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Olopatadine Nasal Spray
Olopatadine is a selective H1-receptor antagonist and mast cell stabilizer that blocks histamine-mediated allergic responses in the nasal mucosa.
Olopatadine is a selective H1-receptor antagonist and mast cell stabilizer that blocks histamine-mediated allergic responses in the nasal mucosa. Used for Allergic rhinitis (nasal symptoms).
At a glance
| Generic name | Olopatadine Nasal Spray |
|---|---|
| Sponsor | ORA, Inc. |
| Drug class | Selective H1-receptor antagonist / mast cell stabilizer |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy / Immunology |
| Phase | FDA-approved |
Mechanism of action
Olopatadine works through dual action: it competitively antagonizes H1 histamine receptors on nasal tissues, preventing histamine-induced symptoms like itching and congestion, while also stabilizing mast cells to reduce the release of inflammatory mediators. This combination provides both immediate symptom relief and longer-term reduction in allergic inflammation.
Approved indications
- Allergic rhinitis (nasal symptoms)
Common side effects
- Headache
- Bitter taste
- Nasal irritation
- Somnolence
Key clinical trials
- Azelastine Allergen Chamber - Onset of Action Study (PHASE2)
- A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis (PHASE4)
- Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes
- 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)
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 Nasal Spray CI brief — competitive landscape report
- Olopatadine Nasal Spray updates RSS · CI watch RSS
- ORA, Inc. portfolio CI