All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
inhibitors of phosphodiesterase PDE5 with vasodilator action	4305	330784-47-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: spedra TA 1790 stendra avanafil

a selective inhibitor of cGMP-specific PDE5 has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum Molecular weight: 483.96 Formula: C23H26ClN7O3 CLOGP: 2.71 LIPINSKI: 0 HAC: 10 HDO: 3 TPSA: 125.39 ALOGS: -4.21 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 21, 2013	EMA
April 27, 2012	FDA	VIVUS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

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
Drug ineffective	62.18	60.97	28	75	456723	34500105

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G04BE10	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs used in erectile dysfunction
FDA MoA	N0000020026	Phosphodiesterase 5 Inhibitors
FDA EPC	N0000175599	Phosphodiesterase 5 Inhibitor
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:50218	phosphodiesterase inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Impotence	indication	397803000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.01	acidic
pKa2	4.93	Basic
pKa3	3.61	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	6656935	April 27, 2025	TREATMENT OF ERECTILE DYSFUNCTION
200MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	6656935	April 27, 2025	TREATMENT OF ERECTILE DYSFUNCTION
50MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	6656935	April 27, 2025	TREATMENT OF ERECTILE DYSFUNCTION

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	Oct. 18, 2025	REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
200MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	Oct. 18, 2025	REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
50MG	STENDRA	METUCHEN PHARMS	N202276	April 27, 2012	RX	TABLET	ORAL	Oct. 18, 2025	REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
cGMP-specific 3',5'-cyclic phosphodiesterase	Enzyme	O76074	PDE5A_HUMAN	INHIBITOR	IC50	8.28		WOMBAT-PK	CHEMBL
Cone cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha'	Enzyme	P51160	PDE6C_HUMAN		IC50	6.20		WOMBAT-PK
cGMP-specific 3',5'-cyclic phosphodiesterase	Enzyme		PDE5A_CANFA		IC50	8.28		CHEMBL

External reference:

ID	Source
D03217	KEGG_DRUG
4032978	VANDF
CHEBI:66876	CHEBI
E6L	PDB_CHEM_ID
CHEMBL1963681	ChEMBL_ID
C553414	MESH_SUPPLEMENTAL_RECORD_UI
7448	IUPHAR_LIGAND_ID
DB06237	DRUGBANK_ID
DR5S136IVO	UNII
1291301	RXNORM
189434	MMSL
28514	MMSL
d07863	MMSL
015259	NDDF
703956007	SNOMEDCT_US
703957003	SNOMEDCT_US
C2698280	UMLSCUI
8572	INN_ID
9869929	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-501	TABLET	50 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-501	TABLET	50 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-501	TABLET	50 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-502	TABLET	100 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-502	TABLET	100 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-502	TABLET	100 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-503	TABLET	200 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-503	TABLET	200 mg	ORAL	NDA	34 sections
STENDRA	HUMAN PRESCRIPTION DRUG LABEL	1	62541-503	TABLET	200 mg	ORAL	NDA	34 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-751	TABLET	50 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-751	TABLET	50 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-751	TABLET	50 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-752	TABLET	100 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-752	TABLET	100 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-752	TABLET	100 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-753	TABLET	200 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-753	TABLET	200 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	72384-753	TABLET	200 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	76299-320	TABLET	50 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	76299-321	TABLET	100 mg	ORAL	NDA	29 sections
Stendra	HUMAN PRESCRIPTION DRUG LABEL	1	76299-322	TABLET	200 mg	ORAL	NDA	29 sections