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    [{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mezzion Pharma's Udenafil Improved Ventricular Function Measured by Myocardial Performance Index in adolescents with SVHD","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"Approved","date":"May 2020","year":"2020","type":"Not Applicable","leadProduct":"Udenafil","moa":"PDE5A","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III","graph3":"Mezzion Pharma Co Ltd","amount2":0,"therapeuticAreaNew":"Cardiology\/Vascular Diseases","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Cardiovascular Diseases","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mezzion Pharma Co Ltd \/ Not 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Applicable","leadProduct":"Udenafil","moa":"","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III","graph3":"Mezzion Pharma Co Ltd","amount2":0,"therapeuticAreaNew":"Cardiology\/Vascular Diseases","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Cardiovascular Diseases","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mezzion Pharma Co Ltd \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Mezzion Pharma Co Ltd \/ Not Applicable"},{"orgOrder":0,"company":"Mezzion Pharma Co Ltd","sponsor":"BRV Capital Management","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"Approved","date":"April 2023","year":"2023","type":"Financing","leadProduct":"Udenafil","moa":"","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III","graph3":"Mezzion Pharma Co Ltd","amount2":0.040000000000000001,"therapeuticAreaNew":"Cardiology\/Vascular Diseases","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Cardiovascular Diseases","productSubType":"Small molecule","amount2New":0.040000000000000001,"dosageForm":"Tablet","sponsorNew":"Mezzion Pharma Co Ltd \/ BRV Capital Management","highestDevelopmentStatusID":"10","companyTruncated":"Mezzion Pharma Co Ltd \/ BRV Capital Management"}]

    Find Clinical Drug Pipeline Developments & Deals for CID6918523

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                            01

                            Mezzion Pharma Co Ltd

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                            34th IFSCC
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                            Mezzion Pharma Co Ltd

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                            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

                            DEALS_DEV arrow-down

                            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

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                            02

                            Mezzion Pharma Co Ltd

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                            34th IFSCC
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                            Mezzion Pharma Co Ltd

                            South Korea arrow
                            34th IFSCC
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                            Lead Product(s) : Udenafil

                            Therapeutic Area : Cardiology/Vascular Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            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

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                            03

                            Mezzion Pharma Co Ltd

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                            34th IFSCC
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                            Lead Product(s) : Udenafil

                            Therapeutic Area : Cardiology/Vascular Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease

                            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

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                            04

                            Mezzion Pharma Co Ltd

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                            34th IFSCC
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                            Mezzion Pharma Co Ltd

                            South Korea arrow
                            34th IFSCC
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                            Lead Product(s) : Udenafil

                            Therapeutic Area : Cardiology/Vascular Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Mezzion's NDA for its Orphan Drug Udenafil for Single Ventricle Heart Disease ("SVHD") has been Accepted for F...

                            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

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                            05

                            Mezzion Pharma Co Ltd

                            South Korea arrow
                            34th IFSCC
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                            Mezzion Pharma Co Ltd

                            South Korea arrow
                            34th IFSCC
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                            Lead Product(s) : Udenafil

                            Therapeutic Area : Cardiology/Vascular Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            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

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                            06

                            Mezzion Pharma Co Ltd

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                            34th IFSCC
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                            34th IFSCC
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                            Lead Product(s) : Udenafil

                            Therapeutic Area : Cardiology/Vascular Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Mezzion Pharma's Udenafil Improved Ventricular Function Measured by Myocardial Performance Index in adolescent...

                            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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