Drugs / AMDIZALISIB
last change Dec 2024 re-read 9 days ago

AMDIZALISIB

also known as HMPL-689

Small molecule

Developed for
lymphoma · follicular lymphoma · marginal zone lymphoma
Investigated by
Hutchison Medipharma Limited · Hutchmed

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT03786926 Aug 2019 → Jun 2024 lymphoma Hutchmed Terminated No outcome recorded Stop: Business
Phase 1 NCT03128164 Aug 2017 → Aug 2023 lymphoma Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT02631642 Mar → Oct 2016 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT05713110 Feb 2023 → Dec 2024 lymphoma Hutchmed Completed No outcome recorded
Phase 2 NCT04849351 Apr 2021 → Feb 2024 follicular lymphoma, marginal zone lymphoma Hutchison Medipharma Limited Completed Met primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2023-06-09 Hutchison Medipharma Limited Results HUTCHMED Highlights Presentations for Hematological Malignancy Programs at the 2023 EHA and ICML Meetings hutch-med.com ↗
Median duration of response (“DoR”) and progression free survival (“PFS”) were not reached for the 26 efficacy evaluable patients in the FL cohort.
2021-09-13 Hutchison Medipharma Limited Regulatory HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma hutch-med.com ↗
The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor.

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as AMDIZALISIB ChEMBL registry synonym — accepted as the source's own label CHEMBL4438249 ↗
Known as HMPL-689 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04849351 ↗
4

NCT02631642 ↗

NCT03128164 ↗

NCT03786926 ↗

NCT05713110 ↗

Action Inhibit “selective PI3Kδ inhibitor” NCT02631642 ↗
Modality Small molecule “selective and potent small molecule inhibitor” NCT03786926 ↗
Route Oral “single oral doses of HMPL-689” NCT02631642 ↗