Clinical Trials

Zandelisib has been evaluated in multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 for various B-cell hematologic malignancies, including follicular, marginal zone, mantle cell, and diffuse large B-cell lymphomas, as well as chronic lymphocytic leukemia. Sponsored by MEI Pharma, Inc., Kyowa Kirin Co. Ltd., and academic investigators, these studies assess both monotherapy and combination regimens, such as zandelisib paired with rituximab. Across the trial portfolio, recruitment statuses range from active not recruiting to terminated and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05604417 WITHDRAWN
Relapsed Follicular Lymphoma; Refractory Follicular Lymphoma
Jacob Soumerai, MD
 2023-01 PHASE1; PHASE2
NCT03768505 TERMINATED
Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MEI Pharma, Inc.
 2019-06-25 PHASE2
NCT04745832 TERMINATED
Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MEI Pharma, Inc.
 2021-08-13 PHASE3
NCT05209308 WITHDRAWN
CLL
MEI Pharma, Inc.
 2022-11-22 PHASE2
NCT04533581 Active not recruiting
Indolent B-cell Non-Hodgkin''s Lymphoma
Kyowa Kirin Co. Ltd.
 2020-09-17 Phase 2
NCT03768505 Terminated
Follicular Lymphoma (FL)|Non Hodgkin Lymphoma|Marginal Zone Lymphoma
MEI Pharma Inc.
 2019-06-25 Phase 2
NCT03985189 Active not recruiting
Relapsed or Refractory Indolent B-cell Non-Hodgkin''s Lymphoma
Kyowa Kirin Co. Ltd.
 2019-04-29 Phase 1
NCT02914938 Terminated
Chronic Lymphocytic Leukemia (CLL)|Small Lymphocytic Lymphoma (SLL)|Follicular Lymphoma (FL)|Marginal Zone B Cell Lymphoma|Diffuse Large B-cell Lymphoma (DLBCL)|High Grade Non-Hodgkin''s Lymphoma|Mantle Cell Lymphoma (MCL)
MEI Pharma Inc.
 2016-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2023-07-07)

Check the Zandelisib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zandelisib is a potent and selective inhibitor of the phosphatidylinositol 3-kinase delta (PI3Kδ) isoform that inhibits the downstream activation of the PI3K/AKT signaling pathway with an IC50 of 3.5 nM. By disrupting this oncogenic signaling cascade, the compound suppresses tumor cell proliferation and induces apoptosis, driving its clinical evaluation for B-cell malignancies including follicular lymphoma and marginal zone lymphoma.

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.