Drugs / Parsaclisib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed follicular lymphoma, susceptibility to 2 milestones | |||||
| Filed | China (NMPA) | — | follicular lymphoma, susceptibility to | 2023-01-06 | “The NDA for parsaclisib in China was accepted and granted Priority Review designation” innoventbio.com ↗ |
| Filed | US (FDA) | — | follicular lymphoma, susceptibility to | 2021-11-01 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib” incyte.com ↗ |
| Filed marginal zone lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | marginal zone lymphoma | — | “An MAA submission for parsaclisib in MZL is under review with the EMA.” incyte.com ↗ |
Trials 32
| 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 | Withdrawn | No outcome recorded Stop: Business |
| 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2020 | HER2 positive breast carcinoma, triple-negative breast carcinoma | UNC Lineberger Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| 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 Stop: Enrollment |
| 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 210 trials · 1 missed | ||||||
| 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 | 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 | Missed primary Stop: Enrollment |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT04796922 | Dec 2022 → Dec 2028 | follicular lymphoma, marginal zone lymphoma | Incyte Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05073458 | Mar 2022 → Oct 2023 | autoimmune hemolytic anemia, warm type | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04551053 | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | Missed primary |
| Phase 3 | NCT04551066 | May 2021 → Aug 2023 | myelofibrosis, primary myelofibrosis | Incyte Corporation | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT02265510 Background | Sep 2014 → Feb 2019 | metastatic malignant neoplasm | Incyte Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT04849715 Comparator | Mar 2022 → Aug 2030 | mantle cell lymphoma | Incyte Corporation | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-05-02 | Incyte Corporation | Results Incyte Reports 2023 First Quarter Financial Results and Provides Updates on Key Clinical Programs incyte.com ↗
Furthermore, in Q1 we made a decision to focus our development efforts on eight programs that have high potential value for us and discontinued six other programs. |
| 2023-03-03 | Incyte Corporation | Results Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis incyte.com ↗
Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study |
| 2023-01-06 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the National Medical Products Administration in China Has Accepted and Granted Priority Review Designation to the New Drug Application for Parsaclisib (PI3Kδ inhibitor) for the Treatment of Relapsed or Refractory Follicular Lymphoma innoventbio.com ↗
The acceptance and Priority Review designation for this NDA are based on the results from a multi-center, single-arm, open-label pivotal Phase II study conducted in China (NCT04298879), most recently presented at the 2022 American Society of Clinical Oncology (ASCO) meeting. |
| 2022-12-10 | Incyte Corporation | Results Incyte Announces Data from Two LIMBER Studies Evaluating Combination Treatments in Patients with Myelofibrosis (MF) Presented at ASH 2022 incyte.com ↗
Phase 2 data demonstrate that the addition of parsaclisib to ruxolitinib (Jakafi®) resulted in spleen volume reduction and improvement in symptom burden in patients with myelofibrosis (MF) |
| 2022-01-25 | Incyte Corporation | Regulatory Incyte Provides Update on Parsaclisib and MCLA-145 incyte.com ↗
Incyte is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). |
| 2021-12-14 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Pivotal Phase 2 Results for Parsaclisib (PI3Kδ inhibitor) Presented at ASH 2021 Show Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma innoventbio.com ↗
In 24 evaluable patients with r/r FL, ORR is 91.7% (95%CI : 73%, 99%), Complete Response(CR) is 16.7%, and Partial Response (PR) is 75%. |
| 2021-12-11 | Incyte Corporation | Results 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 | Regulatory Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). |
| 2021-03-31 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces Parsaclisib (IBI376) was Granted Breakthrough Therapy Designation by the NMPA for the Treatment of Relapsed/Refractory Follicular Lymphoma innoventbio.com ↗ |
| 2020-12-08 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas innoventbio.com ↗
Parsaclisib was generally well tolerated in all studies with a manageable safety profile. |
| 2020-12-07 | Incyte Corporation | Results 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 ↗
Parsaclisib was generally well tolerated in all studies with a manageable safety profile. |
| 2015-04-17 | Incyte Corporation | Results Incyte’s Emerging Development Pipeline Described in Eleven Abstracts at 2015 AACR Annual Meeting incyte.com ↗
INCB050465, a novel PI3Kδ inhibitor, synergizes with PIM protein kinase inhibition to cause tumor regression in a model of DLBCL. |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Parsaclisib | “parsaclisib compared with placebo” NCT05073458 ↗ |
| Known as | INCB050465 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03688152 ↗ |
| Known as | INCB50465 | “Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP)” NCT04323956 ↗ |
| Action | Inhibit | “Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.” NCT02018861 ↗ |
| Route | Oral | “as an oral tablet once a day (QD)” NCT02018861 ↗ |
| Target | PIK3CD | “parsaclisib (selective phosphoinositide 3-kinase δ inhibitor)” PMID 39435908 ↗ Oct 2024 |