Overview
Azelastine, a phthalazine derivative, is an antihistamine available as an intranasal spray for the treatment of allergic and vasomotor rhinitis and as an ophthalmic solution for the treatment of allergic conjunctivitis. It is a racemic mixture, though there is no noted difference in pharmacologic activity between enantiomers, and was first granted FDA approval in 1996. Azelastine is also available in combination with fluticasone propionate as a nasal spray marketed under the trade name Dymista™, which is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 6 years of age and older.
Indication
Intranasal azelastine is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 5 years and older and for the symptomatic treatment of vasomotor rhinitis in patients 12 years and older. Ophthalmic azelastine solution is indicated for the treatment of itchy eyes associated with allergic conjunctivitis. As a 0.15% nasal spray, azelastine hydrochloride is also indicated for over-the-counter treatment of allergies in patients aged six years and older.
Associated Conditions
- Allergic Conjunctivitis (AC)
- Allergic Rhinitis (AR)
- Allergy to Tree Pollen
- Atopy Keratoconjunctivitis
- Blepharitis allergic
- Perennial Allergic Rhinitis (PAR)
- Seasonal Allergic Rhinitis
- Vasomotor Rhinitis
- Allergic eye disorders
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/19 | Phase 3 | Completed | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | ||
2023/12/22 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2023/06/05 | Phase 1 | Terminated | |||
2022/11/25 | Phase 4 | Recruiting | |||
2022/04/05 | Phase 3 | Completed | |||
2021/01/28 | Phase 3 | Completed | Abdi Ibrahim Ilac San. ve Tic A.S. | ||
2020/10/23 | Phase 4 | Withdrawn | |||
2020/09/24 | Not Applicable | UNKNOWN | |||
2020/02/11 | Phase 3 | Completed | |||
2018/07/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-2519 | NASAL | 205.5 ug in 1 1 | 1/7/2022 | |
| RPK Pharmaceuticals, Inc. | 53002-2279 | NASAL | 137 ug in 1 1 | 12/14/2018 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-066 | NASAL | 137 ug in 1 1 | 3/31/2022 | |
| A-S Medication Solutions | 50090-2330 | NASAL | 137 ug in 1 1 | 11/17/2022 | |
| Bryant Ranch Prepack | 72162-1388 | NASAL | 137 ug in 1 1 | 2/8/2024 | |
| Akorn | 50383-942 | NASAL | 1.5 mg in 1 mL | 3/1/2022 | |
| Aurobindo Pharma Limited | 59651-214 | NASAL | 137 ug in 1 1 | 2/3/2023 | |
| Allegiant Health | 69168-479 | NASAL | 202.5 ug in 1 1 | 5/2/2025 | |
| Bryant Ranch Prepack | 72162-1601 | NASAL | 137 ug in 0.137 mL | 1/30/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-2497 | NASAL | 137 ug in 1 1 | 8/9/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SYNAZE NASAL SPRAY | SIN15256P | SPRAY, METERED | 0.1 %w/w | 6/5/2017 | |
| DYMISTA NASAL SPRAY | SIN15255P | SPRAY, METERED | 0.1 %w/w | 6/5/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Azelastine Hydrochloride Nasal Spray | 国药准字H20041039 | 化学药品 | 喷雾剂 | 8/1/2024 | |
| Azelastine Hydrochloride Nasal Spray | 国药准字H20050942 | 化学药品 | 鼻用制剂 | 7/9/2024 | |
| Azelastine Hydrochloride Nasal Spray | 国药准字HJ20150201 | 化学药品 | 鼻用喷雾剂 | 7/14/2020 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20253054 | 化学药品 | 眼用制剂 | 1/2/2025 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20253098 | 化学药品 | 眼用制剂 | 1/8/2025 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20253094 | 化学药品 | 眼用制剂 | 1/8/2025 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20249403 | 化学药品 | 眼用制剂 | 11/15/2024 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20253946 | 化学药品 | 眼用制剂 | 4/15/2025 | |
| Azelastine Hydrochloride Eye Drops | 国药准字HJ20230059 | 化学药品 | 眼用制剂 | 5/29/2023 | |
| Azelastine Hydrochloride Eye Drops | 国药准字H20244119 | 化学药品 | 眼用制剂 | 6/25/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AZETIN NASAL SPRAY 1MG/ML | N/A | N/A | N/A | 3/23/2009 |
TGA Drug Approvals
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