NDAORALTABLETPriority Review
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 20h 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 by the FDA in July 2015 for the treatment of chronic hepatitis C virus (HCV) infection. It is used as part of direct-acting antiviral (DAA) combination regimens to achieve sustained virologic response. The drug inhibits the NS5A protein, a critical component of the HCV replication complex.
Peak5.1 years to LOE
Peak lifecycle stage indicates stable but mature commercial operations; expect focus on market maintenance and operational efficiency rather than aggressive 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
Career Relevance
DAKLINZA roles center on commercial execution, market access strategy, and payer engagement in a mature, competitive HCV market with high generic risk. Career growth on this asset favors professionals skilled in value demonstration, competitive positioning, and transition management as the product approaches loss of exclusivity.
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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.