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

vamorolone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
steroids not used as glucocorticosteroids	5749	13209-41-1

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: vamorolone agamree VBP-15

Vamorolone is a corticosteroid that acts through the glucocorticoid receptor to exert antiinflammatory and immunosuppressive effects. The precise mechanism by which vamorolone exerts its effect in patients with DMD is unknown. Molecular weight: 356.46 Formula: C22H28O4 CLOGP: 2.75 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 74.60 ALOGS: ROTB: 2 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	2.454		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	1.607		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	45.394	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	11.668	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	12.480	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	22.380	%	High	1
herg	hERG pIC50	4.716	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	6.516	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	13.213	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	8.590	%	High	1
kinase-safety-class	ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK	20
kinase-selectivity-class	AXL,EIF2AK3,GRK2,MAP2K6,MAP3K14,TGFBR1	6
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	4.634		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	39.446		High	1
mppb	Mouse plasma protein binding (% unbound)	8.870		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	10.351		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	14.570	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	99.083	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	64.320	%	High	1
rppb	Rat plasma protein binding (% unbound)	9.050	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	171.791	uM	High	1

Approvals:

Date	Agency	Company	Orphan
Oct. 26, 2023	FDA	Santhera Pharmaceuticals

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	H02AB18	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D000893	Anti-Inflammatory Agents
CHEBI has role	CHEBI:35472	anti-inflammatory drug
CHEBI has role	CHEBI:35705	immunosuppressive agent
CHEBI has role	CHEBI:63562	glucocorticoid receptor agonist
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

H02AB Glucocorticoids 15 drugs

betamethasonecloprednolcortivazoldeflazacortdexamethasonefluocortolonehydrocortisonemeprednisonemethylprednisoloneparamethasone acetateprednisoloneprednisone show all 15 →

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

Disease	Relation	SNOMED_ID	DOID
Duchenne muscular dystrophy	indication	76670001	DOID:11723

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	10857161	May 28, 2029	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	8334279	May 28, 2029	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	11690853	March 7, 2033	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	11471471	March 17, 2040	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	12201639	March 17, 2040	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	Oct. 26, 2028	NEW CHEMICAL ENTITY
40MG/ML	AGAMREE	CATALYST PHARMS	N215239	Oct. 26, 2023	RX	SUSPENSION	ORAL	Oct. 26, 2030	TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.70		CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	7		SCIENTIFIC LITERATURE

External reference:

ID	Source
CHEBI:228304	CHEBI
TUV	PDB_CHEM_ID
CHEMBL2348780	ChEMBL_ID
C584811	MESH_SUPPLEMENTAL_RECORD_UI
9247	IUPHAR_LIGAND_ID
DB15114	DRUGBANK_ID
44445811000001109	SNOMEDCT_US
4042881	VANDF
C4726940	UMLSCUI
10419	INN_ID
3035000	PUBCHEM_CID
372968	MMSL
42126	MMSL
d10127	MMSL
019588	NDDF
8XP29XMB43	UNII
2669799	RXNORM
D11000	KEGG_DRUG

Pharmaceutical products:

None