Netarsudil
Also known as Rhopressa, Netarsudil mesylate
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
NDA208259,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ALCON INC ALC Source: Company record for ALCON INC (opens in a new tab)
- Indications
- Ocular Hypertension; Open Angle Glaucoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 208259 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208259 (opens in a new tab)
- NDA 208254 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208254 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 2 Sep 20251 linked trial
- Filed Completed
- Approved Current stageFirst approval 18 Dec 2017
The evidence trail loads here.
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Netarsudil. Editors add each one with its source.
Filed application
No filed application is on record for Netarsudil. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Netarsudil.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07082816ClinicalTrials.gov record for NCT07082816 (opens in a new tab) | Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction | Phase 3 | Completed | 489 (actual) | 6 Apr 2026 (actual) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA208259Action letter for NDA208259 (opens in a new tab) | Original 1 New Combination and New Formulation or New Manufacturer | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208254Action letter for NDA208254 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Rhokiinsa (EMEA/H/C/004583)
- Authorised
- Therapeutic area
- Glaucoma, Open-Angle;Ocular Hypertension
- Marketing authorisation holder
- Santen Oy
- Active substance (INN)
- netarsudil
- ATC code
- S01EX05
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Rhokiinsa (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 208254 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07082816 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA208259 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA208254 (opens in a new tab) Licence: cc0. Fetched
Record updated .
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