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Intra-Cellular Therapies (ITCI) FDA Events

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FDA Events for Intra-Cellular Therapies (ITCI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Intra-Cellular Therapies (ITCI). Over the past two years, Intra-Cellular Therapies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CAPLYTA and Lumateperone. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Intra-Cellular Therapies' Drugs in FDA Review

CAPLYTA (Lumateperone) - FDA Regulatory Timeline and Events

CAPLYTA (Lumateperone) is a drug developed by Intra-Cellular Therapies for the following indication: Depressive Episodes associated with Bipolar. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lumateperone - FDA Regulatory Timeline and Events

Lumateperone is a drug developed by Intra-Cellular Therapies for the following indication: For the treatment of MDD. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Intra-Cellular Therapies FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Intra-Cellular Therapies (ITCI) has reported FDA regulatory activity for the following drugs: CAPLYTA (Lumateperone) and Lumateperone.

The most recent FDA-related event for Intra-Cellular Therapies occurred on July 8, 2025, involving CAPLYTA (Lumateperone). The update was categorized as "sNDA Filing," with the company reporting: "Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia."

Current therapies from Intra-Cellular Therapies in review with the FDA target conditions such as:

  • Depressive Episodes associated with Bipolar - CAPLYTA (Lumateperone)
  • For the treatment of MDD - Lumateperone

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ITCI) was last updated on 7/9/2025 by MarketBeat.com Staff
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