Overview
Beclomethasone dipropionate is a second-generation synthetic corticosteroid and diester of beclomethasone, which is structurally similar to dexamethasone. It is a prodrug of an active metabolite beclomethasone 17-monopropionate (17-BMP) which acts on the glucocorticoid receptor to mediates its therapeutic action. Beclomethasone dipropionate itself posesses weak glucocorticoid receptor binding affinity and is rapidly converted into 17-BMP upon administration. Formulations for oral inhalation, intranasal, and topical use are available for beclomethasone dipropionate. Beclomethasone dipropionate became first available in a pressurized metered-dose inhaler in 1972 and later in a dry powder inhaler and an aqueous nasal spray. Due to its anti-inflammatory, antipruritic, and anti-allergy properties, beclomethasone dipropionate is used in various inflammatory conditions, such as asthma, allergic rhinitis, and dermatoses to reduce symptoms. When inhaled, it is proposed that beclomethasone dipropionate remains active locally in the lung without causing significant side effects associated with systemic corticosteroids. Compared to earlier corticosteroids such as dexamethasone and prednisolone, beclomethasone dipropionate is reported to be less irritating to the nasal mucosa with a longer duration of action when administered intranasally.
Background
Beclomethasone dipropionate is a second-generation synthetic corticosteroid and diester of beclomethasone, which is structurally similar to dexamethasone. It is a prodrug of an active metabolite beclomethasone 17-monopropionate (17-BMP) which acts on the glucocorticoid receptor to mediates its therapeutic action. Beclomethasone dipropionate itself posesses weak glucocorticoid receptor binding affinity and is rapidly converted into 17-BMP upon administration. Formulations for oral inhalation, intranasal, and topical use are available for beclomethasone dipropionate. Beclomethasone dipropionate became first available in a pressurized metered-dose inhaler in 1972 and later in a dry powder inhaler and an aqueous nasal spray. Due to its anti-inflammatory, antipruritic, and anti-allergy properties, beclomethasone dipropionate is used in various inflammatory conditions, such as asthma, allergic rhinitis, and dermatoses to reduce symptoms. When inhaled, it is proposed that beclomethasone dipropionate remains active locally in the lung without causing significant side effects associated with systemic corticosteroids. Compared to earlier corticosteroids such as dexamethasone and prednisolone, beclomethasone dipropionate is reported to be less irritating to the nasal mucosa with a longer duration of action when administered intranasally.
Indication
糖皮质激素类药。主要用于持续性哮喘的长期治疗。按照支气管哮喘严重程度分级标准,在轻度持续(2级以上)即可使用吸入糖皮质激素治疗;外用适用于对糖皮质激素外用有效的各种非感染性炎症性皮肤病,如亚急性和慢性湿疹、脂溢性皮炎、接触性皮炎、特应性皮炎、局限性神经性皮炎、寻常型银屑病、盘状红斑狼疮、扁平苔癣等。亦可用于常年性变应性鼻炎和季节性变应性鼻炎及血管收缩性鼻炎;亦用于鼻息肉切除术后,预防息肉的再生。
Associated Conditions
- Asthma
- Bacterial Sinusitis
- Chronic Sinusitis
- Dermatosis
- Fungal skin infection
- Perennial Allergic Rhinitis (PAR)
- Seasonal Allergic Rhinitis
- Vasomotor Rhinitis
- Corticosteroid-responsive dermatoses
- Recurrent nasal polyps
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/06/05 | Not Applicable | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | ||
2023/04/26 | Phase 1 | Completed | |||
2022/03/23 | Phase 3 | Completed | |||
2021/10/27 | Phase 4 | Completed | |||
2021/05/05 | Phase 1 | Completed | SOFAR S.p.A. | ||
2020/03/25 | Phase 3 | Active, not recruiting | |||
2019/12/04 | Phase 4 | UNKNOWN | |||
2019/03/19 | Phase 3 | Completed | |||
2019/02/15 | Phase 4 | Completed | Medicines Evaluation Unit Ltd | ||
