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Intra-Cellular Poised To Add MDD To Caplyta’s Label

Second Phase III Is Positive

 
• By Joseph Haas

Caplyta succeeded in a second Phase III study as adjunctive therapy for major depression, putting the schizophrenia/bipolar disorder drug on track for sNDA filing later in 2024.

Intra-Cellular will file lumateperone for approval in adjunctive MDD

With a second successful Phase III readout in major depressive disorder this quarter for Caplyta (lumateperone), Intra-Cellular Therapies, Inc. said on 18 June that it intends to seek what would be the drug’s third indication this year, and anticipates approval in the second half of 2025. While Caplyta works toward blockbuster status as a therapy for schizophrenia and bipolar I/II disorder, analysts said an MDD indication should add billions more to its revenue potential.

Key Takeaways

  • Intra-Cellular followed April’s successful Phase III trial of Caplyta in depression with a second trial virtually replicating those results.

  • The New York firm plans...

CEO Sharon Mates told a same-day call that Intra-Cellular will file a supplemental new drug application with the US Food and Drug Administration based on data from the two Phase...

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