This section highlights FDA-related milestones and regulatory updates for drugs developed by Compass Pathways (CMPS).
Over the past two years, Compass Pathways has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XOLREMDI, COMP360, COMP360, COMP005, and COMP004. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XOLREMDI FDA Regulatory Events
XOLREMDI is a drug developed by Compass Pathways for the following indication: for treatment-resistant depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XOLREMDI
- Announced Date:
- April 29, 2026
- Indication:
- for treatment-resistant depression
Announcement
X4 Pharmaceuticals announced today that the European Commission (EC) has granted marketing authorization for XOLREMDI® (mavorixafor) capsules for the treatment of patients with WHIM syndrome in the European Union (EU).
AI Summary
X4 Pharmaceuticals announced that the European Commission has granted marketing authorization for XOLREMDI® (mavorixafor) capsules to treat patients 12 years and older with WHIM syndrome in the European Union. XOLREMDI is an oral, once-daily CXCR4 antagonist intended to increase circulating mature neutrophils and lymphocytes. European commercialization will be led by X4’s partner, Norgine.
The EC decision was supported by data from the pivotal Phase 3 4WHIM trial, a global, randomized, double-blind, placebo-controlled, 52-week multicenter study that enrolled 31 people aged 12 and up with WHIM syndrome to evaluate efficacy and safety. X4 also notes an ongoing global pivotal Phase 3 trial evaluating mavorixafor in chronic neutropenia. The authorization represents a significant regulatory milestone for patients with WHIM syndrome in the EU and establishes an approved oral treatment option aimed at improving immune cell counts.
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COMP360 FDA Regulatory Timeline and Events
COMP360 is a drug developed by Compass Pathways for the following indication: for treatment resistant depression (TRD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COMP360
- Announced Date:
- April 14, 2026
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc announced today an invitation for U.S. based organizations to apply for a grant to create training content for healthcare providers to deliver investigational COMP360 psilocybin treatment, if approved.
AI Summary
Compass Pathways plc has invited U.S.-based organizations to apply for a grant to create training content for healthcare providers who would deliver investigational COMP360 psilocybin treatment, if approved. The program aims to develop structured, high-quality training and materials to support the expected U.S. commercial rollout of COMP360 for treatment-resistant depression. Compass says it will collaborate closely with grant awardees to build training that helps sites of care prepare operationally and maintain consistent, safe delivery of the treatment.
The grant application is two-stage and the full evaluation process will take about three months. Compass frames the effort as part of its broader mission to improve mental health care and readiness across treatment sites. U.S. organizations with experience in clinician education, curriculum design, or psychedelic-assisted therapy training are encouraged to apply and work with Compass to finalize materials ahead of potential approval and launch.
Read Announcement- Drug:
- COMP360
- Announced Date:
- January 7, 2026
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD.
AI Summary
Compass Pathways announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for COMP360, allowing the company to start a late-stage Phase 2b/3 study (COMP202) in people with post-traumatic stress disorder (PTSD). The multicenter, randomized, double-blind, controlled trial includes a blinded 12-week Part A comparing two administrations of COMP360 25 mg to two administrations of 1 mg, with the second dose about four weeks after the first. The main measure is change in CAPS-5 total severity score at Week 8. Part B is a 40-week open-label follow-up to assess longer-term safety and benefit, with eligible participants able to receive one open-label retreatment with 25 mg. COMP360 may be given alongside one allowed antidepressant.
Compass will host a webinar with experts to discuss the PTSD trial and commercial plans for treatment-resistant depression.
Read Announcement- Drug:
- COMP360
- Announced Date:
- May 14, 2025
- Target Action Date:
- May 20, 2025
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc that management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference at 10:30 am ET on May 20th, 2025.
AI Summary
Compass Pathways plc announced that its management will participate in a fireside chat at the upcoming 2025 RBC Capital Markets Global Healthcare Conference. The session is scheduled for May 20, 2025, at 10:30 am ET. During the chat, company leaders will share insights into their efforts to improve access to innovative mental health treatments and discuss the future of mental healthcare. The event aims to provide updates on the company’s strategies, future goals, and its commitment to advancing treatments for serious mental health conditions.
The live audio webcast will be available on the Investors section of the Compass website under the Events page, with a replay accessible for 30 days following the presentation. This upcoming discussion offers a valuable opportunity for investors and industry experts to learn more about Compass Pathways’ vision and its ongoing initiatives in the mental health innovation space.
Read Announcement- Drug:
- COMP360
- Announced Date:
- April 29, 2025
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc announced it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization.
AI Summary
Compass Pathways plc has announced a new strategic collaboration with HealthPort, a multi-site, community health organization known for its integrated care model focused on social determinants of health. Through this partnership, the two organizations aim to study the challenges and barriers that many underserved communities face when seeking innovative mental health treatments. They will work together to explore how Compass’s investigational COMP360 synthesized psilocybin treatment could be delivered in community care settings, if approved. HealthPort, with its 45-year history of providing residential, mobile, and facility-based care in Maryland, offers expertise in addressing issues like poverty, disability, and trauma. This collaboration is part of Compass’s broader effort to understand how new treatments for conditions such as treatment-resistant depression might best be integrated into existing care models to help those most in need.
Read Announcement- Drug:
- COMP360
- Announced Date:
- April 22, 2025
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc announced that all participants have completed dosing in Part A of the COMP005 phase 3 trial for treatment resistant depression (TRD).
AI Summary
Compass Pathways, a biotechnology company focused on mental health innovation, has announced a key milestone in their COMP005 phase 3 trial for treatment resistant depression (TRD). The company confirmed that all participants in Part A have completed dosing. Each participant received a single dose of either 25 mg of COMP360—a synthesized psilocybin formulation—or a placebo after any necessary washout from antidepressant medications.
This milestone is crucial as the trial aims to assess the safety and effectiveness of COMP360 for those who have not responded to traditional treatments. Top-line results for the six-week primary endpoint are expected to be disclosed in late June. The progress of this trial reflects Compass Pathways' commitment to advancing innovative, evidence-based treatments to address the urgent needs of patients with TRD.
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COMP360 psilocybin FDA Regulatory Events
COMP360 psilocybin is a drug developed by Compass Pathways for the following indication: Therapy for treatment-resistant depression (TRD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COMP360 psilocybin
- Announced Date:
- September 2, 2025
- Indication:
- Therapy for treatment-resistant depression (TRD)
Announcement
Compass Pathways plc announced the publication of results from an open-label Phase 2 study evaluating the safety and tolerability of a single-dose of 25 mg of investigational COMP360 synthetic psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD).
AI Summary
Compass Pathways plc published results from an open-label Phase 2 study testing a single 25 mg dose of COMP360, its synthetic psilocybin treatment, in 22 adults with post-traumatic stress disorder (PTSD). The main goal was to assess safety and tolerability.
Participants were closely monitored for adverse events and vital signs before, during, and after dosing. Most side effects were mild to moderate, including headache, nausea, and transient anxiety. No serious adverse events were reported, and all participants completed the study.
The study also measured tolerability of COMP360 alongside psychological support. Results showed that the single dose was well tolerated, and the therapy sessions were completed without major interruptions or drop-outs.
These findings support further exploration of COMP360 as a potential PTSD treatment. Compass Pathways plans to use this data to guide future clinical trials and dosage strategies.
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COMP005 FDA Regulatory Events
COMP005 is a drug developed by Compass Pathways for the following indication: for treatment resistant depression (TRD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COMP005
- Announced Date:
- May 8, 2025
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc provided an update on recent progress across its business.
AI Summary
Compass Pathways plc provided an update on recent progress across its business during its first quarter 2025 financial report. The company is advancing its key COMP360 psilocybin treatment programs for treatment-resistant depression. Top-line 6-week data from the COMP005 Phase 3 trial is on track for late June, and 26-week data from the COMP006 trial is expected in the second half of 2026. These trials are part of the largest controlled, double-blind clinical assessments for psilocybin in mental health. The update also highlighted the company’s strong financial position, reporting cash and cash equivalents of $260.1 million as of March 31, 2025, which is anticipated to support operations through the upcoming data milestones. Compass Pathways remains focused on its leadership in developing innovative psychedelic therapies to provide rapid and durable treatment responses for mental health conditions.
Read Announcement- Drug:
- COMP005
- Announced Date:
- March 26, 2025
- Indication:
- for treatment resistant depression (TRD).
Announcement
Compass Pathways plc announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD).
AI Summary
Compass Pathways plc announced that recruitment for its COMP005 phase 3 trial focused on treatment resistant depression (TRD) is now complete. All screening across sites has wrapped up, and the final participants are being scheduled for dosing. These eligible participants, after completing necessary pre-dosing activities such as a washout of anti-depressant medications, will soon receive either 25 mg of COMP360, a synthetic psilocybin formulation, or a placebo.
The completion of recruitment marks an important milestone in the trial, which is designed to assess the potential of COMP360 as a groundbreaking psilocybin treatment for patients who have not responded well to traditional therapies. Compass Pathways expects to share the six-week primary endpoint results later in the second quarter, moving one step closer to possibly offering a transformative treatment option for those suffering from TRD.
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COMP004 FDA Regulatory Events
COMP004 is a drug developed by Compass Pathways for the following indication: For Treatment-Resistant Depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COMP004
- Announced Date:
- March 18, 2025
- Indication:
- For Treatment-Resistant Depression
Announcement
Compass Pathways plc announced the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression (TRD).
AI Summary
Compass Pathways plc has published results from the COMP004 study, a 52-week observational follow-up from earlier Phase 2 trials (COMP001 and COMP003) of COMP360 psilocybin for treatment-resistant depression. The study showed that a single 25 mg dose of COMP360 produced significantly longer-lasting antidepressant effects compared to doses of 1 mg and 10 mg. On average, the 25 mg dose maintained its impact for about 12 weeks, with one subgroup showing benefits lasting up to 189 days.
The study also found that patients receiving 25 mg experienced a longer time before a relapse in depressive symptoms. Safety monitoring over the year revealed few serious side effects, and those reported were not connected to the study drug. These findings support COMP360’s potential for providing rapid and durable relief from treatment-resistant depression.
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