InnoCare Advances Oral Itch Drug in High-Stakes Dermatology Market

BEIJING – November 27, 2025 – InnoCare Pharma has officially dosed the first patient in a global Phase II clinical trial for its novel oral drug, Soficitinib, targeting prurigo nodularis—a severe, chronic skin disease defined by an unrelenting itch. The move signals a critical step forward for the TYK2 inhibitor and marks another entry into the increasingly competitive, multi-billion-dollar market for advanced dermatological therapies.

This advancement places Soficitinib directly into a landscape recently transformed by powerful biologics, yet where a significant need for effective, convenient oral treatments remains. For the estimated 10 million people worldwide suffering from prurigo nodularis, this trial offers a new glimmer of hope against a condition that profoundly impacts quality of life.

The Unrelenting Burden of Prurigo Nodularis

To understand the significance of InnoCare's trial, one must first grasp the debilitating nature of prurigo nodularis (PN). Far more than a simple rash, PN is a chronic neuroinflammatory disease characterized by an intense, deep-seated itch that triggers a vicious itch-scratch cycle. This relentless scratching leads to the formation of hard, painful, and often disfiguring nodules across the skin.

The patient burden is immense. According to leading dermatologists, the pruritus associated with PN is among the most severe of any skin condition. Patients frequently report significant sleep disruption, anxiety, and depression, with a quality-of-life impact comparable to that of chronic kidney disease or recovery from a stroke. The visible nature of the skin lesions can also lead to social isolation and psychological distress.

Historically, treatment options have been limited and often inadequate. Physicians have relied on off-label use of high-potency topical steroids, phototherapy, and broad systemic immunosuppressants like methotrexate or cyclosporine. While sometimes offering temporary relief, these approaches carry the risk of significant side effects, making them unsuitable for long-term management and leaving a substantial unmet need for safer, more targeted, and more effective therapies.

A Targeted Attack on Inflammation and Itch

Soficitinib represents a new wave of precision medicine aimed at the core drivers of autoimmune disease. As a potent and selective TYK2 (Tyrosine Kinase 2) inhibitor, it works by blocking specific signaling pathways within the immune system that are crucial to the inflammatory process. TYK2 is a member of the Janus kinase (JAK) family, but its selective inhibition is key. This approach allows for the interruption of pro-inflammatory signals mediated by cytokines like IL-12 and IL-23 without the broader immunosuppression associated with less selective JAK inhibitors, which have faced scrutiny over safety concerns.

For prurigo nodularis, Soficitinib’s mechanism is particularly relevant. The drug is designed to block the signaling of cytokines central to both itch and inflammation, including IL-4, IL-13, and IL-31. IL-31, often dubbed the "itch cytokine," is a primary driver of the neurogenic itch response that torments PN patients. By simultaneously targeting these pathways, the therapy aims to not only reduce the inflammatory lesions but, crucially, to break the itch-scratch cycle at its molecular source.

This targeted oral approach stands as a compelling alternative to the recently approved injectable biologics, Sanofi’s Dupixent (dupilumab) and Galderma’s Nemluvio (nemolizumab). While these antibody-based therapies have revolutionized care by proving the efficacy of targeting the IL-4/IL-13 and IL-31 pathways respectively, the market has a strong appetite for an effective oral option that offers greater convenience for chronic disease management.

Navigating a Competitive and Growing Market

InnoCare is not entering an empty field. The prurigo nodularis market, valued at over $2 billion in 2024 and projected to exceed $3 billion by 2034, has become a strategic focus for major pharmaceutical players. Bristol Myers Squibb has already validated the commercial potential of selective TYK2 inhibition with Sotyktu (deucravacitinib), its blockbuster oral treatment for psoriasis, demonstrating that a well-differentiated oral therapy can compete effectively against established biologics.

Soficitinib will face direct competition from both existing treatments and other pipeline candidates. Besides the market-leading injectables Dupixent and Nemluvio, other companies are advancing their own assets. Incyte’s oral JAK1 inhibitor, povorcitinib, is already in Phase III trials for prurigo nodularis, positioning it ahead of Soficitinib in the development race. Meanwhile, a host of other companies, from Takeda to Ventyx Biosciences, are developing their own next-generation TYK2 inhibitors for various autoimmune indications, creating a crowded and fast-moving competitive landscape.

Success for Soficitinib will depend on demonstrating a compelling clinical profile: robust efficacy in reducing both itch and lesions, a clean safety record, and the inherent advantage of being an oral pill. Positive data from this Phase II trial will be essential for InnoCare to differentiate its asset and secure a foothold in this lucrative market.

A Strategic Pillar in InnoCare’s Autoimmune Ambitions

The initiation of this trial is more than a single product milestone; it's a clear indicator of InnoCare's broader corporate strategy. The company has publicly stated its ambition to become a major force in autoimmune diseases, with a pipeline now spanning ten major conditions and a particular focus on the high-growth dermatology sector.

Soficitinib is the cornerstone of this strategy. The drug has already produced promising Phase II results in moderate-to-severe atopic dermatitis, which were highlighted in a late-breaking presentation at the prestigious American Academy of Dermatology (AAD) Annual Meeting. By advancing the same molecule into prurigo nodularis, InnoCare is executing a classic "pipeline-in-a-product" strategy, aiming to maximize the value of a promising asset across multiple indications with shared underlying biology.

As Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, stated in the announcement, “We are accelerating global clinical development to bring innovative therapies to more autoimmune patients as early as possible.” This aggressive posture, backed by a portfolio that balances oncology and immunology, positions the company to capitalize on the convergence of scientific innovation and market opportunity. For investors and industry observers, the progress of Soficitinib serves as a key barometer for InnoCare’s ability to execute on its ambitious vision and transition from a regional player to a global biopharmaceutical competitor. The outcome of this trial will therefore resonate far beyond the prurigo nodularis community, signaling the potential of a new class of oral therapies and the strategic acumen of the company behind it.