Aclidinium

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.

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
ANTES B+ Clinical Trial	2024/02/28	NCT06282861	Phase 4	Recruiting	Fundacio Privada Mon Clinic Barcelona
A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)	2017/11/06	NCT03333018	N/A	Completed	AstraZeneca
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints	2017/09/21	NCT03290287	N/A	Completed	AstraZeneca
A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants	2017/09/08	NCT03276052	Phase 1	Completed	AstraZeneca
Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease	2017/09/08	NCT03276078	Phase 2	Completed	AstraZeneca
The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours.	2017/09/07	NCT03275116	Phase 4	UNKNOWN	Maastricht University Medical Center
To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease	2017/06/09	NCT03181880	Phase 4	Withdrawn	AstraZeneca
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers	2017/04/07	NCT03104634	Phase 3	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients	2017/01/16	NCT03022097	Phase 3	Completed	AstraZeneca
Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial	2016/11/23	NCT02972476	Phase 4	Completed	University of Dundee

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tudorza Pressair	AstraZeneca Pharmaceuticals LP	0310-0800	RESPIRATORY (INHALATION)	400 ug in 1 1	2/23/2021
DUAKLIR PRESSAIR	Covis Pharma US, Inc	70515-001	RESPIRATORY (INHALATION)	400 ug in 1 1	8/1/2022
DUAKLIR PRESSAIR	AstraZeneca Pharmaceuticals LP	0310-0900	RESPIRATORY (INHALATION)	400 ug in 1 1	1/25/2022
Tudorza Pressair	Covis Pharma US, Inc	70515-002	RESPIRATORY (INHALATION)	400 ug in 1 1	8/1/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Duaklir Genuair	Covis Pharma Europe B.V.,Gustav Mahlerplein 2,1082 MA Amsterdam,The Netherlands	Authorised	11/19/2014
Brimica Genuair	Covis Pharma Europe B.V.,Gustav Mahlerplein 2,1082 MA Amsterdam,The Netherlands	Authorised	11/19/2014
Bretaris Genuair	Covis Pharma Europe B.V.,Gustav Mahlerplein 2,1082 MA Amsterdam,The Netherlands	Authorised	7/20/2012
Eklira Genuair	Covis Pharma Europe B.V.,Gustav Mahlerplein 2,1082 MA Amsterdam,The Netherlands	Authorised	7/20/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BRIMICA GENUAIR 340/12 aclidinium bromide and formoterol fumarate dihydrate powder for inhalation dry powder inhaler	224899	A Menarini Australia Pty Ltd	Medicine	A	5/1/2015
BRETARIS GENUAIR aclidinium (as bromide) 322 micrograms powder for inhalation inhaler - dry powder	206071	A Menarini Australia Pty Ltd	Medicine	A	3/25/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DUAKLIR GENUAIR	Covis Pharma GmbH	02439530	Powder (Metered Dose) - Inhalation	400 MCG / ACT	7/9/2015
TUDORZA GENUAIR	Covis Pharma GmbH	02409720	Powder (Metered Dose) - Inhalation	400 MCG / ACT	9/13/2013

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.

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