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Stelara

Stelara

Drug

Drug Profile

Stelara is the brand name for ustekinumab, a human interleukin-12 and interleukin-23 antagonist used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The label includes adult and pediatric indications depending on disease area. U.S. initial approval was in 2009, with recent indication updates in 2026.

Drug Class: Human interleukin-12 and interleukin-23 antagonist monoclonal antibody
Approval Status: FDA approved (Initial U.S. Approval: 2009; major indication update April 2026)
Mechanism of Action: Therapeutic activity is based on antagonism of IL-12 and IL-23 pathways.

Brand Names

STELARA

Indications

\Moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are candidates for phototherapy or systemic therapy\
\Active psoriatic arthritis in adults and pediatric patients 6 years and older\
\Moderately to severely active Crohn's disease in adults and pediatric patients 2 years and older\
\Moderately to severely active ulcerative colitis in adults\

Related News

Patent Rights and Competition: FTC Challenges J&J Case as Turkish Court Clarifies Pharma Patent Boundaries

Jun 25, 2026

The US FTC is challenging a court ruling involving Johnson & Johnson's patent acquisition for Stelara, arguing it could weaken antitrust enforcement in pharma. Separately, Turkey's Court of Cassation ruled that patent holders who file infringement actions and send warning letters to third parties are exercising lawful patent rights, dismissing an unfair competition claim by a generic company.

Biosimilar and biologic updates include approvals, review decisions and licensing deals

Apr 29, 2026

Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.

Alvotech to Release First-Quarter 2026 Financial Results on May 6

Apr 25, 2026

Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.

Johnson & Johnson raises forecast after earnings beat on drug growth

Apr 15, 2026

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 projects about $100.5 billion in 2026 revenue amid litigation and patent headwinds

Apr 11, 2026

Johnson & Johnson said revenue could reach about $100.5 billion at the midpoint in 2026 after 2024 net sales rose 6% to $94.2 billion. The company faces talc litigation, Stelara patent losses and U.S. drug price negotiations.

Johnson & Johnson Shares Hit 52-Week High as 2026 Revenue Outlook Tops $100 Billion

Apr 11, 2026

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.

Johnson & Johnson Reports Strong Q4 2025 Results, Faces Ongoing Talc Litigation Challenges

Mar 29, 2026

Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.

Related Clinical Trials

NCT ID	Title	Status	Phase
NCT05890118	Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule	COMPLETED	PHASE1
NCT05335356	Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis	COMPLETED	PHASE3
NCT04930042	Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis	COMPLETED	PHASE3
NCT04785326	Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis	COMPLETED	PHASE3
NCT04673786	A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis	COMPLETED	PHASE3
NCT03651518	Personalized Therapies in Inflammatory Complex Disease	COMPLETED	PHASE2