Intra-Cellular Therapies

- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2002-01-01
- Employees
- 610
- Market Cap
- $7.8B
- 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
Trial Phases
3 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (60 trials with phase data)• Click on a phase to view related trials
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
- 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
- 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
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Drug: ITI-1284 10 mgDrug: ITI-1284 20 mgDrug: 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
- 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
- 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
- Prev
- 1
- 2
- 3
- 4
- 5
- 8
- Next
News
Lumateperone Shows Significant Efficacy as Adjunctive Therapy for Treatment-Resistant Major Depression
Lumateperone 42 mg as adjunctive therapy demonstrated significant improvement in depression symptoms versus placebo in a phase 3 trial of 485 patients with major depressive disorder and inadequate antidepressant response.
Major Pharmaceutical Companies Face Surge in Generic Drug Patent Challenges in Early 2025
Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025.
Major Pharma M&A Surge and Landmark Antitrust Rulings Shape 2025 Life Sciences Landscape
The first half of 2025 witnessed unprecedented M&A activity with major deals including Merck's $3.9 billion SpringWorks acquisition, Sanofi's $9.5 billion Blueprint Medicines purchase, and Johnson & Johnson's $14.6 billion Intra-Cellular Therapies acquisition.
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.