Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NS Pharma Shares Preliminary Results Of Viltolarsen Phase 3 Trial
Details : Viltepso (viltolarsen), an antisense oligonucleotide, is being investigated in ambulatory boys with Duchenne muscular dystrophy.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 27, 2024
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : VILTEPSO® (viltolarsen) injection,is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 24, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : VILTEPSO (viltolarsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 04, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : VILTEPSO (Viltolarsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 31, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 17, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In addition to this Phase 2 open-label extension study, NS Pharma continues to investigate the efficacy and safety of VILTEPSO in the confirmatory Phase 3 RACER53 trial.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 01, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Phase 2 open-label extension study, NS Pharma continues to investigate the efficacy and safety of VILTEPSO in the confirmatory Phase 3 RACER53 trial. This study was initiated in October 2019 and is currently enrolling patients.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 12, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : NS Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Details : Option Care Health has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 skipping therapy.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Undisclosed
September 02, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : NS Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : U.S. Food & Drug Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy.
Brand Name : Viltepso
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 12, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EC Grants Orphan Drug Designation to Nippon Shinyaku's viltolarsen (NS-065/NCNP-01)
Details : The NDA for viltolarsen is also being reviewed under an accelerated approval pathway in the U.S. The clinical study in the US is being conducted by NS Pharma, Inc.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 08, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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