Luye

(Olverembatinib)

Phase 3Protein / enzyme

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 5 indications[3], with its most advanced program in Phase 3.[1]

Luye is one of 183 small molecule programs targeting Chronic Myelogenous Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

182

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Myelogenous LeukemiaActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Gastrointestinal Stromal TumorActive, not recruiting

Myeloid LeukemiaActive, not recruiting

Chronic Myelogenous LeukemiaPhase 3

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Gastrointestinal Stromal TumorPhase 3

Active, not recruiting

Myeloid LeukemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

32 2

Vepesid

AAvyxa

Phase 3

50 3

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

31 4

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 5

Cytoxan

BBaxter Healthcare Corporation

Phase 3

28 6

Clolar

GGenzyme, a Sanofi Company

Phase 3

21 7

Peony

Takeda

Phase 3

6 8

Novantrone

EMD Serono

Phase 3

19 9

Empaveli

Gilead

Phase 3

4 10

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

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

Myeloid Leukemia

NCT06817720

Q3 2027

Phase 2Recruiting

Olverembatinib

NCT05521204

Q4 2027

Recruiting

Efficacy and Safety

NCT06390306

Phase 2Recruiting

Olverembatinib

NCT06754267

Clinical

Trials by Indication[1]

Olverembatinib10 trials

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

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 in SDH-deficient GIST.

Recruiting· Ascentage Pharma Group Inc. logo

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

Show 7 more trials

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

Study of Olverembatinib (HQP1351) in Patients With CP-CML

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06423911·285 enrolled

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

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

Olverembatinib for FGFR1-rearranged Neoplasms

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

Efficacy and Safety2 trials

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

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

Acute Lymphoblastic Leukemia2 trials

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

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

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

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

Newly Diagnosed2 trials

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

Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07493161·100 enrolled

5 more indications

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

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

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

Pediatric1 trial

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

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

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

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.

Luye

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Olverembatinib10 trials

Efficacy and Safety2 trials

Acute Lymphoblastic Leukemia2 trials

Myeloid Leukemia2 trials

Newly Diagnosed2 trials

Relapsed/Refractory AML1 trial

Hepatic Impairment1 trial

Acute Myeloid Leukemia1 trial

Pediatric1 trial

JAK Inhibitor1 trial

References

Drug Info

Quick Facts

Related News