Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : BRV Capital Management
Deal Size : $40.0 million
Deal Type : Financing
Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients
Details : The financing will fund FUEL-2, Mezzion's confirmatory phase 3 trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion is looking to market JURVIGO® (udenafil), a highly selective, unique and po...
Brand Name : Jurvigo
Molecule Type : Small molecule
Upfront Cash : Undisclosed
April 25, 2023
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : BRV Capital Management
Deal Size : $40.0 million
Deal Type : Financing
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mezzion Pharma Submits Protocol for Confirmatory Pivotal Phase 3 Trial ("FUEL-2") in Fontan Subjects
Details : MZ101 (udenafil) is a phosphodiesterase type 5 inhibitor, improves measures of exercise performance at the ventilatory anaerobic threshold in individuals with fontan physiology.
Brand Name : MZ101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 21, 2023
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Mezzion sought clarity on the critical elements of an additional clinical trial that may be needed to complete the NDA submission for Udenafil for Single Ventricle Heart Disease.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2022
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The FDA had previously granted Mezzion's request to designate udenafil for treatment of single ventricle congenital heart disease as a drug for a Rare Pediatric Disease.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 25, 2021
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mezzion Announces Submission of NDA for its Orphan Drug Udenafil
Details : The NDA submission, which totals nearly 100,000 pages, is supported by data from more than 700 documents including more than 200 studies that Mezzion has completed during the last 2 decades since its founding in 2002.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 30, 2020
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Subjects on udenafil therapy showed a statistically significant improvement in ventricular performance as measured by MPI as compared to subjects taking placebo over the same time period.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 18, 2020
Lead Product(s) : Udenafil
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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