Overview
Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.
Background
Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.
Indication
For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older .
Associated Conditions
- Chronic Spontaneous Urticaria
- Seasonal Allergic Rhinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/24 | Phase 1 | Not yet recruiting | |||
2021/03/23 | Phase 3 | Completed | |||
2018/08/16 | Phase 1 | UNKNOWN | |||
2018/03/27 | Phase 3 | Completed | |||
2017/07/27 | Phase 2 | Completed | |||
2016/05/04 | Phase 4 | Completed | |||
2015/10/15 | Phase 4 | Completed | |||
2015/09/23 | Phase 4 | UNKNOWN | Association Asthma, Bulgaria | ||
2015/07/31 | Phase 4 | Completed | Universidade do Sul de Santa Catarina | ||
2014/08/11 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| ALIGRIN TABLET 20MG | SIN16474P | TABLET | 20MG | 4/12/2022 | |
| BILAXTEN TABLET 20 mg | SIN14661P | TABLET | 20.00 mg | 11/11/2014 | |
| BILAXTEN ORODISPERSIBLE TABLET 10MG | SIN15874P | TABLET, ORALLY DISINTEGRATING | 10MG/TABLET | 1/13/2020 | |
| BILAXTEN ORAL SOLUTION 2.5MG/ML | SIN15963P | SOLUTION | 2.5MG/ML | 6/24/2020 | |
| BILAXTEN TABLET 20 MG (PHARMACY ONLY) | SIN17104P | TABLET | 20.00 mg | 10/2/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bilastine Tablets | 国药准字HJ20230083 | 化学药品 | 片剂 | 6/21/2023 | |
| Bilastine Tablets | 国药准字H20253972 | 化学药品 | 片剂 | 4/22/2025 | |
| Bilastine Tablets | 国药准字H20249275 | 化学药品 | 片剂 | 11/5/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BILAZIN 20 TABLETS 20MG | N/A | hong kong medical supplies ltd | N/A | N/A | 12/9/2024 |
| VILARIN TABLETS 20MG | N/A | vickmans laboratories ltd | N/A | N/A | 5/26/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ALLERTINE bilastine 20 mg tablet blister pack | 387574 | A Menarini Australia Pty Ltd | Medicine | A | 4/27/2022 |
| ALLERTINE MELTLETS bilastine 20 mg orally disintegrating tablet blister pack | 480827 | A Menarini Australia Pty Ltd | Medicine | A | 2/26/2025 |