Daclatasvir is a direct-acting antiviral agent against Hepatitis C Virus (HCV) used for the treatment of chronic HCV genotype 1 and 3 infection. It is marketed under the name DAKLINZA and is contained in daily oral tablets as the hydrochloride salt form . Hepatitis C is an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients. Daclatasvir was the first drug with demonstrated safety and therapeutic efficacy in treating HCV genotype 3 without the need for co-administration of interferon or [DB00811]. It exerts its antiviral action by preventing RNA replication and virion assembly via binding to NS5A, a nonstructural phosphoprotein encoded by HCV. Binding to the N-terminus of the D1 domain of NS5A prevents its interaction with host cell proteins and membranes required for virion replication complex assembly. Daclatasvir is shown to target both the cis- and trans-acting functions of NS5A and disrupts the function of new HCV replication complexes by modulating the NS5A phosphorylation status. The most common critical NS5A amino acid substitutions that led to reduced susceptibility to daclatasvir therapy occured at position Q30 (Q30H/K/R) and M28 in genotype 1a patients and Y93H in genotype 3 patients. According to 2017 American Association for the Study of Liver Diseases (AASLD), 60mg of daclatasvir is recommended with 400mg [DB08934] for genotype 1a/b patients with or without cirrhosis as second-line therapy. The same dosing regimen can be used as first-line therapy in patients with genotype 3 without cirrhosis and second-line therapy in genotype 3 patients with compensated cirrhosis. Combination therapies that include daclatasir can be used for challenging-to-treat patients who have HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The therapy is intended to cure or achieve a sustained virologic response (SVR12), after 12 weeks of daily therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality. Daclatasvir was FDA-approved in July 2015 for use with [DB08934] (Sovaldi) with or without [DB00811] to treat HCV genotype 1 and 3 infections. The SVR12 in HCV genotype 1a-infected treatment-naïve subjects without and with cirrhosis undergoing daclatasvir and [DB08934] therapy were 88% and 99%, respectively. The same dosing regimen in treatment-naïve patients with HCV genotype 3 infection with or without cirrhosis achieved SVR12 rates of 71% and 98%, respectively.
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Daclatasvir
Drug Overview
What is Daclatasvir?
To derive PDE/ADE, OEL, and OEB values, Masuu Global follows a scientifically justified, risk-based toxicological assessment approach in accordance with internationally recognized guidelines and industry best practices that are widely accepted by regulatory authorities, including European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Agência Nacional de Vigilância Sanitária (ANVISA).
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Regulatory Framework
Assessment Methodology
Masuu Global follows a scientifically justified, risk-based toxicological approach aligned with internationally recognized guidelines accepted by EMA, PIC/S, and ANVISA.
EMA – Guideline on Setting Health-Based Exposure Limits (HBELs)
Provides the framework for establishing scientifically justified PDE/ADE values for use in shared manufacturing facilities.
PIC/S – Shared Facilities and Contamination Control Guidance
Supports the application of HBEL-based approaches for cross-contamination prevention and cleaning validation.
ICH Q9 – Quality Risk Management
Provides a structured methodology for risk identification, assessment, control, communication, and review.
ICH M7 – Assessment and Control of DNA-Reactive (Mutagenic) Impurities (where applicable)
Applied for compounds with potential mutagenic or genotoxic concerns.
Risk-Based Toxicological Assessment
Comprehensive evaluation of available toxicological and pharmacological data, including NOAEL, LOAEL, BMDL, pharmacological potency, carcinogenicity, reproductive and developmental toxicity, sensitization potential, and target organ toxicity.
Weight-of-Evidence (WoE) Approach
Integration and critical review of all relevant data sources, including non-clinical studies, clinical studies, human exposure data, pharmacological information, post-marketing safety data, and structure–activity relationship (SAR/QSAR) assessments.
How We Work
Report Preparation Process
Every assessment moves through a rigorous five-stage workflow — from data gathering to regulatory-ready delivery.
Comprehensive Data Review
Assessment of pharmacology, toxicology, clinical data, literature, and available regulatory information.
Scientific Evaluation
Identification of critical endpoints and selection of appropriate exposure limits.
PDE / HBEL Derivation
Transparent and scientifically justified calculations aligned with global toxicological principles.
Ex-Agency Expert Review (Our Differentiator)
Reports are reviewed with an ex-agency perspective, bringing regulatory expectations, inspection readiness, and practical implementation into every assessment.
Final Report Delivery
Regulatory-ready reports with scientific rationale, calculations, and clear recommendations by certified toxicologists (ERT, UKRT and DABT).
Ex-Agency Advantage
Why Masuu Global?
Our ex-agency toxicologists bring a practical regulatory perspective that transforms how assessments are built, reviewed, and defended.
Regulatory expectation–driven assessments aligned with how authorities actually evaluate submissions.
Inspection-ready reports — scientifically defensible and audit-prepared from day one.
Faster review cycles with direct decision support from certified toxicologists (ERT, UKRT, DABT).
Practical implementation recommendations that translate science into actionable contamination control.
Reduced internal effort — offload complex assessments without sacrificing quality or defensibility.
Global reach across PDE/ADE, HBEL, OEL, OEB, cleaning validation, and impurity assessments.
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