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SYMDEKO (COPACKAGED) (IVACAFTOR, TEZACAFTOR)
SYMDEKO (COPACKAGED) (generic name: IVACAFTOR, TEZACAFTOR) is a drug developed by VERTEX PHARMS INC. It is currently FDA-approved.
SYMDEKO (COPACKAGED) is a small molecule that acts as a positive modulator of the cystic fibrosis transmembrane conductance regulator. It is classified as a positive modulator of the same molecular target, with its mechanism of action being to positively modulate the cystic fibrosis transmembrane conductance regulator.
At a glance
| Generic name | IVACAFTOR, TEZACAFTOR |
|---|---|
| Sponsor | VERTEX PHARMS INC |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Headache
- Upper respiratory tract infection
- Abdominal pain
- Diarrhea
- Rash
- Alanine aminotransferase increased
- Nasal congestion
- Blood creatine phosphokinase increased
- Aspartate aminotransferase increased
- Rhinorrhea
- Rhinitis
- Influenza
Serious adverse events
- Rash
- Influenza
- Transaminase elevations
Key clinical trials
- A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects W (Phase 2)
- Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior: an Evaluation of Triple Combination Therapy in Children Aged 6 to 11 Years (N/A)
- Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations (Phase 4)
- A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects (Phase 1)
- A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor (N/A)
- Impact d'un Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre d'Adultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor : Essai contrôl (NA)
- : TRANSITION: An Observational Study of the Effects on Sweat Chloride and Clinical Outcomes of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva) (N/A)
- A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SYMDEKO (COPACKAGED) CI brief — competitive landscape report
- SYMDEKO (COPACKAGED) updates RSS · CI watch RSS
- VERTEX PHARMS INC portfolio CI
Frequently asked questions about SYMDEKO (COPACKAGED)
What is SYMDEKO (COPACKAGED)?
Who makes SYMDEKO (COPACKAGED)?
What is the generic name of SYMDEKO (COPACKAGED)?
What development phase is SYMDEKO (COPACKAGED) in?
What are the side effects of SYMDEKO (COPACKAGED)?
Related
- Manufacturer: VERTEX PHARMS INC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing