NDAORALTABLETPriority Review
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAKLINZA (daclatasvir dihydrochloride) is an oral small-molecule NS5A inhibitor approved in 2015 for chronic hepatitis C virus (HCV) infection. It functions as a direct-acting antiviral that disrupts viral replication by inhibiting the NS5A protein, a critical component of the HCV replication complex. The drug is typically used in combination with other antivirals as part of interferon-free regimens.
Peak4.8 years to LOE
Product is at peak lifecycle stage; commercial teams are focused on maximizing existing market penetration and managing competitive erosion rather than growth expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Started Nov 2018
0Hepatitis C
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Started Oct 2015
10 enrolled
Hepatitis C
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.