Drugs / Phentolamine

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed presbyopia 2 milestones
Filed US (FDA) — presbyopia 2026-02-25

“FDA has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia.” viatris.com ↗

“The FDA accepted the Company’s supplemental New Drug Application (sNDA) for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia” opusgtx.com ↗

“accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.” opusgtx.com ↗

Filed US (FDA) — presbyopia 2026-01-08

“Phentolamine Ophthalmic Solution 0.75% (PS) Supplemental New Drug Application (sNDA) submitted for the treatment of presbyopia” opusgtx.com ↗

Approved Indication not stated 3 milestones
Filed US (FDA) Nyxol pharmacologically-induced mydriasis 2022-12-06

“submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Phentolamine Ophthalmic Solution 0.75% (Nyxol ® )” opusgtx.com ↗

“Nyxol’s NDA under the 505(b)(2) pathway for the first indication, RM, has been accepted” opusgtx.com ↗

Label expansion US (FDA) ORAVERSE — 2016-03-18 fda.gov ↗
Approved US (FDA) REGITINE — 1952-01-30 fda.gov ↗

Trials 34

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT06787066 Jul 2025 → Dec 2026 expected — University of Missouri-Columbia Recruiting No outcome recorded
Phase 0 NCT05219799 Mar 2023 → Jun 2026 overdue isoproterenol-mediated vasodilatation, obesity disorder University of Missouri-Columbia Recruiting No outcome recorded
Phase 0 NCT06172998 Apr 2022 → Apr 2024 obstructive sleep apnea syndrome Xu J Unknown No outcome recorded
Phase 0 NCT04436731 Dec 2020 → Jun 2026 overdue obesity disorder University of Missouri-Columbia Active not recruiting No outcome recorded
Phase 0 NCT04110808 Oct 2019 → Jan 2020 — Beni-Suef University Unknown No outcome recorded
Phase 13 trials
Phase 1 NCT03318094 Oct 2017 → Nov 2026 expected obesity disorder Vanderbilt University Medical Center Active not recruiting No outcome recorded
Phase 1 NCT03098680 Apr 2017 → Feb 2020 cardiovascular disorder Cambridge University Hospitals NHS Foundation Trust Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02966665 Sep 2008 → Aug 2030 expected chronic obstructive pulmonary disease, heart failure, pulmonary arterial hypertension D. Walter Wray Recruiting No outcome recorded
Phase 27 trials · 2 met primary · 1 missed
Phase 2 NCT04675151 Feb → May 2021 presbyopia Ocuphire Pharma, Inc. Completed Met primary
Phase 2 NCT04024891 Aug → Sep 2019 — Ocuphire Pharma, Inc. Completed Met primary
Phase 2 NCT03960866 May → Sep 2019 ocular hypertension, open-angle glaucoma Ocuphire Pharma, Inc. Completed Missed primary
Phase 2 NCT01703559 Sep 2011 → Apr 2012 acquired night blindness Opus Genetics, Inc Completed No outcome recorded
Phase 2 NCT04004507 Aug → Oct 2007 night blindness Ocuphire Pharma, Inc. Completed No outcome recorded
Phase 2 NCT00309322 Mar → Aug 2006 — Novalar Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT00154167 Feb → Jun 2003 — Novalar Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06286059 Mar → Dec 2024 acute coronary syndrome, acute kidney injury, coronary artery disorder Helwan University Unknown No outcome recorded
Phase 38 trials · 3 met primary
Phase 3 NCT07140783 Sep 2025 → Aug 2027 expected night blindness Ocuphire Pharma, Inc. Recruiting No outcome recorded
Phase 3 NCT05448807 Jul 2025 → Apr 2026 overdue — Cairo University Recruiting No outcome recorded
Phase 3 NCT05646719 Dec 2022 → Oct 2023 presbyopia Ocuphire Pharma, Inc. Completed Met primary
Phase 3 NCT05473858 Dec 2021 → Apr 2026 overdue — sara nabil Recruiting No outcome recorded
Phase 3 NCT04638660 Dec 2020 → May 2022 vision disorder Ocuphire Pharma, Inc. Completed Met primary
Phase 3 NCT04620213 Nov → Dec 2020 — Ocuphire Pharma, Inc. Completed Met primary
Phase 3 NCT00309361 Feb → Jul 2006 — Novalar Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT00309335 Feb → Jul 2006 — Novalar Pharmaceuticals, Inc. Completed No outcome recorded
Phase 44 trials
Phase 4 NCT05997732 Oct 2023 → Dec 2027 expected — University of Alberta Recruiting No outcome recorded
Phase 4 NCT05687669 Jan → Apr 2023 preeclampsia Assiut University Completed No outcome recorded
Phase 4 NCT02995291 Feb 2017 → May 2019 — Dalhousie University Completed No outcome recorded
Phase 4 NCT01474382 Feb 2012 → Aug 2014 — Novocol Pharmaceutical of Canada, Inc. Completed No outcome recorded
Phase not applicable6 trials
— NCT07012512 Jun → Dec 2025 overdue eye accommodation disease Mansoura University Not yet recruiting No outcome recorded
— NCT06620991 Oct 2024 → Apr 2025 overdue — Ain Shams University Not yet recruiting No outcome recorded
— NCT05525416 Jul 2022 → Feb 2023 — University of Alberta Completed No outcome recorded
— NCT03740386 Jan 2016 → Nov 2018 — León Formación Completed No outcome recorded
— NCT02861378 Oct 2015 → Mar 2016 — Dalhousie University Completed No outcome recorded
— NCT00132106 Aug 2005 → ? congestive heart failure Radboud University Medical Center Unknown No outcome recorded
Comparator or background therapy10 trials
Phase 0 NCT03079921 Comparator Jan 2017 → Apr 2019 hypoglycemia, type 1 diabetes mellitus University of Pennsylvania Completed No outcome recorded
Phase 1 NCT02584686 Background Oct 2015 → May 2016 vasculogenic impotence Cairo University Completed Met primary
Phase 2 NCT00080808 Comparator Aug 2001 → Jul 2006 prostate cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 3 NCT06542497 Comparator Aug 2024 → Apr 2025 presbyopia Ocuphire Pharma, Inc. Completed No outcome recorded
Phase 3 NCT06349759 Comparator Apr 2024 → Apr 2025 night blindness Ocuphire Pharma, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 29

