Are there new drugs for Crohn's Disease approved by the FDA?

The FDA has approved several newer drugs for Crohn's disease in recent years. These include biologic therapies that target specific immune pathways involved in inflammation. Two notable examples are Stelara (ustekinumab) and Hadlima (adalimumab). Additionally, a class of drugs called selective IL-23 inhibitors is showing promise in clinical trials, though not all have received FDA approval yet. This answer covers what is currently approved and what may be coming.

What the research says

Stelara (ustekinumab) is an FDA-approved biologic for moderately to severely active Crohn's disease in adults ⁸. It works by blocking interleukin-12 and interleukin-23, two proteins that drive inflammation. Hadlima (adalimumab) is another FDA-approved option for Crohn's disease in adults and children aged 6 and older ¹. It is a TNF blocker that reduces signs and symptoms of the disease. Both drugs are considered newer compared to older treatments like corticosteroids or immunomodulators. A 2025 review highlights that selective IL-23 inhibitors, which target the p19 subunit of IL-23, have recently expanded treatment options for moderate to severe Crohn's disease ⁹. These drugs have shown efficacy and safety in phase 3 trials, though not all are yet FDA-approved. In contrast, drugs that block IL-17 (such as secukinumab) have been found to worsen Crohn's disease and are not approved for this condition ¹⁰.

What to ask your doctor

• Could Stelara or Hadlima be a good option for my Crohn's disease?
• What are the potential side effects of these newer biologics?
• Are there any selective IL-23 inhibitors available or in clinical trials that I might consider?
• How do these newer drugs compare to older treatments like steroids or immunomodulators?
• Should I be tested for any infections before starting a biologic?