Psyence Biomedical
Phase II1 active candidate
same indication: Palliative & End-of-Life DistressPhase II peersame regulator: Australia TGAsimilar active pipeline size
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Lead program: Phase II
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MindBio TherapeuticsCSE: MBIO
Data updated
1 Drug Candidate1 Paper
MindBio Therapeutics is a clinical-stage biotechnology company developing MB22001, a proprietary titratable form of LSD designed for take-home microdosing. The company's Phase 2B trials in major depressive disorder and advanced-stage cancer distress have reported strong antidepressant effects, with Phase 2a data showing a 72% reduction in depressive symptoms and 58% remission at six months. MindBio is listed on the Canadian Securities Exchange and the Frankfurt Stock Exchange.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 2
- Lead stage
- Phase II
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Current furthest stage
2 active programmes with forecast fields
Latest sourced update
MindBio Therapeutics - Current Website
Jun 26, 2026 - company-website - MindBio Therapeutics - MB22001 (Titratable Microdose LSD)
Next known catalyst
Phase II publication
Q4 2026 - MB22001 (Titratable Microdose LSD) / MB22001 Phase 2B MDD Programme (ACTRN12624000128594) - Confidence: 30%
5 sources0 pipeline-linked trials0 pipeline-linked papers
Development Programmes
1MB22001 (Titratable Microdose LSD)
Phase II
MDD, cancer-related distress, PMDD/PMS — titratable take-home microdose LSD capsule
Programme Tracker
Major Depressive Disorder (MDD)
Primary: Australia (TGA)
Phase IIActive
Forecast
Phase II publication - Likely: Q4 2026
Phase 2B MDD completed in November 2025 and did not show superiority for repeated microdosed LSD over active placebo on MADRS at week 8. MindBio reported 29.9% MADRS reduction in the LSD arm versus 36.4% in placebo/caffeine (p=0.5469), with favorable tolerability and no serious adverse events in the LSD arm. The next watch item is whether MindBio publishes the dataset or redirects MB22001 development toward cancer distress/PMDD rather than MDD.
Milestones
Phase II started
CompletedActual: Aug 1, 2023
First patients dosed in Phase 2 take-home microdosing study — world-first take-home LSD microdosing clinical trial in MDD patients
Why it matters: MB22001 is a take-home, self-administered microdose LSD capsule — fundamentally different from clinic-supervised macrodose psychedelic therapy. The take-home model could scale to primary care if efficacy is proven.
Phase II topline
CompletedActual: Nov 13, 2025
Phase 2B MDD results: PRIMARY ENDPOINT MISSED. No significant difference vs placebo on MADRS at 8 weeks (p=0.5469). LSD group 29.9% MADRS reduction; placebo (caffeine) 36.4% reduction. N=89.
Why it matters: Critical setback. The strong open-label Phase 2A data (60% improvement) did not replicate in a controlled setting — the placebo group actually outperformed LSD. This is a cautionary example of how psychedelic open-label results can be inflated by expectancy effects. The microdosing hypothesis for MDD is seriously challenged by this result.
Watch next: Cancer and PMDD trials may use different endpoints/populations that could still show effects
Efficacy data
CompletedActual: Feb 1, 2024
Phase 2A positive results: 60% reduction in depressive symptoms, 53% complete remission at 8 weeks (open-label)
Why it matters: Impressive open-label results generated significant media coverage and investor interest. However, open-label psychedelic studies carry high placebo-response risk due to participant expectancy effects.
Watch next: 6-month follow-up and Phase 2B controlled data
Efficacy data
CompletedActual: Jun 1, 2024
6-month follow-up data: 72% sustained reduction in depression severity, 58% complete remission
Why it matters: Durable open-label response is encouraging but does not control for placebo effects. The real test is the randomised Phase 2B.
Recorded Events
Nov 13, 2025: Phase II topline
Jun 1, 2024: Efficacy data
Feb 1, 2024: Efficacy data
Aug 1, 2023: Phase II started
Palliative & End-of-Life Distress
Primary: Australia (TGA)
Phase IIActive
Phase 2B in 40 advanced-stage cancer patients ongoing. Existential distress, depression, anxiety in cancer as indication.
Milestones
Phase II started
In progressPhase 2B cancer distress trial (ACTRN12623000478617) enrolling 40 advanced-stage cancer patients
Why it matters: Cancer-related existential distress is a distinct indication from MDD — patients may respond differently to microdose LSD. The failed MDD trial does not necessarily predict failure in cancer distress, where psilocybin has shown strong effects (Johns Hopkins, NYU studies).
Watch next: Enrollment completion and data readout
Evidence Links
MindBio Enrols Final Participant in Phase 2B Depression Trial
Press release - TheNewswire - Jun 18, 2025 - Verified
MindBio announced enrollment of the 90th and final participant in its Phase 2B MB22001 MDD trial and said it was aligning toward Phase 3 planning.
MindBio Completes Dosing in Take-Home Phase 2B Microdosing Depression Trial
Press release - TheNewswire - Nov 6, 2025 - Verified
MindBio announced dosing complete in the 90-patient Phase 2B MDD trial and said results were expected shortly.
LSDDEP2 Phase 2b MB22001 Protocol Publication
Publication - Trials / PubMed Central - Jul 3, 2024 - Verified
Published protocol for a randomized, double-dummy, triple-blind Phase 2b trial of microdosing LSD for MDD.
MindBio Therapeutics - Current Website
company-website - MindBio Therapeutics - Jun 26, 2026 - Verified
Current rendered website emphasizes AI voice biomarker and telehealth products; no MB22001 pipeline page was visible in the June 2026 check, so programme status should be reviewed after results disclosure search.
MindBio reports Phase 2B MB22001 MDD results
Press release - MindBio Therapeutics / TheNewswire - Nov 13, 2025 - Verified
Company release says repeated microdosed LSD did not show superiority over active placebo for MDD at week 8, while tolerability was favorable.
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Quick Facts
- Type
- Public Biotech
- Ticker
- CSE: MBIO
- Lead Stage
- Phase II
- Website
- Visit