Cebranopadol hemicitrate

Agreement Grants Maruishi Rights for the Development and Commercialization of Cebranopadol for Pain in Japan and South Korea, Marking Adneuris' Second Ex-U.S. Licensing Transaction Under the Terms of the Agreement, Adneuris Will Receive an Upfront Payment of $35 Million (USD), Including a U.S. Royalty Investment, Along with Substantial Development and Commercial Milestone Payments and Tiered Royalties on Net Sales Starting in the Double Digits Adneuris Anticipates Submitting a New Drug Application (NDA) for Cebranopadol to the U.S. Food and Drug Administration (FDA) Later This Year for the Treatment of Acute Pain MONMOUTH JUNCTION, N.J., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma advancing a new kind of pain medicine, today announced that it has entered into an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd. ("Maruishi"), a privately held, perioperative and pain-focused pharmaceutical company based in Osaka, Japan. This agreement grants Maruishi the rights to develop and commercialize cebranopadol, Adneuris' lead investigational therapy, for the treatment of pain in Japan and South Korea. The agreement marks Adneuris' second ex-U.S. licensing transaction, following its agreement for Greater China, and underscores the company's vision for advancing a new era in pain medicine to treat severe pain. Central to that strategy is cebranopadol, a first-in-class dual-NMR (nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors) agonist that has completed Phase 3 clinical development for moderate-to-severe acute pain and Phase 2 for multiple chronic pain indications. Adneuris plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. Under the terms of the agreement, Maruishi will pay Adneuris an upfront payment of $35 million (USD), including a $10 million U.S. royalty investment. Adneuris is also eligible to receive substantial development and commercial milestone payments, plus tiered royalties on net sales in Japan and South Korea starting in the double digits. Maruishi will hold exclusive rights to develop and commercialize cebranopadol for pain in the licensed territory. “Maruishi's deep expertise in perioperative and pain management, combined with its established commercial infrastructure across Japan, make them an ideal partner to help bring cebranopadol to patients in these important markets across the globe,” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma, the parent company of Adneuris Therapeutics. “This partnership builds on the momentum of our most recent ex-U.S. agreement and reflects the growing recognition of cebranopadol's potential to offer a new first-in-class option for patients living with pain.” "We are pleased to expand our long-standing focus on pain management through this collaboration with Adneuris," said Katsuhito Inoue, President and Representative Director, Maruishi Pharmaceutical Co., Ltd. "Cebranopadol's differentiated mechanism and clinical profile suggest the potential to become an important new option for patients living with pain, and we look forward to working with Adneuris to advance its development in Japan and South Korea." Cebranopadol was evaluated in two pivotal Phase 3 trials — ALLEVIATE-1 (following abdominoplasty) and ALLEVIATE-2 (following bunionectomy) — and overall enrolling more than 2,400 participants across its broader clinical programs. In both ALLEVIATE studies, cebranopadol demonstrated a significant reduction in pain compared with placebo over 48 hours, reduced use of opioid rescue medication, and sustained pain control, supporting its potential to deliver efficacy comparable to standard-of-care therapies, with a differentiated safety profile designed to reduce the risk of side effects associated with conventional opioid treatments, such as dependence and misuse. Aurora Partners served as an advisor to Adneuris in connection with the transaction. About Adneuris Therapeutics Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma, is dedicated to developing new therapies for people living with pain. Guided by a patient-first approach, the company is focused on advancing innovative science with the goal of improving pain management and addressing unmet patient needs. Adneuris is committed to helping shape the future of pain care through research, collaboration, and a focus on delivering meaningful treatment options. For more information, visit https://adneuris.com/. About Tris Pharma, Inc. Tris Pharma, Inc. is a privately held, innovation-driven biopharmaceutical commercial-stage company that is applying drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, and disorders of the central nervous system into advanced, targeted drug delivery. Tris markets a portfolio of best-in-class ADHD products and is developing a robust pipeline of differentiated near-term drug candidates. For more information, visit www.trispharma.com. About Cebranopadol Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual-NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). Studied in over 34 clinical trials in more than 2,400 subjects, cebranopadol's profile has been well characterized in pain management studies, demonstrating positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it has the potential to become the first dual-NMR agonist to provide robust pain relief with a reduced risk of dependence, misuse, addiction or overdose than selective MOP agonists such as oxycodone. Cebranopadol's novel mechanism of action also has potential in treating patients with substance use disorders (SUDs). The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol's potential to treat OUDs and SUDs. About Maruishi Pharmaceutical Co., Ltd. Founded in 1888 and headquartered in Osaka, Japan, Maruishi Pharmaceutical Co., Ltd. is a privately held specialty pharmaceutical company focused on the perioperative and pain management fields. Maruishi researches, develops, manufactures and markets anesthetics and perioperative drugs, as well as disinfectants, antiseptics and essential drugs, with the goal of improving the quality of life of patients undergoing medical procedures and living with pain. Maruishi has a strong presence in the Japanese market and a history of partnering with innovative biopharmaceutical companies to bring new therapies to patients across Asia. For more information, visit https://www.maruishi-pharm.co.jp/english/. Contact: Cheryl PatnickTris Pharma732-823-4940 Media Contact: Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com