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Disease
Asthma
Late-stage therapeutic developmentActively researchedRising momentum
25
Publications
24
Clinical trials
6
Related conditions
12
Associated genes
12
Related proteins
2024
Latest publication
Current focus
3' biologyAdenosine a1 biologyTherapeutic developmentInflammation & immunityMetabolic & lifestyle factors
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Clinical trial2026-10-15Status changed to Completed · ClinicalTrials.gov
Clinical trial2026-10-06Results posted · ClinicalTrials.gov
Clinical trial2026-09-24Status changed to Active, not recruiting · ClinicalTrials.gov
CHMP positive opinion: Adcomfo (EMA)
Regulatory2026-09-18EMA
Clinical trial2026-09-08Status changed to Completed · ClinicalTrials.gov
Clinical trial2026-08-12Status changed to Completed · ClinicalTrials.gov
Marketing authorisation: Exdensur (EMA)
Regulatory2026-02-12EMA
Potential Use of GLP-1 and GIP/GLP-1 Receptor Agonists for Respiratory Disorders: Where Are We at?
Research2024-12-09Medicina (Kaunas, Lithuania)
Biosimilar medicine authorisation: Omlyclo (EMA)
Regulatory2024-05-16EMA
Airway remodelling in asthma and the epithelium: on the edge of a new era.
Research2024-04-18The European respiratory journal
The airway neuro-immune axis as a therapeutic target in allergic airway diseases.
Research2024-02-08Respiratory research
Mucus Structure, Viscoelastic Properties, and Composition in Chronic Respiratory Diseases.
Research2024-02-05International journal of molecular sciences
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: High
Key developments
- 5 clinical trials expected to report results, the earliest in Q1 2028.
- 12 industry developments reported.
Upcoming Milestones
- Q1 2028TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab
- Q4 2028A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma
- Q1 2029A Multinational, Investigator-initiated, Parallel Group, Randomised, Double-blind, Placebo-controlled Phase 3b Superiority Trial Assessing the Effect of Dupilumab on Inducing Clinical Remission Outcomes in At-risk Type-2 Inflammatory Asthma (HOTHOT)
- Q1 2029A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma
- Q3 2030The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
Major developments
Upcoming trial readoutHigh impact
Results expected Q1 20292026-10-20
Upcoming trial readoutHigh impact
Results expected Q1 20282026-09-03
CHMP positive opinion (EU decision pending)Important
Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)2026-09-18
Clinical MilestonesView all 13Hide
Results expected
- 2026-10-20A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled AsthmaResults expected Q1 2029
- 2026-09-03TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With TezepelumabResults expected Q1 2028
- 2026-08-17The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 WeeksResults expected Q3 2030
- 2026-04-28A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe AsthmaResults expected Q4 2028
- 2026-03-04A Multinational, Investigator-initiated, Parallel Group, Randomised, Double-blind, Placebo-controlled Phase 3b Superiority Trial Assessing the Effect of Dupilumab on Inducing Clinical Remission Outcomes in At-risk Type-2 Inflammatory Asthma (HOTHOT)Results expected Q1 2029
Recently completed
- 2026-07-31Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol in Individuals With Cough Variant Asthma and Chronic CoughCompleted
- 2026-06-24The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary PatternCompleted
- 2026-06-23REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With AsthmaCompleted
- 2026-05-13STEP: A Prospective, Interventional, Multicenter, Single-Arm Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Eosinophilic Asthma Treated With BenralizumabCompleted
- 2026-04-26A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric AsthmaCompleted
Other updates
- 2027-11-01Phase 3, Multicenter, Randomized, Parallel-Group, Open-Label, Comparative Non-Inferiority Fixed-Dose Combination Formoterol 6 mcg/Fluticasone 125 mcg Versus Alenia® (Formoterol 6 mcg/Budesonide 200 mcg) in the Treatment of Moderate AsthmaWithdrawn
- 2026-12-01A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With AsthmaWithdrawn
- 2025-12-08A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Dexpramipexole Administered Orally for 52 Weeks in Participants With Severe Eosinophilic AsthmaTerminated
+5 more in the activity timeline below
Industry & MarketView all 12Hide
- 2026-10-23Heterogeneity of child and adolescent asthma determinants across urbanization stages: a 21-year global analysisIndustry · Nature — Climate Sciences
- 2026-10-20Quality of life improves in asthma with depemokimabIndustry · Healio Pulmonology
- 2026-10-12Dupilumab Wins Across Components of Pediatric AsthmaIndustry · Medscape Medical News
- 2026-10-07Meta-analysis of empirical evidence on biodiversity and the risk of asthmaIndustry · Nature — Environmental Sciences
- 2026-10-06Vaping Plus Smoking in the Home Might Be Worst for Kids' AsthmaIndustry · MedPage Today
+7 more in the activity timeline below
Regulatory UpdatesViewHide
- 2026-09-18CHMP positive opinion — OmalizumabTreatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
- 2026-02-12Original application approval — DepemokimabAsthma Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP) Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Activity timeline27
- 2027-11-01ClinicalPhase 3, Multicenter, Randomized, Parallel-Group, Open-Label, Comparative Non-Inferiority Fixed-Dose Combination Formoterol 6 mcg/Fluticasone 125 mcg Versus Alenia® (Formoterol 6 mcg/Budesonide 200 mcg) in the Treatment of Moderate AsthmaWithdrawn
- 2026-12-01ClinicalA Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With AsthmaWithdrawn
- 2026-10-23IndustryHeterogeneity of child and adolescent asthma determinants across urbanization stages: a 21-year global analysisIndustry · Nature — Climate Sciences
- 2026-10-20IndustryQuality of life improves in asthma with depemokimabIndustry · Healio Pulmonology
- 2026-10-20IndustryTezepelumab curbs asthma exacerbations across neutrophil countsIndustry · Healio Pulmonology
- 2026-10-20ClinicalA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled AsthmaResults expected Q1 2029
- 2026-10-19IndustryMost patients with severe asthma switch or discontinue biologicsIndustry · Healio Pulmonology
- 2026-10-19IndustryAsthma ‘weekend effect’ due to poorer health upon admissionIndustry · Healio Pulmonology
- 2026-10-16IndustryStandard care beneficial in many biologic-eligible asthma casesIndustry · Healio Pulmonology
- 2026-10-12IndustryDupilumab Wins Across Components of Pediatric AsthmaIndustry · Medscape Medical News
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approved & established therapies
Depemokimabapproved
Original application approval — Asthma Exdensur is indicated as add-on maintenance treatment for severe asthma with… (2026)
Omalizumabapproved
Biosimilar approval — Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 yea… (2024)
Tezepelumabapproved
Original application approval — AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents… (2022)
Benralizumabapproved
Original application approval — AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with seve… (2018)
Dupilumabapproved
Original application approval — Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of mode… (2017)
Reslizumabapproved
Original application approval — Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma… (2016)
Mepolizumabapproved
Original application approval — Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractor… (2015)
Clinical trials
The current development programme across all trial phases.
