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Beclomethasone Dipropionate

Generic Name
Beclomethasone Dipropionate
Brand Names
Alanase, Beconase, Propaderm, Qnasl, Qvar, Rivanase AQ, Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), Trydonis
Drug Type
Small Molecule
Chemical Formula
C28H37ClO7
CAS Number
5534-09-8
Unique Ingredient Identifier
5B307S63B2

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

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

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
QVAR 50 AUTOHALER beclometasone dipropionate 50mcg per actuation pressurised inhalation
71991
Medicine
A
11/23/1999
QVAR 100 INHALER beclometasone dipropionate 100mcg per actuation pressurised inhalation
71993
Medicine
A
11/23/1999
CIPLA BECLOMETASONE/FORMOTEROL 100/6 beclometasone dipropionate 100 mcg formoterol fumarate dihydrate 6 mcg pressurised inhalation aerosol can
408415
Medicine
A
3/24/2025
FOSTAIR 100/6 beclometasone dipropionate 100 microgram and formoterol fumarate dihydrate 6 microgram pressurised inhalation solution
310360
Medicine
A
2/12/2020
QVAR 100 AUTOHALER beclometasone dipropionate 100mcg per actuation pressurised inhalation
71994
Medicine
A
11/23/1999
CIPLA BECLOMETASONE/FORMOTEROL 200/6 beclometasone dipropionate 200 mcg formoterol fumarate dihydrate 6 mcg pressurised inhalation aerosol can
408416
Medicine
A
3/24/2025
BECLOFORM 100/6 beclometasone dipropionate 100 mcg formoterol fumarate dihydrate 6 mcg pressurised inhalation aerosol can
408409
Medicine
A
3/24/2025
FOSTAIR 200/6 beclometasone dipropionate 200 microgram and formoterol fumarate dihydrate 6 microgram pressurised inhalation solution
373934
Medicine
A
8/5/2022
BECLOFORM 200/6 beclometasone dipropionate 200 mcg formoterol fumarate dihydrate 6 mcg pressurised inhalation aerosol can
408414
Medicine
A
3/24/2025
TRIMBOW 100/6/10 beclometasone dipropionate 100 ug formoterol fumarate dihydrate 6 ug glycopyrronium 10 ug pressurised inhalation solution pack
314166
Medicine
A
6/24/2020
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