Asset profile

CYB003

Small molecule

Phase 3underway

Evidence outlook · registrational

Major Depressive Disorder: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2027-03-18.

NCT05385783: The study randomized 57 participants and used quadruple masking, with placebo comparator sessions in both the major depressive disorder and healthy-participant groups. Its primary outcomes focused on adverse events and ECG measures, but no results are posted, so whether the primary comparisons were met is unknown.

Registered primary outcomes are safety measures; the MADRS result is the sponsor-designated primary efficacy endpoint from topline press releases, not yet peer reviewed.

How the evidence outlook works ↗

Upcoming events

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov — registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
March 2027 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2027-03-18 · NCT06793397 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (2)
March 2028 (1)
Phase 3Major Depressive DisorderEnrolling by invitation
Est. primary completion 2028-03-15 · NCT06605105 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2028 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-09 · NCT06820723 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

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