Wednesday, July 8, 2026

Drug profile · INN

ponatinib hydrochloride

ponatinib hydrochloride (PONATINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 15
News articles 0
Drug details — ponatinib hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
15
Data quality
0.89

Quick answer

ponatinib hydrochloride (PONATINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ponatinib hydrochloride
Brand PONATINIB HYDROCHLORIDE
Mechanism Bcr/Abl fusion protein inhibitor
Target Bcr/Abl fusion protein
Route ORAL
Formulation TABLET
Originator Takeda

Mechanism of action

Bcr/Abl fusion protein inhibitor

Primary target: Bcr/Abl fusion protein

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Ponatinib Phase 3 · Takeda · Philadelphia Chromosome Positive Acute Lymphoblastic Leukemi
  2. SARCLISA for Patients aged 18-65 years old w… Phase 3 · PARItec · Patients aged 18-65 years old with newly diagnosed previousl
  3. ALL2620 Phase 2 · Telethon Foundation · Ph+ Acute Lymphoblastic Leukemia
  4. AP24534-14-203 Phase 2 · Takeda · Chronic Phase Chronic Myeloid Leukemia
  5. GIMEMA ALL2922 Phase 2 · Telethon Foundation · Adult Philadelphia Chromosome-Negative Acute Lymphoblastic L
  6. INCB 84344-102 Phase 2 · Incyte · Recurrent or Refractory Leukemias, Lymphomas, and Solid Tumo
  7. Iclusig 15 mg film-coated tablets Phase 2 · Ningbo Cancer Hospital · Chronic myelogenous leukemia
  8. Ponatinib Phase 2 · Takeda · Myeloid Leukemia, Chronic, Chronic Phase

Related & competitor drugs

  1. dasatinib Antineoplastic and immunomodulating agents (L01)
  2. imatinib mesylate Platelet-derived growth factor receptor beta inhibitor
  3. asciminib hydrochloride Bcr/Abl fusion protein inhibitor
  4. bosutinib monohydrate Bcr/Abl fusion protein
  5. nilotinib hydrochloride Bcr/Abl fusion protein inhibitor
  6. dasatinib (anhydrous) Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is ponatinib hydrochloride?

ponatinib hydrochloride (PONATINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Associated with Takeda. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ponatinib hydrochloride?

PONATINIB HYDROCHLORIDE is a marketed brand name for ponatinib hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ponatinib hydrochloride?

ponatinib hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.