Adneuris Therapeutics grants Maruishi Pharmaceutical exclusive license to develop cebranopadol in Japan and South Korea

Agreement gives Maruishi rights to develop and commercialize cebranopadol for pain in Japan and South Korea, marking Adneuris’ second licensing deal outside the U.S.

Under the terms of the agreement, Adneuris will receive an upfront payment of $35 million, 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 expects to submit a New Drug Application for cebranopadol to the U.S. Food and Drug Administration later this year for the treatment of acute pain

Adneuris Therapeutics, a wholly owned subsidiary of Tris Pharma focused on developing a new category of pain medicine, announced it has signed an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd., a privately held pharmaceutical company based in Osaka, Japan that specializes in perioperative and pain related treatments. Under the agreement, Maruishi gains the rights to develop and commercialize cebranopadol, Adneuris’ lead investigational therapy, for pain treatment in Japan and South Korea.

This is Adneuris’ second licensing deal outside the United States, following an earlier agreement covering Greater China, and reflects the company’s broader strategy of advancing a new generation of medicines for severe pain. At the center of that strategy is cebranopadol, a first in class dual receptor agonist that acts on both the nociceptin/orphanin FQ peptide (NOP) and mu opioid peptide (MOP) receptors. The therapy has completed Phase 3 development for moderate to severe acute pain and Phase 2 development across several chronic pain indications, and Adneuris plans to file a New Drug Application with the FDA later this year.

Under the agreement’s terms, Maruishi will pay Adneuris an upfront sum of $35 million, which includes a $10 million U.S. royalty investment. Adneuris also stands to receive substantial development and commercial milestone payments, along with tiered royalties on net sales in Japan and South Korea that start in the double digits. Maruishi will hold exclusive rights to develop and commercialize cebranopadol for pain within the licensed territory.

Ketan Mehta, founder and chief executive officer of Tris Pharma, the parent company of Adneuris Therapeutics, said Maruishi’s deep expertise in perioperative and pain management, paired with its well established commercial presence across Japan, makes it an ideal partner for bringing cebranopadol to patients in these important markets. He said the partnership builds on the momentum from Adneuris’ most recent licensing agreement outside the U.S. and reflects growing recognition of cebranopadol’s potential as a new first in class option for people living with pain.

Katsuhito Inoue, president and representative director of Maruishi Pharmaceutical Co., Ltd., said the company is pleased to expand its long standing focus on pain management through this collaboration with Adneuris. He said cebranopadol’s distinct mechanism and clinical profile suggest it could become an important new option for pain patients, and that Maruishi is looking forward to working with Adneuris to advance its development in Japan and South Korea.

Cebranopadol was studied in two pivotal Phase 3 trials, ALLEVIATE-1, conducted following abdominoplasty, and ALLEVIATE-2, conducted following bunionectomy, with more than 2,400 participants enrolled across the therapy’s broader clinical development program. Across both ALLEVIATE studies, cebranopadol showed a significant reduction in pain compared with placebo over a 48 hour period, along with reduced use of opioid rescue medication and sustained pain control. These results support the therapy’s potential to deliver efficacy comparable to existing standard of care treatments, while offering a distinct safety profile intended to lower the risk of side effects commonly associated with conventional opioid therapy, such as dependence and misuse.

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Adneuris Therapeutics, cebranopadol, Maruishi Pharmaceutical