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.
Select a button below to view the list of FDA events for that drug.
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.
- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- July 8, 2025
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
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.
AI Summary
Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for CAPLYTA® (lumateperone) based on long-term Phase 3 data. The data show that CAPLYTA® significantly reduces the risk of relapse in adults with schizophrenia by 63% compared to placebo. In a double-blind, randomized withdrawal trial, patients receiving CAPLYTA® experienced a longer time before relapse, indicating improved long-term stability and reduced risk of hospitalizations. The study further demonstrated a delay in overall treatment discontinuation, and no new safety concerns were noted. This submission highlights CAPLYTA®’s potential to help prevent debilitating relapses, providing more treatment stability for individuals with schizophrenia. With this move, Johnson & Johnson continues to offer a broad range of treatment options, aiming to improve quality of life for patients and their families.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- December 11, 2024
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Intra-Cellular Therapies, announced presentations at the 63rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) which included new efficacy, safety, and tolerability analyses from its CAPLYTA adjunctive major depressive disorder (MDD) pivotal program.
AI Summary
Intra-Cellular Therapies announced new presentations at the 63rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP). These presentations focused on new efficacy, safety, and tolerability data from its CAPLYTA adjunctive major depressive disorder (MDD) pivotal program. Specifically, two Phase 3 trials (Studies 501 and 502) evaluated lumateperone as an add-on treatment for patients with MDD who had an inadequate response to current antidepressant therapies. The studies showed robust clinical benefits, with significantly improved remission and response rates, and notable enhancements in both depressive and anxiety symptoms as measured by established rating scales like MADRS and GAD-7. Additionally, pooled safety data from these studies confirmed a favorable safety and tolerability profile for CAPLYTA. Overall, the new data further support lumateperone as a promising treatment option for adults suffering from major depressive disorder.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- December 3, 2024
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Intra-Cellular Therapies, announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants.
AI Summary
Intra-Cellular Therapies recently submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for CAPLYTA (lumateperone) as an adjunctive treatment for Major Depressive Disorder (MDD) in adults. This submission is based on promising results from two Phase 3 clinical trials, Studies 501 and 502. Both studies showed that adding CAPLYTA to an existing antidepressant regimen led to a significant improvement in depressive symptoms compared to a placebo. The trials also highlighted CAPLYTA’s robust antidepressant effects, along with a favorable safety and tolerability profile. With over 30 million adults affected by MDD in the U.S., the company believes that, pending FDA approval, CAPLYTA could become a first-choice add-on treatment for patients who do not fully respond to antidepressants alone. Intra-Cellular Therapies now looks forward to working closely with the FDA during the review process.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- April 16, 2024
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Intra-Cellular Therapies, announced positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
AI Summary
Intra-Cellular Therapies announced positive topline results from Study 501, which evaluated lumateperone 42 mg as an add-on to antidepressants for treating major depressive disorder (MDD). In the study, patients taking lumateperone showed significant improvement compared to those on placebo. At Week 6, the drug demonstrated a 4.9-point greater reduction on the Montgomery-Åsberg Depression Rating Scale, and improvements were also noted on the Clinical Global Impression Scale for Severity of Illness. Results showed meaningful benefits as early as Week 1 that were maintained throughout the study. Patient self-reports using the Quick Inventory of Depressive Symptomatology further supported these findings. The drug was well tolerated with a favorable safety profile similar to previous research. These outcomes support further investigation and potential approval of lumateperone as an effective adjunctive treatment for MDD.
Read Announcement- Drug:
- CAPLYTA (Lumateperone)
- Announced Date:
- April 16, 2024
- Indication:
- Depressive Episodes associated with Bipolar
Announcement
Intra-Cellular Therapies announced that Topline results from our second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
AI Summary
Intra-Cellular Therapies announced positive results from its Phase 3 Study 501, where lumateperone 42 mg, used as an add-on to antidepressants, showed statistically significant improvements in patients with major depressive disorder. The study met both the primary endpoint—reducing the Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6—and the key secondary endpoint on the Clinical Global Impression Scale for Severity of Illness (CGI-S). Notably, significant benefits were observed as early as Week 1 and continued throughout the study. The treatment also improved patient-reported symptoms on the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR). In addition to these promising efficacy results, lumateperone demonstrated a favorable safety profile with generally mild and short-lived side effects such as dry mouth, fatigue, and tremor. Topline results from their second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
Read Announcement
Lumateperone FDA Regulatory 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.
- Drug:
- Lumateperone
- Announced Date:
- January 10, 2025
- Indication:
- For the treatment of MDD
Announcement
Intra-Cellular Therapies announced that it has entered into a settlement agreement with Sandoz Inc. (Sandoz) resolving patent litigation related to Intra-Cellular Therapies' product CAPLYTA® (lumateperone). ,
AI Summary
Intra-Cellular Therapies has reached a settlement agreement with Sandoz Inc. to resolve a patent dispute over its product CAPLYTA® (lumateperone). The disagreement arose after Sandoz submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. Sandoz is seeking approval to market a generic version of CAPLYTA.
According to the settlement, Sandoz will be allowed to begin selling its generic version of CAPLYTA on July 1, 2040, or possibly sooner under certain conditions. As a part of the legal requirements, the agreement will be submitted to both the U.S. Federal Trade Commission and the U.S. Department of Justice. This resolution helps clarify market expectations for CAPLYTA, while patent litigation involving other parties is still ongoing in the same court.
Read Announcement- Drug:
- Lumateperone
- Announced Date:
- June 18, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the treatment of MDD
Announcement
Intra-Cellular Therapies announced that Supplemental NDA (sNDA) submission for the adjunctive treatment of major depressive disorder (MDD) anticipated in the second half of 2024
AI Summary
Intra-Cellular Therapies announced strong topline results from Study 502, which evaluated lumateperone 42 mg as an add-on therapy for major depressive disorder (MDD). The study showed that patients receiving lumateperone experienced significant improvements in depression scores compared to those on placebo. In addition to promising efficacy data, the safety and tolerability profile of lumateperone was consistent with earlier trials.
Based on these positive findings, the company expects to submit a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024. This submission aims to gain approval for lumateperone as an adjunct treatment for MDD, potentially offering a new option for patients who have not achieved an adequate response to standard antidepressant therapies.
Read Announcement- Drug:
- Lumateperone
- Announced Date:
- June 18, 2024
- Indication:
- For the treatment of MDD
Announcement
Intra-Cellular Therapies, announced positive topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.
AI Summary
Intra-Cellular Therapies recently announced positive topline results from Study 502, which evaluated lumateperone 42 mg as an adjunctive treatment with antidepressants for major depressive disorder (MDD). The study showed that patients receiving lumateperone experienced a statistically significant improvement in depressive symptoms. Specifically, the primary endpoint measured by the Montgomery-Åsberg Depression Rating Scale revealed a 4.5-point greater reduction compared to placebo (p<0.0001, effect size 0.56). Additionally, the Clinical Global Impression Scale for Severity demonstrated significant improvement (p<0.0001, effect size 0.51), and patients reported better outcomes on the Quick Inventory of Depressive Symptomatology.
The treatment was well tolerated and had a favorable safety profile. These robust results support lumateperone as a promising option for patients with MDD who do not adequately respond to standard antidepressant therapies. Intra-Cellular Therapies plans to submit a supplemental NDA to the FDA in the second half of 2024.
Read Announcement
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