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)
Research Report
A Comprehensive Monograph on Aclidinium Bromide: Pharmacology, Clinical Efficacy, and Therapeutic Profile
Section 1: Drug Identity and Physicochemical Properties
1.1. Nomenclature and Identifiers
Aclidinium bromide is a small molecule pharmaceutical agent classified as a long-acting muscarinic antagonist (LAMA), a subclass of anticholinergic bronchodilators.[1] Its chemical identity is precisely defined by a comprehensive set of internationally recognized identifiers, which are essential for its unambiguous reference in clinical, regulatory, and research contexts.
The International Nonproprietary Name (INN) for the active substance is Aclidinium Bromide.[2] Chemically, it is a quaternary ammonium ion and a carboxylic ester, structurally characterized as a member of thiophenes and an aromatic ether, functionally related to 3-quinuclidinol.[1] For database and informatics purposes, it is assigned DrugBank ID DB08897 [1], ChEBI ID CHEBI:65346 [1], and ChEMBL ID CHEMBL1194325.[1]
A point of potential confusion is the existence of two primary CAS Numbers associated with the substance. The CAS Number 727649-81-2 refers to the aclidinium cation itself, while 320345-99-1 is often used for the bromide salt form in which the drug is formulated and administered.[1] Its IUPAC name is formally stated as-1-azoniabicyclo[2.2.2]octan-8-yl] 2-hydroxy-2,2-di(thiophen-2-yl)acetate or, more completely for the salt,octan-3-yl] 2-hydroxy-2,2-dithiophen-2-ylacetate;bromide.[3]
Aclidinium bromide is marketed globally under several brand names. In the United States, it is known as Tudorza Pressair.[2] In the United Kingdom and other European Union member states, it is available as
Eklira Genuair.[2] The name
Bretaris Genuair is used in the majority of EU states where it is licensed to Menarini.[2] In Canada, it is marketed as
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/02/28 | Phase 4 | Terminated | |||
2017/11/06 | N/A | Completed | |||
2017/09/21 | N/A | Completed | |||
2017/09/08 | Phase 1 | Completed | |||
2017/09/08 | Phase 2 | 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 Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP | 0310-0800 | RESPIRATORY (INHALATION) | 400 ug in 1 1 | 2/23/2021 | |
Covis Pharma US, Inc | 70515-001 | RESPIRATORY (INHALATION) | 400 ug in 1 1 | 8/1/2022 | |
AstraZeneca Pharmaceuticals LP | 0310-0900 | RESPIRATORY (INHALATION) | 400 ug in 1 1 | 1/25/2022 | |
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 |
---|---|---|---|
Authorised | 11/19/2014 | ||
Authorised | 11/19/2014 | ||
Authorised | 11/19/2014 | ||
Authorised | 7/20/2012 | ||
Authorised | 7/20/2012 | ||
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 | 02439530 | Powder (Metered Dose) - Inhalation | 400 MCG / ACT | 7/9/2015 | |
TUDORZA GENUAIR | 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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