Phentolamine mesylate is under clinical development by Ocuphire Pharma and currently in the Phase III and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Phentolamine mesylate’s likelihood of approval (LoA) and phase transition for Mydriasis took place on 15 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 15 Dec 2022 decreased Phentolamine mesylate’s LoA and PTSR for Nyctalopia (Night Blindness) due to Vitamin A Deficiency.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Phentolamine mesylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Phentolamine mesylate overview

Phentolamine mesylate (Nyxol eye drops) is under development for the treatment of severe night vision complaints (NVCs), mydriasis reversal and presbyopia. Nyxol eye drops contain phentolamine mesylate that targets alpha-1 and alpha-2 adrenergic receptors.

It was also under development for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).

Ocuphire Pharma overview

Ocuphire Pharma is an ophthalmic biopharmaceutical company that develops and commercializes medicines to treat eye disorders. It is investigating Nyxol, a preservative-free ophthalmic solution for dim light and night vision disturbances (DLD), reversal of Mydriasis (RM), presbyopia, and glaucoma. The company is also evaluating APX3330, an oral pill targeting diabetic retinopathy (DR) and macular edema (DME); and APX2009 drug against wet age-related macular degeneration (wAMD). Ocuphire Pharma seeks to work in partnership with pharmaceutical companies for development and commercialization of its drug candidates. It carters its product under the brand Nyxol. Ocuphire Pharma is headquartered in Farmington Hills, Michigan, the US.

Quick View Phentolamine mesylate LOA Data

Report Segments
  • Innovator
Drug Name
  • Phentolamine mesylate
Administration Pathway
  • Ophthalmic
Therapeutic Areas
  • Nutritional Disorders
  • Ophthalmology
Key Developers
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.