Kowa Initiates Phase 3 Safety Trial for NCX 470 in Japan
Kowa officially initiated a phase 3 safety clinical trial for NCX 470 (K-911), a nitric oxide-donating bimatoprost analog developed by Nicox for the treatment of open-angle glaucoma and ocular hypertension. This pivotal study marks a significant milestone for the compound’s development in Japan and triggers a €2 million ($2.3 million) milestone payment to Nicox, as outlined in the companies' licensing agreement from February 2024.
NCX 470 is currently under phase 3 evaluation across the United States, China, and Japan, representing Nicox’s most advanced clinical asset. By combining the intraocular pressure (IOP)-lowering efficacy of bimatoprost with nitric oxide (NO) donation, the dual mechanism is designed to offer superior IOP reduction compared to prostaglandin analog monotherapy.
Trial Details and Regulatory Pathway in Japan
The newly launched trial, JRCT Safety Trial NCX 470, is one of two studies required to support a New Drug Application (NDA) for regulatory approval in Japan. The second study, the 500-patient JRCT Confirmatory Trial, is expected to begin shortly. Both clinical trials are being fully managed and financed by Kowa, Nicox’s exclusive Japanese partner.
“Thanks to our continuing collaborative efforts after Kowa received approval to initiate this trial, we are very pleased to announce that the first patient has been enrolled,” said Doug Hubatsch, Executive Vice President, Scientific Officer of Nicox. “The Phase 3 trials in Japan are being managed and financed by Kowa, and only one confirmatory Phase 3 trial is expected to be needed to make a submission for marketing approval of NCX 470 in Japan.”
Global Phase 3 Program Progress
The initiation of the Japanese safety study complements ongoing international development programs. The Mont Blanc trial in the United States has been completed, with results already published. The Denali trial, conducted across the U.S. and China, has completed patient follow-up, and topline results are anticipated between mid-August and mid-September 2025. Meanwhile, the Japanese program now includes the active safety study as well as the upcoming 500-patient confirmatory trial.
The Mont Blanc and Denali studies are designed to meet regulatory standards for NDAs in the United States and China, respectively, while the Japanese studies are aligned with local regulatory requirements for approval.
Licensing Strategy and Global Expansion
NCX 470 has been strategically licensed to maximize its global reach. Kowa holds the rights for Japan and all territories outside China, Korea, and Southeast Asia, while Ocumension Therapeutics is licensed to develop and commercialize the drug in China, Korea, and Southeast Asia.
