Friday, July 10, 2026

Drug profile · INN

tezacaftor

tezacaftor (SYMKEVI) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty..

EMA: approved Respiratory system (R07) R07AX31
Patents linked 20
Pipeline programs 2
News articles 1
Drug details — tezacaftor

Quick answer

tezacaftor (SYMKEVI) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty..

Key facts

INN tezacaftor
Brand SYMKEVI
Mechanism Cystic fibrosis transmembrane conductance regulator positive modulator
Target Cystic fibrosis transmembrane conductance regulator
Therapeutic class Respiratory system (R07)
ATC code R07AX31

Mechanism of action

Cystic fibrosis transmembrane conductance regulator positive modulator

Primary target: Cystic fibrosis transmembrane conductance regulator

Approval history

Authority Status Date
EMA approved

Recent coverage

Pipeline programs

  1. Tezacaftor/Ivacaftor Phase 3 · Vertex Pharmaceuticals (Australia) · Cystic Fibrosis
  2. Tezacaftor/Ivacaftor + Ivacaftor Phase 2 · Vertex Pharmaceuticals (Australia) · Cystic Fibrosis

Related & competitor drugs

  1. desloratadine Respiratory system (R01)
  2. deutivacaftor Cystic fibrosis transmembrane conductance regulator activator
  3. deutivacaftor / tezacaftor / vanzacaftor Respiratory system (R07)
  4. ivacaftor Respiratory system (R07)
  5. lumacaftor Respiratory system (R07)
  6. mannitol Respiratory system (R05)
  1. US 12186306

    Methods of treatment for cystic fibrosis

    Expires Mon Jan 02 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11951212

    Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases

    Expires Mon Apr 04 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11873300

    Crystalline forms of CFTR modulators

    Expires Mon Jan 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11866450

    Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators

    Expires Mon Jan 04 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11639347

    Modulators of ATP-binding cassette transporters

    Expires Mon Apr 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11578062

    Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide

    Expires Mon Feb 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11564916

    Pharmaceutical composition and administrations thereof

    Expires Mon Jan 26 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11066417

    Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators

    Expires Mon Jul 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10646481

    Pharmaceutical composition and administrations thereof

    Expires Mon May 07 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10239867

    Modulators of ATP-binding cassette transporters

    Expires Mon Mar 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10206877

    Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases

    Expires Mon Feb 14 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10081621

    Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide

    Expires Mon Sep 20 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10058546

    Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof

    Expires Mon Aug 23 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10022352

    Modulators of ATP-binding cassette transporters

    Expires Mon Jul 12 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 9974781

    Modulators of ATP-binding cassette transporters

    Expires Mon May 17 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 9931334

    Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide

    Expires Mon Mar 29 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9670163

    Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide

    Expires Mon Jun 01 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 9012496

    Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof

    Expires Mon Apr 16 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 8754224

    Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide

    Expires Mon Jun 12 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 8623905

    Modulators of ATP-binding cassette transporters

    Expires Mon Jan 02 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is tezacaftor?

tezacaftor (SYMKEVI) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty..

What is the brand name for tezacaftor?

SYMKEVI is a marketed brand name for tezacaftor. Check FDA Drugs@FDA for the current US label holder and prescribing information.