drugset

Drugs / Zandelisib

Follow last change Jan 2025 re-read 9 days ago

Zandelisib

also known as ME-401 · ACC-524 · PW-143 · PWT-143

Small molecule targets PIK3CD via inhibition

Developed for: follicular lymphoma · marginal zone lymphoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · indolent B-cell non-Hodgkin lymphoma · diffuse large B-cell lymphoma · high grade B-cell lymphoma · mantle cell lymphoma
Investigated by: MEI Pharma, Inc. · Kyowa Kirin, Inc. · Case Comprehensive Cancer Center · Deepa Jagadeesh · Jacob Soumerai, MD · Quotient Clinical

Trials 9

today NCT05604417 · Ph 1/2 NCT05209308 · Ph 2 NCT04745832 · Ph 3 NCT04517435 · Ph 1/2 NCT04533581 · Ph 2 NCT03768505 · Ph 2 NCT03985189 · Ph 1 NCT02914938 · Ph 1 NCT02521389 · Ph 1

2016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
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Phase 1/2	NCT05604417	Jan 2023 → Dec 2024	follicular lymphoma	Jacob Soumerai, MD	Withdrawn	No outcome recorded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 Stop: Business
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Phase 2	NCT05209308	Nov 2022 → Mar 2023	chronic lymphocytic leukemia/small lymphocytic lymphoma	MEI Pharma, Inc.	Withdrawn	No outcome recorded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

News releases announcing trial results or a regulatory action · 6

Date	Issuer	Release
2022-06-10	Kyowa Kirin, Inc.	Results MEI Pharma and Kyowa Kirin Report Clinical Data on Zandelisib at European Hematology Association 2022 Hybrid Congress - Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate - - 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of Complete Responses in first four cycles - - 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - Primarily, Grade 3 AESIs to Date Occurred in Cycles 1-3. - kyowakirin.com ↗
2022-06-05	Kyowa Kirin, Inc.	Results MEI Pharma and Kyowa Kirin Report New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2022 - Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate - - 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of CRs in First Four Cycles - - 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - 83% Reported Grade 3 Adverse Events of Special Interest in Cycles 1-3 - kyowakirin.com ↗
2022-03-25	Kyowa Kirin, Inc.	Regulatory MEI Pharma and Kyowa Kirin Provide Regulatory Update on Zandelisib Following Meeting with the FDA - MEI to Host Zandelisib Program Update Webcast Today at 4:30 p.m. Eastern Time - kyowakirin.com ↗ In the meeting, the FDA informed the companies of its position that a randomized trial is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib.
2021-11-30	Kyowa Kirin, Inc.	Results MEI Pharma and Kyowa Kirin Announce Data From the Ongoing Global Phase 2 TIDAL Study Evaluating Zandelisib as a Single Agent in Patients with Relapsed or Refractory Follicular Lymphoma - Zandelisib Demonstrated 70.3% Objective Response Rate; 35.2% Achieved Complete Response - -9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - MEI to Host Webcast Today at 8:00am Eastern Time - kyowakirin.com ↗ In addition, 35.2% of patients achieved a complete response.
2021-05-20	Kyowa Kirin, Inc.	Results MEI Pharma and Kyowa Kirin Announce New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2021 –Zandelisib, an investigational agent, +/- rituximab demonstrated 82% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) who had progression of disease within 24 months of first line chemoimmunotherapy (POD24); overall response rate of 93% in non-POD24– –An 8% discontinuation rate was observed in the combined study population– –Zandelisib and zanubrutinib combination therapy demonstrated 100% response rate in patients with r/r indolent B-cell malignancies; combination administered on an optimized dosing regimen with no additive toxicity to each agent alone– –Trial design for Phase 3 COASTAL study, intended to act as the required confirmatory study for the potential U.S. accelerated approval of zandelisib, will also be featured in a poster– kyowakirin.com ↗
2020-05-14	Kyowa Kirin, Inc.	Results MEI Pharma and Kyowa Kirin Announce Updated Clinical Data from the Phase 1b Study Evaluating ME-401 on an Intermittent Schedule in Patients with Follicular Lymphoma and Other B-cell Malignancies; Data to be Featured in the American Society of Clinical Oncology 2020 Virtual Scientific Program– 83% overall response rate in patients with relapsed or refractory follicular lymphoma – – Median duration of response in follicular lymphoma patients not reached across all patient subsets analyzed – – Remains generally well-tolerated with 7% discontinuation rate due to adverse events in this study – kyowakirin.com ↗ These new data evaluating patients on an intermittent dosing schedule of ME-401 show that treatment was generally well tolerated with an 83% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) (n=36).

