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aclidinium bromide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4484	320345-99-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: aclidinium bromide Tudorza Pressair aclidinium LAS 34273 LAS W-330	a long-acting, inhaled antimuscarinic; in phase I trial 8/2008 Molecular weight: 484.65 Formula: C26H30NO4S2 CLOGP: 2.34 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 55.76 ALOGS: -5.53 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

aclidinium bromide
Tudorza Pressair
aclidinium
LAS 34273
LAS W-330

a long-acting, inhaled antimuscarinic; in phase I trial 8/2008

Molecular weight: 484.65
Formula: C26H30NO4S2
CLOGP: 2.34
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 55.76
ALOGS: -5.53
ROTB: 10

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.64	mg	Inhal.powder

ADMET properties:

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Property	Value	Reference
CL (Clearance)	48.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	4.30 L/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	0.04 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
July 20, 2012	EMA
July 23, 2012	FDA	ASTRAZENECA PHARMS

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Obstructive airways disorder	466.14	33.98	168	12019	20531	63456304
Nasal polyps	378.81	33.98	107	12080	5932	63470903
Bronchiectasis	355.78	33.98	129	12058	16013	63460822
Wheezing	292.65	33.98	198	11989	95397	63381438
Asthma	280.27	33.98	216	11971	127345	63349490
Asthma-chronic obstructive pulmonary disease overlap syndrome	231.82	33.98	58	12129	2003	63474832
Total lung capacity increased	220.38	33.98	57	12130	2253	63474582
Urinary tract discomfort	196.16	33.98	41	12146	619	63476216
Polymyalgia rheumatica	188.07	33.98	56	12131	3735	63473100
Alveolar osteitis	183.44	33.98	41	12146	860	63475975

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Asthma	179.44	26.82	97	4839	42559	34909436
Dyspnoea	161.66	26.82	229	4707	376553	34575442
Wheezing	159.89	26.82	89	4847	41313	34910682
Chronic obstructive pulmonary disease	133.37	26.82	84	4852	48834	34903161
Obstructive airways disorder	105.75	26.82	49	4887	15445	34936550
Device malfunction	103.77	26.82	43	4893	10378	34941617
Breath sounds abnormal	98.77	26.82	37	4899	6844	34945151
Productive cough	85.97	26.82	58	4878	37755	34914240
Loss of personal independence in daily activities	80.50	26.82	53	4883	33126	34918869
Congenital hiatus hernia	77.52	26.82	19	4917	825	34951170

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Obstructive airways disorder	462.29	26.19	185	14531	31274	79698398
Asthma	412.26	26.19	275	14441	134820	79594852
Bronchiectasis	390.07	26.19	149	14567	22237	79707435
Wheezing	371.60	26.19	244	14472	116420	79613252
Nasal polyps	358.07	26.19	106	14610	7221	79722451
Chronic obstructive pulmonary disease	258.05	26.19	173	14543	85246	79644426
Total lung capacity increased	217.99	26.19	56	14660	2242	79727430
Asthma-chronic obstructive pulmonary disease overlap syndrome	203.81	26.19	57	14659	3164	79726508
Dyspnoea	192.43	26.19	460	14256	856565	78873107
Urinary tract discomfort	181.66	26.19	39	14677	702	79728970

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R03AL05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS, INHALANTS Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
ATC	R03BB05	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Anticholinergics
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:48876	muscarinic antagonists
FDA EPC	N0000175574	Anticholinergic
FDA MoA	N0000175370	Cholinergic Antagonists

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Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic obstructive lung disease	indication	13645005	DOID:3083

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.97	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.4MG/INH	TUDORZA PRESSAIR	COVIS	N202450	July 23, 2012	RX	POWDER, METERED	INHALATION	RE46417	Feb. 10, 2025	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH	TUDORZA PRESSAIR	COVIS	N202450	July 23, 2012	RX	POWDER, METERED	INHALATION	10085974	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH	TUDORZA PRESSAIR	COVIS	N202450	July 23, 2012	RX	POWDER, METERED	INHALATION	11000517	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	RE46417	Feb. 10, 2025	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	10085974	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
0.4MG/INH;0.012MG/INH	DUAKLIR PRESSAIR	COVIS	N210595	March 29, 2019	RX	POWDER, METERED	INHALATION	11000517	March 13, 2029	MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN	ANTAGONIST	Ki	10.15	CHEMBL	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	10.10	CHEMBL
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	10.10	CHEMBL
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		IC50	9.70	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		IC50	9.80	CHEMBL

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External reference:

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ID	Source
014613	NDDF
014614	NDDF
11519741	PUBCHEM_CID
1303097	RXNORM
192177	MMSL
28687	MMSL
4031719	VANDF
4031720	VUID
4031720	VANDF
703921008	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DUAKLIR PRESSAIR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-0900	POWDER, METERED	400 ug	RESPIRATORY (INHALATION)	NDA	27 sections
DUAKLIR PRESSAIR	HUMAN PRESCRIPTION DRUG LABEL	2	72124-001	POWDER, METERED	400 ug	RESPIRATORY (INHALATION)	NDA	26 sections
Tudorza Pressair	HUMAN PRESCRIPTION DRUG LABEL	1	0310-0800	POWDER, METERED	400 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Tudorza Pressair	HUMAN PRESCRIPTION DRUG LABEL	1	72124-002	POWDER, METERED	400 ug	RESPIRATORY (INHALATION)	NDA	28 sections

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