psychedelic therapy and the FDA: where every drug actually stands

the status table

last verified: august 18, 2026. we update this page monthly, or sooner when a milestone lands — the next scheduled update follows the Panorama phase 3 topline expected in september 2026. numbered references link to the primary sources at the bottom of the page.

is MDMA therapy FDA-approved?

no — and the 2026 resubmission is narrower than most coverage suggests. FDA rejected the original application on august 9, 2024, after its advisory committee voted 9-2 that effectiveness was not established and 10-1 against benefit-risk, citing near-total functional unblinding in the phase 3 trials and trial-conduct concerns [7]. the sponsor — MAPS PBC, renamed Lykos in 2024, renamed Resilient Pharmaceuticals in august 2025 — resubmitted the NDA in august 2026 under the proposed brand name Rysanso [8]. the resubmission adds a third-party audit of the original trials, a new phase 1 cardiac-safety study, and VA follow-up data. it does not include the new efficacy trial FDA's rejection letter asked for, so the central efficacy question is unchanged until FDA rules — on a roughly 6-month class 2 review clock from august 2026.

when could psilocybin be approved?

psilocybin (COMP360) is the furthest along. Compass Pathways completed two positive phase 3 trials — COMP005 in june 2025 and COMP006 on february 17, 2026 — and is submitting its NDA on a rolling basis, with the final module on track for Q4 2026 [5][6]. the company targets a commercial launch in the first half of 2027, which depends on two things that have not happened: FDA approval and DEA rescheduling. Usona Institute runs a separate phase 3 (uAspire); enrollment completed in november 2025 and no results have been released. worth holding onto: in the one head-to-head trial against an SSRI (escitalopram), psilocybin was not significantly better on the primary endpoint [16] — the phase 3 wins were against control doses, not against existing treatment.

what about LSD, DMT, and ibogaine?

LSD. Definium Therapeutics (the company formerly known as MindMed) has two positive phase 3 toplines for its LSD tablet DT120: Emerge in major depression (june 22, 2026) and Voyage in generalized anxiety (august 12, 2026) [10][11]. both exist only as company press releases — no peer-reviewed publication yet — and a third phase 3 (Panorama) reads out around september 2026. the published evidence base is a sponsor-funded phase 2b in JAMA [9].

DMT and analogs. everything is phase 2. the most advanced program, BPL-003, is intranasal 5-MeO-DMT — pharmacologically a different drug from ayahuasca — with a positive phase 2b (july 2025) and phase 3 in planning [12]. VLS-01 (buccal DMT) is fully dosed in phase 2b with topline expected Q4 2026 [13]; the IV DMT product SPL026 was published in Nature Medicine but is not advancing as-is [14]. ayahuasca itself has no US approval pathway in progress.

ibogaine. there are no FDA efficacy trials at all — the evidence is observational, self-selected, and mostly gathered abroad, and ibogaine carries documented cardiac risk (QT prolongation, fatal arrhythmias in unscreened settings). what changed recently is money: Texas SB 2308, signed june 11, 2025, created a $50M matched fund specifically to take ibogaine through FDA trials for opioid use disorder, PTSD, and TBI [15]. until those trials exist, ibogaine has promising signals and no efficacy evidence in the regulatory sense.

what "breakthrough therapy" does and doesn't mean

most of the drugs in this table hold FDA breakthrough therapy designation, and it is routinely misread as near-approval. it isn't. the designation speeds up FDA meetings and review logistics for drugs showing preliminary promise on serious conditions — that's all. it says nothing final about efficacy, and it guarantees nothing: MDMA-assisted therapy held breakthrough designation from august 2017 and was rejected in 2024. when a press release leads with "FDA breakthrough therapy," read it as "FDA agreed to talk faster," not "FDA agreed."