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Report Overview

Moderate to severe atopic dermatitis (AD) is a chronic inflammatory condition characterized by persistent itching, dryness, lesions, and recurrent flares that can substantially affect quality of life. The National Eczema Association estimates that about 16.5 million U.S. adults have AD, including 6.6 million with moderate to severe disease. Current therapies include biologics, JAK inhibitors, topical treatments, and immunosuppressants, while the pipeline increasingly focuses on targeted mechanisms, longer-lasting control, and improved itch relief. According to the moderate to severe atopic dermatitis pipeline analysis by Expert Market Research, rising disease burden, unmet treatment needs, and continued innovation are expected to support pipeline growth in the coming years.

  • Major companies involved in the moderate to severe atopic dermatitis pipeline analysis include Shanghai Longwood Biopharmaceuticals Co., Ltd., Akeso, and others.

  • Leading drugs currently in the pipeline include LW402, AK139, APG777 + APG990, and others.

  • Bispecific antibodies, novel immune targets, and extended-interval biologics are expected to accelerate pipeline growth, improving itch control, skin clearance, treatment durability, and dosing convenience.

Report Coverage

The Moderate to Severe Atopic Dermatitis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into moderate to severe atopic dermatitis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for moderate to severe atopic dermatitis. The moderate to severe atopic dermatitis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The moderate to severe atopic dermatitis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with moderate to severe atopic dermatitis treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to moderate to severe atopic dermatitis.

Moderate to Severe Atopic Dermatitis Pipeline Analysis by Drug Class

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Moderate to Severe Atopic Dermatitis Pipeline Outlook

Moderate to severe atopic dermatitis is a chronic inflammatory skin disorder characterized by persistent itching, dryness, redness, and recurrent lesions. It occurs when impaired skin-barrier function and immune system dysregulation increase inflammation and sensitivity. Genetic, environmental, and immunological factors can contribute to disease development, progression, and recurrent flare-ups.

Moderate to severe atopic dermatitis is treated with topical corticosteroids, calcineurin inhibitors, biologic therapies, oral or injectable immunomodulators, and other targeted treatments to reduce inflammation, relieve itching, restore skin-barrier function, control flares, and support long-term disease management. In December 2024, the Food and Drug Administration approved Nemluvio (nemolizumab-ilto) for patients aged 12 years and older with moderate to severe atopic dermatitis inadequately controlled by topical prescription therapies. The approval was supported by ARCADIA 1 and ARCADIA 2 trials, which demonstrated improvements in Investigator’s Global Assessment success and Eczema Area and Severity Index-75.

Moderate to Severe Atopic Dermatitis Epidemiology

Epidemiological trends continue to support demand for moderate to severe atopic dermatitis therapies. According to the National Eczema Association, approximately 16.5 million U.S. adults have atopic dermatitis, including 6.6 million with moderate to severe disease. In 2026, Jonathan I. Silverberg et al. reported pediatric prevalence ranging from 9.8% in the United States to 20.1% in Brazil, demonstrating substantial geographic variation. These prevalence patterns highlight a significant patient population and a continued need for effective therapies, supporting ongoing clinical development and pipeline expansion.

Moderate to Severe Atopic Dermatitis – Pipeline Therapeutic Assessment

This section of the report covers the analysis of moderate to severe atopic dermatitis drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase 1)
  • Preclinical and Discovery Stage Products

By Drug Class

The moderate to severe atopic dermatitis pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecule
  • Monoclonal Antibodies
  • Gene Therapies
  • Polymers
  • Peptides

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration:

  • Oral
  • Parenteral
  • Others

Moderate to Severe Atopic Dermatitis Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to Expert Market Research's analysis, phase II covers a major share of the total Moderate to Severe Atopic Dermatitis clinical trials, accounts for 46%. Phase III at 36%, phase I representing 14% and phase IV accounts for 4%. The strong presence of phase II and phase III candidates indicates an active development landscape, supporting the expansion of treatment options, accelerating innovation, and strengthening future growth opportunities in the moderate to severe atopic dermatitis market.

Moderate to Severe Atopic Dermatitis Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the moderate to severe atopic dermatitis pipeline analysis include small molecules, monoclonal antibodies, gene therapies, polymers, and peptides. The moderate to severe atopic dermatitis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for moderate to severe atopic dermatitis. Janus kinase 1 inhibitors are emerging as targeted therapies for moderate to severe atopic dermatitis. For instance, Ivarmacitinib, a selective oral Janus kinase 1 inhibitor, demonstrated significant improvements in Investigator Global Assessment and Eczema Area and Severity Index outcomes in a Phase 3 clinical trial. Its favorable safety profile further supports its potential as a treatment option for moderate to severe atopic dermatitis.

