Press release
September 4th, 2026
AlphaNavi Pharma Inc. (Head Office: Osaka, Japan; President and CEO: Yoshihiro Oyamada; hereinafter, the “Company”) hereby announces that, based on the worldwide “Collaboration and License Agreement” concerning certain pain drug candidates concluded with Navigate Therapeutics, Inc. (Head Office: Delaware, USA; hereinafter, “Navigate”), a U.S. biotech company specializing in the development of non-opioid pain drugs, it will undertake global clinical development.
Since entering into the agreement in 2025, the two companies have jointly advanced preparations for clinical development, and have now completed new patent filings, non-clinical pharmacology study with competitors, and the establishment of a global clinical trial plan. Going forward, they plan to advance to the next stage of clinical development while putting the necessary conditions in place.
Under this agreement, Navigate will obtain the exclusive worldwide rights to develop, manufacture, and commercialize these candidates, and will lead global development centered on the United States.
As consideration for this agreement, we have received a certain percentage of Navigate’s shares, and we also have the right to receive milestone payments of up to USD 345 million depending on the progress of future development, approval, and sales. In addition, after the product launch, AlphaNavi is eligible to receive royalties based on product sales.
In global markets including the United States, against the backdrop of the drug abuse and side effect issues associated with existing opioids (the opioid crisis), there are strong unmet medical needs to develop safe and highly effective non-opioid pain drugs.
These candidates were originally created at Sumitomo Pharma Co., Ltd. (formerly Sumitomo Dainippon Pharma Co., Ltd.), after which our company succeeded the business through a carve-out and has been advancing its research and clinical development. These candidates are novel voltage-gated sodium channel inhibitors that do not rely on opioids, and are small-molecule compounds already in the clinical stage. Aiming to improve convenience for patients and provide treatment options tailored to symptoms, we are advancing the development of transdermal formulations, including patches, in addition to oral formulations.
The Company considers it one of our important roles to connect drug discovery seeds originating in Japan to global pharmaceutical development. As part of this partnership with Navigate, the Company will not remain merely a licensor, rather as a shareholder and strategic partner of Navigate, we will support the company’s global development.
With a view to advancing future clinical development, we and Navigate will explore the potential for broad collaboration with pharmaceutical companies, CROs, CDMOs, and other business companies in areas such as strategic partnerships including capital participation, research and development, investigational drug manufacturing, technology transfer, and business development.
Our President and CEO, Yoshihiro Oyamada, stated as follows:
“This program originated from Japan’s outstanding drug discovery platform and is an important Japan-originated pipeline that we have been developing for intractable pain. By joining forces with Navigate’s U.S. team, which has a strong track record of success at the Roivant Group and elsewhere, the Company will promote global development centered on the United States, the world’s largest pharmaceutical market. To lead pharmaceutical development to success, not only funding but also a strong ecosystem for manufacturing, development, and commercialization is indispensable. The Company will broadly seek collaboration with outstanding pharmaceutical companies, CROs, and CDMOs in Japan and overseas, and establish a new global expansion model that delivers excellent Japan-originated drug discovery seeds to patients around the world.”
AlphaNavi Pharma Inc. is a drug discovery biotech start-up primarily engaged in research and development focused on the pain field. Founded in 2019, the company originated from a business carve-out from Sumitomo Pharma Co., Ltd. (formerly Dainippon Sumitomo Pharma Co., Ltd.) and received investment from venture capital firms including Kyoto University Innovation Capital and Shinsei Capital Partners.
With a focus on non-opioid pain drug candidates, the company is advancing the research and development of new treatments for intractable pain, neuropathic pain, and other conditions for which existing therapies have not provided sufficient efficacy.
Navigate Therapeutics, Inc. is a U.S. clinical-stage biotechnology company established in 2025 to globally develop and commercialize novel non-opioid voltage-gated sodium channel inhibitors. Navigate’s pipelines consist of ANP-230 (current development code: NTX-230) and ANP-390 (current development code: NTX-390), licensed from the Company. Navigate’s co-founders include members with experience in company formation, business operations, and clinical development at U.S. drug discovery ventures, including Roivant Sciences and its affiliated biotech companies.
The co-founders include the following.
Kunal Kishnani, Board of Directors. Current and previous roles include serving as Co-Founder and Senior Vice President, Corporate Development of Ambros Therapeutics, as Co-Founder and Head of Operations of Genevant Sciences, and Founder and Chief Executive Officer of Warden Bio (acquired by Kriya Therapeutics). Alex Nguyen, JD, Board of Directors. Previous roles include serving as Chief Legal Officer and Head of Operations of UNITY Biotechnology, along with several roles at Roivant Sciences and its subsidiaries. Tharak Rao, MD, Chief Medical Officer. Previous roles include serving as Chief Medical Officer and Head of Clinical Development at multiple biotech companies.
ANP-230 and ANP-390 are orally available small-molecule non-opioid pain drug candidates that target voltage-gated sodium channels (Nav) in peripheral nerves, which play important roles in the generation and transmission of pain. ANP-230 inhibits Nav1.7, Nav1.8, and Nav1.9, which are involved in pain, while ANP-390 selectively inhibits Nav1.7.
In nonclinical studies for both candidates to date, efficacy has been confirmed in multiple models of neuropathic pain, inflammatory pain, and pruritus, among others. Additionally, clinical trials are being conducted both in Japan, the United States, and the United Kingdom and based on the clinical and non-clinical data obtained to date, the Company will promote global development mainly in the United States together with Navigate.
AlphaNavi Pharma Inc.
Contact: Hirotsugu Hayashi
E-mail: h.hayashi@alphanavi.com