Drugs / Netarsudil
Netarsudil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rhokiinsa | — | 2019-11-19 | europa.eu ↗ |
| Approved | US (FDA) | RHOPRESSA | — | 2017-12-18 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04752020 | Mar 2021 → Jun 2023 | Fuchs' endothelial dystrophy | Massachusetts Eye and Ear Infirmary | Completed | No outcome recorded |
| Phase 0 | NCT04234932 | Jan 2020 → Jan 2021 | open-angle glaucoma | University of the Incarnate Word | Unknown | No outcome recorded |
| Phase 0 | NCT04057053 | Oct 2018 → Dec 2020 | Fuchs' endothelial dystrophy, cataract | Massachusetts Eye and Ear Infirmary | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02406287 | Apr 2015 → Apr 2016 | — | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01997879 | Nov 2013 | — | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06033703 | Jan 2025 → Sep 2026 overdue | proliferative vitreoretinopathy, rhegmatogenous retinal detachment | Massachusetts Eye and Ear Infirmary | Recruiting | No outcome recorded |
| Phase 28 trials · 4 met primary | ||||||
| Phase 2 | NCT04498169 | Sep 2020 → Aug 2021 | corneal edema | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03844945 | Mar → Sep 2019 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03310580 | Nov 2017 → Oct 2018 | open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03233308 | Oct 2017 → Apr 2018 | open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02874846 | Jul → Sep 2016 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02057575 | Jan → Jun 2014 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01731002 | Nov 2012 → May 2013 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01528787 | Mar → Jul 2012 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06960629 | May 2025 → Apr 2026 | bullous keratopathy, glaucoma | University Hospital Dubrava | Completed | No outcome recorded |
| Phase 2/3 | NCT05660447 | Feb 2023 → Dec 2024 overdue | proliferative vitreoretinopathy, rhegmatogenous retinal detachment | Wills Eye | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03971357 | Jul 2019 → Aug 2021 | Fuchs' endothelial dystrophy | Price Vision Group | Terminated | No outcome recorded |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04620135 | Nov 2020 → Jul 2021 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03284853 | Sep 2017 → Nov 2020 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03248037 | Sep 2017 → Jul 2019 | Fuchs' endothelial dystrophy, bullous keratopathy | Cornea Research Foundation of America | Completed | Missed primary |
| Phase 3 | NCT02558374 | Sep 2015 → Dec 2016 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02246764 | Sep 2014 → Dec 2016 | glaucoma, ocular hypertension | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02207621 | Jul 2014 → Mar 2016 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02207491 | Jul 2014 → Mar 2015 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07847073 | Oct 2026 → Jan 2028 expected | open-angle glaucoma | Brett King | Recruiting | No outcome recorded |
| Phase 4 | NCT04401982 | Jul 2026 → Mar 2027 expected | borderline glaucoma, ocular hypertension | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 4 | NCT07465913 | May 2026 → May 2027 expected | glaucoma | Eye Centers of Southeast Texas | Recruiting | No outcome recorded |
| Phase 4 | NCT06865144 | Jun 2025 → Jul 2026 overdue | open-angle glaucoma | East Coast Institute for Research | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06883123 | May 2025 → Apr 2026 overdue | open-angle glaucoma | Prairie Eye Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06449352 | Jun 2024 → Sep 2025 | low tension glaucoma | Westlake Eye Specialists | Completed | No outcome recorded |
| Phase 4 | NCT04981886 | Aug 2021 → Jul 2022 | low tension glaucoma | Salus University | Unknown | No outcome recorded |
| Phase 4 | NCT03808688 | Dec 2018 → Jul 2019 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT06441643 Comparator | Sep 2024 → Nov 2025 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase 2 | NCT06394973 Comparator | Aug → Nov 2024 | glaucoma, ocular hypertension | Laboratoires Thea | Completed | Missed primary |