Clinical programme
24
6
18
6
Late-stage studies
Recruiting
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
Product approvals and authorisations
2026emaOriginal application approval — Depemokimab· Asthma Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP) Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. source ↗
2024emaBiosimilar approval — Omalizumab· Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 years of age). Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Omlyclo is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. source ↗
2022emaOriginal application approval — Tezepelumab· AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control. source ↗
2018emaOriginal application approval — Benralizumab· AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists (see section 5.1).Eosinophilic granulomatosis with polyangiitis (EGPA)Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (see section 5.1). source ↗
2017emaOriginal application approval — Dupilumab· Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma Adults and adolescents Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Children 6 to 11 years of age Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Prurigo Nodularis (PN) Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. Eosinophilic esophagitis (EoE) Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Chronic obstructive pulmonary disease (COPD) Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Chronic Spontaneous Urticaria (CSU) Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents and children (2 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU. source ↗
2016emaOriginal application approval — Reslizumab· Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. source ↗
2015emaOriginal application approval — Mepolizumab· Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause. source ↗
2005emaOriginal application approval — Omalizumab· Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. source ↗
Other regulatory activity
2026emaCHMP positive opinion — Omalizumab· Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU) source ↗
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Publications over time
Most influential
Recent publications
Major themes8
- Asthma13
- Pulmonary Disease, Chronic Obstructive3
- Respiration Disorders3
- Rhinitis, Allergic3
- Air Pollution2
- Gastrointestinal Microbiome2
- Hypersensitivity2
- Microbiota2
Leading journals6
- Allergy3
- The European respiratory journal3
- Frontiers in immunology2
- Medicina (Kaunas, Lithuania)2
- The Journal of allergy and clinical immunology2
- Biomolecules1
Leading researchers8
- Bush A3
- Adcock IM2
- Akdis CA2
- Akdis M2
- Bachert C2
- Bateman ED2
- Bousquet J2
- Canonica GW2
Affiliations (unnormalised)6
- National Heart and Lung Institute4
- Department of Clinical and Experimental Medicine3
- Medical University of Graz3
- Charles University and Thomayer Hospital2
- Department of Clinical Immunology and Allergology2
- Ghent University Hospital2
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Interleukin-4 receptor subunit alphavia IL4R0.74Adenosine receptor A1via ADORA10.72Interleukin-33via IL330.72Interleukin-5via IL50.71Interleukin-13via IL130.703',5'-cyclic-AMP phosphodiesterase 4Dvia PDE4D0.68Muscarinic acetylcholine receptor M2via CHRM20.64Beta-2 adrenergic receptorvia ADRB20.63Glucocorticoid receptorvia NR3C10.633',5'-cyclic-AMP phosphodiesterase 4Avia PDE4A0.62Alpha-2A adrenergic receptorvia ADRA2A0.62Adenosine receptor A2avia ADORA2A0.61
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Overview
Asthma is a bronchial disorder marked by three core features: airway hyper-responsiveness, airway inflammation, and intermittent airway obstruction. It is characterized by spasmodic contraction of airway smooth muscle, wheezing, and paroxysmal dyspnea.
Causes
Asthma development is influenced by environmental and other exogenous factors acting together with genetic predisposition. The supplied literature also links asthma onset or aggravation to air pollution, indoor allergens, tobacco smoke, viral respiratory infections, and altered gut and lung microbiota.
Pathophysiology
The disease involves airway inflammation, hyper-responsiveness, and intermittent obstruction driven by spasmodic airway smooth muscle contraction. The literature also supports inflammatory pathway activation and bronchoconstriction in association with microbiome dysbiosis, and many patients show a type 2 inflammatory signature with cytokine involvement.
Risk factors
Risk is increased by exposure to air pollution, indoor allergens such as house dust mites, pets, and molds, tobacco smoke, and viral respiratory infections. Genetic predisposition, early-life microbiome shaping, and sex- and hormone-related factors are also associated with differences in asthma incidence, prevalence, and severity.
Current standard of care
Treatment includes allergen immunotherapy for allergic asthma in appropriate patients. For severe uncontrolled disease, type 2-targeting biologics are used, including anti-IgE, anti-IL4Rα, anti-IL5, and anti-IL5Rα therapies.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.