Kowa Initiates Phase 3 Safety Trial for Glaucoma Drug Candidate NCX 470 in Japan
Nicox announced that its exclusive Japanese partner, Kowa, has officially initiated a phase 3 safety clinical trial for NCX 470 (also referred to as K-911) in Japan. NCX 470 is Nicox’s lead clinical candidate, currently undergoing phase 3 clinical evaluations in the United States, China, and Japan. It is a nitric oxide (NO)-donating bimatoprost analog designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. The drug’s dual mechanism combines the IOP-lowering power of bimatoprost with the benefits of NO donation, potentially offering enhanced efficacy.
This milestone triggers a €2 million ($2.3 million) milestone payment to Nicox under their February 2024 licensing agreement.
The newly initiated safety trial, registered as the JRCT Safety Trial NCX 470, is one of only two trials required to support a new drug application (NDA) in Japan for the treatment of ocular hypertension. In parallel, a second 500-patient confirmatory phase 3 clinical trial, known as the JRCT Confirmatory Trial NCX 470, is set to begin shortly. Both trials are being fully funded and managed by Kowa.
“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, EVP 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 Development Milestones
Mont Blanc Trial (U.S.): Completed and results published.
Denali Trial (U.S. & China): All patients have completed the trial; topline results are expected between mid-August and mid-September 2025.
Japan Program: Now includes the ongoing safety trial and imminent start of the 500-patient confirmatory trial.
The Mont Blanc and Denali trials are designed to satisfy regulatory safety and efficacy requirements for NDAs in the US and China. Meanwhile, the separate Japanese clinical program is intended to meet local approval standards.
Strategic Global Licensing
NCX 470 is licensed to:
Kowa: For all markets outside China, Korea, and Southeast Asia.
Ocumension Therapeutics: For commercialization in China, Korea, and Southeast Asia.
Both partners are responsible for conducting and funding clinical trials in their respective territories, helping to expand the global footprint of NCX 470.