Wednesday, July 8, 2026

Drug profile · INN

ledipasvir

ledipasvir (HARVONI) is a nonstructural protein 5a inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — ledipasvir
US status
approved
Class
Route
ORAL
Patents
0
Programs
2
Data quality
0.84

Quick answer

ledipasvir (HARVONI) is a nonstructural protein 5a inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ledipasvir
Brand HARVONI
Mechanism Nonstructural protein 5A inhibitor
Target Nonstructural protein 5A
Route ORAL
Formulation TABLET

Mechanism of action

Nonstructural protein 5A inhibitor

Primary target: Nonstructural protein 5A

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Harvoni (Fixed dose combination ledipasvir/sofosbuvir) Approved · BRIGHT MINDS BIOSCIENCES · Hepatitis C
  2. Ledipasvir 90mg/Sofosbuvir 400 mg Approved · Chinese Academy of · Hepatocellular Carcinoma

Related & competitor drugs

  1. daclatasvir dihydrochloride Nonstructural protein 5A inhibitor
  2. elbasvir Antiinfectives for systemic use (J05)
  3. ombitasvir Antiinfectives for systemic use (J05)
  4. daclatasvir hydrochloride Nonstructural protein 5A inhibitor

Frequently asked questions

What is ledipasvir?

ledipasvir (HARVONI) is a nonstructural protein 5a inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ledipasvir?

HARVONI is a marketed brand name for ledipasvir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ledipasvir?

ledipasvir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.