NDAORALGRANULEPriority Review
Approved
Apr 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRIKAFTA is a copackaged oral granule formulation combining three small-molecule CFTR modulators: elexacaftor, tezacaftor, and ivacaftor. It is indicated for cystic fibrosis patients with specific CFTR mutations and represents a major advance in CF treatment by addressing the underlying protein defect. The triple combination works synergistically to increase CFTR protein production, localization, and function.
Growth12.2 years to LOE
The product is in active growth phase post-approval with expanding patient population reach; commercial team expansion and field-based roles are likely active.
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 (1)
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Started Jan 2017
225 enrolled
Cystic Fibrosis
Career Relevance
TRIKAFTA represents a high-impact career opportunity at Vertex Pharmaceuticals with 207 linked job openings across R&D, Commercial, Regulatory, and Engineering functions. Working on this franchise provides exposure to a blockbuster CF therapy in growth phase with strong commercial momentum and long patent runway.
Director
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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.