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 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRIKAFTA is a triple combination oral granule therapy comprising elexacaftor, tezacaftor, and ivacaftor for cystic fibrosis (CF). It works by increasing both the quantity and function of CFTR protein at the cell surface through dual corrector and potentiator mechanisms, resulting in enhanced chloride transport. The combination targets multiple CFTR variants, including F508del and over 350 responsive mutations.
Peak11.9 years to LOE
Product is at peak commercial momentum post-2023 approval; significant team growth expected in commercial, medical affairs, and manufacturing functions.
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 career opportunity in a high-impact rare disease franchise with 231 open positions spanning commercial, R&D, regulatory, and manufacturing. The product's recent 2023 approval positions professionals at the peak revenue growth phase, with stable 12-year patent protection enabling long-term team building and specialization.
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.