| Phase 2/3 | NCT04051463 Comparator | Aug 2019 → Jul 2020 | Fuchs' endothelial dystrophy | Price Vision Group | Completed | No outcome recorded |
| Phase 3 | NCT02674854 Comparator | Feb 2016 → Mar 2017 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02558400 Comparator | Sep 2015 → May 2017 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT07588152 Comparator | Jun 2026 → Jun 2028 expected | glaucoma, ocular hypertension | Indiana University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-06-19 | Santen Gmbh | Regulatory Santen Obtains Manufacturing and Marketing Approval in Japan for Rhopressa® Ophthalmic Solution 0.02%, a Treatment for Glaucoma and Ocular Hypertension santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has obtained manufacturing and marketing approval in Japan for Rhopressa® Ophthalmic Solution 0.02% (generic name: netarsudil mesylate; development code: STN1013900; hereinafter the product), a treatment for glaucoma and ocular hypertension. |
| 2025-07-30 | Santen Gmbh | Regulatory Santen Applies for Manufacturing and Marketing Approval in Japan for STN1013900 (netarsudil mesylate), Treatment for Glaucoma and Ocular Hypertension santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application in Japan for manufacturing and marketing approval of STN1013900 (generic name: netarsudil mesylate) for the treatment of glaucoma and ocular hypertension. |
| 2021-10-21 | Skye Bioscience, Inc. | Results Skye Bioscience Sponsored Research Presented at American Association of Pharmaceutical Scientists Meeting PharmSci 360 skyebioscience.com ↗
Both THC-VHS-NEC and netarsudil formulations performed better than latanoprost in terms of average max drop (p<0.05) in IOP as well as duration of activity (p<0.05). |
| 2021-05-17 | Skye Bioscience, Inc. | Results Skye Bioscience’s THCVHS Demonstrates Superior Therapeutic Benefit Compared to Glaucoma Standard of Care, both as Combination and Single Agent, in Preclinical Study skyebioscience.com ↗
THCVHS combined with netarsudil (Rhopressa®) achieves an average maximum intraocular pressure (IOP) reduction of 32.4% and maintains an average IOP reduction of 26.5% at 9 hours, significantly better than any single drug or combination tested |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Netarsudil | “The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active...” NCT02246764 ↗31“Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension” NCT02207621 ↗ “Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%)” NCT06394973 ↗ “Netarsudil (AR-13324) Ophthalmic Solution 0.02%” NCT02057575 ↗ “netarsudil and latanoprost 0.02%/0.005%” NCT07465913 ↗ “netarsudil and latanoprost” NCT06883123 ↗ |
| Known as | AR-11324 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | AR-13324 | “A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With...” NCT03233308 ↗12“Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension” NCT02207621 ↗ “Netarsudil (AR-13324) Ophthalmic Solution 0.02%” NCT02057575 ↗ “Netarsudil (AR-13324) ophthalmic solution 0.02%” NCT02674854 ↗ “Netarsudil (AR-13324) Ophthalmic Solution 0.02%” NCT02558400 ↗ “Netarsudil (AR-13324) Ophthalmic Solution” NCT02406287 ↗ |
| Known as | NETARSUDIL DIMESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | Netarsudil dimesylate component of rocklatan | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | Netarsudil mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | Netarsudil mesylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | Netarsudil Ophthalmic | “Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution” NCT04498169 ↗ |
| Known as | Rhokiinsa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594250 ↗ |
| Known as | Rhopressa | “Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)” NCT04234932 ↗4“netarsudil (Rhopressa; Aerie Pharmaceuticals Inc, Durham, NC) 0.02%” PMID 33250082 ↗ Apr 2020 “Rhopressa® Ophthalmic Solution (Preserved Netarsudil 0.02%)” NCT06394973 ↗ “Topical sterile ophthalmic solution Other Name: Rhopressa®” NCT04620135 ↗ “Netarsudil Ophthalmic Solution (Rhopressa)” NCT07588152 ↗ |
| Action | Inhibit | “Netarsudil, a novel Rho kinase inhibitor” PMID 32166538 ↗ Mar 2020 |
| Modality | Small molecule | — CHEMBL4594250 ↗ |
| Route | Other | “Eyedrop” NCT01997879 ↗ |