Drugs / Olverembatinib
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Olverembatinib

Small molecule targets ABL1, FGFR1 via inhibition

Developed for
chronic myeloid leukemia · B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) · acute lymphoblastic leukemia · precursor B-cell acute lymphoblastic leukemia · acute leukemia · adult acute lymphoblastic leukemia · childhood acute lymphoblastic leukemia · gastrointestinal stromal tumor
+7 more · Philadelphia-positive myelogenous leukemia · acute myeloid leukemia · blast phase chronic myelogenous leukemia, BCR-ABL1 positive · cancer · myeloproliferative neoplasm · phosphohydroxylysinuria · precursor lymphoblastic lymphoma/leukemia
Investigated by
Ascentage Pharma Group Inc. · Institute of Hematology & Blood Diseases Hospital, China · HealthQuest Pharma Inc. · M.D. Anderson Cancer Center · Nanfang Hospital, Southern Medical University · The First Affiliated Hospital of Soochow University
+12 more · Guangzhou Healthquest Pharma Co., Ltd · Amgen · Chen Suning · First Affiliated Hospital of Zhejiang University · Fundamenta Therapeutics, Ltd. · Guangdong Second Provincial General Hospital · Shenzhen Second People's Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Suzhou Yasheng Pharmaceutical Co., Ltd. · Third Affiliated Hospital, Sun Yat-Sen University · Xijing Hospital · xuna

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07074496 Jan 2024 → Nov 2025 overdue B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 17 trials
Phase 1 NCT07282093 Nov 2025 → Jun 2026 overdue Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1 NCT06401603 Aug 2024 → Jan 2027 expected Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT05495035 Sep 2022 → Aug 2024 B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), childhood acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
Phase 1 NCT04260022 Jan 2020 → Dec 2029 expected chronic myeloid leukemia, precursor B-cell acute lymphoblastic leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1 NCT04126707 Nov 2019 → Jan 2020 chronic myeloid leukemia Ascentage Pharma Group Inc. Completed No outcome recorded
Phase 1 NCT03882281 Mar → Nov 2019 chronic myeloid leukemia Ascentage Pharma Group Inc. Completed No outcome recorded
Phase 1 NCT03594422 Jul 2018 → Dec 2027 expected cancer, gastrointestinal stromal tumor Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06757855 Jan 2025 → Dec 2026 expected blast phase chronic myelogenous leukemia, BCR-ABL1 positive Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 1/2 NCT06082934 Nov 2023 → Nov 2026 expected acute lymphoblastic leukemia Xijing Hospital Recruiting No outcome recorded
Phase 1/2 NCT04501120 Sep 2020 → Sep 2028 expected acute myeloid leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 215 trials
Phase 2 NCT07178912 Aug 2026 → Sep 2031 expected acute leukemia, precursor lymphoblastic lymphoma/leukemia M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 2 NCT07443488 Mar 2026 → Oct 2027 expected acute lymphoblastic leukemia, disease related to hematopoietic stem cell transplant Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT06817720 Oct 2025 → Mar 2027 expected chronic myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06754267 Dec 2024 → Dec 2025 overdue precursor B-cell acute lymphoblastic leukemia First Affiliated Hospital of Zhejiang University Recruiting No outcome recorded
Phase 2 NCT06658925 Nov 2024 → Aug 2027 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT06220487 Feb 2024 → Dec 2025 overdue B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), Philadelphia-positive myelogenous leukemia, adult acute lymphoblastic leukemia Nanfang Hospital, Southern Medical University Recruiting No outcome recorded
Phase 2 NCT05931757 Jul 2023 → Jun 2025 overdue B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) The First Affiliated Hospital of Soochow University Not yet recruiting No outcome recorded
Phase 2 NCT05594784 Oct 2022 → Mar 2025 B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Completed No outcome recorded
Phase 2 NCT05466175 Oct 2022 → Sep 2023 B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Chen Suning Unknown No outcome recorded
Phase 2 NCT05521204 Sep 2022 → Aug 2024 overdue acute leukemia, myeloproliferative neoplasm The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT07152041 Mar 2025 → Dec 2029 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), childhood acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 3 NCT06640361 Nov 2024 → Mar 2027 expected gastrointestinal stromal tumor Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT06423911 Feb 2024 → Dec 2025 overdue chronic myeloid leukemia Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT06051409 Aug 2023 → Dec 2027 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT05311943 Jul 2022 → Jun 2024 chronic myeloid leukemia Shenzhen Second People's Hospital Unknown No outcome recorded
Phase not applicable3 trials
NCT07454226 May 2026 → Mar 2028 expected acute lymphoblastic leukemia, phosphohydroxylysinuria Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
NCT06481228 Jun 2024 → Jun 2026 overdue adult acute lymphoblastic leukemia, precursor B-cell acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
NCT05603156 Oct 2022 → Jul 2024 B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Unknown No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase not applicable1 trial
NCT07493161 Background Apr 2026 → Mar 2028 expected B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase not stated1 trial
NCT05594758 Background Ascentage Pharma Group Inc. Available No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 35 sources stand behind the page.

FieldValueCited text
Known as olverembatinib Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label,...” PMID 35982483 Aug 2022
29

Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia” PMID 35982483 Aug 2022

NCT06423911

NCT05495035

NCT06481228

NCT06401603

NCT06220487

NCT05466175

NCT05594784

NCT05594758

NCT07152041

NCT07178912

NCT07282093

NCT06051409

NCT06082934

NCT06757855

NCT07493161

NCT07454226

NCT07074496

NCT06658925

NCT05376852

NCT05931757

NCT05603156

NCT06817720

NCT04501120

NCT06754267

NCT06640361

NCT05311943

NCT05521204

NCT07443488

Known as [14C] HQP1351 “A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in...” NCT04126707
Known as D-824 ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582
Known as D-824 DIMESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582
Known as GZD-824 ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582
Known as GZD-824 DIMESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582
Known as HQP-1351 DIMESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL2316582
Known as HQP1351 “This phase II trial studies how well the combination of based decitabine and olverembatinib(HQP1351)chemotherapy work for the treatment of blast phase or accelerated phase...” NCT05376852
8

“Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label,...” PMID 35982483 Aug 2022

“This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia” NCT06423911

“Named Patient Program for Olverembatinib (HQP1351)” NCT05594758

NCT04126707

NCT03594422

NCT05604755

NCT03882281

NCT04126681

Known as Olverembatinib dimesylate “HQP1351( Olverembatinib dimesylate)” NCT05604755
Known as OVB “All Ph+-ALL patients will uniformly use the 3rd generation of TKI olverembatinib (OVB) instead of dasatinib throughout the regimen.” NCT07152041
Action Inhibit “Olverembatinib is a new potent BCR-ABL1 TKI” PMID 35982483 Aug 2022
Modality Small molecule “Olverembatinib is a new potent BCR-ABL1 TKI” PMID 35982483 Aug 2022
Route Oral “HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.” NCT03594422
Target ABL1 “Olverembatinib is a new potent BCR-ABL1 TKI with preclinical activity against T315I-mutated CML.” PMID 35982483 Aug 2022