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Details:
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is being evaluated for the treatment of patients with IgA nephropathy (IgAN).
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: Fabhalta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2024
Details:
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is being evaluated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: Fabhalta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2024
Details:
LNP023 (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway being developed in Phase 3 for patients with C3 glomerulopathy, which met its primary endpoint by providing clinically meaningful and statistically significant proteinuria reduction.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2023
Details:
FDA approved Fabhalta® (iptacopan), a Factor B inhibitor of the alternative complement pathway 15-17, as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: Fabhalta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2023
Details:
LNP023 (iptacopan) is an investigational first-in-class, orally administered targeted factor B inhibitor of the alternative complement pathway. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
LNP023 (iptacopan) is an investigational first-in-class, orally administered targeted factor B inhibitor of the alternative complement pathway. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
LNP023 (iptacopan) is an investigational first-in-class, orally administered targeted factor B inhibitor of the alternative complement pathway. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
LNP023 (iptacopan) is an investigational first-in-class, orally administered targeted factor B inhibitor of the alternative complement pathway. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
LNP023 (Iptacopan) is an investigational first-in-class, orally administered targeted factor B inhibitor of alternative complement pathway. It acts upstream of the C5 terminal pathway, preventing not only intravascular but also extravascular hemolysis in PNH.
Lead Product(s): Iptacopan
Therapeutic Area: Rare Diseases and Disorders Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
LNP023 (Iptacopan ), an oral, selective factor B inhibitor in patients with C3 glomerulopathy met primary endpoints in both patient cohorts. Iptacopan showed a favorable safety and tolerability profile in the Phase II final analysis, with no serious adverse events.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
After the 12-week main treatment period, patients responding to iptacopan treatment had the option to enter an approximately two-year treatment extension period1.
Lead Product(s): Iptacopan
Therapeutic Area: Hematology Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
The kidney function of 12 patients treated with iptacopan for 12 weeks was compared with their historical kidney function data for the two-year period before they entered the study.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
With potential to be the first oral treatment for a range of complement-driven diseases, complement factor B inhibitor iptacopan targets the underlying cause of these conditions through its action on the complement system’s alternative pathway.
Lead Product(s): Iptacopan
Therapeutic Area: Hematology Product Name: LNP023
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
Data presented at the ASN 2020 Annual Meeting shows that investigational iptacopan effectively and safely reduced proteinuria in patients with C3 glomerulopathy.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Iptacopan (LNP023) is a potential first-in-class, oral, potent and selective factor B inhibitor of the alternative complement pathway, which is involved in the underlying pathophysiology of IgA nephropathy.
Lead Product(s): Iptacopan
Therapeutic Area: Immunology Product Name: LNP023
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
Iptacopan is a first-in-class oral, small-molecule, reversible inhibitor of factor B, a key serine protease of the alternative pathway of the complement cascade.
Lead Product(s): Iptacopan
Therapeutic Area: Nephrology Product Name: LNP023
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis.
Lead Product(s): Iptacopan
Therapeutic Area: Hematology Product Name: LNP023
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2020
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