What development phase is Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir in?

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir

Sherief Abd-Elsalam · FDA-approved active Small molecule Quality 2/100

At a glance

Generic name	Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir
Also known as	Sofaldy, Harvony
Sponsor	Sherief Abd-Elsalam
Modality	Small molecule
Phase	FDA-approved

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C (PHASE4)

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 and Ledipasvir or sofosbuvir and daklatasuvir CI brief — competitive landscape report
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