FDA Events for Karuna Therapeutics (KRTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Karuna Therapeutics (KRTX).
Over the past two years, Karuna Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KarXT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KarXT (xanomeline-trospium) - FDA Regulatory Timeline and Events
KarXT (xanomeline-trospium) is a drug developed by Karuna Therapeutics for the following indication: Healthy Elderly Volunteers.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- January 17, 2025
- Indication:
- Healthy Elderly Volunteers
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
AI Summary
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted their New Drug Application for KarXT, which is being developed to treat schizophrenia in adults. This important step could bring a new treatment option to over 8 million Chinese patients who currently face challenges with available therapies. Clinical trials have shown that KarXT significantly reduces symptoms of schizophrenia while offering a safety profile that is manageable. The acceptance of the application indicates that regulators see potential in this novel treatment approach, which could help patients experience fewer side effects compared to current medications. If approved, KarXT may pave the way for a fresh and innovative method to manage schizophrenia, potentially improving the quality of life for many patients in China and possibly influencing treatment practices globally.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- September 27, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
PureTech Health plc announced that KarXT (xanomeline and trospium chloride), which was initially invented and advanced by PureTech, has received U.S. Food and Drug Administration ("FDA") approval for the treatment of schizophrenia in adults.
AI Summary
PureTech Health plc announced that its drug KarXT—a combination of xanomeline and trospium chloride—has received U.S. FDA approval for treating schizophrenia in adults. Originally invented and developed by PureTech, KarXT overcomes previous tolerability issues, paving the way for a novel approach to treating neuropsychiatric conditions. With this approval, milestone payments worth $29 million have been triggered under agreements with Royalty Pharma and Karuna Therapeutics, the latter of which was acquired by Bristol Myers Squibb in March 2024.
Marketed by Bristol Myers Squibb under the name Cobenfy, this breakthrough marks a significant advancement in addressing schizophrenia with a treatment that represents the first new drug mechanism approved for the condition in over 50 years. PureTech’s innovation in drug development continues to demonstrate its impact on both clinical outcomes and future financial growth.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- April 6, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
Bristol Myers Squibb announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
AI Summary
Bristol Myers Squibb recently shared promising interim results from the Phase 3 EMERGENT-4 trial. This open-label extension study evaluated KarXT (xanomeline-trospium) in adults with schizophrenia over 52 weeks, focusing on long-term safety, tolerability, and efficacy. The trial showed a steady improvement in schizophrenia symptoms, with over 75% of participants experiencing more than a 30% symptom reduction on the PANSS scale at one year. Patients who switched from placebo in earlier trials began to see significant improvements as early as the second week after starting KarXT, and these gains were maintained throughout treatment. Additionally, improvements were also observed on the Clinical Global Impression-Severity scale. These findings support KarXT as a promising long-term treatment option for managing schizophrenia and add to the growing data from the EMERGENT program.
Read Announcement
Karuna Therapeutics FDA Events - Frequently Asked Questions
Yes, Karuna Therapeutics (KRTX) has received FDA approval for KarXT (xanomeline-trospium). This page tracks recent and historical FDA regulatory events related to Karuna Therapeutics' drug portfolio.
In the past two years, Karuna Therapeutics (KRTX) has reported FDA regulatory activity for KarXT (xanomeline-trospium).
The most recent FDA-related event for Karuna Therapeutics occurred on January 17, 2025, involving KarXT (xanomeline-trospium). The update was categorized as "Provided Update," with the company reporting: "Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults."
Currently, Karuna Therapeutics has one therapy (KarXT (xanomeline-trospium)) targeting the following condition: Healthy Elderly Volunteers.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:KRTX) was last updated on 7/12/2025 by MarketBeat.com Staff
