Wednesday, July 8, 2026

Drug profile · INN

asciminib hydrochloride

asciminib hydrochloride (SCEMBLIX) 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 7
News articles 0
Drug details — asciminib hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
7
Data quality
0.84

Quick answer

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

Key facts

INN asciminib hydrochloride
Brand SCEMBLIX
Mechanism Bcr/Abl fusion protein inhibitor
Target Bcr/Abl fusion protein
Route ORAL
Formulation TABLET

Mechanism of action

Bcr/Abl fusion protein inhibitor

Primary target: Bcr/Abl fusion protein

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. ASCIMINIB HYDROCHLORIDE, ASCIMINIB Phase 3 · Novartis India · Chronic Myelogenous Leukemia in chronic phase (CML-CP)
  2. CABL001A2001B Phase 3 · Novartis India · chronic myelogenous leukemia (CML) or Philadelphia Chromosom
  3. CABL001J12301 Phase 3 · Novartis India · Chronic Myeloid Leukemia
  4. CABL001J12302 Phase 3 · Novartis India · Chronic Myeloid Leukemia
  5. Asciminib, ASCIMINIB HYDROCHLORIDE Phase 2 · Novartis India · Philadelphia positive Chronic Myeloid leukemia in Chronic Ph
  6. CABL001I12201 Phase 2 · Novartis India · Pediatric patients with Philadelphia chromosome positive chr
  7. CABL001L12101 Phase 2 · Novartis India · relapsed or refractory BCR::ABL1-positive (Philadelphia posi

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. 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 asciminib hydrochloride?

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

What is the brand name for asciminib hydrochloride?

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

What is the US approval status of asciminib hydrochloride?

asciminib 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.