Otsuka to Terminate Development of AVP-786

Tokyo and Princeton, N.J. – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announce termination of development of the novel compound AVP-786, which was in development as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. Otsuka initiated Phase 3 clinical trials for AVP-786. In the top-line results of the Phase 3 trial NCT03393520 (#305 trial) that Otsuka announced in February this year, no statistically significant difference was observed between AVP-786 and placebo in the primary endpoint—average change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score. After a detailed analysis of results from the completed trial, Otsuka and OPDC have decided to terminate the development of this drug candidate. As a leading company in the central nervous system field, Otsuka will continue research and development efforts to meet unresolved medical needs and will continue to focus on addressing agitation associated with Alzheimer's disease. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/. Contacts Otsuka in the U.S. Robert Murphy Corporate Communications Otsuka America Pharmaceutical, Inc. [email protected] +1 609 249 7262 Otsuka outside the U.S. Jeffrey Gilbert Leader, Pharmaceutical PR Otsuka Pharmaceutical Co., Ltd. [email protected] News Keywords CNS Contacts for media Otsuka in Japan Jeffrey Gilbert (Outside the US)Leader, Pharmaceutical PR Otsuka Pharmaceutical, Co., Ltd. [email protected] Phone: +81 3 6361 7379 Otsuka in the US Jill RomanDirector, External Communications,Otsuka America Pharmaceutical, Inc. [email protected] Phone: +1 (609) 524-6788 Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults Next article We defy limitation, so that others can too. Follow us LinkedIn Facebook X Instagram Threads YouTube Footer Links California Supply Chains Act Returned Goods Authorized Distributor of Record Terms and Conditions OAPI and OPDC Privacy Policy Anthem Transparency in Coverage OAPI and OPDC Locations 508 Carnegie Center Dr,Princeton, NJ 08540, United States Phone 609-524-6788 2440 Research Blvd,Rockville, MD 20850, United States Phone 301-424-9055 3956 Point Eden WayHayward, CA 94545, United States Phone 800-562-3974 © 2025 Otsuka America Pharmaceutical, Inc All rights reserved. June 2024 01US24EXC0009 Otsuka's affiliated companies around the world work with a shared commitment to contribute to better health worldwide. Otsuka Global Site Japan Asia, The Middle East& Oceania Australia China Egypt Indonesia Pakistan Philippines South Korea Taiwan Thailand Vietnam North &South America Brazil Canada US Europe EU Denmark Finland France Germany Italy Norway Spain Sweden Switzerland UK Search

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