Iclusig
(Ponatinib)ApprovedProtein / enzyme
TakedaPonatinib is used to treat certain types of blood cancer, particularly chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), especially in patients whose cancer is resistant to other treatments.[2] Iclusig is currently approved and in use across 18 indications[4].[1]
Iclusig is one of 293 small molecule programs targeting Endometrial Neoplasm. It is currently in Approved.
18
Indications
57
Total Trials
20
Active Trials
292
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
6
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 18 indications
Competition
Competitive Landscape
255 competitors in Acute Myeloid Leukemia
#DrugCompanyPhaseTrials
1Novantrone
PfizerPhase 3
Xospata
AstellasPhase 3
Fludara
SanofiPhase 3
Cerubidine
EEastern Cooperative Oncology Group
Phase 3
Vepesid
AAvyxa
Phase 3
Mylotarg
WWyeth-Lederle Vaccines
Phase 3
Vanflyta
Daiichi SankyoPhase 3
Neupogen
EEastern Cooperative Oncology Group
Phase 3
Nexavar
BayerPhase 3
Iclusig
TakedaApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Acute Lymphoblastic Leukemia12 trials
Show 9 more trials
Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients
Active, not recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT05306301·32 enrolled
Myeloid Leukemia6 trials
Show 3 more trials
Chronic Myelogenous Leukemia4 trials
Show 1 more trial
Acute Myeloid Leukemia2 trials
28 more indications
Treatment2 trials
Thyroid Cancer2 trials
CML2 trials
Study to Evaluate the Reinduction and Second Stop of TKI with Ponatinib in CML in Molecular Response (ResToP)
Active, not recruiting·FFundacion CRIS de Investigación para Vencer el Cáncer·Phase 2·NCT04160546·80 enrolled
Trial1 trial
Efficacy and Safety1 trial
Immunotherapy1 trial
Lung Cancer1 trial
Glioblastoma1 trial
Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma
Completed·—·Phase 2·NCT02478164·17 enrolled
Endometrial Carcinoma1 trial
Newly Diagnosed1 trial
Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL
Active, not recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 3·NCT04722848·236 enrolled
Head and Neck Cancers1 trial
Ponatinib for Squamous Cell Lung and Head and Neck Cancers
Terminated·—·Phase 2/3·NCT01761747·3 enrolled
Chemotherapy1 trial
Adult1 trial
Study in Adult Ph-positive ALL
Unknown status·—·Phase 2·NCT04688983·180 enrolled
Allogeneic Stem Cell Transplantation1 trial
First-line Treatment1 trial
Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph+ ALL
Terminated·IInstitute of Hematology and Blood Transfusion, Czech Republic·Phase 2·NCT04554459·4 enrolled
Non-Small Cell Lung Cancer1 trial
T-cell acute lymphoblastic leukemia1 trial
Gastrointestinal Stromal Tumor1 trial
Ph+ ALL1 trial
Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse
Active, not recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT04475731·67 enrolled
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial
Regulatory
FDA Approval Timeline[5]
Dec 18, 2020
ICLUSIG
NDA NDA203469
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Iclusig drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Ponatinib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]