Last reviewed 2026-05-27 · How we verify

Sofosbuvir/Ledipasvir 24W

Iran Hepatitis Network · Phase 3 active Small molecule Under review Quality 0/100

Sofosbuvir/Ledipasvir 24W is a Direct-acting antiviral (DAA) combination Small molecule drug developed by Iran Hepatitis Network. It is currently in Phase 3 development for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6), Hepatitis C virus infection in treatment-naïve and treatment-experienced patients.

Sofosbuvir/Ledipasvir is a fixed-dose combination of a nucleotide polymerase inhibitor and a non-structural protein 5A inhibitor that blocks hepatitis C virus replication.

Sofosbuvir/Ledipasvir 24W is a treatment for Hepatitis C virus infection. It works by inhibiting the nonstructural protein 5A, a key enzyme in the virus's replication process, through a small molecule mechanism.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Sofosbuvir/Ledipasvir 24W
Sponsor	Iran Hepatitis Network
Drug class	Direct-acting antiviral (DAA) combination
Target	HCV NS5B polymerase and HCV NS5A protein
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 3

Mechanism of action

Sofosbuvir inhibits the HCV NS5B RNA-dependent RNA polymerase, preventing viral RNA synthesis. Ledipasvir inhibits the HCV NS5A protein, which is essential for viral replication and assembly. Together, they provide direct-acting antiviral activity against hepatitis C virus across multiple genotypes.

Approved indications

Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)
Hepatitis C virus infection in treatment-naïve and treatment-experienced patients

Common side effects

Headache
Fatigue
Nausea
Diarrhea
Insomnia

Key clinical trials

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Sofosbuvir/Ledipasvir 24W CI brief — competitive landscape report
Sofosbuvir/Ledipasvir 24W updates RSS · CI watch RSS
Iran Hepatitis Network portfolio CI

Frequently asked questions about Sofosbuvir/Ledipasvir 24W

What is Sofosbuvir/Ledipasvir 24W?

Sofosbuvir/Ledipasvir 24W is a Direct-acting antiviral (DAA) combination drug developed by Iran Hepatitis Network, indicated for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6), Hepatitis C virus infection in treatment-naïve and treatment-experienced patients.

How does Sofosbuvir/Ledipasvir 24W work?

Sofosbuvir/Ledipasvir is a fixed-dose combination of a nucleotide polymerase inhibitor and a non-structural protein 5A inhibitor that blocks hepatitis C virus replication.

What is Sofosbuvir/Ledipasvir 24W used for?

Sofosbuvir/Ledipasvir 24W is indicated for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6), Hepatitis C virus infection in treatment-naïve and treatment-experienced patients.

Who makes Sofosbuvir/Ledipasvir 24W?

Sofosbuvir/Ledipasvir 24W is developed by Iran Hepatitis Network (see full Iran Hepatitis Network pipeline at /company/iran-hepatitis-network).

What drug class is Sofosbuvir/Ledipasvir 24W in?

Sofosbuvir/Ledipasvir 24W belongs to the Direct-acting antiviral (DAA) combination class. See all Direct-acting antiviral (DAA) combination drugs at /class/direct-acting-antiviral-daa-combination.

What development phase is Sofosbuvir/Ledipasvir 24W in?

Sofosbuvir/Ledipasvir 24W is in Phase 3.

What are the side effects of Sofosbuvir/Ledipasvir 24W?

Common side effects of Sofosbuvir/Ledipasvir 24W include Headache, Fatigue, Nausea, Diarrhea, Insomnia.

What does Sofosbuvir/Ledipasvir 24W target?

Sofosbuvir/Ledipasvir 24W targets HCV NS5B polymerase and HCV NS5A protein and is a Direct-acting antiviral (DAA) combination.

Drug class: All Direct-acting antiviral (DAA) combination drugs
Target: All drugs targeting HCV NS5B polymerase and HCV NS5A protein
Manufacturer: Iran Hepatitis Network — full pipeline
Therapeutic area: All drugs in Infectious Disease / Virology
Indication: Drugs for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)
Indication: Drugs for Hepatitis C virus infection in treatment-naïve and treatment-experienced patients

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing