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Non sedating H1-antihistamine
Selectively blocks H1 histamine receptors on mast cells and basophils without crossing the blood-brain barrier, preventing histamine-mediated allergic responses without causing sedation.
Selectively blocks H1 histamine receptors on mast cells and basophils without crossing the blood-brain barrier, preventing histamine-mediated allergic responses without causing sedation. Used for Allergic rhinitis, Chronic urticaria, Allergic conjunctivitis.
At a glance
| Generic name | Non sedating H1-antihistamine |
|---|---|
| Sponsor | Sanofi |
| Drug class | H1-receptor antagonist (non-sedating antihistamine) |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | Phase 3 |
Mechanism of action
Non-sedating H1-antihistamines are second-generation antihistamines that competitively antagonize H1 receptors, preventing histamine binding and subsequent allergic cascade activation. Unlike first-generation antihistamines, they are highly selective for peripheral H1 receptors and have poor CNS penetration due to their larger molecular size and/or substrate for efflux transporters, thereby avoiding sedation while maintaining efficacy in allergic conditions.
Approved indications
- Allergic rhinitis
- Chronic urticaria
- Allergic conjunctivitis
Common side effects
- Headache
- Pharyngitis
- Somnolence (minimal)
- Dry mouth
Key clinical trials
- Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (PHASE1)
- Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS) (PHASE3)
- Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID) (PHASE3)
- A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200) (PHASE3)
- An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Non sedating H1-antihistamine CI brief — competitive landscape report
- Non sedating H1-antihistamine updates RSS · CI watch RSS
- Sanofi portfolio CI