Wednesday, July 8, 2026

Drug profile · INN

guselkumab

guselkumab (TREMFYA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AC
US status approved
Patents linked 0
Pipeline programs 21
News articles 1
Drug details — guselkumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
21
Data quality
0.84

Quick answer

guselkumab (TREMFYA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN guselkumab
Brand TREMFYA
Mechanism Interleukin-23 inhibitor
Target Interleukin-23
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AC

Mechanism of action

Interleukin-23 inhibitor

Primary target: Interleukin-23

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Recent coverage

Pipeline programs

  1. CNTO1275JPA3001 Phase 3 · Janssen-Cilag International N.V · Juvenile psoriatic arthritis
  2. CNTO1959CRD3001 Phase 3 · Janssen-Cilag International N.V · Moderately to Severely Active Crohn's Disease
  3. CNTO1959CRD3004 Phase 3 · Janssen-Cilag International N.V · Moderately to Severely Active Crohn's Disease
  4. CNTO1959CRD3005 Phase 3 · Janssen-Cilag International N.V · Fistulizing perianal Crohn's Disease
  5. CNTO1959CRD3008 Phase 3 · Janssen-Cilag International N.V · Crohn’s Disease
  6. CNTO1959ISD3001 Phase 3 · Janssen-Cilag International N.V · Juvenile psoriatic arthritis (jPsA), Moderately to severely
  7. CNTO1959PBCRD3007 Phase 3 · Janssen-Cilag International N.V · Moderately to Severely Active Crohn's Disease
  8. CNTO1959PSA3004 Phase 3 · Janssen-Cilag International N.V · Psoriatic arthritis (PsA)

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 guselkumab?

guselkumab (TREMFYA) is a interleukin-23 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for guselkumab?

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

What is the US approval status of guselkumab?

guselkumab 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.