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Disease

Asthma

Late-stage therapeutic developmentActively researchedRising momentum
MeSHAsthma
25
Publications
24
Clinical trials
6
Related conditions
2
Related proteins
2024
Latest publication
Current focus
Therapeutic developmentInflammation & immunityMetabolic & lifestyle factors
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Approval: 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)

Approval: 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

The Effects of Environmental Exposure on Epigenetic Modifications in Allergic Diseases.

Research2024-01-07Medicina (Kaunas, Lithuania)

Delayed gut microbiota maturation in the first year of life is a hallmark of pediatric allergic disease.

Research2023-08-29Nature communications

Autophagy/Mitophagy in Airway Diseases: Impact of Oxidative Stress on Epithelial Cells.

Research2023-08-04Biomolecules

Higher systemic immune-inflammation index and systemic inflammation response index levels are associated with stroke prevalence in the asthmatic population: a cross-sectional analysis of the NHANES 1999-2018.

Research2023-08-04Frontiers in immunology

Global, regional, and national burden of allergic disorders and their risk factors in 204 countries and territories, from 1990 to 2019: A systematic analysis for the Global Burden of Disease Study 2019.

Research2023-07-11Allergy

Approval: Tezspire (EMA)

Regulatory2022-09-19EMA

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
  • 1 regulatory approval from EMA on record.
  • 6 clinical trials expected to report results, the earliest in Q3 2027.
  • 2 industry developments reported.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
TAPER: 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
Results expected Q3 20272026-06-25
Upcoming trial readoutHigh impact
The 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
Results expected Q3 20302026-06-25
Important regulatory approvalHigh impact
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.2026-02-12
Clinical Milestones15View all 15
Results expected 5
Recently completed 5
Other updates 3
+7 more in the activity timeline below
Industry & Market2View
Regulatory Updates1View
  • 2026-02-12Approval — 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 timeline18

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

Approval — Asthma  Exdensur is indicated as add-on maintenance treatment for severe asthma with… (2026)

Omalizumabapproved

Approval — Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 yea… (2024)

Tezepelumabapproved

Approval — AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents… (2022)

Benralizumabapproved

Approval — AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with seve… (2018)

Dupilumabapproved

Approval — Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of mode… (2017)

Reslizumabapproved

Approval — Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma… (2016)

Mepolizumabapproved

Approval — Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractor… (2015)

Clinical trials

16 sponsors · 6 new · 6 completed in the last 12 months (net +5)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

The 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

Phase 3 · Recruiting · GlaxoSmithKline

TAPER: 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

Phase 3 · Recruiting · AstraZeneca

A 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)

Phase 3 · Recruiting · Université de Sherbrooke

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma

Phase 3 · Recruiting · CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Individualizing Treatment for Asthma in Primary Care (Full Study)

Phase 4 · Recruiting · DARTNet Institute

A 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

Phase 3 · Recruiting · Generate Biomedicines
Recruiting

The 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

Phase 3 · Recruiting · GlaxoSmithKline

TAPER: 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

Phase 3 · Recruiting · AstraZeneca

A 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)

Phase 3 · Recruiting · Université de Sherbrooke

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma

Phase 3 · Recruiting · CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Individualizing Treatment for Asthma in Primary Care (Full Study)

Phase 4 · Recruiting · DARTNet Institute

A 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

Phase 3 · Recruiting · Generate Biomedicines
Recently completed

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

Phase 3 · Completed · Bridgette Jones

REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma

Phase 3 · Completed · University Hospital, Montpellier

The Efficacy and Mechanisms of Action of n-3 Poly-unsaturated Fatty Acid Supplementation in People With Non-steroidal Exacerbated Airways Disease and Uncontrolled Asthma

Phase 3 · Completed · Norfolk and Norwich University Hospitals NHS Foundation Trust

A Two-arm, Placebo-controlled, Randomized Clinical Trial to Evaluate the Effect of Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma

Phase 3 · Completed · McMaster University

Establishment of a FeNO Cutoff Value for Evaluating the Response to Budesonide-formoterol in Patients With Chronic Cough Suggestive of Cough Variant Asthma: a Multicenter Prospective Clinical Study

Phase 4 · Completed · AstraZeneca

A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis

Phase 4 · Completed · Kafrelsheikh University

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2026emaApproval — 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 ↗
2024emaApproval — 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 ↗
2022emaApproval — 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 ↗
2018emaApproval — 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 ↗
2017emaApproval — 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 ↗
2016emaApproval — 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 ↗
2015emaApproval — 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 ↗
2005emaApproval — 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 ↗

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

25 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20102024
Recent publications

Airway remodelling in asthma and the epithelium: on the edge of a new era.

The European respiratory journal · 2024 · 82 cites

Mucus Structure, Viscoelastic Properties, and Composition in Chronic Respiratory Diseases.

International journal of molecular sciences · 2024 · 43 cites

The Effects of Environmental Exposure on Epigenetic Modifications in Allergic Diseases.

Medicina (Kaunas, Lithuania) · 2024 · 12 cites

The airway neuro-immune axis as a therapeutic target in allergic airway diseases.

Respiratory research · 2024 · 9 cites

Potential Use of GLP-1 and GIP/GLP-1 Receptor Agonists for Respiratory Disorders: Where Are We at?

Medicina (Kaunas, Lithuania) · 2024 · 8 cites

Global, regional, and national burden of allergic disorders and their risk factors in 204 countries and territories, from 1990 to 2019: A systematic analysis for the Global Burden of Disease Study 2019.

Allergy · 2023 · 284 cites
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

Disease biology

2 matches

Key proteins & gene products studied in this disease. Number shows shared papers.

Cytokines2Protein Serine-Threonine Kinases2

Related conditions

6 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Respiration Disorders4Hypersensitivity3Inflammation3Pulmonary Disease, Chronic Obstructive3Rhinitis, Allergic3COVID-192

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
MeSHAsthma
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.