Both Phase 3 Part A readouts hit primary endpoint (p<0.001). Placebo-adjusted magnitudes are materially smaller than reported 5-MeO-DMT Phase 2b results.
Single-dose LSD - protocol does not mandate in-session psychotherapy. Effect durable through Week 12. Asset + company rebranded Jan 2026 (MindMed → Definium Therapeutics; MM-120 → DT120 ODT; ticker MNMD → DFTX).
Phase 3 pivotal in MDD; second MDD Phase 3 (Ascend) planned mid-2026. Asset renamed from MM-120 to DT120 ODT following the Jan 2026 MindMed → Definium rebrand.
FDA AdCom 2–9 against efficacy (4 Jun 2024). CRL cited functional unblinding (>94% of MDMA arm guessed assignment), therapist misconduct, therapy-protocol variability, and insufficient durability data. ~75% staff cut Aug 2024. Lykos rebranded to Resilient Therapeutics in September 2025 following board reshuffling.
Largest placebo-adjusted delta among reported psychedelic TRD trials. OLE: 77.8% of completers in remission at 6 months. No SAEs; 97.4% discharge-ready within 1 hour.
Small N (12–28) in Ph2; adjunctive design (patients remain on antidepressant) differentiates programme commercially. Company rebranded Cybin → Helus Pharma on 5 Jan 2026 (ticker CYBN → HELP, Nasdaq + Cboe Canada).
2:1 randomisation 20 mg vs 2 mg IM. Direct competitor to DT120 ODT in GAD. Q1 2026 topline guidance has slipped into Q2; no public data release as of 20 Apr 2026. Actively monitored.
N = 193 across 6 countries; 8 mg dose selected for Phase 3. Second 5-MeO-DMT programme with pivotal-scale efficacy.
Non-profit sponsor; N ≈ 240; 6-week double-blind with 12-month follow-up. ClinicalTrials.gov lists estimated primary completion date April 2026 - actively concluding its primary endpoint phase this month.
AbbVie acquired Gilgamesh bretisilocin for up to $1.2 B (25 Aug 2025) - the first major-pharma acquisition of a classical psychedelic asset. Effect sizes not publicly disclosed.
Differentiated delivery - buccal film vs IV/IM DMT.
R-enantiomer approach may reduce abuse liability vs racemic MDMA.
Ibogaine carries QT/torsades cardiac risk. AZ HB 2871 opened a $5 M state-funded US pathway.
Non-hallucinogenic psychoplastogen. Ph1b reported a −12 point MADRS reduction in MDD patients (Oct 2025). At-home dosing cleared for Phase 2 - removes facilitated-session requirement if efficacy confirms. UC Davis Health Ventures IFM Fund made Delix its inaugural investment in Sep 2025.
Non-hallucinogenic methylone - positioned as the primary PTSD successor to MDMA-AT following the Lykos/Resilient CRL. Does not require the heavy in-session psychotherapy wrap-around that the FDA cited as disqualifying for midomafetamine. FDA Breakthrough Therapy Designation granted July 2025.
Proprietary sublingual esketamine oral thin film for severe AUD - the first dedicated commercial Ph2b/3 sponsor for an AUD indication in the psychedelic space. Awakn Life Sciences was acquired by Solvonis Therapeutics in May 2025; LTS Lohmann is the OTF manufacturing partner.
60 mg −15.3 vs placebo −13.7, p = 0.5. Programme effectively shelved.