Caplyta

Treats schizophrenia. NDA 209500, held by Intra-Cellular. Lumateperone Tosylate.

As of Nov 14, 2026, NDA 209500 (Caplyta), held by Intra-Cellular, was first approved by FDA on Dec 20, 2019, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2019
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CAPLYTA is indicated for: Treatment of schizophrenia in adults. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Apr 24, 2026	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 5, 2025	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Medication Guide
Dec 17, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 17, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 20, 2019	Original applicationNew molecular entity · Standard review	Approved	Review Letter
Dec 20, 2019	Supplement 1New molecular entity · Standard review	Approved	Label Letter

Products

3 strengths and forms


CaplytaEQ 42MG BASE · capsule;oral	Lumateperone Tosylate	RxReference drug
CaplytaEQ 10.5MG BASE · capsule;oral	Lumateperone Tosylate	RxReference drug
CaplytaEQ 21MG BASE · capsule;oral	Lumateperone Tosylate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 24, 2026	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 5, 2025	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label Medication Guide
Jun 28, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 26, 2022	Supplement 9Manufacturing · Standard review	Approved	Label
Dec 17, 2021	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 17, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 20, 2019	Original applicationNew molecular entity · Standard review	Approved	Review Letter
Dec 20, 2019	Supplement 1New molecular entity · Standard review	Approved	Label Letter

Identifiers

Application: NDA 209500
Drugs@FDA: Overview at FDA
Company: Intra-Cellular Therapies

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters