Daclatasvir

Hepatitis C Virus NS5A Inhibitor — ANTIINFECTIVES FOR SYSTEMIC USE

Key facts

Daclatasvir is an ofm drug in the Hepatitis C Virus NS5A Inhibitor class catalogued in DrugCentral. It was first approved by the EMA in 2014. Its mechanism of action is classified as Breast Cancer Resistance Protein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors and Organic Anion Transporting Polypeptide 1B3 Inhibitors. DrugCentral lists 4 molecular targets, including Genome polyprotein, NS5A and Genome polyprotein. Recorded indications include Chronic hepatitis C.

• Approval status: ofm (first approved 2014 by the EMA).
• Drug class: Hepatitis C Virus NS5A Inhibitor.
• Mechanism of action: Breast Cancer Resistance Protein Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors.
• Molecular targets: Genome polyprotein, NS5A, Genome polyprotein and KCNH2 (4 listed in DrugCentral).
• Indications: Chronic hepatitis C.
• ATC code: J05AP07 (Antivirals for treatment of HCV infections).
• Molecular formula: C40H50N8O6; molecular weight 738.89 g/mol.

Indications & contraindications

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

Indications (1)

• Chronic hepatitis C

Mechanism & targets

• Mechanism of action (MoA): Breast Cancer Resistance Protein Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; P-Glycoprotein Inhibitors
• Established pharmacologic class: Hepatitis C Virus NS5A Inhibitor

Molecular targets (4)

Target	Gene	Action	Activity
Genome polyprotein	—	inhibitor	EC50 11.05
Nonstructural protein 5A	NS5A	unknown	IC50 10.64
Genome polyprotein	—	inhibitor	EC50 10.30
Potassium voltage-gated channel subfamily H member 2	KCNH2	unknown	IC50 4.53

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2015-07-24	FDA	—	BRISTOL MYERS SQUIBB
2014-06-27	EMA	—	—

ATC classification

ATC code	Therapeutic hierarchy
J05AP07	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HCV infections
J05AP58	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HCV infections

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

• FDA label: IFNL3 · No Clinical PGx
• Swissmedic label: IFNL3 · Informative PGx

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
Hepatocellular carcinoma	1943.1
Hepatitis C	1092.8
Genotype drug resistance test positive	886.0
Viral mutation identified	476.2
Virologic failure	445.0
Hepatic encephalopathy	437.1
Hepatic failure	390.7
Ascites	381.8
Treatment failure	366.7
Liver transplant	301.2
Hepatitis B reactivation	224.2
Hyperbilirubinaemia	172.5

Chemical structure

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

• Molecular formula: C₄₀H₅₀N₈O₆
• Molecular weight: 738.89 g/mol
• CAS number: 1009119-64-5
• InChIKey: FKRSSPOQAMALKA-CUPIEXAXSA-N
• PubChem CID: 25154714

COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C

Frequently asked questions

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

What is Daclatasvir used for?

DrugCentral lists the following indications for Daclatasvir: Chronic hepatitis C.

How does Daclatasvir work?

Daclatasvir is classified as Breast Cancer Resistance Protein Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors and Organic Anion Transporting Polypeptide 1B3 Inhibitors; its molecular targets in DrugCentral include Genome polyprotein (inhibitor), NS5A, Genome polyprotein (inhibitor) and KCNH2.

When was Daclatasvir first approved?

Daclatasvir was first approved by the EMA in 2014.

What drug class does Daclatasvir belong to?

Daclatasvir is in the Hepatitis C Virus NS5A Inhibitor class.

What is the chemical formula of Daclatasvir?

Daclatasvir has the molecular formula C40H50N8O6 and a molecular weight of 738.89 g/mol.

Sources

• DrugCentral drug card 4875 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL2023898 — compound record and bioactivity
• PubChem CID 25154714 — chemical identifiers
• DrugBank DB09102 — drug record
• FDA UNII LI2427F9CI — substance identity
• DailyMed: FDA labels for Daclatasvir — current prescribing information (label search)
• UniProt Q12809 (KCNH2) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
• PharmGKB / CPIC — pharmacogenomic label annotations

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