Drugs / Parsaclisib
Parsaclisib
also known as
INCB050465 · IBI376 · INCB050465 hydrochloride · INCB50465 · PARSACLISIB HYDROCHLORIDE
Small molecule targets PIK3CD via inhibition
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT05867030 | Jul 2023 → Aug 2029 | follicular lymphoma | Innovent Biologics (Suzhou) Co. Ltd. | Withdrawn | No outcome recorded |
| Phase 1 | NCT05083208 | Feb 2022 → Jun 2024 | peripheral T-cell lymphoma, not otherwise specified | Henan Cancer Hospital | Terminated | No outcome recorded |
| Phase 1 | NCT04774068 | Sep 2021 → Oct 2024 | anaplastic large cell lymphoma, mycosis fungoides variant | Walter Hanel | Completed | No outcome recorded |
| Phase 1 | NCT04831996 | May 2021 → Jul 2022 | cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04831944 | Mar 2021 → Mar 2022 | cancer | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04323956 | Jun 2020 → Oct 2023 overdue | diffuse large B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, marginal zone lymphoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04142554 | Jun → Sep 2020 | HER2 positive breast carcinoma, triple-negative breast carcinoma | UNC Lineberger Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT03688152 | Dec 2018 → Sep 2020 | diffuse large B-cell lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03589651 | Aug 2018 → Nov 2022 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03314922 | Aug 2018 → May 2020 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03424122 | Jul 2018 → Jun 2022 | B-cell non-Hodgkin lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03039114 | Feb 2017 → Mar 2021 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02646748 | Jan 2016 → Nov 2019 | breast cancer, colorectal cancer, endometrial cancer, head and neck cancer +5 | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02559492 | Nov 2015 → Sep 2018 | cancer | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05238064 | Mar 2022 → Mar 2025 | — | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04809467 | Sep 2021 → Oct 2024 | B-cell chronic lymphocytic leukemia | Incyte Corporation | Terminated | No outcome recorded |
| Phase 1/2 | NCT04661007 | Dec 2020 → Jul 2025 overdue | diffuse large B-cell lymphoma | Incyte Biosciences Japan GK | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02018861 | Sep 2016 → Apr 2021 | B-cell neoplasm | Incyte Corporation | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT05073250 | Dec 2021 → Dec 2023 | indolent B-cell non-Hodgkin lymphoma | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04434937 | Sep 2020 → Feb 2023 | lymphoma | Incyte Biosciences Japan GK | Completed | No outcome recorded |
| Phase 2 | NCT04509700 | Aug 2020 → Nov 2026 expected | B-cell neoplasm | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04298879 | Apr 2020 → Jul 2021 | indolent B-cell non-Hodgkin lymphoma | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03780166 | Mar 2019 → Nov 2020 | pemphigus vulgaris | Incyte Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT03627065 | Feb → Dec 2019 | Sjogren syndrome | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03538041 | Nov 2018 → Aug 2021 | autoimmune hemolytic anemia | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03126019 | Mar 2018 → Feb 2021 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03144674 | Dec 2017 → Jan 2021 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03235544 | Nov 2017 → Apr 2024 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02998476 | Mar 2017 → Feb 2019 | lymphoma | Incyte Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02718300 | Feb 2017 → Jan 2021 | myeloproliferative neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04796922 | Dec 2022 → Dec 2028 | follicular lymphoma, marginal zone lymphoma | Incyte Corporation | Withdrawn | No outcome recorded |
| Phase 3 | NCT05073458 | Mar 2022 → Oct 2023 | autoimmune hemolytic anemia, warm type | Incyte Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT04551053 | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT04551066 | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02265510 Background | Sep 2014 → Feb 2019 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04849715 Comparator | Mar 2022 → Aug 2030 | mantle cell lymphoma | Incyte Corporation | Withdrawn | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-03-03 | Incyte Corporation | Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis incyte.com ↗ |
| 2022-01-25 | Incyte Corporation | Incyte Provides Update on Parsaclisib and MCLA-145 incyte.com ↗ |
| 2021-12-11 | Incyte Corporation | Incyte Announces Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas incyte.com ↗ |
| 2021-11-01 | Incyte Corporation | Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas incyte.com ↗ |
| 2020-12-07 | Incyte Corporation | Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas incyte.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | parsaclisib | “parsaclisib compared with placebo” NCT05073458 ↗28 |
| Known as | IBI376 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04298879 ↗ |
| Known as | INCB050465 | “IBI376 (INCB050465) is a second generation, effective and highly selective PI3Kδ inhibitor.” NCT05073250 ↗ |
| Known as | INCB050465 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297615 ↗ |
| Known as | INCB50465 | “Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP)” NCT04323956 ↗ |
| Known as | PARSACLISIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297615 ↗ |
| Action | Inhibit | “Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.” NCT02018861 ↗ |
| Modality | Small molecule | — CHEMBL4297615 ↗ |
| Route | Oral | “as an oral tablet once a day (QD)” NCT02018861 ↗ |
| Target | PIK3CD | “parsaclisib (selective phosphoinositide 3-kinase δ inhibitor)” PMID 39435908 ↗ Oct 2024 |