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

Stem definition	Drug id	CAS RN
antivirals bicyclic heterocycle compounds	1277	82410-32-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ganciclovir denosine gancyclovir hydroxyacyclovir natclovir ganciclovir sodium	An ACYCLOVIR analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections. Molecular weight: 255.23 Formula: C9H13N5O4 CLOGP: -2.15 LIPINSKI: 0 HAC: 9 HDO: 4 TPSA: 134.99 ALOGS: -1.35 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ganciclovir
denosine
gancyclovir
hydroxyacyclovir
natclovir
ganciclovir sodium

An ACYCLOVIR analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.

Molecular weight: 255.23
Formula: C9H13N5O4
CLOGP: -2.15
LIPINSKI: 0
HAC: 9
HDO: 4
TPSA: 134.99
ALOGS: -1.35
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
3	g	O
0.50	g	P

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	91 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	78.36 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	4.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	4 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	3.70 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	3 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	1 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.99 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
June 23, 1989	FDA	ROCHE PALO

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
Cytomegalovirus infection	524.43	22.95	182	11521	20770	63456549
Drug resistance	456.02	22.95	168	11535	22765	63454554
Post transplant lymphoproliferative disorder	318.46	22.95	89	11614	4942	63472377
Pathogen resistance	306.00	22.95	91	11612	6307	63471012
Cytomegalovirus viraemia	299.37	22.95	87	11616	5562	63471757
Smooth muscle cell neoplasm	274.10	22.95	56	11647	785	63476534
Epstein-Barr virus infection	264.92	22.95	86	11617	7964	63469355
Multiple organ dysfunction syndrome	242.19	22.95	143	11560	56609	63420710
Encephalitis cytomegalovirus	216.48	22.95	43	11660	518	63476801
Graft versus host disease	173.83	22.95	60	11643	6703	63470616

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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
Cytomegalovirus infection	731.63	19.11	322	16824	25813	34913972
Drug resistance	527.03	19.11	256	16890	25671	34914114
Cytomegalovirus viraemia	389.66	19.11	144	17002	7286	34932499
Pathogen resistance	348.67	19.11	142	17004	9340	34930445
Pneumonia cytomegaloviral	231.97	19.11	78	17068	2976	34936809
Cytomegalovirus infection reactivation	185.85	19.11	76	17070	5042	34934743
Pancytopenia	174.93	19.11	224	16922	94933	34844852
End stage renal disease	169.30	19.11	84	17062	8777	34931008
Leukopenia	158.55	19.11	174	16972	62682	34877103
Graft versus host disease	149.77	19.11	82	17064	10487	34929298

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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
Cytomegalovirus infection	1195.25	18.61	473	26556	42171	79675188
Drug resistance	1006.56	18.61	417	26612	41796	79675563
Pathogen resistance	647.44	18.61	226	26803	14116	79703243
Cytomegalovirus viraemia	628.99	18.61	215	26814	12606	79704753
Post transplant lymphoproliferative disorder	358.87	18.61	138	26891	11326	79706033
Multiple organ dysfunction syndrome	354.98	18.61	307	26722	119939	79597420
Pneumonia cytomegaloviral	339.10	18.61	107	26922	4862	79712497
Pancytopenia	331.63	18.61	341	26688	165404	79551955
Cytomegalovirus infection reactivation	320.32	18.61	118	26911	8598	79708761
Encephalitis cytomegalovirus	314.71	18.61	74	26955	1076	79716283

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J05AB06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleosides and nucleotides excl. reverse transcriptase inhibitors
ATC	S01AD09	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antivirals
CHEBI has role	CHEBI:35441	antiinfective agents
CHEBI has role	CHEBI:36044	antiviral drugs
FDA EPC	N0000175461	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
FDA EPC	N0000175466	Nucleoside Analog Antiviral
FDA EXT	N0000175459	Nucleoside Analog
FDA MoA	N0000020060	DNA Polymerase Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral Agents

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

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Disease	Relation	SNOMED_ID
Cytomegaloviral retinitis	indication	22455005
Herpes simplex dendritic keratitis	indication	29943008
Paroxysmal supraventricular tachycardia	indication	67198005
CMV Retinitis in AIDS Patients	indication
Prevention of CMV Disease After Kidney-Pancreas Transplantation	indication
CMV Retinitis in Immunocompromised Patients	indication
Prevention of CMV Disease After Organ Transplant	indication
Prevention of CMV Disease After Kidney Transplantation	indication
Myocardial Perfusion Imaging Adjunct	indication
Prevention of CMV Disease in Advanced HIV Patients	indication

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.97	acidic
pKa2	12.38	acidic
pKa3	12.98	acidic
pKa4	3.68	Basic
pKa5	2.12	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Metabotropic glutamate receptor 1	GPCR	Q13255	GRM1_HUMAN		Ki	6.05	WOMBAT-PK
Metabotropic glutamate receptor 5	GPCR	P41594	GRM5_HUMAN		Ki	5.41	WOMBAT-PK
Transitional endoplasmic reticulum ATPase	Enzyme	P55072	TERA_HUMAN		IC50	5.89	CHEMBL
DNA polymerase catalytic subunit	Enzyme		DPOL_HHV11	INHIBITOR			WOMBAT-PK	CHEMBL
Thymidine kinase	Kinase		KITH_HHV1				WOMBAT-PK
Capsid scaffolding protein	Enzyme		SCAF_HHV11		EC50	6.07	WOMBAT-PK
Purine nucleoside phosphorylase	Enzyme		PUNA_MYCTU		Kd	4.80	CHEMBL

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External reference:

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ID	Source
003444	NDDF
003445	NDDF
107910-75-8	SECONDARY_CAS_RN
135398740	PUBCHEM_CID
177021	MMSL
33722	MMSL
34097	MMSL
372848001	SNOMEDCT_US
4019457	VANDF
4019764	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CytoveneIV	HUMAN PRESCRIPTION DRUG LABEL	1	61269-450	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	31 sections
Ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9299	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	29 sections
Ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	14335-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENTRICULAR	ANDA	30 sections
ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	25021-185	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	28 sections
ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	25021-185	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	28 sections
Ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	42023-173	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	29 sections
GANCICLOVIR	HUMAN PRESCRIPTION DRUG LABEL	1	51754-2500	INJECTION, SOLUTION	2 mg	INTRAVENOUS	NDA	18 sections
Ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	51817-171	INJECTION, SOLUTION	500 mg	INTRAVENOUS	ANDA	29 sections
Ganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	51817-171	INJECTION, SOLUTION	500 mg	INTRAVENOUS	ANDA	29 sections
GANCICLOVIR	HUMAN PRESCRIPTION DRUG LABEL	1	63304-636	CAPSULE	250 mg	ORAL	ANDA	23 sections

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