Developer · United States

Intra-Cellular Therapies, Inc.

A biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders; developer of CAPLYTA (lumateperone). Acquired by Johnson & Johnson in April 2025 and now operated as part of Johnson & Johnson Innovative Medicine.

intracellulartherapies.com ↗

3compounds
9programs
9indications
Approvedlead asset

Phase distribution

  • Approved3
  • Phase 32
  • Phase 24

Modality

  • Small molecule 3

Mechanism focus

Pipeline (3)

Deals & partnerships

  • Apr 2, 2025AcquisitionJohnson & Johnson acquires Intra-Cellular TherapiesJohnson & Johnson completed its acquisition of Intra-Cellular Therapies for $132.00 per share in cash (~$14.6B), closing April 2, 2025. ITCI delisted from NASDAQ and became a unit within Johnson & Johnson Innovative Medicine. Adds CAPLYTA (lumateperone) and the pipeline (ITI-1284, lenrispodun).ITI-1284 (deulumateperone)·Lenrispodun (ITI-214)·Lumateperone (ITI-007)source ↗
  • May 2005Licensing dealIntra-Cellular in-licenses lumateperone (ITI-007) from Bristol-Myers SquibbIntra-Cellular Therapies obtained an exclusive, worldwide license to lumateperone (ITI-007) and related CNS compounds from Bristol-Myers Squibb in 2005, the basis for its worldwide rights to CAPLYTA.Lumateperone (ITI-007)source ↗

Catalysts · 9 upcoming · 8 reported

Recently reported

Recent activity

  • Apr 27, 2026ReadoutLumateperone (ITI-007)·SchizophreniametFDA approved Caplyta (lumateperone) sNDA adding relapse-prevention data in schizophrenia (Study 304: HR 0.37, 63% lower relapse risk, p=0.0002).source ↗
  • Nov 6, 2025ReadoutLumateperone (ITI-007)·Major depressive disordermetFDA approved Caplyta (lumateperone) as adjunctive therapy with antidepressants for MDD in adults.source ↗
  • Nov 4, 2025Phase changeLenrispodun (ITI-214)·Parkinson's diseasePhase 2Phase 2 ITI-214-202 reached final completion (primary completion 2025-10-28); 79 patients enrolled. Registry status COMPLETED as of last update 2026-05-22. No topline results disclosed yet.source ↗
  • Feb 21, 2025Phase changeITI-1284 (deulumateperone)·Agitation in Alzheimer's diseasePhase 2Intra-Cellular Therapies FY2024 corporate update reports patient enrollment ongoing in the Phase 2 program evaluating ITI-1284 in agitation associated with Alzheimer's disease (alongside the Phase 2 Alzheimer's psychosis program).source ↗
  • Feb 21, 2025Phase changeLumateperone (ITI-007)·Autism spectrum disorderPhase 3Intra-Cellular Therapies FY2024 corporate update: 'in the fourth quarter of 2024, we commenced patient enrollment in two Phase 3 studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder' (Studies 601/602; NCT06690398, NCT06706674).source ↗
  • Dec 3, 2024Phase changeLumateperone (ITI-007)·Major depressive disorderFiled (NDA)Intra-Cellular Therapies submitted the sNDA to FDA for Caplyta (lumateperone) as adjunctive therapy for MDD, based on Studies 501 and 502.source ↗
  • Nov 22, 2024Phase changeLumateperone (ITI-007)·Autism spectrum disorderPhase 3Study 601 (NCT06690398, ITI-007-601) Phase 3 in pediatric irritability associated with autism spectrum disorder started; randomized, double-blind, placebo-controlled, n=174, primary endpoint ABC-Irritability at Week 6. Study start date per ClinicalTrials.gov.source ↗
  • Nov 21, 2024Phase changeITI-1284 (deulumateperone)·Generalized anxiety disorderPhase 2Second GAD trial started: monotherapy Phase 2 study NCT06701903 (ITI-1284 10 mg / 20 mg sublingual vs placebo, n~570).source ↗
  • Oct 22, 2024Phase changeITI-1284 (deulumateperone)·Agitation in Alzheimer's diseasePhase 2Phase 2 agitation-in-Alzheimer's-dementia trial started: NCT06651567 (ITI-1284 10-20 mg sublingual ODT once daily vs placebo, flexible-dose, n~320; primary endpoint CMAI total score at Week 12). Actual study start per ClinicalTrials.gov.source ↗
  • Aug 15, 2024Phase changeITI-1284 (deulumateperone)·Alzheimer's diseasePhase 2Phase 2 Alzheimer's-disease psychosis trial started: NCT06540833, a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of ITI-1284 10 mg / 20 mg once-daily sublingual ODT vs placebo (n=370), 6-week treatment, primary outcome BEHAVE-AD psychosis subscale at Week 6.source ↗
  • Aug 5, 2024Phase changeITI-1284 (deulumateperone)·Generalized anxiety disorderPhase 2First GAD trial started: adjunctive Phase 2 study NCT06480383 (ITI-1284 10 mg / 20 mg sublingual vs placebo in patients with inadequate response to GAD treatment, n~705).source ↗
  • Jul 17, 2024Phase changeLumateperone (ITI-007)·Bipolar disorderPhase 3Study 452 (NCT06462612, ITI-007-452) started — second Phase 3 acute bipolar-mania study, same design (lumateperone 42 mg vs placebo, 3-week, YMRS Week 3 primary). CT.gov start date 17 Jul 2024; status RECRUITING. Together the two studies form the pivotal acute-mania package. Intra-Cellular reported both were initiated in Q2 2024 with enrollment ongoing.source ↗

