Drugs / Phentolamine
Phentolamine
also known as
Phentolamine Mesylate · Oraverse · NV-101 · PMOS · POS · Fentolamina · Mesylate phentolamine · NSC-757431 · +11 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ORAVERSE | — | 2016-03-18 | fda.gov ↗ |
| Approved | US (FDA) | REGITINE | — | 1952-01-30 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
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| 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 |
| Phase 1 | NCT02966665 | Sep 2008 → Aug 2026 overdue | chronic obstructive pulmonary disease, heart failure, pulmonary arterial hypertension | Russell Richardson | Recruiting | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04675151 | Feb → May 2021 | presbyopia | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04024891 | Aug → Sep 2019 | — | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03960866 | May → Sep 2019 | ocular hypertension, open-angle glaucoma | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01703559 | Sep 2011 → Apr 2012 | night blindness | Ocuphire Pharma, 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 | ||||||
| Phase 3 | NCT07140783 | Sep 2025 → Jun 2026 overdue | night blindness | Ocuphire Pharma, Inc. | Active not 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT04620213 | Nov → Dec 2020 | — | Ocuphire Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00309335 | Feb → Jul 2006 | — | Novalar Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00309361 | 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 |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03079921 Comparator | Jan 2017 → Apr 2019 | hypoglycemia, type 1 diabetes mellitus | University of Pennsylvania | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02584686 Background | Oct 2015 → May 2016 | vasculogenic impotence | Cairo University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00080808 Comparator | Aug 2001 → Jul 2006 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| 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 |
| Phase not applicable3 trials | ||||||
| — | 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 |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-25 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia viatris.com ↗ |
| 2024-04-01 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States viatris.com ↗ |
| 2023-09-27 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 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 ↗ |
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 ↗35“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)” NCT00309361 ↗ “Phentolamine Mesylate (NV-101)” NCT00309335 ↗ “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 (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist” NCT01703559 ↗14“Phentolamine Mesylate Ophthalmic Solution 1%” NCT04004507 ↗ “Phentolamine Mesylate 0.235 MG/ML [OraVerse]” NCT03740386 ↗ “Phentolamine Mesylate Ophthalmic Solution 1%” NCT03960866 ↗ “NV-101 (phentolamine mesylate solution)” NCT00154167 ↗ “Phentolamine Mesylate (NV-101)” NCT00309361 ↗ “Phentolamine Mesylate (NV-101)” NCT00309335 ↗ “Phentolamine Mesylate (NV-101)” NCT00309322 ↗ “Drug: Phentolamine Mesylate” NCT05525416 ↗ “Drug: Phentolamine Mesylate” NCT05997732 ↗ “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 ↗ |