2016/01/06 | Phase 4 | Completed | Stefania La Grutta, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
A-S Medication Solutions | 50090-5032 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 4/28/2023 | |
STAT RX USA LLC | 16590-860 | RESPIRATORY (INHALATION) | 40 ug in 1 1 | 8/4/2011 | |
Teva Respiratory, LLC | 59310-410 | NASAL | 80 ug in 1 1 | 9/27/2022 | |
Physicians Total Care, Inc. | 54868-5857 | RESPIRATORY (INHALATION) | 40 ug in 1 1 | 3/24/2011 | |
A-S Medication Solutions | 50090-3459 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 5/17/2018 | |
Teva Respiratory, LLC | 59310-406 | NASAL | 40 ug in 1 1 | 9/27/2022 | |
Teva Respiratory, LLC | 59310-302 | RESPIRATORY (INHALATION) | 40 ug in 1 1 | 2/1/2024 | |
RPK Pharmaceuticals, Inc. | 53002-3477 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 4/28/2023 | |
A-S Medication Solutions | 50090-1342 | RESPIRATORY (INHALATION) | 80 ug in 1 1 | 6/11/2018 | |
RPK Pharmaceuticals, Inc. | 53002-2436 | RESPIRATORY (INHALATION) | 40 ug in 1 1 | 4/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/17/2017 | ||
Withdrawn | 4/23/2018 | ||
Withdrawn | 4/23/2018 | ||
Authorised | 4/26/2018 | ||
Authorised | 4/26/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
FOSTER NEXTHALER INHALATION POWDER 100 MCG/6 MCG PER DOSE | SIN15332P | POWDER, METERED | 100mcg/dose | 9/19/2017 | |
Foster Pressurised Inhalation Solution 100mcg/6mcg per Actuation | SIN13932P | AEROSOL, METERED | 0.100mg/ actuation | 3/15/2011 | |
BECLOMET EASYHALER 200 mcg/inhalation dose | SIN08674P | POWDER, METERED | 200mcg/metered dose | 4/24/1996 | |
CLENIL 50 mcg PRESSURISED INHALATION SOLUTION | SIN03597P | AEROSOL, METERED | 50 mcg/dose | 7/12/1989 | |
DECOMIT NASAL SPRAY 50 mcg/actuation | SIN10521P | SPRAY | 50 mcg/actuation | 12/8/1998 | |
BECLO-ASMA CFC FREE INHALLER 250mcg | SIN13671P | AEROSOL, METERED | 250mcg/dose | 7/9/2009 | |
CANDID-B CREAM | SIN03941P | CREAM | 0.025% w/w | 2/21/1990 | |
BECLO-ASMA CFC-FREE INHALER 50 mcg | SIN12634P | AEROSOL, METERED | 50 mcg/dose | 12/23/2004 | |
Clenil Pressurised Solution For Inhalation 250mcg | SIN13313P | AEROSOL, METERED | 250mcg/dose | 7/12/2007 | |
TRIMBOW PRESSURISED INHALATION SOLUTION 100/6/12.5 μg PER ACTUATION | SIN15924P | AEROSOL, METERED | 0.1mg/actuation | 4/2/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Beclomethasone Dipropionate Nasal Aerosol | 国药准字H20113273 | 化学药品 | 气雾剂 | 2/20/2021 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H37022928 | 化学药品 | 气雾剂 | 1/16/2020 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H37022152 | 化学药品 | 气雾剂 | 2/8/2020 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H31020770 | 化学药品 | 吸入气雾剂 | 3/23/2021 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H44024063 | 化学药品 | 气雾剂 | 1/6/2021 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H20059866 | 化学药品 | 气雾剂 | 1/16/2020 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H20059867 | 化学药品 | 气雾剂 | 1/16/2020 | |
Beclometasone Dipropionate Inhalation Aerosol | 国药准字H14020317 | 化学药品 | 气雾剂 | 7/16/2021 | |
Beclometasone Dipropionate Suspension for Inhalation | 国药准字H20253765 | 化学药品 | 吸入制剂 | 4/1/2025 | |
Beclometasone Dipropionate Suspension for Inhalation | 国药准字HJ20130214 | 化学药品 | 吸入混悬剂 | 2/14/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
BECLATE-50 INHALER 50MCG/ACTUATION | N/A | N/A | N/A | 7/24/2003 | |
FOSTER PRESSURISED INHALATION SOLUTION 200/6 MICROGRAMS PER ACTUATION | N/A | N/A | N/A | 12/3/2024 | |
FOSTER NEXTHALER INHALATION POWDER 200 MICROGRAMS/6 MICROGRAMS PER ACTUATION | N/A | N/A | N/A | 12/3/2024 | |
BECLATE-100 INHALER 100 MCG/ACTUATION | N/A | N/A | N/A | 5/23/2003 | |
BECONASE AQUEOUS NASAL SPRAY 0.05% | N/A | N/A | N/A | 3/2/1987 | |
BECLATE-250 INHALER 250MCG/ACTUATION | N/A | N/A | N/A | 7/24/2003 |