia Life Sciences) | N,N-DMT | IND | Phase 2 (Elumina) underway; first patient dosed 2025-03-11; Phase 2b last-patient reported; Phase 3 in MDD planned. No FDA designation claimed. | 2025-03 |
| BPL-003 (intranasal mebufotenin benzoate) for treatment-resistant depression ↗ | atai Life Sciences / Beckley Psytech (AtaiBeckley) | 5-MeO-DMT (mebufotenin) | FDA designation | FDA Breakthrough Therapy Designation GRANTED; Phase 3 planned for 2026 | 2025-10 |
| GH001 (inhaled mebufotenin) for treatment-resistant depression ↗ | GH Research PLC | 5-MeO-DMT (mebufotenin) | IND | Phase 2b completed (positive); FDA clinical hold on the IND lifted Jan 2026; Phase 3 planned. No FDA Breakthrough/Fast Track designation confirmed. | 2026-01 |
| Eli Lilly to acquire AtaiBeckley — 5-MeO-DMT (BPL-003) & DMT (VLS-01) depression programs ↗ | Eli Lilly & Company ← AtaiBeckley | 5-MeO-DMT / N,N-DMT | Acquisition (pending) | Announced 2026-07-16; up to ~$3.8B (~$2.8B upfront + contingent value right); expected to close Q3 2026 | 2026-07 |
✦Scheduling & drug law
How DMT is classified — the US Controlled Substances Act, the UN Convention, and the Federal Register notices that record every change.
| Jurisdiction | Action | Citation | Summary | Date |
|---|---|---|---|---|
| US | N,N-DMT placed in Schedule I of the Controlled Substances Act ↗ | 21 U.S.C. sec. 812, Schedule I(c); Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91-513 (effective May 1, 1971) | N,N-dimethyltryptamine (DMT) was placed in Schedule I of the federal Controlled Substances Act, enacted as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and taking effect in 1971. Schedule I reflects a finding of high abuse potential, no currently accepted medical use, and lack of accepted safety under medical supervision. Because ayahuasca contains DMT, the brew's DMT content is what brings it within CSA control -- ayahuasca is not separately named in the statute. | 1971 |
| UN | DMT listed in Schedule I of the UN Convention on Psychotropic Substances ↗ | Convention on Psychotropic Substances, 1971 (opened for signature 21 Feb 1971, Vienna), Schedule I | The 1971 United Nations Convention on Psychotropic Substances placed DMT in Schedule I, the treaty's most restrictive category, obligating parties to limit its use to scientific and very limited medical purposes and to closely monitor international trade. The INCB has separately noted that plant preparations such as ayahuasca are not themselves listed under the Convention, even though the DMT they contain is. | 1971 |
| US | DEA final rule: AMT and 5-MeO-DIPT placed in Schedule I (related tryptamine analogs) ↗ | 69 FR 58050; DEA final rule, document 04-21755 | DEA final rule placing alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I, following an emergency/temporary placement in 2003 (68 FR 4127). These are tryptamine-class hallucinogens (not DMT or 5-MeO-DMT themselves); included as context showing DEA's approach to scheduling the tryptamine family. Molecule labeled accordingly. | 2004-09 |
| US | DEA notice of proposed rulemaking to schedule 5-MeO-DMT (Schedule I) ↗ | 74 FR 42217; DEA NPRM, document E9-20204 (comment period reopened 2009-10-28, 74 FR 55502) | DEA's notice of proposed rulemaking proposing to place 5-MeO-DMT and its salts into Schedule I of the CSA, on a recommendation from the Acting Assistant Secretary for Health (HHS). This is the proposal stage of the rulemaking finalized in 2010 (75 FR 79296). | 2009-08 |
| US | DEA final rule: 5-MeO-DMT placed in Schedule I of the CSA ↗ | 75 FR 79296; DEA final rule, document 2010-31854 | The DEA issued a final rule placing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts and isomers, into Schedule I of the Controlled Substances Act, based on an HHS scheduling recommendation and DEA's own review. This followed a notice of proposed rulemaking published 2009-08-21 (74 FR 42217) with a comment period reopened 2009-10-28 (74 FR 55502). 5-MeO-DMT is the molecule now used in the GH001 and BPL-003 clinical programs. | 2010-12 |
✦Case law — the ayahuasca religious-liberty cases
The courtroom record, led by Gonzales v. O Centro (2006), in which the US Supreme Court held that a church may use ayahuasca as a sacrament under religious-freedom law.
