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Details:
Varenicline is a nAChRα4&β2 (Neuronal acetylcholine receptor; alpha4/beta2) agonist, small molecule drug. It is approved for the treatment of smoking cessation.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
RLD Chantix (varenicline) is a nAChRα4&β2 (Neuronal acetylcholine receptor; alpha4/beta2) agonist, small molecule drug. It is approved for the treatment of smoking cessation.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: RLD Chantix
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2024
Details:
TYRVAYA (varenicline solution) Nasal Spray 0.03 mg, is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya-Generic
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 June 14, 2023
Details:
Varenicline Tablet, for oral use is a nicotinic receptor partial agonist that is FDA-approved for use as an aid to smoking cessation treatment and Chantix is a RFLAD.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Chantix-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2023
Details:
TYRVAYA® (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: $415.0 million Upfront Cash: $415.0 million
Deal Type: Acquisition January 03, 2023
Details:
With the combination of Viatris' R&D and regulatory capabilities, along with Oyster Point's commercial asset, Tyrvaya (varenicline), for the treatment of dry eye disease, the Company has the foundation to create a leading global ophthalmology franchise.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viatris
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition November 07, 2022
Details:
TYRVAYA® (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2022
Details:
TYRVAYA® (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
TYRVAYA® (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
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 27, 2022
Details:
TYRVAYA (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
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 19, 2022
Details:
TYRVAYA Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: Tyrvaya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
Company has begun shipping varenicline, a generic version of Pfizer's Chantix® (varenicline) 0.5 mg and 1 mg tablets. Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Endo International
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
Ji Xing Pharmaceuticals to develop and commercialize OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays for patients with dry eye disease in Greater China.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: OC-01
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ji Xing Pharmaceuticals
Deal Size: $222.3 million Upfront Cash: $17.5 million
Deal Type: Licensing Agreement August 05, 2021
Details:
The NDA submission for OC-01, is based on efficacy and safety results from a comprehensive clinical trial program conducted in patients with a broad range of dry eye disease.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: OC-01
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 18, 2020
Details:
The OLYMPIA Phase 2 trial aims to evaluate the safety and effectiveness of OC-01 nasal spray as compared to placebo for complete resolution of corneal staining in subjects with Stage 1 or Stage 2 NK in one or both eyes.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: OC-01
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Results from the Phase 2 IMPERIAL study illustrate OC-01 nasal spray caused a decrease in goblet cell size, as compared to placebo, indicating mucin secretion after a single administration.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: OC-01
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 November 13, 2020
Details:
ONSET-2 met the primary endpoint in both doses tested, demonstrating significant improvement in Schirmer’s score from baseline to Week 4 in subjects receiving OC-01 nasal spray vs control.
Lead Product(s): Varenicline Tartrate
Therapeutic Area: Ophthalmology Product Name: OC-01
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 11, 2020
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