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DRUG:

Nailike (olverembatinib)

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Other names: APG1351, D 824, GZD 824, HQP 1351, IBI 348, HQP1351, APG-1351, APG 1351, HQP1351, GZD824, D824, IBI-348, D-824, GZD-824, HQP-1351, IBI348
Company:
Ascentage Pharma, Innovent Biologics, Takeda
Drug class:
Bcr-abl inhibitor
4d
New P2 trial
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
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Besponsa (inotuzumab ozogamicin) • Nailike (olverembatinib)
10d
Olverembatinib and high-dose methotrexate in acute lymphoblastic leukemia: delayed methotrexate clearance and increased nephrotoxicity. (PubMed, Leuk Lymphoma)
Flumatinib likewise lowered MTX clearance and raised ≥ grade 2 nephrotoxicity to 29.4%, yet neither effect reached statistical significance. Temporary withdrawal of olverembatinib before HD-MTX infusion may prevent MTX-related nephrotoxicity.
Journal
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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methotrexate • Nailike (olverembatinib) • Hansoh Xinfu (flumatinib) • methotrexate IV
1m
New trial
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ABL1 (ABL proto-oncogene 1)
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Nailike (olverembatinib)
1m
Advances and Controversies in the Management of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Navigating First-Line Therapies. (PubMed, Curr Hematol Malig Rep)
Successive generations of TKIs have transformed Ph + ALL from a uniformly fatal leukemia into a highly treatable disease, with dasatinib or ponatinib-based and TKI-blinatumomab regimens achieving high rates of complete molecular remission...Novel agents, including asciminib and olverembatinib, are expanding options for resistant or relapsed disease, while CAR-T cell therapy and next-generation bispecific T-cell engagers are emerging as promising tools for refractory and post-TKI settings...Integrating potent TKIs with immunotherapy enables deep and durable remissions, potentially eliminating the need for upfront transplantation in selected patients. Future research should define molecular predictors of treatment-free remission, optimize CNS prophylaxis in targeted regimens, and establish standardized monitoring for safe TKI discontinuation.
Review • Journal • IO biomarker
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IKZF1 (IKAROS Family Zinc Finger 1)
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dasatinib • Iclusig (ponatinib) • Blincyto (blinatumomab) • Scemblix (asciminib) • Nailike (olverembatinib)
1m
Observational Study on Dose Optimization of Olverembatinib in Patients with Chronic Myeloid Leukemia in Chronic or Accelerated Phase (ChiCTR2500115245)
P=N/A, N=100, Not yet recruiting, Peking University People's Hospital; Peking University People's Hospital
New trial
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ABL1 (ABL proto-oncogene 1)
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Nailike (olverembatinib)
1m
VOP regimen for the treatment of adult de novo Ph+ B/myeloid mixed phenotype acute leukemia (ChiCTR2500112802)
P2, N=10, Not yet recruiting, The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University
New P2 trial
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Venclexta (venetoclax) • Nailike (olverembatinib)
1m
Advances in Targeting BCR-ABLT315I Mutation with Imatinib Derivatives and Hybrid Anti-Leukemic Molecules. (PubMed, Molecules)
Combination strategies, such as vorinostat with ponatinib, provide complementary therapeutic avenues...Hybrid molecules derived from approved TKIs, including GNF-7, olverembatinib, and HG-7-85-01, exemplify rational design trends that balance efficacy with improved safety. Molecular modeling continues to deepen understanding of ligand engagement within the T315I-mutated active site, supporting the development of next-generation inhibitors. In this review, we summarized recent progress in the design, optimization, and biological evaluation of small molecules targeting the BCR-ABLT315I mutation.
Review • Journal
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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imatinib • Iclusig (ponatinib) • Zolinza (vorinostat) • Nailike (olverembatinib)
2ms
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (clinicaltrials.gov)
P2, N=50, Recruiting, M.D. Anderson Cancer Center | Initiation date: Jul 2026 --> Oct 2025 | Not yet recruiting --> Recruiting
Enrollment open • Trial initiation date
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ABL1 (ABL proto-oncogene 1)
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Nailike (olverembatinib)
2ms
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment (clinicaltrials.gov)
P1, N=48, Recruiting, Ascentage Pharma Group Inc. | Not yet recruiting --> Recruiting
Enrollment open
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Nailike (olverembatinib)
3ms
New P1 trial
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Nailike (olverembatinib)
3ms
Overcoming Multidrug Resistance in Cancer Cells Targeting ABC Transporter ABCB1 with Tyrosine Kinase Inhibitor: Olverembatinib. (PubMed, Exp Cell Res)
Non-cytotoxic concentrations of olverembatinib significantly increased the sensitivity of ABCB1-overexpressing cells to paclitaxel and vincristine. Additionally, olverembatinib activated the ATPase activity of ABCB1 in a concentration-dependent manner and exhibited potent binding affinity to ABCB1 in docking simulations. These findings suggest that olverembatinib holds promise as a potent reversal agent for MDR, paving the way for its integration into novel combination chemotherapy regimens to improve cancer treatment outcomes.
Journal
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ABCB1 (ATP Binding Cassette Subfamily B Member 1)
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paclitaxel • vincristine • Nailike (olverembatinib)
3ms
Olverembatinib for 8p11 myeloproliferative syndrome with a positive BCR-FGFR1 fusion gene: a case report. (PubMed, Ann Hematol)
The treatment safety of the entire process was excellent. In summary, olverembatinib provides more treatment options for rare diseases such as 8p11 myeloproliferative syndrome.
Journal
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BCR (BCR Activator Of RhoGEF And GTPase) • FGFR1 (Fibroblast growth factor receptor 1)
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Nailike (olverembatinib)