Asthma Clinical Trial Landscape

The asthma clinical trial landscape in 2026

Severe asthma has been transformed over the past decade by the arrival of targeted biologics, and the pipeline shows no signs of slowing. The approvals of mepolizumab (Nucala, GSK), benralizumab (Fasenra, AstraZeneca), dupilumab (Dupixent, Sanofi/Regeneron), and tezepelumab (Tezspire, AstraZeneca/Amgen) have established IL-5, IL-4/IL-13, and TSLP as clinically validated targets. As of 2026, the competitive landscape includes agents advancing through Phase 2 and Phase 3 with refined phenotypic selection, pediatric extensions, and new formulations. AstraZeneca remains the most active sponsor in our database, with PT027 (budesonide-albuterol fixed-dose combination inhaler) and continued post-approval work on benralizumab. Sanofi is expanding dupilumab's evidence base in asthma subtypes and younger age groups.

The shift from empiric treatment to biomarker-driven therapy has fundamentally altered how asthma trials are designed and enrolled. Blood eosinophil counts, fractional exhaled nitric oxide (FeNO), periostin, and IgE levels now routinely stratify patients across study arms. This phenotypic precision has improved trial efficiency but also increased the intelligence burden on BD and pipeline teams, a new biologic registering on ClinicalTrials.gov with a specific eosinophil threshold or FeNO cutoff is a fundamentally different signal than a broad population trial from five years ago.

Non-type 2 asthma, characterized by neutrophilic or paucigranulocytic inflammation, remains a major unmet need. Type 2 biologics provide little benefit to this population, which represents approximately 40% of severe asthma. JAK inhibitors (targeting the JAK-STAT pathway downstream of type 2 cytokines) and novel innate immune targets are active areas of development for non-type 2 phenotypes. DataLookout tracks trials across both type 2 and non-type 2 mechanisms so BD and research teams have complete pipeline visibility.

• IL-5 / IL-5R antagonists, mepolizumab (approved), benralizumab (approved), reslizumab (approved), next-generation anti-IL-5 candidates
• IL-4/IL-13 / IL-4Rα, dupilumab (approved), tralokinumab combinations, IL-13-specific agents
• TSLP, tezepelumab (approved 2021), TSLP receptor antibodies
• IL-33, itepekimab (AstraZeneca/Sanofi, Phase 3), astegolimab (Genentech)
• IgE, omalizumab (Genentech, approved), ligelizumab (Novartis)
• JAK inhibitors for severe eosinophilic asthma, oral small molecules, inhaled JAK inhibitor formulations
• Bronchial thermoplasty, catheter-based device procedure, ongoing real-world and registry studies
• PT027, budesonide/albuterol fixed-dose combination ICS/SABA (AstraZeneca, approved in U.S.)

What we monitor for asthma

Our system pulls from the ClinicalTrials.gov API every day. For an asthma watch profile, you can configure a saved search for:

• Keywords: "asthma," "severe asthma," "eosinophilic asthma," "type 2 asthma," "non-type 2 asthma," "bronchial thermoplasty," "tezepelumab," "dupilumab," "benralizumab," "mepolizumab," "omalizumab," "TSLP," "IL-5," "IL-33"
• Phase filters: Phase 1 (novel mechanisms, first-in-human), Phase 2 (proof-of-concept, biomarker studies), Phase 3 (pivotal/registration, label expansions)
• Sponsor type: large respiratory pharma (AstraZeneca, Sanofi, Genentech, GSK), specialty biotech, NIH/NHLBI-funded academic centers
• Study status: not yet recruiting, recruiting, active not recruiting (completed enrollment)
• Sub-population: pediatric asthma, severe uncontrolled asthma, oral corticosteroid-dependent asthma, exercise-induced bronchoconstriction

Type 2 vs. non-type 2 asthma: the phenotyping revolution

The single most important conceptual shift in severe asthma over the past decade is the recognition that "asthma" is not one disease. Type 2 inflammation, driven by ILC2 cells, Th2 lymphocytes, and the cytokines IL-4, IL-5, and IL-13, underlies approximately 60% of severe asthma cases. These patients have elevated eosinophils, high FeNO, and often concurrent atopic disease (allergic rhinitis, atopic dermatitis). Every approved biologic to date targets this pathway: mepolizumab and benralizumab block IL-5 or its receptor; dupilumab blocks the shared IL-4Rα subunit; tezepelumab acts upstream on TSLP, which drives both type 2 and some non-type 2 inflammation. ICS/LABA combinations remain the pharmacological backbone for all patients, with biologics added for those inadequately controlled despite maximized inhaled therapy.

The roughly 40% of severe asthma patients without type 2 inflammation, the non-type 2 or "T2-low" phenotype, have elevated neutrophils or near-normal inflammatory markers. Current biologics provide little to no benefit for this population. This is where the next decade of severe asthma development is likely headed: macrolide antibiotics (azithromycin) have shown some benefit; JAK inhibitors targeting downstream STAT3/STAT6 signaling are in early development; and innate immune mediators including IL-17A and the NLRP3 inflammasome are under investigation. For BD teams, a new Phase 2 trial enrolling T2-low patients is a particularly high-signal registration because the competitive field remains sparse.

Biomarker-driven enrollment has also changed the practical logistics of asthma trials. Sites must have reliable eosinophil differential counting, FeNO measurement equipment, and electronic spirometry. Trials with narrow biomarker entry criteria take longer to enroll. This creates an intelligence need: BD and CRO teams tracking the pipeline need to understand not just mechanism but the specific patient selection criteria being used, which DataLookout captures from each trial registration.

Who uses asthma trial monitoring

• Respiratory pharma and biotech BD teams: tracking IL-5, IL-4/IL-13, TSLP, IL-33, and non-type 2 mechanisms across Phase 2 and 3 registrations; monitoring competitors' label expansion strategies
• Pulmonology CROs: identifying new sponsor relationships, site qualification opportunities for biomarker-stratified severe asthma protocols
• Patient advocacy organizations for severe and pediatric asthma: tracking access to novel biologics, pediatric extension trials, and inclusion of underserved populations
• Respiratory and allergy investors: monitoring Phase 2/3 data catalysts and new program registrations from companies in or entering the severe asthma space
• Academic pulmonology and allergy research groups: tracking industry programs for potential investigator-site participation and publication collaborations