netarsudil
Trade name: Rhopressa
Approved
Dec 18, 2017
Netarsudil ophthalmic solution (Rhopressa) is a Rho kinase inhibitor for the treatment of open-angle glaucoma or ocular hypertension. As of December 18, 2017 the FDA approved Aerie Pharmaceutical's Rhopressa (netarsudil ophthalmic solution) 0.02% for the indication of reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Acting as both a rho kinase inhibitor and a norepinephrine transport inhibitor, Netarsudil is a novel glaucoma medication in that it specifically targets the conventional trabecular pathway of aqueous humour outflow to act as an inhibitor to the rho kinase and norepinephrine transporters found there as opposed to affecting protaglandin F2-alpha analog like mechanisms in the unconventional uveoscleral pathway that many other glaucoma medications demonstrate. — NCATS
Clinical trial activity
36 trials · 16 clinical orgs · 4 marketing orgs
Earliest trial started Mar 1, 2012 (NCT01528787)
Timeline
2010s
- Jan 1, 2012
Aerie Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2013
Aerie Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2014
Aerie Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Dec 18, 2017
Aerie Pharmaceuticals — Earliest FDA Approval
- Dec 18, 2017
Aerie Pharmaceuticals — NDA Secondary Org
- Dec 18, 2017
Aerie Pharmaceuticals — NDA Organization
- Dec 18, 2017
Alcon — NDA Secondary Org
- Dec 18, 2017
Nestle — NDA Secondary Org
2020s
- Jan 5, 2024
Gland Pharma Ltd — Marketing Organization
Indications
Approved for
Studied for
- Cataract · Early Phase 1
- Corneal Diseases · Phase 3
- Corneal Edema · Phase 2
- Fuchs' Endothelial Dystrophy · Phase 3
- Glaucoma · Phase 4
- Glaucoma, Open-Angle · Phase 4
- Healthy Volunteers · Phase 1
- Low Tension Glaucoma · Phase 4
- Ocular Hypertension · Phase 4
- Retinal Diseases · Phase 2/Phase 3
- Vitreoretinopathy, Proliferative · Phase 2/Phase 3
Mechanism of action
- Rho-associated protein kinaseINHIBITOR
Rho-associated protein kinase inhibitor
Combination products
rocklatan
with latanoprost
Approval history
- approvedDec 18, 2017
Chemistry & pharmacology
SMILES
Cc1ccc(C(=O)OCC2=CCC(C=C2)[C@@H](CN)C(=O)Nc3ccc4cnccc4c3)c(C)c1.CS(=O)(=O)O.CS(=O)(=O)O- Mol. weight
- 647.77 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL3545126 ↗
- WikipediaNetarsudil ↗
- NCATS4MVW7F3BCT ↗
- ChEMBLCHEMBL4594251 ↗
- ChEMBLCHEMBL4594250 ↗
- ChEMBLCHEMBL3545127 ↗
Also known as
- ar-13324
- ar-13324
- ar-13324
- netarsudil
- netarsudil
- netarsudil
- netarsudil
- netarsudil dimesylate
- pg324
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07082816 | Phase 3 | Sep 2, 2025 | Alcon |
| NCT07048886 | Phase 4 | Jul 15, 2025 | Center for Sight |
| NCT06883123 | Phase 4 | May 14, 2025 | Prairie Eye Center, Sengi |
| NCT06865144 | Phase 4 | Apr 1, 2025 | East Coast Institute for Research, Novartis |
| NCT06441643 | Phase 2 | Sep 4, 2024 | Alcon |
| NCT06394973 | Phase 2 | Aug 5, 2024 | Laboratoires Thea |
| NCT06449352 | Phase 4 | Jun 13, 2024 | Sengi, Westlake Eye Specialists |
| NCT06033703 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2023 | Harvard University |
| NCT05660447 | Phase 2/Phase 3 (Phase 3) | Dec 19, 2022 | Thomas Jefferson University |
| NCT05283395 | Phase 4 | Mar 28, 2022 | Aerie Pharmaceuticals, Alcon |
| NCT04981886 | Phase 4 | Aug 31, 2021 | Salus University |
| NCT04752020 | Early Phase 1 (Phase 1) | Mar 28, 2021 | Harvard University |
| NCT04620135 | Phase 3 | Nov 12, 2020 | Aerie Pharmaceuticals |
| NCT04498169 | Phase 2 | Sep 17, 2020 | Aerie Pharmaceuticals |
| NCT04234932 | Early Phase 1 (Phase 1) | Jan 31, 2020 | University of the Incarnate Word |
| NCT04064918 | N/A | Oct 31, 2019 | Aerie Pharmaceuticals, University of California, San Diego |
| NCT04051463 | Phase 2/Phase 3 (Phase 3) | Aug 5, 2019 | Price Vision Group |
| NCT03971357 | Phase 2/Phase 3 (Phase 3) | Jun 30, 2019 | Cornea Research Foundation of America, Price Vision Group |
| NCT03844945 | Phase 2 | Mar 19, 2019 | Aerie Pharmaceuticals |
| NCT03808688 | Phase 4 | Dec 27, 2018 | Aerie Pharmaceuticals |
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Aerie Pharmaceuticals | For profit | 20 | 19 | 5 | 2012 |
| Alcon | For profit | 3 | 2 | 3 | 2022 |
| Harvard University | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Price Vision Group | Academic/Hospital | 3 | 1 | 1 | 2017 |
| Cornea Research Foundation of America | Academic/Hospital | 2 | 2 | 1 | 2017 |
| Sengi | For profit | 2 | 0 | 1 | 2024 |
| Center for Sight | Academic/Hospital | 1 | 1 | 1 | 2025 |
| East Coast Institute for Research | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Laboratoires Thea | For profit | 1 | 1 | 1 | 2024 |
| Novartis | For profit | 1 | 0 | 1 | 2025 |
| Prairie Eye Center | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Salus University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Thomas Jefferson University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of California, San Diego | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of the Incarnate Word | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Westlake Eye Specialists | Academic/Hospital | 1 | 1 | 1 | 2024 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aerie Pharmaceuticals | For profit | NDA2 | Dec 18, 2017 |
| Aerie Pharmaceuticals | For profit | NDA | Dec 18, 2017 |
| Alcon | For profit | NDA2 | Dec 18, 2017 |
| Gland Pharma Ltd | For profit | MKTG | Jan 5, 2024 |
| Nestle | For profit | NDA2 | Dec 18, 2017 |