All press releases naming this drug 12 releases

Date	Issuer	Release
2022-06-10	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Report Clinical Data on Zandelisib at European Hematology Association 2022 Hybrid Congress - Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate - - 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of Complete Responses in first four cycles - - 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - Primarily, Grade 3 AESIs to Date Occurred in Cycles 1-3. - kyowakirin.com ↗
2022-06-05	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Report New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2022 - Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate - - 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of CRs in First Four Cycles - - 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - 83% Reported Grade 3 Adverse Events of Special Interest in Cycles 1-3 - kyowakirin.com ↗
2022-03-25	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Provide Regulatory Update on Zandelisib Following Meeting with the FDA - MEI to Host Zandelisib Program Update Webcast Today at 4:30 p.m. Eastern Time - kyowakirin.com ↗
2021-11-30	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce Data From the Ongoing Global Phase 2 TIDAL Study Evaluating Zandelisib as a Single Agent in Patients with Relapsed or Refractory Follicular Lymphoma - Zandelisib Demonstrated 70.3% Objective Response Rate; 35.2% Achieved Complete Response - -9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event - - MEI to Host Webcast Today at 8:00am Eastern Time - kyowakirin.com ↗
2021-08-17	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce First Patient Dosed in the Phase 3 COASTAL Study Evaluating Zandelisib Plus Rituximab in Relapsed or Refractory Indolent Non Hodgkin’s B-cell Lymphoma -COASTAL is intended to support FDA and global marketing approvals in patients with relapsed or refractory follicular or marginal zone lymphomas who have received at least one prior line of treatment - kyowakirin.com ↗
2021-05-20	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2021 –Zandelisib, an investigational agent, +/- rituximab demonstrated 82% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) who had progression of disease within 24 months of first line chemoimmunotherapy (POD24); overall response rate of 93% in non-POD24– –An 8% discontinuation rate was observed in the combined study population– –Zandelisib and zanubrutinib combination therapy demonstrated 100% response rate in patients with r/r indolent B-cell malignancies; combination administered on an optimized dosing regimen with no additive toxicity to each agent alone– –Trial design for Phase 3 COASTAL study, intended to act as the required confirmatory study for the potential U.S. accelerated approval of zandelisib, will also be featured in a poster– kyowakirin.com ↗
2020-10-02	Kyowa Kirin, Inc.	Kyowa Kirin and MEI Pharma Announce First Patient Dosed in Japanese Pivotal Phase 2 Study of Zandelisib in Patients with Indolent B-cell non-Hodgkin's Lymphoma kyowakirin.com ↗
2020-05-15	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce ME-401 Phase 1b Study to be Highlighted in a Presentation at the Virtual Edition of the 25th European Hematology Association Annual Congress kyowakirin.com ↗
2020-05-14	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce Updated Clinical Data from the Phase 1b Study Evaluating ME-401 on an Intermittent Schedule in Patients with Follicular Lymphoma and Other B-cell Malignancies; Data to be Featured in the American Society of Clinical Oncology 2020 Virtual Scientific Program– 83% overall response rate in patients with relapsed or refractory follicular lymphoma – – Median duration of response in follicular lymphoma patients not reached across all patient subsets analyzed – – Remains generally well-tolerated with 7% discontinuation rate due to adverse events in this study – kyowakirin.com ↗
2020-04-14	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Kirin Announce Global License, Development and Commercialization Agreement for ME-401 kyowakirin.com ↗
2018-11-05	Kyowa Kirin, Inc.	MEI Pharma and Kyowa Hakko Kirin Announce License Agreement to Develop and Commercialize ME-401 in JapanMEI to Receive $10 Million Upfront Payment, Plus Milestones and Tiered Royalty Payments kyowakirin.com ↗
2018-10-12	BeOne Medicines	MEI Pharma and BeiGene Announce Clinical Collaboration to Evaluate ME-401 in Combination with Zanubrutinib in Patients with B-Cell Malignancies beonemedicines.com ↗

Evidence & citations 9 cited values

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

Field	Value	Cited 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 NCT05209308 ↗ NCT05604417 ↗ NCT04745832 ↗ NCT03768505 ↗
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 ↗