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Intra-Cellular Therapies

Intra-Cellular Therapies logo
🇺🇸United States
Ownership
Public
Established
2002-01-01
Employees
610
Market Cap
$7.8B
Website
http://www.intracellulartherapies.com
Introduction

Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in New York, NY.

Clinical Trials

61

Active:15
Completed:23

Trial Phases

3 Phases

Phase 1:28
Phase 2:8
Phase 3:24

Drug Approvals

1

FDA:1

Drug Approvals

CAPLYTA

Approval Date
Jun 29, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (60 trials with phase data)• Click on a phase to view related trials

Phase 1
28 (46.7%)
Phase 3
24 (40.0%)
Phase 2
8 (13.3%)

A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: [14C]-ITI-1284
First Posted Date
2025-01-22
Last Posted Date
2025-04-16
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
8
Registration Number
NCT06786286
Locations
🇬🇧

Clinical Site 1, Nottingham, United Kingdom

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Phase 3
Recruiting
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
First Posted Date
2024-11-26
Last Posted Date
2025-07-08
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
174
Registration Number
NCT06706674
Locations
🇺🇸

Clinical Site, Everett, Washington, United States

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

Phase 2
Recruiting
Conditions
Generalized Anxiety Disorder
Interventions
Drug: ITI-1284 10 mg
Drug: ITI-1284 20 mg
Drug: Placebo
First Posted Date
2024-11-22
Last Posted Date
2025-02-20
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
570
Registration Number
NCT06701903
Locations
🇺🇸

Clinical Site, Bellevue, Washington, United States

🇺🇸

Cinical Site, Orlando, Florida, United States

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Phase 3
Recruiting
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
First Posted Date
2024-11-15
Last Posted Date
2025-07-04
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
174
Registration Number
NCT06690398
Locations
🇺🇸

Clinical Site, Bellevue, Washington, United States

A study to assess the efficacy and safety of ITI-1284 in the treatment of Agitation Associated with Alzheimer's Dementia

Phase 2
Not yet recruiting
Conditions
Agitation Associated with Alzheimer’s Dementia
First Posted Date
2025-05-27
Last Posted Date
2025-06-02
Lead Sponsor
Intra-Cellular Therapies Inc.
Target Recruit Count
137
Registration Number
2024-514680-26-00
Locations
🇧🇬

Umbal - Prof. D-R Stoyan Kirkovich AD, Stara Zagora, Bulgaria

🇧🇬

Center For Mental Health Prof. N. Shipkovenski EOOD, Sofia, Bulgaria

🇧🇬

Medical Center Medconsult Pleven OOD, Pleven, Bulgaria

and more 31 locations
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News

Johnson & Johnson Strengthens Neuroscience Portfolio with $14.6 Billion Intra-Cellular Acquisition

Johnson & Johnson completed its $14.6 billion acquisition of Intra-Cellular Therapies on April 2, marking the company's strategic re-entry into the neuroscience field.

Alzheimer's Drug Market Sees 780% Investment Surge Following Leqembi and Kisunla Approvals

Total M&A deal value in Alzheimer's disease jumped from $2 billion in 2022 to $18 billion in 2024, representing a 780% increase following the approval of disease-modifying treatments.

Big Pharma M&A Activity Surges as Companies Target Undervalued Biotechs Amid Market Recovery

Pharmaceutical M&A activity is experiencing a significant rebound with major deals including Novartis's $1.7 billion acquisition of Regulus Therapeutics and Merck KGaA's $3.9 billion purchase of SpringWorks Therapeutics.

Merck KGaA to Acquire SpringWorks Therapeutics in $3.9 Billion Deal for Rare Disease Portfolio

German pharmaceutical giant Merck KGaA has agreed to acquire Connecticut-based SpringWorks Therapeutics for $3.9 billion, paying $47 per share in cash, representing a 26% premium over SpringWorks' unaffected 20-day average price.

J&J Raises 2025 Sales Forecast Despite $400M Tariff Impact Following Intra-Cellular Acquisition

• Johnson & Johnson has increased its 2025 sales forecast by $700 million to $92 billion following the $14.6 billion acquisition of Intra-Cellular Therapies and its antipsychotic drug Caplyta. • The company expects a $400 million hit from tariffs while simultaneously lowering its adjusted operational EPS growth projection from 8.7% to 6.2% due to acquisition-related dilution. • J&J secured key regulatory approvals in Q1 2025, including FDA clearance for Tremfya to treat Crohn's disease and European Commission approval for Rybrevant for specific lung cancer indications.

Bipolar Depression Market Set to Grow Through 2034 with New Therapies in Pipeline

• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions. • Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector. • Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.

J&J Discontinues Depression Trials for Aticaprant After Insufficient Efficacy Results

• Johnson & Johnson has terminated Phase III VENTURA trials for aticaprant as an add-on therapy for major depressive disorder due to insufficient efficacy, despite previous projections of $1-5 billion in peak annual sales. • The setback impacts J&J's goal of becoming the top neuroscience company by 2030, though the company remains committed to exploring aticaprant's potential in other therapeutic areas with high unmet needs. • The failure raises doubts about kappa opioid receptor antagonists in depression treatment, affecting other companies like Neumora Therapeutics, whose similar drug navacaprant also failed in Phase III trials earlier this year.

Biopharma Industry Faces Pivotal Year: J.P. Morgan Conference Signals Key 2025 Challenges

The 2024 J.P. Morgan Healthcare Conference kicked off with significant M&A activity, including Johnson & Johnson's $15 billion acquisition of Intra-Cellular Therapies.

J&J Boosts Neuroscience Pipeline with ITCI Acquisition, FDA Approves Spravato Monotherapy for TRD

• Johnson & Johnson (J&J) is set to acquire Intra-Cellular Therapies (ITCI) for $14.6 billion, adding Caplyta for bipolar disorder and schizophrenia to its neuroscience pipeline. • The FDA has approved J&J's Spravato as a monotherapy for treatment-resistant depression (TRD), based on positive data from the phase IV TRD4005 study. • AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) received FDA priority review for a lung cancer indication and was approved for previously treated breast cancer.

Johnson & Johnson to Acquire Intra-Cellular Therapies for $14.6 Billion, Bolstering Neuroscience Portfolio

Johnson & Johnson (J&J) will acquire Intra-Cellular Therapies for $14.6 billion, gaining access to Caplyta and a pipeline of CNS disorder treatments.

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