Trials recruiting · 10 recruiting of 22 sponsored

  • Phase 3Lumateperone (ITI-007)n=17439 sites · United States

    Study 602: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

    Irritability Associated With Autism Spectrum DisorderNCT06706674 ↗

  • Phase 3Lumateperone (ITI-007)n=17437 sites · United States

    Study 601: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

    Irritability Associated With Autism Spectrum DisorderNCT06690398 ↗

  • Phase 3Lumateperone (ITI-007)n=35035 sites · United States, Serbia, Bulgaria

    Study 452: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

    Bipolar Disorder, ManicBipolar I DisorderNCT06462612 ↗

  • Phase 3Lumateperone (ITI-007)n=35042 sites · United States, Bulgaria, India

    Study 451: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

    Bipolar Disorder, ManicBipolar I DisorderNCT06462586 ↗

  • Phase 3Lumateperone (ITI-007)n=50050 sites · United States, Serbia

    An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

    Autism Spectrum DisorderSchizophreniaBipolar DisorderNCT06229210 ↗

  • Phase 3Lumateperone (ITI-007)n=47060 sites · United States, India, Bulgaria

    Study 505: A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

    Major Depressive DisorderNCT05850689 ↗

  • Phase 2ITI-1284 (deulumateperone)n=57060 sites · United States, Bulgaria, Serbia

    A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

    Generalized Anxiety DisorderNCT06701903 ↗

  • Phase 2ITI-1284 (deulumateperone)n=32069 sites · United States, Bulgaria, Romania

    A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia

    Agitation Associated With Alzheimer's DementiaNCT06651567 ↗

  • Phase 2ITI-1284 (deulumateperone)n=37065 sites · United States, Bulgaria, Slovakia

    A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

    Psychosis Associated With Alzheimer's DiseaseNCT06540833 ↗

  • Phase 2ITI-1284 (deulumateperone)n=70569 sites · United States, Bulgaria, Serbia

    A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

    Generalized Anxiety DisorderNCT06480383 ↗

Competitive landscape

Other companies developing against Intra-Cellular Therapies, Inc.'s targets or indications.

Leadership & advisors (9)