Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 10 drugs with upcoming expirations

Activity

Recent Activity

Last 14 days

Jul 8, 2026

Recruiting

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

Jul 7, 2026

Recruiting

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Earlier

Jun 24, 2026TrialA Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Jun 24, 2026TrialA Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Jun 24, 2026TrialA Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia

Dec 5, 2023FDASprycel — PHYRAGO

Nov 15, 2023FDAAugtyro — AUGTYRO

Dec 12, 2022FDAKrazati — KRAZATI

2 more events

Sep 9, 2022FDASotyktu — SOTYKTU

Apr 28, 2022FDACamzyos — CAMZYOS

Details

Company Info

Company Overview

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Regulatory

Regulatory Timeline

20021 event

FDADec 31

Zerit — ZERIT XR

Application NDA021453 (NDA)

20031 event

FDAJun 20

Reyataz — REYATAZ

Application NDA021567 (NDA)

20041 event

FDAMay 19

Vidaza — VIDAZA

Application NDA050794 (NDA)

20053 events

FDAJul 5

Megace — MEGACE ES

Application NDA021778 (NDA)

FDAMar 29

Baraclude — BARACLUDE

Application NDA021797 (NDA)

FDAMar 29

Baraclude — BARACLUDE

Application NDA021798 (NDA)

20061 event

FDAJun 28

Sprycel — SPRYCEL

Application NDA021986 (NDA)

20101 event

FDAFeb 22

Azactam — CAYSTON

Application NDA050814 (NDA)

20111 event

FDADec 21

Revlimid — REVLIMID

Application NDA021880 (NDA)

20131 event

FDAFeb 8

Pomalyst — POMALYST

Application NDA204026 (NDA)

20141 event

FDAJun 2

Reyataz — REYATAZ

Application NDA206352 (NDA)

20161 event

FDAApr 29

Vidaza — AZACITIDINE

Application NDA208216 (NDA)

20171 event

FDAAug 1

Idhifa — IDHIFA

Application NDA209606 (NDA)

20202 events

FDASep 1

Vidaza — ONUREG

Application NDA214120 (NDA)

FDAMar 25

Zeposia — ZEPOSIA

Application NDA209899 (NDA)

20223 events

FDADec 12

Krazati — KRAZATI

Application NDA216340 (NDA)

FDASep 9

Sotyktu — SOTYKTU

Application NDA214958 (NDA)

FDAApr 28

Camzyos — CAMZYOS

Application NDA214998 (NDA)

20232 events

FDADec 5

Sprycel — PHYRAGO

Application NDA216099 (NDA)

FDANov 15

Augtyro — AUGTYRO

Application NDA218213 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)