ICLUSIG (ponatinib hydrochloride)
ICLUSIG is indicated for the treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia.
How ICLUSIG Works
Ponatinib is a potent pan-BCR::ABL tyrosine kinase inhibitor. It is specifically designed to inhibit the activity of native BCR::ABL as well as various mutations that confer resistance to other TKIs, most notably the T315I "gatekeeper" mutation. Beyond ABL, ponatinib inhibits the activity of several other kinase families, including VEGFR, PDGFR, FGFR, and SRC, as well as KIT, RET, TIE2, and FLT3. By blocking these signaling pathways, ponatinib inhibits the proliferation and viability of cells expressing these oncogenic kinases.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-14
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
ICLUSIG Approval History
What ICLUSIG Treats
2 indicationsICLUSIG is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Chronic Myeloid Leukemia
ICLUSIG Boxed Warning
ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning. Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need ...
WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning. Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG. ( 2.2 , 5.1 ) Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity. ( 2.2 , 5.2 ) Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure. ( 2.2 , 5.3 ) Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity. ( 2.2 , 5.4 ) Arterial Occlusive Events: Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG
ICLUSIG Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
ICLUSIG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ICLUSIG's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ICLUSIG treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ICLUSIG
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT01424982 | 2011-0030 NCI-2011-02941, 2011-0030 | Ph 2 | active not recruiting | Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT01746836 | 2012-0669 NCI-2014-01911, 2012-0669 | Ph 2 | recruiting | Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib |
| NCT03576547 results posted | 2017-0313 NCI-2018-01100, 2017-0313 | Ph 1, Ph 2 | terminated | Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia |
| NCT02272998 results posted | OSU-14078 NCI-2014-01499 | Ph 2 | completed | Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT. |
| NCT01620216 results posted | IRB00007195 NCI-2012-01084, CA180-392 | Ph 2 | terminated | Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia |
| NCT02265341 results posted | MC1345 NCI-2014-02075, MC1345 | Ph 2 | completed | Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ICLUSIG FDA Label Details
Indications & Usage
FDA Label (PDF)ICLUSIG is indicated for the treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia.
WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning. Arterial occlusive events (AOEs), inclu...
ICLUSIG Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ICLUSIG
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 272 active patents
Trial Analysis
- • 8 total trials
- • Stage: Stable
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment