Friday, July 10, 2026

Drug profile · INN

siltuximab

siltuximab (SYLVANT) is a interleukin-6 inhibitor. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AC11
US status approved
Patents linked 0
Pipeline programs 15
News articles 0
Drug details — siltuximab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
15
Data quality
0.84

Quick answer

siltuximab (SYLVANT) is a interleukin-6 inhibitor. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN siltuximab
Brand SYLVANT
Mechanism Interleukin-6 inhibitor
Target Interleukin-6
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AC11

Mechanism of action

Interleukin-6 inhibitor

Primary target: Interleukin-6

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. 20200041 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC)
  2. 20230005 Phase 3 · Amgen · Metastatic castration-resistant prostate cancer (mCRPC)
  3. 20230016 Phase 3 · Amgen · Limited-Stage Small-Cell Lung Cancer (LS SCLC)
  4. 20230239 Phase 3 · Amgen · Metastatic castration-resistant prostate cancer (mCRPC)
  5. 20240178 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC).
  6. GCT3013-05 Phase 3 · Genmab · B-cell Lymphoma
  7. 20200491 Phase 2 · Amgen · Relapsed/Refractory Small Cell Lung Cancer
  8. 20240092 Phase 2 · Amgen · Small Cell Lung Cancer (SCLC)

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 siltuximab?

siltuximab (SYLVANT) is a interleukin-6 inhibitor. Associated with Recordati Rare Diseases Australia Pty.. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for siltuximab?

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

What is the US approval status of siltuximab?

siltuximab 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.