Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otsuka Files BLA for Sibeprenlimab in Immunoglobulin A Nephropathy Treatment
Details : VIS649 (sibeprenlimab) is an investigational humanized IgG2 monoclonal antibody that reduces Gd-IgA1 by binding to APRIL. It is being developed for Immunoglobulin A Nephropathy.
Product Name : VIS649
Product Type : Antibody
Upfront Cash : Inapplicable
March 31, 2025
Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otsuka Shows Positive Interim Results for Sibeprenlimab in IgA Nephropathy
Details : VIS649 (sibeprenlimab) is an investigational monoclonal antibody that blocks the action of APRIL (A PRoliferation-Inducing Ligand) for the treatment of immunoglobulin a nephropathy in adults.
Product Name : VIS649
Product Type : Antibody
Upfront Cash : Inapplicable
October 22, 2024
Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sibeprenlimab Receives FDA Breakthrough Therapy Designation for IgA Nephropathy
Details : VIS649 (sibeprenlimab) is a humanized IgG2 monoclonal antibody reducing Gd-IgA1 production by binding APRIL, under development for Immunoglobulin A Nephropathy treatment.
Product Name : VIS649
Product Type : Antibody
Upfront Cash : Inapplicable
February 16, 2024
Lead Product(s) : Sibeprenlimab
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : EC approval is based on positive results, which demonstrated that treatment with voclosporin (lupkynis), in combination with MMF and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low...
Product Name : Lupkynis
Product Type : Peptide
Upfront Cash : Inapplicable
September 20, 2022
Lead Product(s) : Voclosporin
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolvaptan
Therapeutic Area : Nephrology
Study Phase : Approved FDF
Sponsor : Millmount Healthcare
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Oral vasopressin V2-receptor antagonists Samsca® Tablets, Samsca® OD Tablets and SAMSCA® Granules 1% have received regulatory approval in Japan for the indication of hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secreti...
Product Name : Samsca
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 29, 2020
Lead Product(s) : Tolvaptan
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Sponsor : Millmount Healthcare
Deal Size : Inapplicable
Deal Type : Inapplicable