Tremfya (guselkumab) is an FDA-approved biologic interleukin-23 antagonist used across plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease in specified adult and pediatric populations. It is available for subcutaneous and intravenous use depending on indication and treatment phase. Initial U.S. approval was in 2017 with major label updates through 2025.
Drug Class
Interleukin-23 antagonist biologic
Approval Status
FDA approved (initial U.S. approval 2017; revised September 2025)
Mechanism of Action
Targets IL-23 pathway as an interleukin-23 antagonist
Brand Names
TREMFYA
Indications
\Moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years and older weighing at least 40 kg\
\Active psoriatic arthritis in adults and pediatric patients 6 years and older weighing at least 40 kg\
\Moderately to severely active ulcerative colitis in adults\
\Moderately to severely active Crohn's disease in adults\
Johnson & Johnson said Tremfya met the primary endpoint in the Phase 3 FUZION study in active perianal fistulizing Crohn’s disease. At Week 24, both Tremfya dosing regimens showed statistically significant combined fistula remission versus placebo.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
Johnson & Johnson shares hit a 52-week high after the company reported 2025 revenue of $94.19 billion and forecast 2026 revenue above $100 billion. The company also filed a shelf registration and said Innovative Medicine growth offset pressure from Stelara.
The FDA has approved icotrokinra, the first oral IL-23 therapy for moderate-to-severe plaque psoriasis. Meanwhile, real-world research shows IL-23 inhibitors produce site-specific responses in high-impact areas like scalp and nails, and combination therapy with ixekizumab and tirzepatide shows superior results for psoriasis patients with obesity.
AbbVie reported positive Phase 3 data for Skyrizi's subcutaneous Crohn's disease treatment and is advancing lutikizumab and Rinvoq in hidradenitis suppurativa, with multiple readouts expected throughout 2026 as the company pursues combination therapy strategies.
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.