BiotechReadouts
Get updates

Intra-Cellular Therapies (ITCI): next trial readout expected around 2026-08-19

$ITCI · Intra-Cellular Therapies, Inc.Trials that could report in the next 12 months: 11
BiopharmaCTG

Catalyst timeline

Dates are estimated from each trial's registered completion date — none are FDA decision dates. Counts trials that fit our shared poll budget, not everything ITCI is running — see methodology.

  1. 2026-08-19todayPET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
  2. 2027-03-16in 30wStudy of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
  3. 2027-04-05in 33wStudy of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
  4. 2027-06-21in 44wMulticenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
  5. 2027-06-21in 44wMulticenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
  6. 2027-10-14in 60wStudy of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
  7. 2027-12-28in 71wA Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
  8. 2028-09-30in 110wA Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
  9. 2029-09-20in 161wA Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder
  10. 2031-10-31in 271wMulticenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
  11. 2032-04-28in 297wSafety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Pipeline

ProgramPhaseStatusPrimary completionTrial
Safety and Tolerability Trial of Lumateperone in Pediatric Patients Wi…Phase 3Recruitingstill enrolling patients2032-04-28NCT06229210
Multicenter Study of Lumateperone for the Treatment of Bipolar Depress…Phase 3Recruitingstill enrolling patients2031-10-31NCT06372964
A Study of Lumateperone Versus Placebo in Participants With Major Depr…Phase 3Not Yet Recruitingnot open yet2029-09-20NCT07747389
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment…Phase 2Recruitingstill enrolling patients2028-09-30NCT06540833
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment…Phase 2Recruitingstill enrolling patients2027-12-28NCT06651567
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalize…Phase 2Recruitingstill enrolling patients2027-10-14NCT06701903
Multicenter Study of Lumateperone for the Treatment of Irritability As…Phase 3Recruitingstill enrolling patients2027-06-21NCT06706674
Multicenter Study of Lumateperone for the Treatment of Irritability As…Phase 3Recruitingstill enrolling patients2027-06-21NCT06690398
+ 3 more tracked trials
ProgramPhaseStatusPrimary completionTrial
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patien…Phase 3Recruitingstill enrolling patients2027-04-05NCT05850689
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generali…Phase 2Recruitingstill enrolling patients2027-03-16NCT06480383
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokin…Phase 1Recruitingstill enrolling patients2026-08-19NCT06299410

Status-change history

Every ClinicalTrials.gov change recorded for ITCI's trials — a running history no other tracker shows.

No status changes detected yet for this ticker.

Frequently asked

When is ITCI's next PDUFA date?

No disclosed PDUFA date is currently tracked for this ticker.

What phase is ITCI's lead program in?

Phase 3 — recruiting.

Where does this data come from?

ClinicalTrials.gov v2 API (trial status + diffs) and company 8-K/press-release disclosures (PDUFA dates). Every number links to its source.