- BXCL501, a dexmedetomidine sublingual film, is under FDA review for first-ever at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
- Acquisition adds differentiated late-stage investigational asset with potential to address a significant unmet need for patients
- Transaction supports Teva’s Pivot to Growth strategy and the company’s disciplined approach to business development
TEL AVIV, Israel, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that it has completed the acquisition of assets from BioXcel Therapeutics, Inc., including worldwide rights to BXCL501. BXCL501 is an investigational dexmedetomidine sublingual film under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, BXCL501 would be the first FDA-approved treatment patients could use at home for this condition. The acquisition expands Teva’s innovative neuroscience pipeline with a late-stage asset with the potential to address a significant unmet patient need.
“Business development plays an important role in accelerating our Pivot to Growth strategy by bringing targeted external innovation into Teva,” said Evan Lippman, Executive Vice President, Business Development at Teva. “BXCL501 is a strong strategic fit with our neuroscience portfolio and reflects our disciplined focus on differentiated, late-stage opportunities that address unmet patient needs and create long-term value for Teva’s shareholders.”
Acute agitation associated with schizophrenia or bipolar I or II disorder affects between 25% and 40%1 of patients across these conditions. Acute agitation can escalate quickly, creating significant challenges for patients, families and caregivers and, in some cases, resulting in an emergency department visit or hospitalization. Acute treatment options remain limited, particularly outside healthcare settings.
“Agitation can escalate quickly, which is why the ability to intervene early matters,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “If approved, BXCL501 could give adults living with schizophrenia or bipolar I or II disorder the ability to treat agitation at home, closer to the moment symptoms emerge and before they could become more difficult to manage.”
About the Transaction
Teva acquired the neuroscience assets of BioXcel Therapeutics, Inc. and its affiliates through a court-supervised sale process under Section 363 of the U.S. Bankruptcy Code. The assets include worldwide rights to BXCL501 and IGALMI® (dexmedetomidine), an FDA-approved dexmedetomidine sublingual film for the treatment of agitation associated with schizophrenia or bipolar I or II disorder in a hospital setting. The application for the approval of BXCL501 has been submitted as a supplemental New Drug Application (NDA) to the IGALMI® NDA. The transaction does not involve the acquisition of BioXcel Therapeutics.
The transaction closed following Teva’s selection as the successful bidder, approval by the U.S. Bankruptcy Court and satisfaction of other closing conditions.
Teva acquired the assets for $57.5 million upfront and up to $67.5 million in contingent payments. These include a range of time-based payments linked to regulatory approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones.
About dexmedetomidine sublingual film (BXCL501)
Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist. BXCL501 is a proprietary, investigational, orally dissolving film formulation currently under FDA review for potential at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