O Centro Espirita Beneficente Uniao do Vegetal v. Ashcroft (preliminary injunction) ↗
Holding: The district court granted a preliminary injunction under RFRA barring the government from prohibiting the UDV's importation and sacramental use of hoasca, finding the government's evidence of harm and diversion in equipoise and thus insufficient to meet its compelling-interest burden.
Why it matters: The trial-court order that began the litigation chain, entered after a 2001 DEA/Customs seizure of a UDV hoasca shipment. Its factual findings on safety and RFRA burden-shifting carried through the entire appellate process to the Supreme Court.
O Centro Espirita Beneficente Uniao do Vegetal v. Ashcroft (en banc) ↗
Holding: The en banc Tenth Circuit affirmed the district court's preliminary injunction, holding the government had not shown a compelling interest under RFRA sufficient to override the UDV's sacramental ayahuasca use pending trial.
Why it matters: The appellate ruling the Supreme Court reviewed and affirmed. Followed a divided 2003 panel decision (342 F.3d 1170) and rehearing en banc; framed the RFRA compelling-interest/least-restrictive-means analysis the Supreme Court adopted.
Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal ↗
Holding: Under the Religious Freedom Restoration Act (RFRA), the federal government failed to demonstrate a compelling interest in barring the UDV church's sacramental use of hoasca (ayahuasca) tea containing DMT; a unanimous Court affirmed the preliminary injunction protecting the church's religious use.
Why it matters: THE landmark decision. Establishes that RFRA can compel a case-by-case, sect-specific exemption from the Controlled Substances Act for sincere religious use of a Schedule I substance, rejecting the government's argument that Schedule I's uniform prohibition and treaty (1971 UN Convention) obligations were per se compelling. Every subsequent ayahuasca-church exemption case is measured against it.
Church of the Holy Light of the Queen v. Mukasey ↗
Holding: Applying O Centro and RFRA, the court held that Oregon Santo Daime (CEFLURIS) congregations were entitled to import and drink Daime tea (ayahuasca) for religious ceremonies, subject to reasonable DEA regulatory conditions, and entered a permanent injunction against prohibition of that use.
Why it matters: The first post-O Centro extension of the sacramental-ayahuasca exemption to a second church tradition (Santo Daime, distinct from the UDV). On appeal the Ninth Circuit (Church of the Holy Light of the Queen v. Holder, No. 13-35058) later modified the specific DEA-compliance conditions but left the core RFRA protection intact.
O Centro Espirita Beneficente Uniao do Vegetal v. Duke ↗
Holding: Follow-on litigation in which the UDV challenged specific DEA conditions/guidance governing its now-recognized exemption; the court addressed the scope of permissible regulatory controls DEA may impose on the church's sacramental ayahuasca.
Why it matters: Shows that the O Centro exemption did not end the dispute -- the operational terms (import permits, inventory tracking, membership rules) DEA may attach to a RFRA exemption remained contested more than a decade after the Supreme Court ruling. Relevant to how any future church exemption is administered.
Soul Quest Church of Mother Earth, Inc. v. Attorney General of the United States ↗
Holding: The Eleventh Circuit held that the district court lacked subject-matter jurisdiction to review the DEA's denial of Soul Quest's petition for a RFRA/CSA religious exemption to use ayahuasca; because the denial was a final CSA determination reviewable only in the court of appeals (21 U.S.C. sec. 877), and the church's constitutional and procedural claims were 'inescapably intertwined' with that decision, the suit was dismissed on jurisdictional grounds rather than on the merits.
Why it matters: A cautionary counterpoint to O Centro: an ayahuasca church that pursued (and was denied) DEA's administrative exemption process found the courthouse doors procedurally closed. Underscores that DEA had by this point instituted a formal exemption-petition process, and that the CSA's channeling of review into the appellate courts is a significant procedural hurdle for new churches. DEA had concluded Soul Quest failed to show a sincerely held religious exercise.
Sources: US Federal Register, CourtListener, and FDA/company filings. Verify each at its linked record; statuses change.