Wednesday, July 8, 2026

Drug profile · INN

canakinumab

canakinumab (CANAKINUMAB NOVARTIS) is a interleukin-1 beta inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AC08
US status approved
Patents linked 0
Pipeline programs 7
News articles 0
Drug details — canakinumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
SUBCUTANEOUS
Patents
0
Programs
7
Data quality
0.84

Quick answer

canakinumab (CANAKINUMAB NOVARTIS) is a interleukin-1 beta inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN canakinumab
Brand CANAKINUMAB NOVARTIS
Mechanism Interleukin-1 beta inhibitor
Target Interleukin-1 beta
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route SUBCUTANEOUS
Formulation INJECTABLE
ATC code L04AC08

Mechanism of action

Interleukin-1 beta inhibitor

Primary target: Interleukin-1 beta

Approval history

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

Pipeline programs

  1. CANAKINUMAB, PEMETREXED Phase 3 · Novartis India · Non-small cell lung cancer
  2. PAPA-Can Phase 3 · Istituto Gentili Italia · PAPA syndrome
  3. canakinumab Phase 3 · Novartis India · Non-small Cell Lung Cancer
  4. Canakinumab 150 mg Phase 2 · Novartis India · Type 2 Diabetes Mellitus
  5. CPDR001X2X01B Phase 1 · Novartis India · Different types of advanced cancer
  6. PDY18058 Phase 1 · Sanofi-Aventis U.S · Immuun system diseases
  7. Salkera Emollient Foam Approved · Chongqing Precision Biotech · Keratosis Pilaris

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)

Frequently asked questions

What is canakinumab?

canakinumab (CANAKINUMAB NOVARTIS) is a interleukin-1 beta inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for canakinumab?

CANAKINUMAB NOVARTIS is a marketed brand name for canakinumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of canakinumab?

canakinumab 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.