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.
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
Research Report
Beclomethasone Dipropionate (DB00394): A Comprehensive Monograph
Executive Summary
Beclomethasone Dipropionate (BDP), identified by DrugBank ID DB00394 and CAS Number 5534-09-8, is a second-generation synthetic, chlorinated glucocorticoid that functions as a potent anti-inflammatory agent.[1] It operates as a prodrug, undergoing rapid hydrolysis by esterase enzymes in tissues to its highly active metabolite, Beclomethasone 17-Monopropionate (17-BMP). This active metabolite exerts strong, localized anti-inflammatory effects through high-affinity binding to glucocorticoid receptors, modulating gene expression to suppress inflammatory pathways.[1]
The primary therapeutic applications of BDP include the long-term maintenance and prophylactic treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD), where it is used both as a monotherapy and as a component of combination treatments.[4] It is also widely indicated for the management of seasonal and perennial allergic rhinitis, the prevention of nasal polyp recurrence, and the treatment of various corticosteroid-responsive dermatoses.[4] To meet these diverse clinical needs, BDP is available in multiple formulations, including pressurized metered-dose inhalers (pMDI), dry powder inhalers (DPI), breath-actuated inhalers (BAI), aqueous nasal sprays, and topical creams.[4]
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 | 8/20/2025 | |
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 | ||
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
BECLOMETHASONE AQUEOUS NASAL SPRAY 50MCG/METERED DOSE | prempharm inc | 02229998 | Metered-Dose Aerosol
,
Suspension - Nasal | 50 MCG / ACT | 1/3/1997 |
BECLOVENT ROTACAPS 100MCG | glaxo canada inc | 01949993 | Capsule - Inhalation | 100 MCG / CAP | 12/31/1985 |
BECLOVENT ROTACAPS 200MCG | glaxo canada inc | 01950002 | Capsule - Inhalation | 200 MCG / CAP | 12/31/1985 |
BECLOMETHASONE NASAL SPRAY | 02238577 | Suspension - Nasal | 50 MCG / ACT | N/A | |
PROPADERM | bausch health, canada inc. | 02089602 | Cream - Topical | 0.025 % / W/W | 3/30/1998 |
PROPADERM CREAM 0.025% | allen & hanburys a glaxo canada ltd. co. | 00002712 | Cream - Topical | .025 % | 12/15/1989 |
BECLODISK - PWR INH 100MCG/BLISTER | glaxo wellcome inc. | 02213710 | Powder - Inhalation | 100 MCG / BLISTER | 9/3/1997 |
BECONASE AQ NASAL AEM 50MCG/AEM | glaxo canada inc | 01923935 | Metered-Dose Aerosol - Nasal | 50 MCG / ACT | 12/31/1991 |
BECLOMETHASONE DIPROPIONATE NASAL INHALER | pharmaco canada inc. | 02079984 | Metered-Dose Aerosol - Inhalation
,
Nasal | 50 MCG / ACT | 12/31/1994 |
BECLOMETHASONE DIPROPIONATE NAS-SPR 50MCG/AEM | kenral inc. | 00872326 | Metered-Dose Aerosol - Nasal | 50 MCG / ACT | 12/31/1992 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.