Icotrokinra Approved in China for Plaque Psoriasis: The World’s First Oral IL-23R-Targeted Drug

On August 27, Johnson & Johnson announced that Icotrokinra had been approved by NMPA for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older weighing at least 40 kg.

As the world’s first approved IL-23R-targeted oral peptide drug, icotrokinra approved in China for plaque psoriasis further expands its global regulatory footprint and provides eligible patients with a new oral targeted treatment option.

DengYueMed explores Icotrokinra’s mechanism of action, China-approved indication, key Phase 3 clinical data, and global regulatory progress, highlighting its role as a key immunology drug in Johnson & Johnson’s pipeline.

What Is Icotrokinra? The World’s First Oral IL-23R Antagonist

Icotrokinra was originally developed by Protagonist Therapeutics and is a first-in-class oral peptide drug designed to selectively target the interleukin-23 receptor (IL-23R) and block IL-23 signaling.

The IL-23/IL-23R pathway plays an important role in inflammatory processes associated with psoriasis and other immune-mediated diseases.

Its key innovation lies in combining precise IL-23R targeting with oral administration, offering a different drug modality from traditional injectable biologic therapies in the treatment of immune-mediated diseases.

Icotrokinra Quick Facts

China Approval: Which Patients Is Icotrokinra Approved For?

The icotrokinra approved in China for plaque psoriasis indication includes:

• Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy;
• Pediatric patients aged 12 years and older who weigh at least 40 kg.

Plaque psoriasis is the most common clinical form of psoriasis and is characterized by chronic and recurrent disease. For patients with moderate-to-severe disease, systemic therapy or phototherapy may be considered based on disease severity, previous treatments, and individual patient factors.

According to public data, China has approximately 8.4 million people with psoriasis, while more than 125 million are affected worldwide. Psoriasis can affect both the skin and quality of life, particularly when lesions involve the scalp, hands, feet, or genital areas.

The Icotrokinra China approval provides eligible adult and adolescent patients with an additional oral targeted treatment option.

Icotrokinra Phase 3 Clinical Trials: Key Clinical Data and Safety Results

The icotrokinra approved in China for plaque psoriasis was primarily supported by the ICONIC clinical development program.

The program includes four pivotal Phase 3 studies involving approximately 2,500 adults and adolescents with moderate-to-severe plaque psoriasis. These studies evaluated clinical outcomes and safety, including treatment of lesions affecting high-impact areas such as the scalp and genitals.

In the ICONIC-LEAD study, the icotrokinra treatment group showed notable response rates in measures of skin clearance and PASI response.

At Week 16, the IGA 0/1 response rate was 64.7%, while the PASI 90 response rate was 49.6%, compared with 8.3% and 4.4%, respectively, in the placebo group. By Week 24, the two response rates increased to 74.1% and 64.9%, respectively.

Clinical Data in Chinese Patients

The ICONIC-LEAD study also included patients from mainland China.

At Week 16, 85.1% of Chinese participants achieved an IGA 0/1 response, while 71.6% achieved a PASI 90 response. By Week 24, approximately 70% of Chinese participants achieved IGA 0, indicating complete clearance of skin lesions.

These findings provide clinical data supporting the use of Icotrokinra in Chinese patients with plaque psoriasis.

Long-Term Data and Safety of Icotrokinra

Data presented at the 2025 EADV Congress showed that after 52 weeks of treatment, PASI 90 and IGA 0/1 response rates were 84% and 82%, respectively, among adults, and 86% and 91%, respectively, among adolescents.

In terms of safety, the difference in the incidence of treatment-emergent adverse events (TEAEs) between the icotrokinra and placebo groups was no more than 1.1% through Week 16. No new safety signals were identified through Week 52.

Note: IGA 0/1 indicates completely clear or almost clear skin. PASI 90 indicates a ≥90% improvement from baseline in the Psoriasis Area and Severity Index (PASI). TEAE refers to treatment-emergent adverse events.

What Are the Key Drug Innovations of Icotrokinra?

The key innovations of icotrokinra can be considered at two levels: its target and its drug modality.

First, icotrokinra directly targets IL-23R. The IL-23/IL-23R signaling pathway is an important pathway in research into psoriasis and other immune-mediated diseases.

Second, icotrokinra is formulated as an oral peptide drug and is administered once daily. Compared with conventional injectable biologic therapies, oral administration offers a different mode of treatment and makes icotrokinra an important development in the field of oral targeted peptide therapies.

✨ Therefore, the combination of IL-23R targeting + oral administration + peptide drug technology represents the core innovation of icotrokinra.

From the U.S. to China: Icotrokinra Global Approval Timeline

The global regulatory progress of icotrokinra began in 2025, when applications were subsequently submitted in major markets including the United States, Europe, Japan, and China.

In March 2026, the U.S. Food and Drug Administration (FDA) became the first regulatory authority to approve icotrokinra, under the brand name ICOTYDE, for adults and adolescents aged 12 years and older with moderate-to-severe plaque psoriasis.

In China, the Center for Drug Evaluation (CDE) of the NMPA granted icotrokinra priority review status in November 2025.

On August 27, 2026, icotrokinra was approved in China for plaque psoriasis, marking an important milestone in its global development.

The Icotrokinra China approval further strengthens the drug’s presence across major pharmaceutical markets following its initial U.S. approval.

What Other Immune-Mediated Diseases Could Icotrokinra Treat in the Future?

The development of icotrokinra approved in China for plaque psoriasis is not limited to plaque psoriasis.

Johnson & Johnson is currently exploring icotrokinra in several IL-23-mediated diseases, including:

1. Psoriatic Arthritis

Psoriatic arthritis is an important comorbidity associated with psoriasis. Icotrokinra development in this indication has advanced into late-stage clinical development.

2. Ulcerative Colitis

The IL-23 pathway is closely associated with inflammatory bowel disease, and icotrokinra is also being investigated for ulcerative colitis.

3. Crohn’s Disease

In addition to ulcerative colitis, icotrokinra is being developed for Crohn’s disease, potentially expanding its application across multiple immune-mediated diseases.

If these indications generate positive results in future clinical development, the potential clinical applications and commercial value of icotrokinra could expand further.

Conclusion: Oral IL-23R-Targeted Therapy Enters a New Stage

The icotrokinra approved in China for plaque psoriasis milestone brings the world’s first approved oral IL-23R-targeted peptide drug to the Chinese market, providing eligible patients with moderate-to-severe plaque psoriasis with an additional oral targeted treatment option.

At the same time, ongoing development of icotrokinra in psoriatic arthritis, ulcerative colitis, and Crohn’s disease makes the future development of the IL-23R target an area worth monitoring.

As a China-based pharmaceutical wholesaler, DengYueMed monitors China’s innovative medicines and global pharmaceutical market developments, providing global industry clients with insights into the Chinese pharmaceutical market and pharmaceutical supply chain through its distribution services.

FAQ about Icotrokinra Approved in China for Plaque Psoriasis