NCX 470 advances toward US, China NDA submissions for NCX 470

Nicox has announced it has acquired and analyzed all key data required to support the submission of New Drug Applications (NDAs) in the US and China for NCX 470.¹

NCX 470 is Nicox’s lead clinical product candidate and 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

Doug Hubatsch, EVP and chief scientific officer of Nicox, commented in a press release, saying, “We have achieved this milestone through close collaboration of our committed and dedicated team with our clinical and manufacturing partners and specialist research organizations. […] Focus for the development team is now on accompanying our licensing partner for the US, Kowa, with preparation for our upcoming meeting with the Food and Drug Administration and subsequent submission of the New Drug Application.”

Kowa and Nicox entered into an agreement in July 2025 in which Kowa received exclusive rights to develop and commercialize NCX 470 in the US and all other territories of the world excluding Japan, China, Korea, and Southeast Asia. Additionally, Kowa has rights in Japan, where the company initiated a phase 3 safety clinical trial of NCX 470 for the treatment of ocular hypertension. The trial is expected to enroll 500 patients with POAG, and the primary outcome is changes from baseline in intraocular pressure at weeks 2, 4, and 6.³

NCX 470 is currently licensed to Ocumension Therapeutics for China, Korea, and Southeast Asia.

According to Nicox, projected submission of the NDA to the FDA is expected in the first half of 2026, with NDA submission in China following shortly after.

In August 2025, Nicox announced the phase 3 Denali trial of NCX 470 0.1% met the primary endpoint of non-inferiority in lowering IOP from baseline in open-angle glaucoma or ocular hypertension patients compared to the standard of care, latanoprost 0.005%.⁴

The trial was a randomized, multi-regional, double-masked, parallel-group trial that evaluated the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, compared to latanoprost ophthalmic solution, 0.005%, in 696 patients in 90 sites in the US and China. It completed treatment and follow-up visits in June 2025.

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.

References:

1. Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026. Published December 16, 2025. Accessed December 16, 2025. http://nicox.com/wp-content/uploads/EN_NCX470NDADataGenerationDecember2025_FINAL.pdf

2. Portfolio and disease areas. Nicox SA. Accessed December 16, 2025. https://www.nicox.com/pipeline-markets-and-science/#product-ncx-470

3. Japan Registry of Clinical Trials. jRCT2051250050. Accessed December 16, 2025. https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051250050

4. Harp MD. Nicox releases topline data from phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension patients. Published August 21, 2025. Accessed December 16, 2025. https://www.ophthalmologytimes.com/view/nicox-releases-topline-data-from-phase-3-denali-trial-of-ncx-470-in-open-angle-glaucoma-or-ocular-hypertension-patients