Defined as urticaria persisting for six weeks or more, chronic urticaria can severely impact a patient’s quality of life, making effective management key to improving outcomes. In some cases, chronic spontaneous urticaria may be present, can further contribute to a patient's physical and psychological burden.
Today, we are taking a look at the latest regarding chronic urticaria in relation to clinical guidance, FDA approvals, and clinical trials.
Current Chronic Urticaria Guidelines
The following clinical guidelines focus on or include guidance regarding chronic urticaria.
- Definition, Classification, Diagnosis and Management of Urticaria
- Global Allergy and Asthma Excellence Network (GALEN)
- February 2026
- Management of People with Chronic Urticaria
- British Association of Dermatologists (BAD)
- November 2021
- Definition, Classification, Diagnosis, and Management of Urticaria
- European Academy of Allergy and Clinical Immunology (EAACI), European Dermatology Forum (EDF)
- September 2021
- Diagnosis and Management of Acute and Chronic Urticaria
- American College of Allergy, Asthma, and Immunology (AAAAI), American Academy of Allergy, Asthma & Immunology (ACAAI)
- February 2014
Recent FDA Approvals for Chronic Urticaria
Below are the medications and therapies recently approved by the FDA that we anticipate being incorporated into future clinical guidelines:
(Rhapsido) remibrutinib
- Novartis
- September 2025
- Indicated for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
(Dupixent) dupilumab
- Sanofi/Regeneron
- April 2025
- Indicated for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
(Omlyclo) omalizumab-igec
- Celltrion
- March 2025
- Indicated for chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.
Ongoing Clinical Trials for Chronic Urticaria
The following are ongoing, Phase 3 clinical trials based in the United States that we anticipate may impact future chronic urticaria clinical guidelines.
- Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- Celldex Therapeutics
- Anticipated Primary Completion: September 2028
- A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines (RECLAIM)
- Novartis Pharmaceuticals
- Anticipated Primary Completion: February 2027
- 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
- Novartis Pharmaceuticals
- Anticipated Primary Completion: November 2026
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) (EMBARQ-CSU2)
- Celldex Therapeutics
- Anticipated Primary Completion: October 2026
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