Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial
Nicox SA announced the completion of patient treatment and follow-up in the Denali phase 3 clinical trial for NCX 470, its lead candidate for the treatment of open-angle glaucoma and ocular hypertension.
In total, 696 patients were enrolled across the United States and China. Topline results from the trial are expected between mid-August and mid-September 2025.
“Reaching the milestone of the last patient last visit in the Denali phase 3 trial is a great achievement by our clinical sites, our partner Ocumension, and the Nicox development team who have continued to drive this trial,” Doug Hubatsch, Chief Scientific Officer of Nicox, said in a company news release. “We look forward to announcing the topline results in the near future, which we expect will further consolidate the profile of NCX 470 and confirm its potential in the glaucoma market.”
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop designed to lower IOP. The Denali trial is comparing the efficacy of once-daily NCX 470 0.1% to the standard treatment latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension.
Conducted jointly by Nicox and its partner Ocumension Therapeutics—Nicox’s exclusive licensee for China, Korea, and Southeast Asia—the Denali study is one of two pivotal phase 3 trials supporting regulatory submissions for NCX 470 in both the US and China. The first, Mont Blanc, has already been completed. Additional pharmacokinetic and nonclinical studies required for the US new drug application (NDA) are also on track.
Pending successful results and the securing of a US commercial partner or adequate funding, Nicox said it anticipates submitting an NDA for NCX 470 in the first half of 2026. The company also plans to launch additional phase 3 clinical efficacy and long-term safety trials in Japan beginning in the second half of 2025.
Key Upcoming Milestones:
Topline Denali results: Expected mid-August to mid-September 2025
Phase 3 trials in Japan: Initiation expected in H2 2025
U.S. NDA submission: Targeted for H1 2026, subject to partnership or funding