DateIssuerRelease
2026-04-10 Ocuphire Pharma, Inc. Results Opus Genetics Announces Data Presentations at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting opusgtx.com ↗
Phentolamine Ophthalmic Solution Provides Durable Improvement in Distance Corrected Near Vision for Presbyopic Patients in a Phase 3 Study
2026-02-25 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Regulatory FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia.
2026-02-25 Ocuphire Pharma, Inc. Regulatory Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia opusgtx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.
2025-06-26 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Results Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from VEGA-3, the second pivotal Phase 3 trial evaluating MR-141 (phentolamine ophthalmic solution 0.75%) in treating presbyopia.
2025-06-26 Ocuphire Pharma, Inc. Results Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia opusgtx.com ↗
2025-06-02 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Results Viatris Announces Positive Top-Line Results from Phase 3 LYNX-2 Trial of MR-142 in Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from LYNX-2, a pivotal Phase 3 trial evaluating MR-142 (phentolamine ophthalmic solution 0.75%) in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.
2025-06-02 Ocuphire Pharma, Inc. Results Opus Genetics Announces LYNX-2 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients with Visual Disturbances Under Mesopic, Low-Contrast Conditions opusgtx.com ↗
Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced positive topline results from LYNX-2, a pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.
2025-03-21 Ocuphire Pharma, Inc. Results Opus Genetics Announces Presentation on Phentolamine Ophthalmic Solution 0.75% in Dim Light Disturbances at World Cornea Congress IX opusgtx.com ↗
Patient reported outcomes for glare, halos, and starbursts were significantly lower for the Phentolamine Ophthalmic Solution 0.75% group compared to placebo at Day 15 (p<0.01).
2025-02-26 Ocuphire Pharma, Inc. Regulatory Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs opusgtx.com ↗
FDA Fast Track Designation granted for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision
2024-09-30 Ocuphire Pharma, Inc. Results Ocuphire Pharma Announces Publication of Full Phase 3 Results of Phentolamine Ophthalmic Solution 0.75% for Pharmacologically-Induced Mydriasis in Ophthalmology opusgtx.com ↗
The results demonstrated that Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, rapidly and effectively reversed pharmacologically-induced pupil dilation with a favorable safety profile.
2024-01-04 Ocuphire Pharma, Inc. Regulatory Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions opusgtx.com ↗
2023-09-27 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Regulatory Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tropicamide) Agents viatris.com ↗

All press releases naming this drug 57 releases

DateIssuerRelease

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 48 sources stand behind the page.

