Adneuris Therapeutics has entered into an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd., a privately held, perioperative and pain-focused pharmaceutical company based in Osaka, Japan.
This agreement grants Maruishi the rights to develop and commercialise 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 US 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 commercialise cebranopadol for pain in the licensed territory.
Cebranopadol was evaluated in two pivotal phase 3 trials, overall enrolling more than 2,400 participants across its broader clinical programs. In both 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.
