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Luye

(Olverembatinib)

Phase 3Protein / enzyme

Ascentage Pharma Group Inc.

Olverembatinib is used to treat certain types of lung cancer, specifically non-small cell lung cancer that has specific genetic mutations.[1] Luye is currently being investigated across 12 indications[3], with its most advanced program in Phase 3.[1]

Luye is one of 220 small molecule programs targeting Chronic Myeloid Leukemia. It is currently in Phase 3.

12

Indications

23

Total Trials

19

Active Trials

219

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Myeloid LeukemiaRecruiting

OlverembatinibUnknown status

GISTRecruiting

Ph+ ALLRecruiting

Efficacy and SafetyRecruiting

Newly DiagnosedRecruiting

Hepatic ImpairmentRecruiting

JAK InhibitorNot yet recruiting

PediatricRecruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Chronic Myeloid LeukemiaPhase 2

Recruiting

OlverembatinibPhase 3

Unknown status

GISTPhase 3

Recruiting

Ph+ ALLPreclinical

Recruiting

Efficacy and SafetyPreclinical

Recruiting

Newly DiagnosedPhase 3

Recruiting

Hepatic ImpairmentPhase 1

Recruiting

JAK InhibitorPreclinical

Not yet recruiting

PediatricPhase 3

Recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Novantrone

Xospata

Fludara

Cerubidine

EEastern Cooperative Oncology Group

Vepesid

Mylotarg

WWyeth-Lederle Vaccines

Vanflyta

Neupogen

EEastern Cooperative Oncology Group

Cerubidine

HHikma Pharmaceuticals LLC

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Hepatic Impairment

NCT07282093

Q1 2027

Phase 2Recruiting

Chronic Myeloid Leukemia

NCT06817720

Q3 2027

Phase 2Recruiting

Olverembatinib

NCT05521204

Q4 2027

Efficacy and Safety

NCT06390306

Phase 2Recruiting

Olverembatinib

NCT06754267

Clinical

Trials by Indication[1]

Olverembatinib8 trials

A Study of Olverembatinib in the Treatment of Ph+ ALL

Unknown status·CChen Suning·Phase 2·NCT05466175·55 enrolled

Named Patient Program for Olverembatinib (HQP1351)

Available· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.··NCT05594758

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06754267·36 enrolled

Show 5 more trials

Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06757855·29 enrolled

Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Unknown status·SShenzhen Second People's Hospital·Phase 3·NCT05311943·40 enrolled

A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05931757·22 enrolled

Olverembatinib for FGFR1-rearranged Neoplasms

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05521204·20 enrolled

Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for de Novo Ph+ ALL

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05594784·79 enrolled

Efficacy and Safety2 trials

The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

Recruiting·PPeking University People's Hospital··NCT06390306·30 enrolled

Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06481228·82 enrolled

Chronic Myeloid Leukemia2 trials

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06817720·50 enrolled

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06423911·333 enrolled

Newly Diagnosed1 trial

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06051409·350 enrolled

Acute Myeloid Leukemia1 trial

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06401603·30 enrolled

9 more indications

JAK Inhibitor1 trial

ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07454226·30 enrolled

Hepatic Impairment1 trial

Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1·NCT07282093·48 enrolled

Myeloid Leukemia1 trial

Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase

Enrolling by invitation·QQian Jiang··NCT07383298·100 enrolled

Relapsed/Refractory AML1 trial

Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04501120·458 enrolled

Pediatric1 trial

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT07152041·150 enrolled

Acute Lymphoblastic Leukemia1 trial

Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.

Active, not recruiting·TThe First Affiliated Hospital of Soochow University·Phase 1·NCT07074496·20 enrolled

Blinatumomab1 trial

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07178912·60 enrolled

Ph+ ALL1 trial

Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07493161·110 enrolled

GIST1 trial

A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06640361·40 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Olverembatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Olverembatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Olverembatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ascentage Pharma Group Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bcr/abl Fusion Protein Inhibitor[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Ascentage Pharma Group Inc.

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