Phentolamine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| Phase 3 | NCT05223478 Comparator | Dec 2021 → Apr 2022 | — | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05134974 Comparator | Nov 2021 → Mar 2022 | — | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| — | NCT06422494 Comparator | Jan → Sep 2025 overdue | type 1 diabetes mellitus | Radboud University Medical Center | Active not recruiting | No outcome recorded |
| — | NCT06385600 Comparator | May 2024 → Jan 2026 | severe pre-eclampsia | Assiut University | Unknown | No outcome recorded |
| — | NCT00226096 Background | Nov 2005 → Sep 2007 | intracerebral hemorrhage | The George Institute | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 2023-09-27 | Ocuphire Pharma, Inc. | Regulatory Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (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 opusgtx.com ↗ |
| 2023-09-07 | Ocuphire Pharma, Inc. | Results Ocuphire Pharma to Present at ESCRS 2023 and MODLive! Conferences in September opusgtx.com ↗
Treatment With 0.75% Phentolamine Ophthalmic Solution Reverses Mydriasis in Healthy Subjects: Results From Mira-2 And Mira-3, Pivotal Phase 3 Clinical Trials |
| 2023-02-13 | Ocuphire Pharma, Inc. | Regulatory Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date of September 28, 2023 for Nyxol® Eye Drops for Reversal of Mydriasis opusgtx.com ↗ |
| 2022-12-06 | Ocuphire Pharma, Inc. | Regulatory Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol® Eye Drops for Reversal of Mydriasis opusgtx.com ↗
The NDA submission for Nyxol is an important step toward our goal of providing a reversal option for the millions of standard eye exams and procedures that involve dilation, |
| 2022-11-02 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Peer-Reviewed Publication in BMC Ophthalmology for Nyxol® and Strategic Partnership with American Society of Ophthalmic Administrators (ASOA) opusgtx.com ↗
A manuscript titled “ A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances ,” has been published in BMC Ophthalmology for clinical trial NCT04004507 and reported Nyxol was well-tolerated and effectively reduced pupil size with improvements in contrast sensitivity and visual acuity. |
| 2022-10-24 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Six Poster Presentations on Nyxol and APX3330 at the American Academy of Optometry Annual Meeting opusgtx.com ↗
Phentolamine Ophthalmic Solution Rapidly Reverses Pharmacologically Induced Mydriasis in Two Pivotal MIRA Phase 3 Trials |
| 2022-09-12 | Ocuphire Pharma, Inc. | Regulatory Ocuphire Pharma Receives PDFUA Fee Waiver for Nyxol New Drug Application from FDA opusgtx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of $3.1 million for the 505(b)(2) New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution), the Company’s late stage product candidate. |
| 2022-05-19 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Positive Topline Results from LYNX-1 Phase 3 Trial Evaluating Nyxol® Eye Drops for Night Vision Disturbances opusgtx.com ↗
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced positive topline results from the LYNX-1 Phase 3 pivotal clinical trial investigating its product candidate Nyxol ® for night (or dim light) vision disturbances (NVD). |
| 2022-04-28 | Ocuphire Pharma, Inc. | Results Ocuphire Completes Last Clinical Trial Supporting the Planned 2022 NDA Submission with the Announcement of Positive Results from MIRA-4 Pediatric Safety Trial Evaluating Nyxol® for Reversal of Mydriasis opusgtx.com ↗
Nyxol Demonstrated a Favorable Safety Profile and Rapidly Reversed Dilated Eyes in Pediatric Subjects 3 to 11 Years Old, Consistent with Findings in MIRA-2 and MIRA-3 Phase 3 Registration Trials |
| 2022-03-29 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Positive Topline Results from MIRA-3 Phase 3 FDA Registration Trial for Nyxol® in the Reversal of Mydriasis opusgtx.com ↗
Meets Primary Endpoint With 58% Of Nyxol treated Subjects Returning to Baseline Pupil Diameter at 90 Minutes Compared to 6% of Placebo Subjects (p<0.0001) |
| 2022-01-31 | Ocuphire Pharma, Inc. | Results Ocuphire Presenting New Data and Updates on APX3330 and Nyxol® Clinical Programs at Virtual Investor R&D Day opusgtx.com ↗
New data from the Phase 2 VEGA-1 clinical trial show that Nyxol had statistically significant improvement in efficacy and long durability compare |
| 2021-08-12 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Financial Results for the Second Quarter 2021 and Provides Corporate Update opusgtx.com ↗
Continued Momentum in Nyxol ® Programs with Announcement of Positive Top-Line Results from VEGA-1 Phase 2 Trial in Presbyopia |
| 2021-06-30 | Ocuphire Pharma, Inc. | Results Ocuphire’s VEGA-1 Phase 2 Trial in Presbyopia Meets Primary and Secondary Endpoints opusgtx.com ↗
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that the VEGA-1 Phase 2 clinical trial evaluating the efficacy and safety of Nyxol in combination with low-dose pilocarpine (LDP) in presbyopic subjects successfully met its primary and many secondary endpoints. |
| 2021-03-15 | Ocuphire Pharma, Inc. | Results Ocuphire Announces MIRA-2 Phase 3 Registration Trial for the Reversal of Mydriasis Meets Primary Endpoint opusgtx.com ↗
Nyxol Meets Its Primary and Multiple Secondary Endpoints Including Statistically Significant Efficacy Returning Subjects More Rapidly to Normal Pupil Size Across a Breadth of Dilating Agents and Iris Colors |
| 2021-03-05 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Publication of MIRA-1 Phase 2b Results in Optometry and Visual Science Demonstrating Reduction of Pharmacologically Induced Mydriasis by Nyxol® opusgtx.com ↗
In the Nyxol treatment group, 29% of subjects met with statistical significance return to within 0.2 mm of their baseline pupil diameter (PD) at 2 hours, compared with 13% in the placebo group. |
| 2021-01-20 | Ocuphire Pharma, Inc. | Results Ocuphire Announces Publication of ORION-1 Phase 2 Results for Nyxol in Clinical Ophthalmology and Presentation at the January OIS Presbyopia Innovation Showcase opusgtx.com ↗
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today that results from its ORION-1 ( NCT03960866 ) Phase 2 clinical trial evaluating the safety and efficacy of Nyxol ® in glaucoma and presbyopia have been published in Clinical Ophthalmology , an international, peer-reviewed, open access journal covering all subspecialties within ophthalmology. |
| 2019-11-07 | Ocuphire Pharma, Inc. | Results Ocuphire Pharma Announces Results from Two Phase 2 Clinical Studies of Nyxol® Eye Drops opusgtx.com ↗
Ocuphire Pharma, Inc., a clinical-stage pharmaceutical company focused on the development and commercialization of therapies to treat patients with a variety of ophthalmic disorders, announced statistically significant and clinically meaningful results from its recently completed two Phase 2b studies of its lead drug candidate, Nyxol Eye Drops. |
All press releases naming this drug 57 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | phentolamine | “20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine” NCT02584686 ↗34“hypotensive anaesthesia using Phentolamine” NCT04110808 ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 20211“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 20261“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 ↗ |