Compass Pathways Plc is an investment holding company. It operates through its subsidiaries which provide mental health care services. The company was founded by Goldsmith George Jay and Malievaskaia Ekaterina in 2016 and is headquartered in London, the United Kingdom.
Clinical Trials
9
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2016
Active, not recruiting
2
22.2%
Completed
6
66.7%
Recruiting
1
11.1%
No approval data available
- Compass Pathways reported statistically significant Phase III results for COMP360 in treatment-resistant depression, with a MADRS change-from-baseline difference of just under four points versus placebo. - The company expects a potential launch in the first half of 2027 and plans to be launch-ready by the end of 2026, pending FDA review and federal rescheduling of psilocybin. - Roughly one-quarter of patients responded after a single dose in COMP005, while about 40% responded after two fixed doses given three weeks apart in COMP006, with durability through 26 weeks. - Compass is also advancing COMP360 in post-traumatic stress disorder, where an open-label Phase II study in 22 patients showed remission in nearly 80% of participants at 12 weeks.
- Definium Therapeutics will file an NDA for its LSD-based medicine DT120 in generalised anxiety disorder after a third positive Phase III readout. - The open-label Panorama study met its primary endpoint with a 5.1-point placebo-adjusted improvement in anxiety scores at week 12 on the 100µg dose. - Definium plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 and a GAD filing in the first half of 2027.
- The FDA held a public hearing on the future therapeutic use of psychedelics, drawing more than 1,800 registered attendees and roughly 80 scheduled speakers. - The hearing followed the agency's July 2026 finalized guidance on psychedelic clinical investigations and an April executive order aimed at accelerating access. - Speakers clashed over provider credentialing, patient safety, rural access, and the need for standardized adverse event and outcome data. - FDA's public docket remains open through October 5, 2026, and written comments will inform continued federal coordination on psychedelic drug development.
- Definium Therapeutics' DT120 ODT met its primary and all key secondary endpoints in the Phase 3 Panorama trial of 245 adults with generalized anxiety disorder. - The 100-microgram dose produced a 9.8-point HAM-A reduction versus 4.7 points for placebo at Week 12, a 5.1-point placebo-adjusted difference (p<0.0001, Cohen's d=0.64). - Panorama is the second positive Phase 3 GAD study for DT120 ODT and the third positive late-stage readout overall, following Voyage in GAD and Emerge in MDD. - Definium has scheduled a pre-NDA meeting with the FDA for Q4 2026 and plans to submit its New Drug Application in the first half of 2027.
- Compass Pathways reported 52-week open-label Part C data from Phase 3 COMP005 showing COMP360 produced an average 13-point MADRS reduction from baseline in the 25 mg arm. - Participants originally randomized to placebo who received their first 25 mg COMP360 dose in Part C achieved a mean 10-point MADRS reduction from baseline. - Across all Part C participants dosed at 25 mg, response rates were 40%-45% and remission rates approximately 30% between Day 1 and Week 6 after treatment. - Compass expects to complete its rolling NDA submission in the fourth quarter, with a potential launch in the first half of next year subject to FDA approval.
- Draig Therapeutics raised $65 million in an oversubscribed Series B round led by Deep Track Capital to accelerate its neuropsychiatric pipeline. - The funding will support two Phase 2 trials of DT-101, an oral AMPA receptor positive allosteric modulator, as both monotherapy and adjunctive treatment for major depressive disorder. - DT-101 aims to deliver rapid antidepressant effects with potential cognitive benefits by amplifying glutamate signaling rather than directly activating AMPA receptors. - Initial clinical readouts from both Phase 2 studies are expected in 2027, with earlier-stage GABA-A modulator programs DT-201 and DT-301 planned to enter the clinic in 2026.
- The 7th Interdisciplinary Conference on Psychedelic Research (ICPR) in Haarlem highlighted Europe's "moderate temperament" toward psychedelics, contrasting with U.S. financial and political pressures. - A dedicated symposium on negative clinical trials featured a ketamine study for suicidality that found no difference versus midazolam, and the EPIsoDe psilocybin trial for treatment-resistant depression that missed its primary endpoint. - An on-stage interview with Garik Rober, imprisoned for negligent homicide after two deaths during an illegal psychedelic session, raised unresolved questions about therapist training and personal drug use. - Patient perspectives from a postpartum depression trial using RE104, a short-duration psilocybin analog, revealed that both positive and distressing drug experiences could lead to remission. - Closing reflections underscored ongoing underrepresentation of Indigenous voices, women's health research, and patient communities in the crystallizing psychedelic field.
- A systematic review of 112 psychedelic RCTs found blinding failure rates exceeding 90%, with only 29.5% of trials evaluating blinding integrity and 57.1% acknowledging it as a limitation. - The FDA's 2024 rejection of MDMA-assisted therapy for PTSD and its 2023 Complete Response Letter for COMP360 both cited functional unblinding as a core evidentiary concern. - Expectancy effects may be an intrinsic part of psychedelic therapy's mechanism, raising fundamental questions about whether the FDA's drug approval architecture can accommodate drug-plus-context systems. - Sex-specific factors including menstrual cycle phase, hormonal status, and contraceptive use remain systematically unaddressed in psychedelic trial design, particularly problematic for female-only indications like postpartum depression.
- The U.S. FDA is considering revoking the GRAS safety status of processed refined carbohydrates including corn syrup following a petition, potentially requiring food companies to prove these ingredients are safe and not contributing to obesity. - Health Secretary Robert F. Kennedy Jr. announced this potential regulatory shift that could significantly impact the food industry's use of processed sweeteners and carbohydrates. - Major corporate consolidation is occurring with Danaher approaching a $10 billion acquisition of medical technology company Masimo, marking significant consolidation in the medical technology sector. - Edwards Lifesciences has abandoned its anti-copycat policy to close an EU antitrust investigation, while pharmaceutical companies continue expanding with obesity drug developments and global market strategies.
- Compass Pathways is planning multiple Phase III data readouts this quarter for its psilocybin-based therapy COMP360 in treatment-resistant depression, with regulatory filing expected by Q3 2025. - Definium is preparing three Phase III data drops for its LSD-based MM120 in generalized anxiety disorder and major depressive disorder, representing a potential "tipping point" for the psychedelics space. - Both companies are positioned to become the first FDA-approved "classic psychedelics" following the 2024 rejection of Lykos Therapeutics' MDMA-based therapy for PTSD. - Analysts predict that by 2027, both MM120 and COMP360 are likely to receive FDA approval, marking the transition from speculative clinical validation to large-scale market launch.
