Wednesday, July 8, 2026

Drug profile · INN

ibrutinib

ibrutinib (IMBRUVICA) is a tyrosine-protein kinase btk inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01EL01
US status approved
Patents linked 1
Pipeline programs 36
News articles 0
Drug details — ibrutinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
36
Data quality
0.89

Quick answer

ibrutinib (IMBRUVICA) is a tyrosine-protein kinase btk inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ibrutinib
Brand IMBRUVICA
Mechanism Tyrosine-protein kinase BTK inhibitor
Target Tyrosine-protein kinase BTK
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EL01

Mechanism of action

Tyrosine-protein kinase BTK inhibitor

Primary target: Tyrosine-protein kinase BTK

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. ACE-CL-006 Phase 3 · Anaxis Pharma · High Risk Chronic Lymphocytic Leukaemia
  2. APG2575CG301 Phase 3 · Anaxis Pharma · Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  3. CCTL019H2301 Phase 3 · Novartis India · Adult patients with relapsed or refractory aggressive B-cell
  4. CLOU064A2303B Phase 3 · Novartis India · Chronic Spontaneous Urticaria
  5. CLOU064A2304 Phase 3 · Novartis India · Chronic Spontaneous Urticaria
  6. CLOU064C12301 Phase 3 · Novartis India · Multiple Sclerosis
  7. CLOU064C12302 Phase 3 · Novartis India · Multiple Sclerosis
  8. CLOU064J12301 Phase 3 · Novartis India · Hidradenitis Suppurativa (HS)

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 10035802

    Solid state forms of ibrutinib

    Expires Mon Jul 26 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ibrutinib?

ibrutinib (IMBRUVICA) is a tyrosine-protein kinase btk inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ibrutinib?

IMBRUVICA is a marketed brand name for ibrutinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ibrutinib?

ibrutinib 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.