Wednesday, July 8, 2026

Drug profile · INN

anakinra

anakinra (KINERET) is a interleukin-1 receptor antagonist. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AC03
US status approved
Patents linked 0
Pipeline programs 18
News articles 0
Drug details — anakinra
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
SUBCUTANEOUS
Patents
0
Programs
18
Data quality
0.84

Quick answer

anakinra (KINERET) is a interleukin-1 receptor antagonist. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN anakinra
Brand KINERET
Mechanism Interleukin-1 receptor antagonist
Target Interleukin-1 receptor type 1
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route SUBCUTANEOUS
Formulation VIAL
ATC code L04AC03

Mechanism of action

Interleukin-1 receptor antagonist

Primary target: Interleukin-1 receptor type 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. APHP180560 Phase 3 · PARItec · Men and women over 18 years of age with renal failure renal
  2. APHP200009 Phase 3 · PARItec · Kawasaki disease
  3. APHP230825 Phase 3 · PARItec · PEDIATRIC ACUTE MYOCARDITIS
  4. Anakinra Phase 3 · Swedish Orphan Biovitrum · Still's Disease, Juvenile Onset
  5. Anakinra 100mg and Placebo Depo-Medrone Phase 3 · United Therapeutics Europe · Gout
  6. GCT1046-06 Phase 3 · Genmab · Non-Small Cell Lung Cancer
  7. GCT3013-05 Phase 3 · Genmab · B-cell Lymphoma
  8. IL-1Ra Phase 3 · United Therapeutics Europe · Subarachnoid Hemorrhage

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 anakinra?

anakinra (KINERET) is a interleukin-1 receptor antagonist. Associated with Swedish Orphan Biovitrum Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for anakinra?

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

What is the US approval status of anakinra?

anakinra 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.