MedPath

Aclidinium

Generic Name
Aclidinium
Brand Names
Bretaris Genuair, Duaklir, Duaklir Genuair, Eklira Genuair, Tudorza, Tudorza Genuair, Brimica Genuair
Drug Type
Small Molecule
Chemical Formula
C26H30NO4S2
CAS Number
727649-81-2
Unique Ingredient Identifier
K17VY42F6C

Overview

Aclidinium is an anticholinergic for the long-term management of chronic obstructive pulmonary disease (COPD). It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012.

Background

Aclidinium is an anticholinergic for the long-term management of chronic obstructive pulmonary disease (COPD). It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012.

Indication

用于治疗慢性支气管炎或肺气肿引起的急性支气管痉挛。

Associated Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/02/28
Phase 4
Recruiting
2017/11/06
N/A
Completed
2017/09/21
N/A
Completed
2017/09/08
Phase 2
Completed
2017/09/08
Phase 1
Completed
2017/09/07
Phase 4
UNKNOWN
2017/06/09
Phase 4
Withdrawn
2017/04/07
Phase 3
Completed
McGill University Health Centre/Research Institute of the McGill University Health Centre
2017/01/16
Phase 3
Completed
2016/11/23
Phase 4
Completed

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
RESPIRATORY (INHALATION)
400 ug in 1 1
2022/08/01
70515-002
RESPIRATORY (INHALATION)
400 ug in 1 1
2022/01/25
0310-0900
RESPIRATORY (INHALATION)
400 ug in 1 1
2021/02/23
0310-0800
RESPIRATORY (INHALATION)
400 ug in 1 1
2022/08/01
70515-001

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
EMEA/H/C/002211
the netherlands
N/A
Authorised
2012/07/20
N/A
21
EMEA/H/C/002706
the netherlands
N/A
Authorised
2012/07/20
N/A
20
EMEA/H/C/003745
the netherlands
N/A
Authorised
2014/11/19
2014/09/25
16
EMEA/H/C/003969
the netherlands
N/A
Authorised
2014/11/19
N/A
16

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字HJ20240081
吸入粉雾剂
N/A
每个吸入器60吸,每吸含阿地溴铵400μg,递送剂量为阿地溴铵375µg
Chemical Drug
Approved
2024/08/05
Import

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
224899
A Menarini Australia Pty Ltd
Active
2015/05/01
aclidinium bromide
206071
A Menarini Australia Pty Ltd
Active
2014/03/25
aclidinium bromide
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