The moderate to severe atopic dermatitis (AD) treatment landscape is undergoing a significant transformation, with 45+ pharmaceutical companies actively developing more than 50 pipeline therapies across various clinical stages. This robust pipeline reflects the growing global prevalence of the condition and increased recognition of the substantial unmet needs among patients with more severe forms of this chronic inflammatory skin disease.
Expanding Pipeline Addresses Significant Unmet Needs
Atopic dermatitis, the most common chronic inflammatory skin condition, affects millions worldwide and often begins in infancy. Moderate to severe cases are characterized by persistent and debilitating symptoms including intense itching, red or discolored patches, dry flaky skin, and areas that may crack, swell, ooze, or develop crusts. These symptoms can significantly impact quality of life, disrupt sleep, and lead to anxiety and depression.
The current treatment paradigm for moderate to severe AD includes topical therapies, systemic immunosuppressants, and biologics. However, many patients continue to experience inadequate disease control, highlighting the need for additional therapeutic options with improved efficacy and safety profiles.
Key Pipeline Developments and Clinical Milestones
Several promising candidates have recently reached significant development milestones:
Nektar Therapeutics announced completion of target enrollment in its Phase IIb REZOLVE-AD study of rezpegaldesleukin in January 2025. This novel IL-2 modulator received FDA fast-track designation in February 2025 for patients 12 years and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies.
Corvus Pharmaceuticals is advancing soquelitinib, an Emt protein-tyrosine kinase inhibitor, with new interim data from its Phase I trial to be presented at the Society for Investigative Dermatology. Previously released data in December 2024 showed promising results in patients with moderate to severe AD.
Apogee Therapeutics announced in February 2025 that the first patient had been dosed in the Part B portion of its Phase II APEX clinical trial of APG777, while also completing enrollment in the Part A portion of the trial.
Kymera Therapeutics initiated dosing in its BroADen Phase Ib clinical trial evaluating KT-621, an oral STAT6 degrader, in April 2025. The company expects to report data from this trial in the fourth quarter of 2025.
Diverse Therapeutic Approaches in Development
The pipeline features diverse therapeutic approaches targeting multiple pathways involved in AD pathogenesis:
JAK Inhibitors: Several companies are developing JAK inhibitors, including Jiangsu Vcare Pharmaceutical's VC005 (Phase III) and E-nitiate Biopharmaceuticals' QY201 (Phase II), which targets both JAK1 and TYK2 kinases.
Biologics and Immunomodulators: Novel biologics include Shanghai Chia Tai Tianqing's TQH2722, targeting IL-4 receptor type I and II, and Tavotek Biotherapeutics' TAVO101, which modulates thymic stromal lymphopoietin.
Oral Small Molecules: In addition to JAK inhibitors, other oral therapies in development include Corvus Pharmaceuticals' soquelitinib and Kymera Therapeutics' KT-621.
Market Growth Drivers and Future Outlook
The moderate to severe AD market is experiencing strong growth driven by several factors:
- Rising global prevalence and heightened awareness, fueling demand for advanced treatments
- Breakthroughs in biologics, small molecules, and personalized medicine reshaping the therapeutic landscape
- Supportive regulatory frameworks, including fast-track designations for promising therapies
- Innovations in pediatric care and improved global access expanding treatment opportunities
With multiple late-stage clinical trials underway and data readouts expected throughout 2025, the treatment landscape for moderate to severe AD is poised for significant evolution. These emerging therapies offer hope for improved disease management and quality of life for patients who continue to struggle with this challenging condition.
Long-Term Safety and Efficacy Data
Long-term safety and efficacy remain critical considerations for chronic conditions like AD. In October 2024, LEO Pharma presented final results from its five-year extension study ECZTEND, demonstrating the long-term safety and efficacy profile of Adbry® (tralokinumab-ldrm) in adults and adolescent patients with moderate-to-severe AD.
Similarly, Celldex Therapeutics initiated a Phase II study of barzolvolimab in moderate to severe AD in December 2024, adding to the growing number of treatment options under investigation.
Comprehensive Treatment Approaches
Effective management of moderate to severe AD requires a comprehensive approach. Beyond pharmacological interventions, treatment strategies include identifying and avoiding triggers, maintaining consistent skincare routines, and regular moisturization. For patients with inadequate response to topical therapies, systemic options including phototherapy and immunosuppressive drugs may be considered.
The development of targeted therapies that address specific immune pathways involved in AD pathogenesis represents a significant advancement in treatment. These therapies aim to provide more precise disease control while potentially reducing the side effects associated with broader immunosuppression.
As the pipeline continues to mature, healthcare providers and patients can anticipate an expanded armamentarium of therapeutic options, potentially enabling more personalized treatment approaches based on individual disease characteristics and response patterns.
