NDAORALTABLETPriority Review
Approved
Feb 2018
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
SYMDEKO is an oral copackaged combination of tezacaftor and ivacaftor, two small-molecule CFTR modulators developed by Vertex Pharmaceuticals for cystic fibrosis. The drug works by improving the function and localization of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. It is indicated for patients with specific CFTR mutations who benefit from dual modulation therapy.
Peak8.7 years to LOE
Product is in peak revenue stage with established market presence; commercial teams are focused on maintaining market share and optimizing patient access programs.
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)
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Started Jan 2013
35 enrolled
Cystic Fibrosis
Career Relevance
Working on SYMDEKO offers 231 linked career opportunities spanning commercial, R&D, regulatory, and manufacturing functions at Vertex. Peak lifecycle status means teams are optimizing market penetration, patient outcomes, and supply chain efficiency rather than building from launch.
Director
Worked on SYMDEKO (COPACKAGED) at Vertex Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.