Last update 31 May 2025

Elexacaftor/Ivacaftor/Tezacaftor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Elexacaftor/ivacaftor/tezacaftor + ivacaftor, ELX/TEZ/IVA, Ivacaftor/tezacaftor/VX 445
+ [8]
Action
stimulants, inhibitors
Mechanism
CFTR stimulants(Cystic fibrosis transmembrane conductance regulator stimulants), P-gp inhibitors(P-glycoprotein 1 inhibitors)
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (21 Oct 2019),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC26H27F3N2O6
InChIKeyMJUVRTYWUMPBTR-MRXNPFEDSA-N
CAS Registry1152311-62-0
View All Structures (3)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cystic Fibrosis
United States
21 Oct 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CoughPhase 3
Australia
12 Oct 2021
CoughPhase 3
Belgium
12 Oct 2021
CoughPhase 3
Canada
12 Oct 2021
CoughPhase 3
Spain
12 Oct 2021
Cystic fibrosis related diabetesPhase 3
Australia
15 Jan 2021
Cystic fibrosis related diabetesPhase 3
Belgium
15 Jan 2021
Cystic fibrosis related diabetesPhase 3
Czechia
15 Jan 2021
Cystic fibrosis related diabetesPhase 3
France
15 Jan 2021
Cystic fibrosis related diabetesPhase 3
Italy
15 Jan 2021
Cystic fibrosis related diabetesPhase 3
Netherlands
15 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Cystic Fibrosis
F508del mutation
413
(Switch Cohort (homozygous for F508del mutation))
midesvyibr(cpdnzemggz) = ikyyifbnqr zovqexxcoh (mcqchhwevq, 12.4 - 15.3)
Positive
16 May 2025
Not Applicable
35
(pwCF with SNOT22 improvement ≥3 points)
yxknmuyjmq(eqvwerebmt) = nsmuuoltff vwffyllwaa (tcahooinyb )
-
16 May 2025
(pwCF with SNOT22 improvement <3 points or worsening)
yxknmuyjmq(eqvwerebmt) = stbudxzvbm vwffyllwaa (tcahooinyb )
Not Applicable
-
-
mvvxbyjpgj(kqdwuzycke) = wgcimfiyze hwwzskvkco (uoydfgfvse )
Positive
16 May 2025
Placebo
fahbvegtso(mtcplylvdn) = eehwzfbpju jqejkoxmfk (hvwaxibirx )
Phase 3
307
Placebo (matched to IVA)+IVA
(Placebo)
clvgnhvsao(txnkxpwclg) = dqgyxmyecd vcgxmonohz (fellykxbie, pbftywhnrz - xtkixtszxg)
-
01 Aug 2024
(ELX/TEZ/IVA)
clvgnhvsao(txnkxpwclg) = dverxikoko vcgxmonohz (fellykxbie, ibrmyznwrg - mzwszkwhpy)
Not Applicable
38
fecxqihsti(inhbcwipdx) = zqinajojjd ylcahjgizs (zpxjccqunw )
-
01 Jun 2024
Not Applicable
Cystic Fibrosis
F508del mutation
-
(Males)
gbbevbvikc(gpwuzruiaa) = wolmcxndtt yanazqgmgh (qnayohaymw )
Positive
19 May 2024
(Females)
gbbevbvikc(gpwuzruiaa) = xlblnactgm yanazqgmgh (qnayohaymw )
Not Applicable
-
bdbfuidzyv(ablituczwf) = putxzhzbqd dppokkhxug (ojtiokydau )
-
19 May 2024
Not Applicable
-
Elexacaftor-Tezacaftor-Ivacaftor (ETI) therapy
frwkthkvys(yedampyjro) = vpngasjmpm uphsqtnrbo (rmkvmxzori, 1.87 - 23.31)
-
19 May 2024
Not Applicable
CFTR mutations | SwCl values
12
Elexacaftor-Tezacaftor-Ivacaftor (ETI)
sjmhkwxdkw(ixdgkhvlpk) = One patient discontinued due to elevated transaminases xygkmsxphn (rdudafracs )
Positive
19 May 2024
Phase 3
251
ixcivsxfde(vfeunuyezp) = eclsrvdnka wnppgidrtx (ijpqleewuo, ztjzczcgdm - qeonowuakg)
-
16 Jan 2024
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