Ponatinib Hydrochloride

Sold as Iclusig. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Ponatinib Hydrochloride (sold as Iclusig), first approved Dec 14, 2012, with 6 new uses approved and 0 published complete response letters.

First approved: Dec 14, 2012
Applications: 2
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $221M
Orphan exclusivity until: Mar 19, 2031
First approved in the EU: Jul 1, 2013
First approved in Japan: Sep 28, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Iclusig	Part D	$221M	+39%	1,318

Orphan Designations (FDA)

4 designations, 3 approved for the designated use; see all orphan designations

Treatment of gastrointestinal stromal tumors (GIST).ARIAD Pharmaceuticals, Inc. · designated Mar 12, 2015 · withdrawn
Treatment of chronic myeloid leukemiaTakeda Pharmaceuticals U.S.A., Inc. · designated Nov 20, 2009 · approved Dec 14, 2012
Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)Takeda Pharmaceuticals U.S.A., Inc. · designated Nov 20, 2009 · approved Mar 19, 2024 · exclusive to Mar 19, 2031
Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)Takeda Pharmaceuticals U.S.A., Inc. · designated Nov 20, 2009 · approved Dec 14, 2012

Approvals in the EU (EMA)

First approved in the EU 7 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Iclusig, new substanceIncyte Biosciences Distribution B.V. · Jul 1, 2013

Approvals in Japan (PMDA)

First approved in Japan 45 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Iclusig, new ingredientA drug with a new active ingredient indicated for the treatment of chronic myelogenous leukemia with resistance or intolerance to prior drug therapies, and… · Otsuka Pharmaceutical Co., Ltd. · Sep 28, 2016

Clinical Trials

24 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)Philadelphia Positive Acute Lymphoblastic Leukemia · Wake Forest University Health Sciences	Phase 1	Recruiting	May 29, 2026
Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-worldAcute Lymphobkastic Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia · Gruppo Italiano Malattie EMatologiche dell'Adulto	—	Not yet recruiting	Jan 21, 2026
Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALLAcute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+), BCR-ABL Positive Acute Lymphoblastic Leukemia · University of Alberta	Phase 2	Not yet recruiting	Dec 24, 2025
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/LymphomaB Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, B Lymphoblastic Leukemia/Lymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1 · University of Washington	Phase 2	Recruiting	Nov 4, 2025
A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia · Assistance Publique - Hôpitaux de Paris	Phase 2 / Phase 3	Recruiting	Mar 6, 2025
Using Tumor Models to Determine TreatmentsPancreatic Ductal Carcinoma, Advanced Cancer · University Health Network, Toronto	Phase 2	Recruiting	Feb 6, 2025
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.Chronic Myeloid Leukemia (CML) · Novartis Pharmaceuticals	Phase 2	Recruiting	Jul 23, 2024
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBPChronic Myeloid Leukemia · Peking University People's Hospital	—	Recruiting	Apr 30, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 14, 2012	IclusigNDA 203469 · New molecular entity	Takeda Pharms USA	33	Marketed
Jul 14, 2023	Ponatinib HydrochlorideANDA 215893	Apotex	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA