Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
May 27, 2024
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
October 24, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
October 04, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
May 31, 2022
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
September 17, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
July 01, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
May 12, 2021
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Undisclosed
September 02, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : NS Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Viltepso
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
August 12, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
June 08, 2020
Lead Product(s) : Viltolarsen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable