Asset profile

Lumateperone · Caplyta

Small molecule

Approvedregulatory verdict

Evidence outlook

Approved — Major Depressive Disorder, Schizophrenia

Regulatory approval supersedes design-level evidence grading — the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

How the evidence outlook works ↗

Upcoming events

(6 total)

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

2026 (1)
December 2026 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2026-12 · NCT06482554 · CT.gov ↗
What to watch

Research analysis

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

2027 (1)
April 2027 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2027-04-05 · NCT05850689 · CT.gov ↗
What to watch

Research analysis

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

2028 (1)
June 2028 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2028-06 · NCT07623135 · CT.gov ↗
What to watch

Research analysis

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

2029 (1)
September 2029 (1)
Phase 3Major Depressive DisorderNot yet recruiting
Est. primary completion 2029-09-20 · NCT07747389 · CT.gov ↗
What to watch

Research analysis

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

2031 (1)
October 2031 (1)
Phase 3Bipolar DepressionRecruiting
Est. primary completion 2031-10-31 · NCT06372964 · CT.gov ↗
What to watch

Research analysis

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

2032 (1)
April 2032 (1)
Phase 3SchizophreniaRecruiting
Est. primary completion 2032-04-28 · NCT06229210 · 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 ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

Research includes every linked study, indication filters, phase grouping and featured-trial cross-links.

Competitive landscape

Research

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