Moderate to Severe Atopic Dermatitis Clinical Trials – Key Players

The EMR report for the moderate to severe atopic dermatitis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed moderate to severe atopic dermatitis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in moderate to severe atopic dermatitis clinical trials:

  • Shanghai Longwood Biopharmaceuticals Co., Ltd.
  • Akeso
  • Apogee Therapeutics, Inc.
  • Guangdong Hengrui Pharmaceutical Co., Ltd.
  • Shanghai Mabgeek Biotech. Co. Ltd.
  • Guangzhou JOYO Pharma Co., Ltd.
  • Qilu Pharmaceutical Co., Ltd.
  • Nektar Therapeutics
  • TRex Bio, Inc.
  • Keymed Biosciences Co. Ltd.
  • Aclaris Therapeutics, Inc.

Moderate to Severe Atopic Dermatitis – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for moderate to severe atopic dermatitis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of moderate to severe atopic dermatitis drug candidates.

Drug: LW402

LW402, sponsored by Shanghai Longwood Biopharmaceuticals Co., Ltd., is a next-generation JAK1-selective inhibitor being developed for autoimmune diseases, including moderate-to-severe atopic dermatitis. The Phase 3 study is evaluating the efficacy and safety of oral LW402 tablets compared with placebo in 480 patients. The study is examining whether LW402 can provide effective disease improvement while maintaining a favorable safety profile. As an orally administered JAK1-selective inhibitor, LW402 is being developed to selectively modulate immune signaling involved in inflammation. The study is expected to be completed in December 2028.

Biological: AK139

AK139, sponsored by Akeso, is being evaluated in a randomized, double-blind Phase II study involving patients with moderate-to-severe atopic dermatitis. The study is examining the efficacy and safety of this first-in-class IL-4Rα/ST2-targeting bispecific antibody, which is simultaneously blocking the IL-4/IL-13 and IL-33/ST2 inflammatory pathways. AK139 is being administered as a biological treatment alongside placebo in the trial. The study is enrolling an estimated 168 participants and is expected to be completed by January 10, 2028, with primary completion anticipated in November 2027.

Drug: APG777 + APG990

APG777 + APG990 is being evaluated by Apogee Therapeutics, Inc. in a Phase 1b study to examine the safety, tolerability, and pharmacokinetic profile of the combination versus dupilumab in adults with moderate-to-severe atopic dermatitis. APG777 is targeting IL-13 to provide deep Type 2 inflammation inhibition, while APG990 is a subcutaneous, half-life-extended monoclonal antibody targeting OX40L, enabling broader inhibition of Type 1, Type 2, and Type 3 inflammatory pathways. The combination is being administered by subcutaneous injections. The study is expected to be completed in December 2027, with primary completion anticipated in December 2026.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Moderate to Severe Atopic Dermatitis Pipeline Insight Report

  • Which companies/institutions are leading the moderate to severe atopic dermatitis drug development?
  • Which company is leading the moderate to severe atopic dermatitis pipeline development activities?
  • What is the current moderate to severe atopic dermatitis commercial assessment?
  • What are the opportunities and challenges present in the moderate to severe atopic dermatitis pipeline landscape?
  • What is the efficacy and safety profile of moderate to severe atopic dermatitis pipeline drugs?
  • Which company is conducting major trials for moderate to severe atopic dermatitis drugs?
  • Which companies/institutions are involved in moderate to severe atopic dermatitis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in moderate to severe atopic dermatitis?

Reasons To Buy This Report

The Moderate to Severe Atopic Dermatitis pipeline analysis report provides a strategic overview of the latest and future landscape of treatments for moderate to severe atopic dermatitis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into moderate to severe atopic dermatitis collaborations, regulatory environments, and potential growth opportunities.

Related Reports

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Moderate to Severe Atopic Dermatitis Epidemiology Forecast

Atopic Dermatitis Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecule
  • Monoclonal Antibodies
  • Gene Therapies
  • Polymers
  • Peptides

Leading Sponsors Covered

  • Shanghai Longwood Biopharmaceuticals Co., Ltd.
  • Akeso
  • Apogee Therapeutics, Inc.
  • Guangdong Hengrui Pharmaceutical Co., Ltd.
  • Shanghai Mabgeek Biotech. Co. Ltd.
  • Guangzhou JOYO Pharma Co., Ltd.
  • Qilu Pharmaceutical Co., Ltd.
  • Nektar Therapeutics
  • TRex Bio, Inc.
  • Keymed Biosciences Co. Ltd.
  • Aclaris Therapeutics, Inc.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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