FDA Approves Tremfya (guselkumab) for Ulcerative Colitis and Crohn's Disease

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FDA Published June 2, 2026 Medically reviewed June 2, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider Tremfya as a treatment option for adults with moderately to severely active ulcerative colitis or Crohn's disease.

The FDA has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, according to the prescribing label. This marks the first approval of an IL-23 antagonist for both inflammatory bowel disease indications. Tremfya was previously approved for plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years and older weighing at least 40 kg. The new indication provides an additional biologic option for patients with moderate-to-severe ulcerative colitis or Crohn's disease who have failed conventional therapy. The label includes both intravenous and subcutaneous induction dosing regimens, with subcutaneous maintenance dosing options. Clinicians should note the requirement for baseline liver enzyme and bilirubin testing before initiating therapy for these indications.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Guselkumab is a human IgG1λ monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

Indication & Patient Population

TREMFYA is indicated for the treatment of: adults with moderately to severely active ulcerative colitis; adults with moderately to severely active Crohn's disease. Also indicated for 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; and adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.

Dosing & Administration

For ulcerative colitis and Crohn's disease: Induction: 200 mg IV infusion over at least 1 hour at Weeks 0, 4, and 8 OR 400 mg SC (given as two consecutive 200 mg injections) at Weeks 0, 4, and 8. Maintenance: 100 mg SC at Week 16 and every 8 weeks thereafter OR 200 mg SC at Week 12 and every 4 weeks thereafter. Use lowest effective dosage. Obtain liver enzymes and bilirubin prior to initiation. Complete age-appropriate vaccinations prior to treatment.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindications: None reported in label. Warnings: Infections (including tuberculosis), hypersensitivity reactions, liver enzyme elevations (for UC and CD, obtain LFTs and bilirubin prior to initiation; for PsO and PsA, evaluate if clinically indicated), and risk of immunization with live vaccines. Evaluate for TB prior to initiation.

Place in Therapy

TREMFYA is an IL-23 antagonist approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease. It offers a targeted biologic option for patients who are candidates for systemic therapy or phototherapy (PsO) or who have failed conventional therapy (PsA, UC, CD).

Study Details

Study typeFda approval

PublishedJul 2017

View Original Abstract ↓

1 INDICATIONS AND USAGE TREMFYA is an interleukin-23 antagonist 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. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis. ( 1.3 ) adults with moderately to severely active Crohn's disease. ( 1.4 ) 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.