PharmaRadar360

PharmaRadar360

ImmunologyDrug intelligence

Tremfya

Guselkumab

IL-23 p19 inhibitor. Developed by Johnson & Johnson. Clinical, regulatory, and source evidence are connected below.

Company
Johnson & Johnson
Target / MOA
IL-23 路 IL23A
Aliases
Tremfya
Signals
20
Clinical trials
19
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Tremfya 路 BLA761061 路 label version 29, effective Jun 4, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. 1.3 Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 1.4 Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

European Union (EMA)

Tremfya 路 EMEA/H/C/004271 路 Authorised, authorised Nov 10, 2017 (Commission decision C(2017) 7649) 路 EPAR

Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.Crohn鈥檚 diseaseTremfya is indicated for the treatment of adult patients with moderately to severely active Crohn鈥檚 disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761061 路 JANSSEN BIOTECH 路 first approved Jul 13, 2017

9 efficacy supplements approved

European Union

  • Tremfya: Authorised since Nov 10, 2017

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761061 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 19 linked records.

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.