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

Stem definition	Drug id	CAS RN
aminoglycosides, antibiotics obtained from various Micromonospora	4180	873857-62-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lipiarmicin lipiarmycin tiacumicin B dificid fidaxomicin dificlir	Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. In vitro, fidaxomicin is active primarily against species of clostridia, including Clostridium difficile by inhibiting RNA synthesis by RNA polymerases. Molecular weight: 1058.05 Formula: C52H74Cl2O18 CLOGP: 7.19 LIPINSKI: 4 HAC: 18 HDO: 7 TPSA: 266.66 ALOGS: -4.93 ROTB: 15 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lipiarmicin
lipiarmycin
tiacumicin B
dificid
fidaxomicin
dificlir

Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. In vitro, fidaxomicin is active primarily against species of clostridia, including Clostridium difficile by inhibiting RNA synthesis by RNA polymerases.

Molecular weight: 1058.05
Formula: C52H74Cl2O18
CLOGP: 7.19
LIPINSKI: 4
HAC: 18
HDO: 7
TPSA: 266.66
ALOGS: -4.93
ROTB: 15

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.40	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 2, 2018	PMDA	Astellas Pharma Inc
May 27, 2011	FDA	CUBIST 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
Clostridium difficile infection	193.23	36.67	54	1162	29868	63457938
Disease recurrence	133.62	36.67	40	1176	27990	63459816
Clostridium difficile colitis	63.07	36.67	21	1195	20548	63467258
Clostridium test positive	62.17	36.67	14	1202	3187	63484619
Avian influenza	61.35	36.67	8	1208	64	63487742
Drug ineffective	58.26	36.67	84	1132	1044681	62443125
Pseudomembranous colitis	57.13	36.67	13	1203	3099	63484707
Renal graft infection	51.03	36.67	8	1208	254	63487552
Urinary tract infection pseudomonal	41.59	36.67	8	1208	845	63486961
Diarrhoea	40.22	36.67	58	1158	715308	62772498

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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
Clostridium difficile infection	81.05	49.98	25	662	18873	34937371
Diarrhoea	58.71	49.98	53	634	389859	34566385
Drug ineffective	55.28	49.98	55	632	456696	34499548

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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
Clostridium difficile infection	211.03	33.15	64	1617	42621	79700086
Disease recurrence	93.26	33.15	35	1646	44074	79698633
Drug ineffective	89.93	33.15	111	1570	1080802	78661905
Clostridium difficile colitis	80.73	33.15	29	1652	32254	79710453
Diarrhoea	68.99	33.15	88	1593	880401	78862306
Pseudomembranous colitis	68.39	33.15	17	1664	5357	79737350
Avian influenza	58.36	33.15	8	1673	87	79742620
Clostridium test positive	55.74	33.15	15	1666	6439	79736268
Treatment failure	53.20	33.15	37	1644	170449	79572258
Renal graft infection	44.32	33.15	8	1673	542	79742165

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07AA12	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Antibiotics
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:37416	RNA polymerase inhibitors
FDA CS	M0028311	Macrolides
FDA EPC	N0000175431	Macrolide Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective 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	DOID
Clostridium difficile infection	indication	186431008
Pseudomembranous enterocolitis	indication	397683000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.95	acidic
pKa2	9.53	acidic
pKa3	11.96	acidic
pKa4	12.76	acidic
pKa5	13.32	acidic
pKa6	13.74	acidic

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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
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	7906489	March 4, 2027	TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	7906489	March 4, 2027	TREATMENT OF MICROBIAL INFECTIONS
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	8859510	July 31, 2027	TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	8859510	July 31, 2027	TREATMENT OF MICROBIAL INFECTIONS
40MG/ML	DIFICID	CUBIST PHARMS LLC	N213138	Jan. 24, 2020	RX	FOR SUSPENSION	ORAL	7906489	March 4, 2027	TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
40MG/ML	DIFICID	CUBIST PHARMS LLC	N213138	Jan. 24, 2020	RX	FOR SUSPENSION	ORAL	8859510	July 31, 2027	TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	Jan. 24, 2023	NEW PATIENT POPULATION
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	July 24, 2023	PEDIATRIC EXCLUSIVITY
200MG	DIFICID	CUBIST PHARMS LLC	N201699	May 27, 2011	RX	TABLET	ORAL	Jan. 24, 2027	PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
40MG/ML	DIFICID	CUBIST PHARMS LLC	N213138	Jan. 24, 2020	RX	FOR SUSPENSION	ORAL	Jan. 24, 2023	NEW PRODUCT
40MG/ML	DIFICID	CUBIST PHARMS LLC	N213138	Jan. 24, 2020	RX	FOR SUSPENSION	ORAL	July 24, 2023	PEDIATRIC EXCLUSIVITY
40MG/ML	DIFICID	CUBIST PHARMS LLC	N213138	Jan. 24, 2020	RX	FOR SUSPENSION	ORAL	Jan. 24, 2027	PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
DNA-directed RNA polymerase	Enzyme		RPOZ_PEPD6 RPOB_PEPD6 RPOC_PEPD6 RPOA_PEPD6	INHIBITOR				CHEMBL	CHEMBL

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External reference:

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ID	Source
FI8	PDB_CHEM_ID
013814	NDDF
10034073	PUBCHEM_CID
10909	IUPHAR_LIGAND_ID
1111103	RXNORM
181510	MMSL
27891	MMSL
4030846	VUID
4030846	VANDF
703664004	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dificid	HUMAN PRESCRIPTION DRUG LABEL	1	52015-080	TABLET, FILM COATED	200 mg	ORAL	NDA	30 sections
Dificid	HUMAN PRESCRIPTION DRUG LABEL	1	52015-080	TABLET, FILM COATED	200 mg	ORAL	NDA	30 sections
DIFICID	HUMAN PRESCRIPTION DRUG LABEL	1	52015-700	GRANULE, FOR SUSPENSION	200 mg	ORAL	NDA	30 sections
DIFICID	HUMAN PRESCRIPTION DRUG LABEL	1	52015-700	GRANULE, FOR SUSPENSION	200 mg	ORAL	NDA	30 sections

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