FieldValueCited text
Known as phentolamine “20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine” NCT02584686 ↗
34

“hypotensive anaesthesia using Phentolamine” NCT04110808 ↗

NCT00132106 ↗

NCT00309335 ↗

NCT00309322 ↗

NCT00080808 ↗

NCT03740386 ↗

NCT07140783 ↗

NCT02966665 ↗

NCT03098680 ↗

NCT07012512 ↗

Show 24 more sources

Known as Fentolamina ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Mesylate phentolamine ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as NSC-757431 ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as NV-101 “NV-101 (phentolamine mesylate solution)” NCT00154167 ↗
3

“Phentolamine Mesylate (NV-101)” NCT00309335 ↗

“Phentolamine Mesylate (NV-101)” NCT00309361 ↗

“Phentolamine Mesylate (NV-101)” NCT00309322 ↗

Known as Nyxol “Nyxol” NCT05646719 ↗
Known as Oraverse “Phentolamine Mesylate 0.235 MG/ML [OraVerse]” NCT03740386 ↗
4

NCT01474382 ↗

NCT02995291 ↗

NCT05473858 ↗

NCT05448807 ↗

Known as Phentolamin ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Phentolamine hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as PHENTOLAMINE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Phentolamine Injection “Drug: Phentolamine Injection” NCT06787066 ↗
Known as Phentolamine mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Phentolamine Mesylate “Phentolamine Mesylate Ophthalmic Solution 1%” NCT04004507 ↗
14

“Phentolamine Mesylate Ophthalmic Solution 1%” NCT03960866 ↗

“Phentolamine Mesylate 0.235 MG/ML [OraVerse]” NCT03740386 ↗

“NV-101 (phentolamine mesylate solution)” NCT00154167 ↗

“Phentolamine Mesylate (NV-101)” NCT00309335 ↗

“Phentolamine Mesylate (NV-101)” NCT00309322 ↗

“Phentolamine Mesylate (NV-101)” NCT00309361 ↗

“Drug: Phentolamine Mesylate” NCT05997732 ↗

“Drug: Phentolamine Mesylate” NCT05525416 ↗

“phentolamine mesylate” NCT02995291 ↗

NCT04024891 ↗

Show 4 more sources

Known as Phentolamine methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as PMOS “Phentolamine mesylate ophthalmic solution (PMOS) may expedite the reversal of mydriasis in patients, potentially facilitating return to functional vision and reducing barriers...” PMID 33633016 ↗ Mar 2021
1

“This exploratory study investigated 1.0% phentolamine mesylate ophthalmic solution (PMOS) as a treatment to improve vision and image quality for patients with DLD.” PMID 36209072 ↗ Oct 2022

Known as POS “PURPOSE: To evaluate the safety and efficacy of 0.75% phentolamine ophthalmic solution (POS), a non-selective adrenergic antagonist, in reversing pharmacologically induced...” PMID 41743463 ↗ Feb 2026
1

“Phentolamine Ophthalmic Solution (POS) 0.75%” NCT06542497 ↗

Known as Regitine ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Rogitamine “Group P will receive phentolamine intravenous infusion (Rogitamine) in a concentration of 10 mg/ml, thus 1 µg/Kg/min equals to 4.8 ml/hr for an 80 Kg patient.” NCT06385600 ↗
Known as Rogitine ChEMBL registry synonym — accepted as the source's own label CHEMBL597 ↗
Known as Ryzumvi “Reversal of Pharmacologic Mydriasis in Pediatric Subjects with Ryzumvi (0.75% Phentolamine Ophthalmic Solution): A Post-Hoc Pooled Analysis from Three Randomized,...” PMID 41743463 ↗ Feb 2026
Action Inhibit “alfa-adrenergic receptor blockade” NCT00132106 ↗
Modality Small molecule — CHEMBL597 ↗
Route Other “intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly” NCT00080808 ↗