Last reviewed 2026-05-23 · How we verify

Sofosbuvir and Daklatasuvir

Sherief Abd-Elsalam · Phase 3 active Small molecule Under review

Sofosbuvir and Daklatasuvir is a NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor Small molecule drug developed by Sherief Abd-Elsalam. It is currently in Phase 3 development for Chronic hepatitis C virus infection, Hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection. Also known as: Sofaldy, mpiviropack, daklanork.

Sofosbuvir and Daklatasuvir work together to inhibit the HCV NS5B RNA-dependent RNA polymerase and NS5A protein, respectively, to treat hepatitis C virus infection.

Sofosbuvir is a small molecule inhibitor of RNA-directed RNA polymerase, classified as an INHIBITOR. It has been studied in clinical trials for the treatment of COVID-19, COVID, and Hepatitis C.

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 and Daklatasuvir
Also known as	Sofaldy, mpiviropack, daklanork
Sponsor	Sherief Abd-Elsalam
Drug class	NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor
Target	HCV NS5B RNA-dependent RNA polymerase and HCV NS5A protein
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Sofosbuvir is a nucleotide analog inhibitor that binds to the NS5B RNA-dependent RNA polymerase, preventing viral replication. Daklatasvir is a NS5A inhibitor that binds to the NS5A protein, also preventing viral replication. By inhibiting these two key proteins, the combination of sofosbuvir and daklatasvir is effective in treating hepatitis C virus infection.

Approved indications

Chronic hepatitis C virus infection
Hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection

Common side effects

Fatigue
Headache
Nausea
Diarrhea

Key clinical trials

Sofosbuvir in Treatment of COVID 19 (PHASE2, PHASE3)
Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients (PHASE2, PHASE3)
Effect of Direct-acting Antiviral Drugs on Erectile Function (PHASE3)
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 Daklatasuvir CI brief — competitive landscape report
Sofosbuvir and Daklatasuvir updates RSS · CI watch RSS
Sherief Abd-Elsalam portfolio CI

Frequently asked questions about Sofosbuvir and Daklatasuvir

What is Sofosbuvir and Daklatasuvir?

Sofosbuvir and Daklatasuvir is a NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor drug developed by Sherief Abd-Elsalam, indicated for Chronic hepatitis C virus infection, Hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection.

How does Sofosbuvir and Daklatasuvir work?

Sofosbuvir and Daklatasuvir work together to inhibit the HCV NS5B RNA-dependent RNA polymerase and NS5A protein, respectively, to treat hepatitis C virus infection.

What is Sofosbuvir and Daklatasuvir used for?

Sofosbuvir and Daklatasuvir is indicated for Chronic hepatitis C virus infection, Hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection.

Who makes Sofosbuvir and Daklatasuvir?

Sofosbuvir and Daklatasuvir is developed by Sherief Abd-Elsalam (see full Sherief Abd-Elsalam pipeline at /company/sherief-abd-elsalam).

Is Sofosbuvir and Daklatasuvir also known as anything else?

Sofosbuvir and Daklatasuvir is also known as Sofaldy, mpiviropack, daklanork.

What drug class is Sofosbuvir and Daklatasuvir in?

Sofosbuvir and Daklatasuvir belongs to the NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor class. See all NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor drugs at /class/ns5b-rna-dependent-rna-polymerase-inhibitor-and-ns5a-inhibitor.

What development phase is Sofosbuvir and Daklatasuvir in?

Sofosbuvir and Daklatasuvir is in Phase 3.

What are the side effects of Sofosbuvir and Daklatasuvir?

Common side effects of Sofosbuvir and Daklatasuvir include Fatigue, Headache, Nausea, Diarrhea.

What does Sofosbuvir and Daklatasuvir target?

Sofosbuvir and Daklatasuvir targets HCV NS5B RNA-dependent RNA polymerase and HCV NS5A protein and is a NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor.

Drug class: All NS5B RNA-dependent RNA polymerase inhibitor and NS5A inhibitor drugs
Target: All drugs targeting HCV NS5B RNA-dependent RNA polymerase and HCV NS5A protein
Manufacturer: Sherief Abd-Elsalam — full pipeline
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Chronic hepatitis C virus infection
Indication: Drugs for Hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection
Also known as: Sofaldy, mpiviropack, daklanork

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