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Details:
Nyxol (phentolamine mesylate ophthalmic solution) an alpha1/2 adrenergic receptor inhibitor, is being investigated in a phase 3 trial for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2024
Details:
Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker, which is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Ryzumvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2024
Details:
Nyxol (phentolamine ophthalmic solution) is anadrenergic receptor antagonist. It is being evaluated in phase 3 clinical trials for the treatment of decreased visual acuity under dim (mesopic) light conditions.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
Ryzumvi (phentolamine ophthalmic solution) 0.75% is a preservative-free ophthalmic solution and a nonselective alpha adrenergic antagonist, which is investigated for Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Ryzumvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2023
Details:
Nyxol® is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha adrenergic antagonist that inhibits the contraction of smooth muscle of the iris.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2023
Details:
Nyxol® is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha adrenergic antagonist that inhibits the contraction of smooth muscle of the iris.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Nyxol is a proprietary, preservative-free, stable, investigational eye drop formulation of phentolamine mesylate 0.75% designed to uniquely modulate the pupil size by blocking the α1 receptors found only on the iris dilator muscle without affecting the ciliary muscle.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2022
Details:
Under the terms of the license agreement, Famy will fund Nyxol (phentolamine mesylate) development through FDA approvals, that will be managed by Ocuphire, including clinical, manufacturing, and regulatory activities required for FDA approval of all three Nyxol indications.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: FamyGen Life Sciences
Deal Size: $45.0 million Upfront Cash: $35.0 million
Deal Type: Licensing Agreement November 07, 2022
Details:
Nyxol® is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha adrenergic antagonist that inhibits the contraction of smooth muscle of the iris.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: American Society of Ophthalmic Administrator
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 02, 2022
Details:
Nyxol® eye drops (0.75% phentolamine ophthalmic solution), is once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
Nyxol® eye drops (0.75% phentolamine ophthalmic solution), is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
Patent provides added intellectual property protection for the company’s late-stage product candidate, Nyxol (phentolamine mesylate), with claims directed to methods for treating mydriasis using phentolamine mesylate.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
Nyxol eye drops (0.75% phentolamine ophthalmic solution), is a oncedaily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Details:
Met FDA-agreed primary endpoint with more Nyxol (phentolamine mesylate) subjects gaining 3 lines of low contrast distance vision under dim light conditions compared to placebo.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Results demonstrated that Nyxol’s efficacy and safety in pediatric subjects 3-11 years of age was consistent with that shown in previous studies, enrolled both adolescents and adults, showing a rapid reversal of pharmacologically-induced mydriasis and favorable safety profile.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
The topline results demonstrated that MIRA-3 trial met its primary endpoint with 58% of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter (PD) at 90 minutes compared to only 6% of subjects treated with placebo.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
With growing rate of childhood myopia, MIRA-4 trial supports a potential broader RM label for Nyxol, containing 0.75% phentolamine, a nonselective alpha-adrenergic antagonist that inhibits contraction of smooth muscle of iris, in pediatric subjects 3 to 11 years.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2021
Details:
61% of subjects treated with Nyxol + LDP improved 15 letters or greater (≥ 3 lines) in photopic binocular near vision at 1 hour compared with 28% of subjects on placebo with statistical significance.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
Ongoing clinical trials investigating Nyxol for various refractive indications, patents like these provide the protection necessary to ensure commercial success. Importantly, Ocuphire owns all of the worldwide rights to Nyxol for all indications.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2021
Details:
The VEGA-1 clinical trial is designed to evaluate the efficacy and safety of Nyxol in combination with low-dose pilocarpine compared to placebo in presbyopic subjects.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Nyxol alone in multiple Phase 2 trials has reduced pupil diameter by approximately 20% and has significantly improved near visual acuity by one eye-chart line for over 24 hours after an evening eye drop.
Lead Product(s): Phentolamine Mesylate,Pilocarpine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
The current study builds on the positive results achieved in Ocuphire's recent Phase 2b MIRA-1 trial, which provided evidence of Nyxol’s ability to more rapidly return pupil diameter back to normal baselines.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
Nyxol, a stable eye drop formulation of phentolamine mesylate, has been shown to reverse mydriasis in a recently completed Phase 2b clinical trial (MIRA-1). MIRA-2 trials are to evaluate the efficacy and safety of Nyxol vs commonly used mydriatic (dilating) drops.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oculos Development Services
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
Ocuphire Pharma received grant from the National Eye Institute (NEI) to continue studies on APX3330, as well as second generation compounds, APX2009 and APX2014. It also received Japanese Patent for daily ophthalmic use of nyxol to Improve Visual Performance.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $1.7 million Upfront Cash: Undisclosed
Deal Type: Funding November 16, 2020
Details:
This merger supports Ocuphire for advancement of its late-clinical stage small molecule ophthalmic pipeline including its Nyxol® Eye Drops, a once-daily eye drop formulation of phentolamine mesylate designed to reduce pupil diameter and improve visual acuity.
Lead Product(s): Phentolamine Mesylate
Therapeutic Area: Ophthalmology Product Name: Nyxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rexahn Pharmaceuticals Inc
Deal Size: $21.1 million Upfront Cash: Undisclosed
Deal Type: Merger June 18, 2020
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