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Olopatadine HCl NS
Olopatadine HCl is a selective H1-receptor antagonist and mast cell stabilizer that reduces allergic inflammation in the nasal cavity.
Olopatadine HCl is a selective H1-receptor antagonist and mast cell stabilizer that reduces allergic inflammation in the nasal cavity. Used for Allergic rhinitis (nasal spray formulation).
At a glance
| Generic name | Olopatadine HCl NS |
|---|---|
| Sponsor | Glenmark Specialty S.A. |
| Drug class | H1-receptor antagonist / mast cell stabilizer |
| Target | H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy / Immunology |
| Phase | Phase 3 |
Mechanism of action
Olopatadine blocks histamine H1 receptors on nasal tissues and stabilizes mast cells, preventing the release of inflammatory mediators responsible for allergic rhinitis symptoms. This dual action reduces both immediate histamine-mediated responses and longer-term allergic inflammation when administered as a nasal spray.
Approved indications
- Allergic rhinitis (nasal spray formulation)
Common side effects
- Headache
- Nasal irritation
- Bitter taste
- Somnolence
Key clinical trials
- To Study GSP 301 in Patients With Seasonal Allergic Rhinitis (PHASE2)
- Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (PHASE3)
- Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (PHASE3)
- Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (PHASE3)
- Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR) (PHASE2)
- Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (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:
- Olopatadine HCl NS CI brief — competitive landscape report
- Olopatadine HCl NS updates RSS · CI watch RSS
- Glenmark Specialty S.A. portfolio CI