Iclusig

(ponatinib hydrochloride)

Phase 2Small molecule

Takeda

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecruiting

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhase 2

Recruiting

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

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 Leukemia3 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

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

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

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

Biliary Cancer1 trial

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

Completed·MMayo Clinic·Phase 2·NCT02265341·12 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

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

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

1 more indication

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

Regulatory

FDA Approval Timeline[4]

Dec 18, 2020

ICLUSIG

NDA NDA203469

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]
OpenFDA — FDA approval records (NDA NDA203469). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Takeda