Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 3 evaluate parsaclisib as both monotherapy and combination regimens across oncology and autoimmune indications, including follicular lymphoma, peripheral T-cell lymphoma, myelofibrosis, triple-negative breast cancer, and warm autoimmune hemolytic anemia. Sponsored by pharmaceutical entities such as Incyte Corporation and Innovent Biologics alongside academic medical centers like Fudan University and the Mayo Clinic, these protocols encompass active, completed, terminated, and withdrawn statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04849715 WITHDRAWN
Mantle Cell Lymphoma
Incyte Corporation
 2022-03-11 PHASE3
NCT05867030 WITHDRAWN
Follicular Lymphoma
Innovent Biologics (Suzhou) Co. Ltd.
 2023-07-28 PHASE1
NCT04796922 WITHDRAWN
Follicular Lymphoma ( FL); Marginal Zone Lymphoma (MZL)
Incyte Corporation
 2022-12-30 PHASE3
NCT04509700 ACTIVE_NOT_RECRUITING
B-Cell Malignancies
Incyte Corporation
 2020-08-03 PHASE2
NCT04661007 ACTIVE_NOT_RECRUITING
Non Hodgkins Lymphoma; Diffuse Large B-cell Lymphoma
Incyte Biosciences Japan GK
 2020-12-15 PHASE1; PHASE2
NCT05238064 UNKNOWN
PI3Kδ Inhibitor; Parsaclisib; CHOP; PTCL
Fudan University
 2022-03 PHASE1; PHASE2
NCT04774068 COMPLETED
Recurrent Anaplastic Large Cell Lymphoma; Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Recurrent Transformed Mycosis Fungoides; Refractory Anaplastic Large Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Transformed Mycosis Fungoides; T-Cell Non-Hodgkin Lymphoma
Walter Hanel
 2021-09-01 PHASE1
NCT04809467 TERMINATED
Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma
Incyte Corporation
 2021-09-16 PHASE1; PHASE2
NCT05083208 TERMINATED
Peripheral T-Cell Lymphoma
Henan Cancer Hospital
 2022-02-20 PHASE1
NCT03235544 COMPLETED
Lymphoma
Incyte Corporation
 2017-11-20 PHASE2
NCT05073458 TERMINATED
Warm Autoimmune Hemolytic Anemia (wAIHA)
Incyte Corporation
 2022-03-15 PHASE3
NCT04323956 ACTIVE_NOT_RECRUITING
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma; Ann Arbor Stage II Follicular Lymphoma; Ann Arbor Stage II Marginal Zone Lymphoma; Ann Arbor Stage III Diffuse Large B-Cell Lymphoma; Ann Arbor Stage III Follicular Lymphoma; Ann Arbor Stage III Marginal Zone Lymphoma; Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma; Ann Arbor Stage IV Follicular Lymphoma; Ann Arbor Stage IV Marginal Zone Lymphoma; Diffuse Large B-Cell Lymphoma; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements; High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements; Indolent Non-Hodgkin Lymphoma
Mayo Clinic
 2020-06-15 PHASE1
NCT04551053 TERMINATED
Myelofibrosis; Primary Myelofibrosis; Post Essential Thrombocythemia Myelofibrosis; Post Polycythemia Vera Myelofibrosis
Incyte Corporation
 2021-05-26 PHASE3
NCT04551066 TERMINATED
Myelofibrosis; Primary Myelofibrosis; Post Essential Thrombocythemia Myelofibrosis; Post Polycythemia Vera Myelofibrosis
Incyte Corporation
 2021-05-24 PHASE3
NCT04434937 COMPLETED
Lymphoma
Incyte Biosciences Japan GK
 2020-09-30 PHASE2
NCT03589651 COMPLETED
Unresectable or Metastatic Solid Tumors
Incyte Corporation
 2018-08-17 PHASE1
NCT04831996 COMPLETED
Advanced Malignancies
Incyte Corporation
 2021-05-04 PHASE1
NCT03424122 COMPLETED
B-cell Lymphoma
Incyte Corporation
 2018-07-02 PHASE1
NCT04831944 COMPLETED
Advanced Malignancies
Incyte Corporation
 2021-03-29 PHASE1
NCT03538041 COMPLETED
Autoimmune Hemolytic Anemia
Incyte Corporation
 2018-11-21 PHASE2
NCT02018861 COMPLETED
B-Cell Malignancies
Incyte Corporation
 2016-09-22 PHASE1; PHASE2
NCT03039114 COMPLETED
Lymphoma
Incyte Corporation
 2017-02-15 PHASE1
NCT03126019 COMPLETED
Lymphoma
Incyte Corporation
 2018-03-14 PHASE2
NCT02718300 TERMINATED
MPN (Myeloproliferative Neoplasms)
Incyte Corporation
 2017-02-08 PHASE2
NCT03144674 COMPLETED
Lymphoma
Incyte Corporation
 2017-12-18 PHASE2
NCT03780166 WITHDRAWN
Pemphigus Vulgaris
Incyte Corporation
 2019-03 PHASE2
NCT04142554 WITHDRAWN
Breast Cancer; Breast Neoplasms; Triple Negative Breast Cancer; HER2-positive Breast Cancer
UNC Lineberger Comprehensive Cancer Center
 2020-06-01 PHASE1
NCT03688152 COMPLETED
Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma
Incyte Corporation
 2018-12-03 PHASE1
NCT03314922 COMPLETED
Lymphoma
Incyte Corporation
 2018-08-02 PHASE1
NCT03627065 COMPLETED
Primary Sjögren's Syndrome
Incyte Corporation
 2019-02-28 PHASE2
NCT02646748 COMPLETED
Colorectal Cancer (CRC); Endometrial Cancer; Melanoma; Head and Neck Cancer; Lung Cancer; MMR-deficient Tumors; Breast Cancer; Pancreatic Cancer; Renal Cell Carcinoma (RCC); Solid Tumors; UC (Urothelial Cancer)
Incyte Corporation
 2016-01-25 PHASE1
NCT02265510 TERMINATED
Solid Tumors; Advanced Malignancies; Metastatic Cancer
Incyte Corporation
 2014-09-10 PHASE1; PHASE2
NCT02998476 COMPLETED
Lymphoma
Incyte Corporation
 2017-03-02 PHASE2
NCT02559492 TERMINATED
Solid Tumors
Incyte Corporation
 2015-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2022-04-29)

Check the Parsaclisib (INCB050465) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Parsaclisib functions as a potent and highly selective inhibitor of phosphoinositide 3-kinase delta (PI3Kδ) that binds the enzyme's ATP-binding pocket, thereby inhibiting downstream AKT kinase activation and blocking essential intracellular signaling cascades. This molecular inhibition impairs aberrant cellular proliferation and promotes apoptosis in target immune and neoplastic cells, providing the therapeutic rationale for its clinical investigation in T-cell non-Hodgkin lymphomas, myelofibrosis, and autoimmune hemolytic anemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.