Wednesday, July 8, 2026

Drug profile · INN

nilotinib hydrochloride

nilotinib hydrochloride (NILOTINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 1
Drug details — nilotinib hydrochloride

Quick answer

nilotinib hydrochloride (NILOTINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN nilotinib hydrochloride
Brand NILOTINIB HYDROCHLORIDE
Mechanism Bcr/Abl fusion protein inhibitor
Target Bcr/Abl fusion protein
Route ORAL
Formulation CAPSULE

Mechanism of action

Bcr/Abl fusion protein inhibitor

Primary target: Bcr/Abl fusion protein

Approval history

Authority Status Date
FDA approved

Recent coverage

Pipeline programs

  1. CABL001A2001B Phase 3 · Novartis India · chronic myelogenous leukemia (CML) or Philadelphia Chromosom
  2. CAMN107AIT15 Phase 2 · Novartis India · Chronic myeloid leukemia
  3. CML1624 Phase 2 · Telethon Foundation · BCR-ABL1+ Chronic Myeloid Leukemia
  4. CML1415 - Sustrenim Approved · Telethon Foundation · Chronic Myeloid Leukemia (CML) in Chronic Phase (CP)

Related & competitor drugs

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

Frequently asked questions

What is nilotinib hydrochloride?

nilotinib hydrochloride (NILOTINIB HYDROCHLORIDE) is a bcr/abl fusion protein inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for nilotinib hydrochloride?

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

What is the US approval status of nilotinib hydrochloride?

nilotinib 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.