Entecavir

ANTIINFECTIVES FOR SYSTEMIC USE

Key facts

Entecavir is an ofp drug catalogued in DrugCentral. It was first approved by the FDA in 2005. DrugCentral lists 3 molecular targets, including HBcAg, P and P. Recorded indications include Chronic type B viral hepatitis and Lamivudine-Refractory Chronic Hepatitis B.

• Approval status: ofp (first approved 2005 by the FDA).
• Molecular targets: HBcAg, P and P (3 listed in DrugCentral).
• Indications: Chronic type B viral hepatitis and Lamivudine-Refractory Chronic Hepatitis B.
• ATC code: J05AF10 (Nucleoside and nucleotide reverse transcriptase inhibitors).
• Molecular formula: C12H15N5O3; molecular weight 277.28 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (2)

• Chronic type B viral hepatitis
• Lamivudine-Refractory Chronic Hepatitis B

Contraindications (5)

• Drug Resistance to Anti-retroviral Therapy
• Impaired renal function disorder
• Lactic acidosis
• Liver function tests abnormal
• Steatosis of liver

Mechanism & targets

Molecular targets (3)

Target	Gene	Action	Activity
Capsid protein	HBcAg	unknown	EC50 9.62
Protein P	P	unknown	—
Protein P	P	inhibitor	—

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2006-06-26	EMA	—	BRISTOL-MYERS SQUIBB PHARMA EEIG
2005-03-29	FDA	—	BRISTOL MYERS SQUIBB

ATC classification

ATC code	Therapeutic hierarchy
J05AF10	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Nucleoside and nucleotide reverse transcriptase inhibitors

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Drug resistance	750.9
Hepatocellular carcinoma	562.5
Hepatitis B	440.0
Hepatitis B DNA increased	437.6
Hepatic cancer	432.1
Hepatitis B reactivation	427.6
Viral mutation identified	401.9
Hepatic failure	331.2
Viral load increased	307.8
Pathogen resistance	301.2
Genotype drug resistance test	212.2
Osteomalacia	211.2

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Entecavir is on its molecule page.

• Molecular formula: C₁₂H₁₅N₅O₃
• Molecular weight: 277.28 g/mol
• CAS number: 142217-69-4
• InChIKey: QDGZDCVAUDNJFG-FXQIFTODSA-N
• PubChem CID: 135398508

NC1=NC2=C(N=CN2[C@H]2C[C@H](O)[C@@H](CO)C2=C)C(=O)N1

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Entecavir used for?

DrugCentral lists the following indications for Entecavir: Chronic type B viral hepatitis and Lamivudine-Refractory Chronic Hepatitis B.

How does Entecavir work?

Its molecular targets in DrugCentral include HBcAg, P and P (inhibitor).

When was Entecavir first approved?

Entecavir was first approved by the FDA in 2005.

What is the chemical formula of Entecavir?

Entecavir has the molecular formula C12H15N5O3 and a molecular weight of 277.28 g/mol.

Sources

• DrugCentral drug card 1019 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL5314362 — compound record and bioactivity
• PubChem CID 135398508 — chemical identifiers
• DrugBank DB00442 — drug record
• FDA UNII 5968Y6H45M — substance identity
• DailyMed: FDA labels for Entecavir — current prescribing information (label search)
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.