Karuna

Cobenfy™ (formerly known as KarXT) now FDA approved for the treatment of schizophrenia in adults

Note: As of March 18, 2024, Karuna Therapeutics is a wholly owned subsidiary of Bristol Myers Squibb, acquired for $14 billion.

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Description

FDA approved for the treatment of schizophrenia in adults

PURETECH ECONOMIC INTEREST¹

PureTech retains rights to 2% royalty on annual Cobenfy sales above $2 billion in addition to milestone payments under its agreements with Royalty Pharma and Bristol Myers Squibb upon the achievements of certain regulatory approvals and Cobenfy sales milestones.

Stage of Development

FDA Approved

Note: Certain third-party trademarks are included here; PureTech does not claim any rights to any third-party trademarks. COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. For Important Safety Information, see U.S. Full Prescribing Information, including Patient Information on COBENFY.com. Following the acquisition of Karuna, KarXT is now under the stewardship of Bristol Myers Squibb and will be marketed as Cobenfy.
¹ Karuna Therapeutics is a wholly owned subsidiary of Bristol Myers Squibb as of March 18, 2024.
2 As of March 22, 2023, PureTech has sold its right to receive a 3% royalty from Karuna to Royalty Pharma on net sales up to $2 billion annually, after which threshold PureTech will receive 67% of the royalty payments and Royalty Pharma will receive 33%. Additionally, under its license agreement with Karuna/BMS, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.

Advancing transformative medicines for people living with psychiatric and neurological conditions

Karuna Therapeutics (Karuna) was a PureTech Founded Entity through which Cobenfy™ (xanomeline and trospium chloride; formerly known as KarXT) was invented and advanced. Cobenfy was approved by the U.S. Food and Drug Administration on September 26, 2024, for the treatment of schizophrenia in adults. It is the first new mechanism approved to treat schizophrenia in decades.

Patient Need
- Schizophrenia affects approximately 21 million people worldwide and remains a serious, chronic mental health condition that affects how a person thinks, behaves, and feels.²
- Prior to the approval of Cobenfy, the treatment landscape had seen limited innovation for decades, with available therapies predominantly targeting dopamine receptors and often constrained by suboptimal efficacy and burdensome side effects. As a result, an estimated 60–70% of patients remained inadequately managed on existing treatments. This gap highlighted a clear need for novel, non-dopaminergic approaches capable of improving outcomes for patients.
Early Development & PureTech Innovation
- Cobenfy exemplifies PureTech’s model: identifying validated pharmacology constrained by solvable limitations and applying targeted innovation to unlock its full therapeutic potential.
- PureTech identified xanomeline, a muscarinic receptor agonist previously developed by Eli Lilly, which had demonstrated compelling efficacy in both schizophrenia and Alzheimer’s disease. Despite this validated pharmacology, its development had been halted due to dose-limiting side effects, particularly related to gastrointestinal issues.
- To address this, the team at PureTech invented and patented a novel combination approach, pairing xanomeline with trospium, a peripherally restricted muscarinic antagonist that does not cross the blood-brain barrier. This design enabled selective activation of the beneficial muscarinic receptors in the brain while mitigating systemic side effects, effectively unlocking the therapeutic potential of xanomeline.
- PureTech advanced this innovation through early clinical development, including key human tolerability proof-of-concept studies, establishing the foundation for further clinical advancement by its Founded Entity, Karuna. In March of 2024, Bristol Myers Squibb announced the completion of its acquisition of Karuna for a total equity value of approximately $14 billion.
Current Developmental Status & Expected Milestones
- Under Bristol Myers Squibb, Cobenfy continues to be evaluated across additional indications, including in the Phase 3 ADEPT program for the treatment of psychosis associated with Alzheimer’s disease. For additional details and updates, please refer to Bristol Myers Squibb’s disclosures.
- PureTech continues to hold rights to receive a 2% royalty on annual Cobenfy sales above $2 billion in addition to milestone payments under its agreements with Royalty Pharma and Bristol Myers Squibb upon the achievements of certain regulatory approvals and Cobenfy sales milestones.³

¹ Certain third-party trademarks are included here; PureTech does not claim any rights to any third-party trademarks. COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. For Important Safety Information, see U.S. Full Prescribing Information, including Patient Information on COBENFY.com. Following the acquisition of Karuna, KarXT is now under the stewardship of Bristol Myers Squibb and is marketed as Cobenfy.
² Schizophrenia Resources | COBENFYTM (xanomeline and trospium chloride). (2024). Cobenfy.com. https://www.cobenfy.com/living-with-schizophrenia
³ As of March 22, 2023, PureTech has sold its right to receive a 3% royalty from Karuna to Royalty Pharma on net sales up to $2 billion annually, after which threshold PureTech will receive 67% of the royalty payments and Royalty Pharma will receive 33%. Additionally, under its license agreement with Karuna/BMS, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.

The key innovation behind the KarXT, which was invented at PureTech, was built around two validated drugs: xanomeline, a novel muscarinic agonist, and trospium, an approved muscarinic antagonist. We were able to ameliorate the GI tolerability issues of xanomeline by pairing it with a gut-restricted muscarinic antagonist to develop a novel formulation that enabled a new approach for the potential treatment of schizophrenia and other serious psychiatric and neurological conditions, an area of major unmet need. KarXT now represents a potential first-in-class and best-in-class therapy for schizophrenia.