Drugs / Zandelisib

Trials 9 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03985189 Apr 2019 → Jan 2025 indolent B-cell non-Hodgkin lymphoma Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT02914938 Oct 2016 → Mar 2023 chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, high grade B-cell lymphoma, mantle cell lymphoma +1 MEI Pharma, Inc. Terminated No outcome recorded
Phase 1 NCT02521389 Jun 2015 → Feb 2017 cancer MEI Pharma, Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05604417 Jan 2023 → Dec 2024 follicular lymphoma Jacob Soumerai, MD Withdrawn No outcome recorded
Phase 1/2 NCT04517435 Apr 2021 → May 2023 diffuse large B-cell lymphoma Deepa Jagadeesh Terminated No outcome recorded
Phase 23 trials
Phase 2 NCT05209308 Nov 2022 → Mar 2023 chronic lymphocytic leukemia/small lymphocytic lymphoma MEI Pharma, Inc. Withdrawn No outcome recorded
Phase 2 NCT04533581 Sep 2020 → May 2028 expected indolent B-cell non-Hodgkin lymphoma Kyowa Kirin, Inc. Active not recruiting No outcome recorded
Phase 2 NCT03768505 Jun 2019 → Mar 2023 follicular lymphoma, marginal zone lymphoma MEI Pharma, Inc. Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT04745832 Aug 2021 → Mar 2023 follicular lymphoma, marginal zone lymphoma MEI Pharma, Inc. Terminated No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as zandelisib Zandelisib, a selective, potent PI3Kδ inhibitor, demonstrated favourable outcomes in patients with relapsed or refractory follicular lymphoma in a global phase II study.” PMID 39778876 Jan 2025
5

Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study.” PMID 36107394 Sep 2022

NCT03768505

NCT04745832

NCT05209308

NCT05604417

Known as ACC-524 ChEMBL registry synonym — accepted as the source's own label CHEMBL4650214
Known as ME-401 “Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study.” PMID 36107394 Sep 2022
3

“This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma” NCT03768505

NCT02914938

NCT04517435

Known as PW-143 ChEMBL registry synonym — accepted as the source's own label CHEMBL4650214
Known as PWT-143 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02521389
Action Inhibit “PI3-kinase p110-delta subunit inhibitor” CHEMBL4650214
1

“PI3Kδ inhibitor Zandelisib (ME-401)” NCT03768505

Modality Small molecule CHEMBL4650214
Route Oral “will be administered 60 mg of ME-401 orally” NCT03768505
Target PIK3CD “PI3-kinase p110-delta subunit inhibitor” CHEMBL4650214