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Nicox completes phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension
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Key Takeaways
- Nicox completed the Denali Phase 3 trial for NCX 470, targeting open-angle glaucoma and ocular hypertension.
- NCX 470 combines nitric oxide and prostaglandin analogs to lower intraocular pressure via dual pathways.
All 696 patients in the trial have completed their treatment and follow-up visits.
(Image Credit: AdobeStock/stokkete)
Nicox announced that the last patient has completed its Denali Phase 3 trial, which is evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension. The company noted that all 696 patients in the trial have completed their treatment and follow-up visits.
Doug Hubatsch, CSO of Nicox, commented on the trial in a press release from the company,1 saying, “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. We remain fully focused on completing the clinical development program and preparing for regulatory submissions.”
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that leverages the IOP-lowering effects of NO and prostaglandin analogs (PGAs) and is designed to release bimatoprost and NO into the eye to lower IOP by 2 different pathways in patients with open-angle glaucoma or ocular hypertension. NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule.2
The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfill the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the US and China. Nicox estimates submitting an NDA to the US FDA in the first half of 2026.
Topline results from the Denali trial are expected mid-August to mid-September 2025, according to the company. Additionally, NCX 470 phase 3 clinical efficacy and long-term safety trials in Japan are expected to begin in the second half of 2025.
References:
Nicox announces last patient completes the NCX 470 Denali phase 3 clinical trial. Published June 30, 2025. Accessed June 30, 2025. https://www.globenewswire.com/news-release/2025/06/30/3107141/0/en/Nicox-Announces-Last-Patient-Completes-the-NCX-470-Denali-Phase-3-Clinical-Trial.html
Portfolio and disease areas. Nicox SA. Accessed June 30, 2025. https://www.nicox.com/pipeline-markets-and-science/#product-ncx-470
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