Drugs / NCX 470
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | open-angle glaucoma | 2026-08-10 | “Ocumension has submitted the New Drug Application (NDA) to the Chinese National Medical Products Administration (NMPA) for NCX 470” nicox.com ↗ “Nicox had previously announced the submission of the NCX 470 NDA in China” nicox.com ↗ |
| Filed | US (FDA) | — | open-angle glaucoma | 2026-06-30 | “The NCX 470 NDA in the U.S. was submitted by Nicox’s exclusive U.S. licensee, Kowa, on June 30, 2026” nicox.com ↗ “today announced the submission of an NDA to the FDA for NCX 470 (also known as K-911)” nicox.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03657797 | Aug 2018 → Aug 2019 | ocular hypertension, open-angle glaucoma | Nicox Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT04630808 | Nov 2020 → Apr 2025 | ocular hypertension, open-angle glaucoma | Nicox Ophthalmics, Inc. | Completed | Met primary |
| Phase 3 | NCT04445519 | Jun 2020 → Sep 2022 | ocular hypertension, open-angle glaucoma | Nicox Ophthalmics, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT05938699 Comparator | Dec 2023 → Mar 2025 | open-angle glaucoma | Nicox Ophthalmics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | NicOx Inc. | Regulatory Nicox Announces NCX 470 NDA in China Accepted for Review nicox.com ↗
This acceptance initiates the review of the NDA by the NMPA. |
| 2026-08-27 | NicOx Inc. | Regulatory Nicox Announces April 2027 PDUFA Date for NCX 470 in Glaucoma nicox.com ↗
FDA acceptance confirms that the application is sufficiently complete for formal review and represents an important regulatory milestone toward potential approval. |
| 2026-08-10 | NicOx Inc. | Regulatory Nicox Announces NCX 470 NDA Submission in China by Partner Ocumension nicox.com ↗
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted the New Drug Application (NDA) for NCX 470 as a treatment to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). |
| 2026-07-01 | NicOx Inc. | Regulatory Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone Payment nicox.com ↗
NCX 470 New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) by exclusive licensee Kowa Company, Ltd. (Kowa) for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
| 2026-06-18 | NicOx Inc. | Regulatory Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470 nicox.com ↗
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive licensee in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation for NCX 470. |
| 2026-02-24 | NicOx Inc. | Results Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting nicox.com ↗ |
| 2025-10-02 | NicOx Inc. | Results Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations nicox.com ↗
NCX 470 maintained robust IOP reduction during this period with no additional safety signals seen. |
| 2025-08-21 | NicOx Inc. | Results Nicox Announces Positive Results from the NCX 470 Phase 3 Denali Trial in Glaucoma Patients nicox.com ↗
Achieving the primary endpoint in both Denali and the first NCX 470 Phase 3 trial, Mont Blanc, meets efficacy requirements for approval in the U.S. and China |
| 2025-05-27 | NicOx Inc. | Regulatory Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan nicox.com ↗
Exclusive Japanese partner Kowa has received regulatory approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan |
| 2025-05-14 | NicOx Inc. | Results Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial nicox.com ↗
IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend. |
| 2025-03-03 | NicOx Inc. | Results Nicox Presents New Analysis from the NCX 470 Mont Blanc Trial and Provides Development Update nicox.com ↗
In this analysis, we demonstrated that more patients achieve intraocular pressure of less than or equal to 18 mmHg on NCX 470 than on latanoprost. |
| 2024-11-19 | NicOx Inc. | Results Nicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont Blanc Phase 3 Trial nicox.com ↗ |
| 2024-03-20 | NicOx Inc. | Results Results from Mont Blanc Phase 3 Trial of Nicox’s NCX 470 in Glaucoma Published in the American Journal of Ophthalmology nicox.com ↗
NCX 470 could become an important first- line therapy for IOP reduction in glaucoma. |
| 2024-03-05 | NicOx Inc. | Results Nicox Announces Presentation of Data on NCX 470 at the 2024 American Glaucoma Society Annual Meeting nicox.com ↗
Furthermore, NCX 470 provided consistent IOP reduction across the spectrum of baseline IOPs while latanoprost IOP reduction was baseline IOP-dependent. |
| 2023-12-14 | NicOx Inc. | Results Nicox’s Announces Publication of New Nonclinical Data Demonstrating More Effective Intraocular Pressure Lowering of NCX 470 compared to Lumigan nicox.com ↗
The publication “ NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non -Human Primates and Human Trabecular Meshwork/Schlemm’s Canal Constructs” by Galli et al. is available by clicking here. |
| 2023-07-03 | NicOx Inc. | Results Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress nicox.com ↗
NCX 470 0.1% showed up to 1.73mmHg greater mean diurnal intraocular pressure ( IOP) reduction from baseline than latanoprost in the adaptive dose selection period of the Phase 3 Mont Blanc trial |
| 2023-04-26 | NicOx Inc. | Results New Data on Two Nicox’s Assets, NCX 470 and NCX 1728, Presented at ARVO 2023 nicox.com ↗
This work shows compelling new evidence of retinal cell protective activity with NCX 470 in addition to its IOP lowering ability. |
| 2023-03-03 | NicOx Inc. | Results Nicox to Present at Upcoming Scientific Conferences nicox.com ↗
NCX 470, a Nitric Oxide Donating Bimatoprost, Demonstrates Non-inferiority to Latanoprost in Phase 3 Mont Blanc Clinical Trial |
| 2022-10-31 | NicOx Inc. | Results Nicox Reports Achieving Primary Objective in Mont Blanc, the First Phase 3 Glaucoma Trial for NCX 470 nicox.com ↗
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that once daily dosing of NCX 470 0.1% met the primary objective of non-inferiority in lowering intraocular pressure (IOP) compared to the standard of care, latanoprost 0.005%, in the 691-patient Mont Blanc Phase 3 clinical trial in patients with open-angle glaucoma or ocular hypertension. |
| 2022-07-07 | NicOx Inc. | Results Nicox Announces Publication of NCX 470 Results Demonstrating Improvements to Ocular Hemodynamics and Retinal Cell Physiology nicox.com ↗
The publication “ NCX 470 restores ocular hemodynamic s and retinal cell physiology after ET -1-induced ischemia/reperfusion injury of optic nerve and retina in rabbits” by Bastia et al. is available by clicking here. |
| 2022-04-11 | NicOx Inc. | Results Nicox’s NCX 470 Dolomites Phase 2 Results Published in Journal of Glaucoma nicox.com ↗ |
| 2021-09-29 | NicOx Inc. | Results Nicox’s NCX 470 Shows Retinal Cell Protection in a Nonclinical Model nicox.com ↗
The results suggest that NCX 470 improves ocular perfusion and retinal function in damaged eyes compared to vehicle and therefore may have therapeutic properties over and above lowering of IOP. |
All press releases naming this drug 47 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NCX 470 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04630808 ↗ |
| Known as | bimatoprost | “A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study.” PMID 39477206 ↗ Oct 2024 |
| Route | Topical | “dosed topically to both eyes once daily” PMID 39477206 ↗ Oct 2024 |