Ledipasvir

Hepatitis C Virus NS5A Inhibitor — ANTIINFECTIVES FOR SYSTEMIC USE

Key facts

Ledipasvir is an onp drug in the Hepatitis C Virus NS5A Inhibitor class catalogued in DrugCentral. It was first approved by the FDA in 2014. Its mechanism of action is classified as Breast Cancer Resistance Protein Inhibitors and P-Glycoprotein Inhibitors. DrugCentral lists 3 molecular targets, including Genome polyprotein, NS5A and Genome polyprotein. Recorded indications include Chronic hepatitis C.

• Approval status: onp (first approved 2014 by the FDA).
• Drug class: Hepatitis C Virus NS5A Inhibitor.
• Mechanism of action: Breast Cancer Resistance Protein Inhibitors; P-Glycoprotein Inhibitors.
• Molecular targets: Genome polyprotein, NS5A and Genome polyprotein (3 listed in DrugCentral).
• Indications: Chronic hepatitis C.
• ATC code: J05AP51 (Antivirals for treatment of HCV infections).
• Molecular formula: C49H54F2N8O6; molecular weight 889.02 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; P-Glycoprotein Inhibitors
• Established pharmacologic class: Hepatitis C Virus NS5A Inhibitor

Molecular targets (3)

Target	Gene	Action	Activity
Genome polyprotein	—	inhibitor	EC50 11.40
Nonstructural protein 5A	NS5A	unknown	EC50 10.51
Genome polyprotein	—	inhibitor	EC50 10.51

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2014-12-04	EMA	—	—
2014-10-10	FDA	—	GILEAD SCIENCES INC

ATC classification

ATC code	Therapeutic hierarchy
J05AP51	ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HCV infections

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
Amaurosis fugax	850.4
Ocular discomfort	797.1
Haemorrhagic stroke	789.2
Urinary tract disorder	709.1
Head discomfort	694.7
Blindness	573.2
Generalised oedema	556.0
Haematemesis	552.7
Altered state of consciousness	546.5
Eye pain	534.7
Diplopia	490.7
Ascites	478.4

Chemical structure

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

• Molecular formula: C₄₉H₅₄F₂N₈O₆
• Molecular weight: 889.02 g/mol
• CAS number: 1256388-51-8
• InChIKey: VRTWBAAJJOHBQU-KMWAZVGDSA-N
• PubChem CID: 67505836

COC(=O)N[C@@H](C(C)C)C(=O)N1CC2(CC2)C[C@H]1C1=NC(=CN1)C1=CC=C2C3=CC=C(C=C3C(F)(F)C2=C1)C1=CC2=C(NC(=N2)[C@@H]2[C@H]3CC[C@H](C3)N2C(=O)[C@@H](NC(=O)OC)C(C)C)C=C1

Frequently asked questions

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

What is Ledipasvir used for?

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

How does Ledipasvir work?

Ledipasvir is classified as Breast Cancer Resistance Protein Inhibitors and P-Glycoprotein Inhibitors; its molecular targets in DrugCentral include Genome polyprotein (inhibitor), NS5A and Genome polyprotein (inhibitor).

When was Ledipasvir first approved?

Ledipasvir was first approved by the FDA in 2014.

What drug class does Ledipasvir belong to?

Ledipasvir is in the Hepatitis C Virus NS5A Inhibitor class.

What is the chemical formula of Ledipasvir?

Ledipasvir has the molecular formula C49H54F2N8O6 and a molecular weight of 889.02 g/mol.

Sources

• DrugCentral drug card 4899 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL2374220 — compound record and bioactivity
• PubChem CID 67505836 — chemical identifiers
• DrugBank DB09027 — drug record
• FDA UNII 013TE6E4WV — substance identity
• DailyMed: FDA labels for Ledipasvir — 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.