ponatinib hydrochloride

Phase 3Small molecule

ponatinib hydrochloride is one of 58 small molecule programs targeting Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1Active, not recruiting

Acute Lymphoblastic LeukemiaTerminated

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhase 2

Recruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1Phase 3

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 2

Terminated

Competition

Competitive Landscape

163 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

40 2

Oncaspar

SServier

Phase 3

48 3

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

43 4

Fludara

Sanofi

Phase 3

15 5

Medrol

Pfizer

Phase 3

12 6

Iclusig

Takeda

Phase 3

12 7

Cellcept

Roche

Phase 3

11 8

Neoral

Novartis

Phase 3

10 9

Neupogen

EEastern Cooperative Oncology Group

Arranon

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

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT01424982

Q3 2028

Phase 3Active, not recruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1

NCT04530565

Q4 2030

Phase 2Recruiting

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

NCT01746836

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia4 trials

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT01620216·12 enrolled

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01424982·88 enrolled

Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT03576547·9 enrolled

Show 1 more trial

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02779283·7 enrolled

Biliary Cancer1 trial

Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions

Completed·MMayo Clinic·Phase 2·NCT02265341·12 enrolled

Advanced Solid Tumor Cancer1 trial

Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.

Completed·SSameek Roychowdhury·Phase 2·NCT02272998·22 enrolled

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Ponatinib as Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib, Dasatinib or Nilotinib

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01746836·50 enrolled

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL11 trial

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04530565·348 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for ponatinib hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ponatinib hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ponatinib hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — M.D. Anderson Cancer Center company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MM.D. Anderson Cancer Center

ponatinib hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2028

Q4 2030

Trials by Indication[1]

Acute Lymphoblastic Leukemia4 trials

Biliary Cancer1 trial

Advanced Solid Tumor Cancer1 trial

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL11 trial

References

Drug Info

Quick Facts

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