Wednesday, July 8, 2026

Drug profile · INN

rilonacept

rilonacept (RILONACEPT FGK REPRESENTATIVE SERVICE GMBH) is a interleukin-1 beta inhibitor. Associated with Regeneron UK Limited. Route of administration: single-use. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn Antineoplastic and immunomodulating agents (L04) L04AC04
US status approved
Patents linked 0
Pipeline programs 10
News articles 0
Drug details — rilonacept
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
SINGLE-USE
Patents
0
Programs
10
Data quality
0.89

Quick answer

rilonacept (RILONACEPT FGK REPRESENTATIVE SERVICE GMBH) is a interleukin-1 beta inhibitor. Associated with Regeneron UK Limited. Route of administration: single-use. Current US regulatory status: approved.

Key facts

INN rilonacept
Brand RILONACEPT FGK REPRESENTATIVE SERVICE GMBH
Mechanism Interleukin-1 beta inhibitor
Target Interleukin-1 beta
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route SINGLE-USE
Formulation VIAL
ATC code L04AC04

Mechanism of action

Interleukin-1 beta inhibitor

Primary target: Interleukin-1 beta

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. Rilonacept Phase 3 · Regeneron UK · Gout
  2. Rilonacept Phase 3 · Regeneron UK · Acute Gout Flare
  3. Rilonacept Phase 3 · Kiniksa Pharmaceuticals International · Recurrent Pericarditis
  4. Rilonacept 80 mg Phase 3 · Regeneron UK · Intercritical Gout
  5. rilonacept 160 mg Phase 3 · Regeneron UK · Familial Cold Autoinflammatory Syndrome (FCAS)
  6. Rilonacept Phase 2 · Regeneron UK · Cold Contact Urticaria
  7. Rilonacept Phase 2 · Regeneron UK · Chronic Kidney Disease
  8. Rilonacept Phase 2 · Regeneron UK · Scleroderma

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 rilonacept?

rilonacept (RILONACEPT FGK REPRESENTATIVE SERVICE GMBH) is a interleukin-1 beta inhibitor. Associated with Regeneron UK Limited. Route of administration: single-use. Current US regulatory status: approved.

What is the brand name for rilonacept?

RILONACEPT FGK REPRESENTATIVE SERVICE GMBH is a marketed brand name for rilonacept. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of rilonacept?

rilonacept 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.