Second generation
therapies using psychedelic drugs to treat mental health, is moving to the
forefront at a rapid pace. The conversation now is which psychedelic will hit
the market first, to serve their unmet need. We initially wrote about the subject here Psychedelic-Based Therapeutics.
Not all
psychedelics are identical in nature. Psilocin, DMT, and MDMA are the popular
ones, all produced to act quickly with minimal dosing requirements. Here’s a
list of five companies furthest along in their clinical trials, that have
successfully raised the needed capital to progress further toward FDA approval,
and commercialization.
ATAIBeckley,
Compass Pathways, Cybin, GH Research, and MindMed.
ATAIBeckley - BLP-003
ATAI is addressing
treatment resistant depression with their psychedelic drug (BLP-003) mebufotenin benzoate, and
their means of dosing is an intranasal inhalant. The company has completed Phase 2b Results and is now in the process of meeting with the FDA to discuss
the design of their phase 3 clinical trials. Those phase 3 trials are expected
to commence in the second quarter of 2026. BLP-003 has Breakthrough Therapy
Designation.
Compass
Pathways - COMP360
Compass is
furthest along in their clinical trials addressing treatment resistant
depression with their lead oral candidate psilocybin COMP360. Completion their
first phase 3 clinical trial is posted here COMP360 Phase 3 With their second phase 3 clinical trial
to be completed in the second half of 2026. COMP360 has Breakthrough Therapy
Designation.
Cybin - CYB003
Cybin is
addressing major depression disorder (MDD) with their lead deuterated
psilocybin oral candidate CYB003. The company recently raised the needed cash
to fund the operation through phase 3 readouts. Cybin is currently running three
phase 3 clinical trials with CYB003 as an adjunctive therapy for patients. The
first phase 3 APPROACH will have data by the fourth quarter 2026. EMBRACE to
begin a global phase 3 in the fourth quarter of 2025, and EXTEND which is the
long-term open label study currently enrolling the completers of APPROACH and
EMBRACE to confirm long-term safety and efficacy. CYB003 has Breakthrough
Therapy Designation.
GH Research - GH001
Similar to ATAI,
GH Research is addressing TRD with an intranasal inhalant with psychedelic
mebufotenin. The company has completed Phase 2b Results, and is on schedule to meet
with the FDA for a post phase 2 meeting to discuss phase 3 clinical design. The
company is well funded, having raised capital after the announcement of phase 2
results. Their goal is to commence phase 3 testing in 2026.
MindMed - MM120
Mind Medicine’s
lead candidate is lysergide D-tartrate (LSD) with MM120 for generalized anxiety
disorder (GAD). The company has completed Phase 2b Results and currently has two
phase 3 clinical trials running called Voyage and Panorama. The potential
completion for Voyage is late 2026 and Panorama mid-year 2027. The long-term
open label 40-week extension study Part B, is available for the completers of
Voyage and Panorama. The company is well financed and has
Breakthrough Therapy Designation for MM120 and GAD.
The companies listed have set up intervention protocols for the patients, after the dosing of their therapeutic. The five companies written about here hold great potential for new innovative therapeutics for mental health, and at the same time, there are many challenges getting the therapies approved. At this writing we are only interested in Cybin for investment. Thank you for reading.
