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

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

Stem definition	Drug id	CAS RN
antivirals	5727	2647530-73-0

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: ensitrelvir ensitrelvir fumarate ensitrelvir fumaric acid xocova S-217622

Ensitrelvir is an orally active 3C-like protease inhibitor and it was approved for emergency use in Japan in November 2022. Ensitrelvir has reached Phase III clinical trials and is being evaluated for its efficacy and safety in patients with mild-to-moderate COVID-19. Molecular weight: 531.88 Formula: C22H17ClF3N9O2 CLOGP: 1.75 LIPINSKI: 2 HAC: 11 HDO: 1 TPSA: 113.54 ALOGS: ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.18	g	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	GRK2,PDK1,PDK2,PDK4	4
kinase-selectivity-class	AXL,EIF2AK3,GRK2,PDK1,TEK	5
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
Nov. 22, 2022	PMDA	Shionogi & Co., Ltd.

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	J05AE16	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:149553	anticoronaviral agent
CHEBI has role	CHEBI:231911	renoprotective agent

Related Drugs by ATC class:

J05AE Protease inhibitors 10 drugs

amprenaviratazanavirdarunavirfosamprenavirindinavirnelfinavirnirmatrelvirritonavirsaquinavirtipranavir

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

Disease	Relation	SNOMED_ID	DOID
Disease caused by Severe acute respiratory syndrome coronavirus 2	indication	840539006

🐶 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
125MG	XOCOVA	SHIONOGI	N220442	May 29, 2026	RX	TABLET	ORAL	11814368	May 1, 2042	POST-EXPOSURE PROPHYLAXIS OF CORONAVIRUS DISEASE 2019 (COVID 19) IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
125MG	XOCOVA	SHIONOGI	N220442	May 29, 2026	RX	TABLET	ORAL	12559474	May 1, 2042	POST-EXPOSURE PROPHYLAXIS OF CORONAVIRUS DISEASE 2019 (COVID 19) IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
125MG	XOCOVA	SHIONOGI	N220442	May 29, 2026	RX	TABLET	ORAL	May 29, 2031	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Replicase polyprotein 1ab	Enzyme		R1AB_SARS2	INHIBITOR	IC50	7.31		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
CHEBI:747786	CHEBI
CHEMBL5183847	ChEMBL_ID
C000722354	MESH_SUPPLEMENTAL_RECORD_UI
11871	IUPHAR_LIGAND_ID
C5690425	UMLSCUI
7YY	PDB_CHEM_ID
CHEMBL5185221	ChEMBL_ID
12284	INN_ID
2757470-18-9	SECONDARY_CAS_RN
162533924	PUBCHEM_CID
D12619	KEGG_DRUG
PX665RAA3H	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
XOCOVA	HUMAN PRESCRIPTION DRUG LABEL	1	59630-711	TABLET	125 mg	ORAL	NDA	33 sections