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 11 drugs with upcoming expirations

Activity

Recent Activity

Last 14 days

Oct 31, 2026

Recruiting

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

Oct 28, 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

Earlier

Oct 17, 2026TrialA 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

Oct 17, 2026TrialOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Oct 16, 2026TrialA Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers

Oct 16, 2026TrialA Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders

Oct 14, 2026TrialA Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

Aug 18, 2026TrialA Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

4 more events

Aug 18, 2026FDABaraclude — BARACLUDE

Aug 13, 2026FDAAzatiq — ZENBEXUS

Aug 1, 2026TrialAn Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Details

Company Info

Regulatory

Regulatory Timeline

20249 events

FDADec 18

Idhifa — IDHIFA

Application NDA209606

FDADec 5

Reyataz — REYATAZ

Application NDA206352

FDADec 5

Reyataz — REYATAZ

Application NDA021567

FDAAug 30

Zeposia — ZEPOSIA

Application NDA209899

FDAAug 30

Zeposia — ZEPOSIA

Application NDA209899

FDAJul 31

Sprycel — SPRYCEL

Application NDA021986

FDAJun 28

Vidaza — VIDAZA

Application NDA050794

FDAJun 21

Krazati — KRAZATI

Application NDA216340

FDAJun 5

Zeposia — ZEPOSIA

Application NDA209899

20253 events

FDAOct 27

Sotyktu — SOTYKTU

Application NDA214958

FDAApr 17

Camzyos — CAMZYOS

Application NDA214998

FDAJan 16

Idhifa — IDHIFA

Application NDA209606

20268 events

FDAAug 18

Baraclude — BARACLUDE

Application NDA021798

FDAAug 18

Baraclude — BARACLUDE

Application NDA021797

FDAAug 13

Azatiq — ZENBEXUS

Application NDA221075 (NDA)

FDAJul 22

Revlimid — REVLIMID

Application NDA021880

FDAJun 30

Sotyktu — SOTYKTU

Application NDA214958

FDAApr 27

Revlimid — REVLIMID

Application NDA021880

FDAMar 25

Krazati — KRAZATI

Application NDA216340

FDAMar 6

Sotyktu — SOTYKTU

Application NDA214958

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