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Adneuris licenses cebranopadol to Maruishi in second ex-US deal within four weeks

Adneuris licenses cebranopadol to Maruishi in second ex-US deal within four weeks

Adneuris Therapeutics has granted Japan-based Maruishi Pharmaceutical Co., Ltd. an exclusive license to develop and commercialize cebranopadol, a first-in-class dual nociceptin/orphanin FQ peptide (NOP) and mu-opioid peptide (MOP) receptor agonist, for pain in Japan and South Korea. The agreement marks the second ex-US territorial licensing deal Adneuris has signed in less than four weeks.

Under the terms of the agreement, Maruishi will pay Adneuris an upfront payment of USD 35 million, including a USD 10 million US royalty investment. Adneuris is also eligible to receive development and commercial milestone payments, as well as tiered royalties on net sales in the licensed territories beginning in the double digits.

Adneuris, a Monmouth Junction, New Jersey-based wholly owned subsidiary of Tris Pharma, launched on July 9, 2026 to advance cebranopadol toward a US FDA new drug application (NDA), which the company said it plans to submit later this year.

Cebranopadol has completed two pivotal Phase III trials: ALLEVIATE-1 in patients undergoing abdominoplasty and ALLEVIATE-2 in patients undergoing bunionectomy. Across its broader clinical development program, the candidate has been evaluated in more than 2,400 participants. In both pivotal studies, cebranopadol demonstrated statistically significant reductions in pain versus placebo over 48 hours, reduced use of opioid rescue medication, and sustained pain control, according to the company. The US FDA has also granted Fast Track Designation to cebranopadol for chronic low back pain.

The Maruishi agreement follows Adneuris' first ex-US licensing transaction, signed with Zhejiang Conba Pharmaceutical on July 14 for Greater China. That deal included a USD 17.5 million upfront payment, more than USD 100 million in potential development and commercial milestone payments, and tiered royalties beginning in the double digits.

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Maruishi is a specialty pharmaceutical company focused on perioperative care and pain management. The company holds exclusive rights in Japan to Allay Therapeutics' ATX-101, a bupivacaine-based implantable analgesic, under a December 2023 agreement that included both an upfront payment and an equity investment in Allay.

According to Adneuris, cebranopadol's dual NOP/MOP mechanism is designed to provide effective analgesia while reducing the risk of dependence, misuse, addiction, and overdose compared with selective MOP agonists such as oxycodone. If approved, it would become the first dual NOP/MOP agonist available globally.

Separately, the US National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris Pharma a five-year grant worth up to USD 16.6 million to study cebranopadol's potential as a treatment for opioid use disorder (OUD) and other substance use disorders (SUDs).


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