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

Stem definition	Drug id	CAS RN
steroids for topical use, acetal derivatives	633	126544-47-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ciclesonide omnaris alvesco	nasal spray approved for seasonal and perennial allergic rhinitis Molecular weight: 540.70 Formula: C32H44O7 CLOGP: 5.25 LIPINSKI: 2 HAC: 7 HDO: 1 TPSA: 99.13 ALOGS: -5.54 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ciclesonide
omnaris
alvesco

nasal spray approved for seasonal and perennial allergic rhinitis

Molecular weight: 540.70
Formula: C32H44O7
CLOGP: 5.25
LIPINSKI: 2
HAC: 7
HDO: 1
TPSA: 99.13
ALOGS: -5.54
ROTB: 6

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	mg	N
0.16	mg	Inhal.aerosol

ADMET properties:

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Property	Value	Reference
CL (Clearance)	33.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	2.90 L/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	1.04 hours	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.00 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Oct. 20, 2006	FDA	TAKEDA GMBH

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
Asthma	2636.93	18.19	1326	34350	126235	63327111
Wheezing	1666.62	18.19	888	34788	94707	63358639
Obstructive airways disorder	1172.77	18.19	440	35236	20259	63433087
Sleep disorder due to a general medical condition	857.15	18.19	304	35372	11884	63441462
Therapeutic product effect incomplete	655.17	18.19	550	35126	124506	63328840
Dyspnoea	615.82	18.19	1223	34453	660090	62793256
Full blood count abnormal	535	18.19	289	35387	31428	63421918
Cough	513.33	18.19	721	34955	292022	63161324
Productive cough	489.97	18.19	351	35325	62857	63390489
Sputum discoloured	435.11	18.19	203	35473	16144	63437202

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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	1981.80	26.01	744	15668	41912	34898607
Wheezing	1140.42	26.01	497	15915	40905	34899614
Therapeutic product effect incomplete	806.78	26.01	417	15995	50124	34890395
Obstructive airways disorder	781.13	26.01	288	16124	15206	34925313
Full blood count abnormal	666.34	26.01	270	16142	18398	34922121
Sleep disorder due to a general medical condition	532.80	26.01	165	16247	5056	34935463
Bronchiectasis	420.28	26.01	162	16250	9639	34930880
Loss of personal independence in daily activities	366.13	26.01	215	16197	32964	34907555
Productive cough	350.24	26.01	219	16193	37594	34902925
Pulmonary function test decreased	304.89	26.01	107	16305	4868	34935651

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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
Asthma	3740.60	19.06	1730	44285	133365	79565008
Wheezing	2245.62	19.06	1168	44847	115496	79582877
Obstructive airways disorder	1666.04	19.06	641	45374	30818	79667555
Full blood count abnormal	1036.27	19.06	493	45522	39981	79658392
Therapeutic product effect incomplete	1008.01	19.06	754	45261	140891	79557482
Sleep disorder due to a general medical condition	897.17	19.06	330	45685	13947	79684426
Productive cough	781.06	19.06	537	45478	87794	79610579
Cough	704.74	19.06	957	45058	365832	79332541
Sputum discoloured	656.23	19.06	297	45718	21446	79676927
Dyspnoea	649.87	19.06	1482	44533	855543	78842830

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R01AD13	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Corticosteroids
ATC	R03BA08	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS Glucocorticoids
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones

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

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Disease	Relation	SNOMED_ID	DOID
Allergic rhinitis	indication	61582004
Asthma	indication	195967001	DOID:2841
Seasonal allergic rhinitis	indication	367498001
Asthma management	indication	406162001
Severe chronic obstructive pulmonary disease	off-label use	313299006
Mycosis	contraindication	3218000	DOID:1564
Ocular hypertension	contraindication	4210003	DOID:9282
Inactive tuberculosis	contraindication	11999007
Epistaxis	contraindication	12441001
Disease caused by parasite	contraindication	17322007

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

Product	Applicant	Ingredients
Aservo EquiHaler	Boehringer lngelheim Animal Health USA Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.78	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
0.037MG/INH	ZETONNA	COVIS	N202129	Jan. 20, 2012	RX	AEROSOL, METERED	NASAL	8371292	Feb. 1, 2028	TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD
0.05MG/SPRAY	OMNARIS	COVIS	N022004	Oct. 20, 2006	RX	SPRAY, METERED	NASAL	8371292	Feb. 1, 2028	TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
0.08MG/INH	ALVESCO	COVIS	N021658	Jan. 10, 2008	RX	AEROSOL, METERED	INHALATION	8371292	Feb. 1, 2028	MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD
0.16MG/INH	ALVESCO	COVIS	N021658	Jan. 10, 2008	RX	AEROSOL, METERED	INHALATION	8371292	Feb. 1, 2028	MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A RESPIRATORY DISEASE IN A CHILD

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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])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	Ki	7.43		WOMBAT-PK	CHEMBL

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External reference:

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ID	Source
008829	NDDF
132906	MMSL
19358	MMSL
274964	RXNORM
4027427	VUID
4027427	VANDF
416739001	SNOMEDCT_US
417420004	SNOMEDCT_US
6546	INN_ID
6918155	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5989	AEROSOL, METERED	80 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5990	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	27 sections
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	70515-711	AEROSOL, METERED	80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	70515-711	AEROSOL, METERED	80 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	70515-712	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Alvesco	HUMAN PRESCRIPTION DRUG LABEL	1	70515-712	AEROSOL, METERED	160 ug	RESPIRATORY (INHALATION)	NDA	28 sections
Omnaris	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6020	SPRAY	50 ug	NASAL	NDA	13 sections
Omnaris	HUMAN PRESCRIPTION DRUG LABEL	1	70515-701	SPRAY	50 ug	NASAL	NDA	27 sections
Omnaris	HUMAN PRESCRIPTION DRUG LABEL	1	70515-701	SPRAY	50 ug	NASAL	NDA	27 sections
Zetonna	HUMAN PRESCRIPTION DRUG LABEL	1	70515-737	AEROSOL, METERED	37 ug	NASAL	NDA	28 sections

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