FDA Approves COBENFY How Segal Trials are Transforming Schizophrenia Treatment

SSegal Trials is proud to have played a significant role in the FDA approval of COBENFY™ (xanomeline and trospium chloride), a pioneering first-in-class muscarinic agonist developed by Bristol Myers Squibb for treating schizophrenia in adults. This landmark approval represents a crucial advancement in schizophrenia care, bringing new hope to individuals living with the disorder.

A New Era in Schizophrenia Treatment

COBENFY™ introduces a novel approach to managing schizophrenia by specifically targeting muscarinic receptors. This innovative treatment offers patients a reduction in psychotic symptoms while minimizing metabolic side effects often associated with traditional antipsychotics. This new pathway signifies a substantial improvement in treatment options, enhancing both patient outcomes and overall quality of life.

Segal Trials’ Commitment and Collaboration

Segal Trials has been involved with COBENFY™ since its early development under Karuna Therapeutics. Our partnership commenced during the initial phases of the EMERGENT program and continued after Bristol Myers Squibb acquired Karuna and advanced COBENFY™ to market. Throughout this journey, Segal Trials has provided crucial data across multiple phases, contributing significantly to the pivotal clinical trials that culminated in FDA approval. This ongoing collaboration underscores Segal Trials’ leadership in schizophrenia research, supported by over 20 years of expertise.

A Transformational Moment in Mental Health Care

Dr. Rishi Kakar, Chief Scientific Officer at Segal Trials, expressed, “The FDA’s approval of COBENFY™ is a monumental step forward in schizophrenia treatment. We are proud to have contributed to this breakthrough, which will provide patients and clinicians with a much-needed alternative in mental health care.”

Bonnie Segal, President of Segal Trials, added, “Our involvement with this innovative treatment spans many years, starting with Karuna Therapeutics when the drug was initially known as KarXT, and continuing our partnership with Bristol Myers Squibb after the acquisition and rebranding to COBENFY™. This approval highlights the strength of longstanding collaborations in clinical research, and we are honored to have been part of bringing such a transformative treatment to patients.

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