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Details:
INCB050465 (parsaclisib) is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.
Lead Product(s): Parsaclisib,Ruxolitinib Phosphate
Therapeutic Area: Oncology Product Name: INCB050465
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 March 03, 2023
Details:
IBI376 (Parsaclisib) is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.
Lead Product(s): Parsaclisib
Therapeutic Area: Oncology Product Name: IBI376
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 January 05, 2023
Details:
INCB050465 (parsaclisib) is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).
Lead Product(s): Parsaclisib
Therapeutic Area: Immunology Product Name: INCB050465
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 May 26, 2022
Details:
Incyte withdrawing NDA for INCB050465 (parsaclisib) for treatment of FL, MZL, and MCL which follow discussion with USFDA regarding confirmatory studies to support accelerated approval, which cannot be completed within time period, and opt-out of MCLA-145 development.
Lead Product(s): Parsaclisib,Rituximab,Obinutuzumab
Therapeutic Area: Oncology Product Name: INCB050465
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merus
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2022
Details:
The oral presentations, includes new data from the CITADEL program evaluating parsaclisib in three types of lymphoma as well as results from the RE-MIND2 study of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Parsaclisib
Therapeutic Area: Oncology Product Name: INCB050465
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 November 04, 2021
Details:
In particular, data being presented at the congress – including the first presentation of data from our Phase 2 study of parsaclisib, our PI3kδ inhibitor, in autoimmune hemolytic anemia.
Lead Product(s): Parsaclisib
Therapeutic Area: Immunology Product Name: INCB050465
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 May 12, 2021
Details:
Company achieved first patient dosing in a pivotal Phase 2 registrational trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor, in China.
Lead Product(s): Parsaclisib
Therapeutic Area: Oncology Product Name: Undisclosed
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 April 27, 2020
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