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Disease

Urticaria

Late-stage therapeutic developmentEmerging research
MeSHUrticaria
1
Publications
19
Clinical trials
12
Associated genes
1
Related proteins
2018
Latest publication
Latest activity
beta

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

CHMP positive opinion: Adcomfo (EMA)

Regulatory2026-09-18EMA

Approval: Rhapsido (EMA)

Regulatory2026-04-23EMA

Approval: Omlyclo (EMA)

Regulatory2024-05-16EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 1 regulatory approval from EMA on record.
  • 4 clinical trials expected to report results, the earliest in Q4 2026.
  • 2 industry developments reported.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)
Results expected Q2 20282026-07-29
Upcoming trial readoutHigh impact
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Results expected Q4 20262026-07-20
Important regulatory approvalHigh impact
Approval — Remibrutinib
Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.2026-04-23
Clinical Milestones6View
Results posted 1
Results expected 4
Recently completed 1
Industry & Market2View
Regulatory Updates2View
  • 2026-09-18CHMP positive opinion — OmalizumabTreatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
  • 2026-04-23Approval — RemibrutinibRhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Activity timeline10

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
Remibrutinibapproved

Approval — Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult p… (2026)

Omalizumabapproved

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

Dupilumabapproved

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

Desloratadineapproved

Approval — Treatment of allergic rhinitis and urticaria. (2012)

Canakinumabapproved

Approval — Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinfla… (2009)

Clinical trials

13 sponsors · 2 new · 0 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
19
All trials
6
Active
16
Late-stage
6
Completed
Late-stage studies

A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years

Phase 3 · Active, not recruiting · Novartis Pharmaceuticals

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Phase 3 · Active, not recruiting · Novartis Pharmaceuticals

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

Phase 3 · Recruiting · Celldex Therapeutics

Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study

Phase 3 · Recruiting · Shandong New Time Pharmaceutical Co., LTD

COrticosteroids in acUte uRticAria in emerGency dEpartment

Phase 3 · Completed · Assistance Publique - Hôpitaux de Paris

A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines

Phase 3 · Completed · Kashiv BioSciences, LLC
Recruiting

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

Phase 3 · Recruiting · Celldex Therapeutics

Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study

Phase 3 · Recruiting · Shandong New Time Pharmaceutical Co., LTD

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)

Phase 2 · Recruiting · Yuhan Corporation

An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Phase 2 · Recruiting · ARS Pharmaceuticals, Inc.
Recently completed

COrticosteroids in acUte uRticAria in emerGency dEpartment

Phase 3 · Completed · Assistance Publique - Hôpitaux de Paris

A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines

Phase 3 · Completed · Kashiv BioSciences, LLC

Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

Phase 3 · Completed · Sanofi

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Phase 3 · Completed · Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment

Phase 3 · Completed · Sanofi

A Phase III, Multi-center, Double Blind, Randomized, Active Controlled Clinical Trial to Evaluate the Non-Inferiority Comparing Cetirizine Injection 10 mg to Diphenhydramine Injection, 50 mg, for the Treatment of Acute Urticaria

Phase 3 · Completed · JDP Therapeutics, Inc.

Regulatory timeline

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

First approvals
2026emaApproval — Remibrutinib· Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment. 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 ↗
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 ↗
2012emaApproval — Desloratadine· Treatment of allergic rhinitis and urticaria. source ↗
2012emaApproval — Desloratadine· Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: allergic rhinitis chronic idiopathic urticaria as initially diagnosed by a physician source ↗
2011emaApproval — Desloratadine· Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria. source ↗
2011emaApproval — Desloratadine· Desloratadine Teva is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria. source ↗
2009emaApproval — Canakinumab· Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Familial Mediterranean fever (FMF) Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of: Still’s disease Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate. 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

1 papers

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

Leading journals1
  • Allergy1
Leading researchers8
  • Abdul Latiff AH1
  • Aberer W1
  • Asero R1
  • Baker D1
  • Ballmer-Weber B1
  • Bernstein JA1
  • Bindslev-Jensen C1
  • Brzoza Z1
Affiliations (unnormalised)6
  • Aarhus University Hospital1
  • Allergology and Clinical Immunology in Katowice1
  • Allergy and Clinical Immunology1
  • Allergy and Clinical Immunology Department1
  • Allergy& Immunology Centre1
  • Baker Allergy Asthma and Dermatology Clinic1

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

HRH10.61GCSAML0.55RAC20.46CBLB0.45FCER1A0.40F120.34GRK60.34TPSB20.33BICD10.27NANOGP80.27TNPO10.26OR10J30.25

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Histamine H1 receptorvia HRH10.61

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Identifiers
MeSHUrticaria
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.