42. Caplyta

purple brain
(Raman Oza/Pixabay)

Active ingredient: lumateperone tosylate
Disease: schizophrenia 
Peak sales estimate: $60 million in 2020, $400 million by 2024
Approved: Dec. 20, 2019
Company: Intra-Cellular Therapies

The scoop: Caplyta’s journey to approval was anything but smooth. The drug was originally slated for an FDA decision in September but weathered the cancellation of an advisory committee meeting and a three-month review extension before the agency finally OK’d it in December. It targets three neurotransmitter pathways—serotonin, dopamine and glutamate—that are important in neuropsychiatric disorders. Intra-Cellular Therapies thinks this mechanism, along with Caplyta’s safety profile, will set it apart from other antipsychotic drugs. The company plans to launch the drug for patients with schizophrenia in the first half of 2020 and hopes to get it approved for other indications, such as bipolar disorder and major depressive disorder. — Amirah Al Idrus 

42. Caplyta

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