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Details:
Joenja (leniolisib) is an oral small molecule PI3K delta inhibitor and the first and only targeted treatment of activated phosphoinositide 3-kinase delta syndrome in 12 years of age and older. It is being developed for in children aged 4 to 11 years with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
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 08, 2024
Details:
Joenja (leniolisib) is an oral small molecule PI3Kẟ inhibitor approved in US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Lead Product(s): Leniolisib
Therapeutic Area: Immunology Product Name: Joenja
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 13, 2023
Details:
Leniolisib is an oral small molecule phosphoinositide 3-kinase delta inhibitor approved in the US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age and older.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 21, 2023
Details:
Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
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 10, 2023
Details:
Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
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 August 09, 2023
Details:
Under the agreement, Pharming will sell its Rare Pediatric Disease Priority Review Voucher, in connection with the approval of Joenja® (leniolisib), an oral, selective PI3Kδ inhibitor, for activated PI3Kδ syndrome, a rare and progressive primary immunodeficiency, to Novartis.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $21.1 million Upfront Cash: Undisclosed
Deal Type: Divestment June 01, 2023
Details:
Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
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 28, 2023
Details:
Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: Joenja
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 24, 2023
Details:
Leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. It is being investigated in children with activated phosphoinositide 3-kinase delta syndrome (APDS).
Lead Product(s): Leniolisib
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 February 21, 2023
Details:
Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3K delta is a valid and potentially effective therapeutic target for immune diseases such as APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 February 16, 2023
Details:
CDZ173 (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 15, 2022
Details:
Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. To date, leniolisib has been well tolerated during both the Phase 1 trial in healthy subjects and Phase II/III registration-enabling study in patients with APDS.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 06, 2022
Details:
Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3Kδ is expressed predominately in hematopoietic cells and is essential to normal immune system function.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 23, 2022
Details:
CDZ173 (leniolisib) is small-molecule inhibitor of delta isoform of the 110 kDa catalytic subunit of class IA PI3K. PI3Kδ is expressed predominately in hematopoietic cells and is essential to normal immune system function through conversion of PIP2 to PIP3.
Lead Product(s): Leniolisib
Therapeutic Area: Immunology Product Name: CDZ173
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 28, 2022
Details:
CDZ173 (leniolisib) is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially anti-neoplastic activities.
Lead Product(s): Leniolisib
Therapeutic Area: Rare Diseases and Disorders Product Name: CDZ173
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 August 01, 2022
Details:
An agreed paediatric investigation plan is regulatory pathway to market authorization for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children.
Lead Product(s): Leniolisib
Therapeutic Area: Immunology Product Name: CDZ173
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2022
Details:
In index lymphadenopathy lesions, a statistically significant adjusted mean change in log10 transformed sum of product of diameters (SPD) of -0.30 among patients who received leniolisib, inhibit the production of PIP3, compared with -0.06 among patients who received placebo.
Lead Product(s): Leniolisib
Therapeutic Area: Immunology Product Name: CDZ173
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
Leniolisib is a small molecule phosphoinositide 3-kinase delta (PI3Kẟ) inhibitor with immunomodulating and potentially anti-neoplastic activities. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3).
Lead Product(s): Leniolisib
Therapeutic Area: Immunology Product Name: CDZ173
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
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