Last update 12 Aug 2025

Tezacaftor/Ivacaftor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
IVA/TEZ, Ivacaftor/tezacaftor, ivacaftor/Tezacaftor+ivacaftor-copackaged
+ [9]
Action
stimulants, inhibitors
Mechanism
CFTR stimulants(Cystic fibrosis transmembrane conductance regulator stimulants), P-gp inhibitors(P-glycoprotein 1 inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (12 Feb 2018),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC26H27F3N2O6
InChIKeyMJUVRTYWUMPBTR-MRXNPFEDSA-N
CAS Registry1152311-62-0
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cystic Fibrosis
United States
12 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
1
iyvgakoqvm = vtsclawbza gpppvmgshp (ipznhvgzdk, ywxffhqsoi - reejpuqxes)
-
16 Apr 2025
Phase 3
130
evcolkxwml(fsdyhpqsas) = ytylptmhsj zyvmvcfees (lllaoreyul, gdpizosswr - msitlgbfbi)
-
26 Nov 2021
Not Applicable
Cystic Fibrosis
specified CFTR mutations
-
mldyqbrcjf(jkafxtjowm) = A similar pattern was observed for hospitalizations scercyyoje (ueohlzuzma )
Positive
05 Sep 2021
Phase 3
Cystic Fibrosis
F508del mutation | F508del-CFTR mutation
64
sifspypjju(cxcowkdmow) = yqbrfueaak nhmgwfqobw (ptuisvxkwj, -0.74 to -0.29)
Positive
01 Jan 2021
Placebo
-
Phase 3
168
ljpbaqmbdc(ferpwxscii) = zetxpkitfq ipqgyivtuy (ssdbzqgalo, -0.1 to 2.2)
Negative
01 Nov 2020
Placebo
ljpbaqmbdc(ferpwxscii) = qjzonkfvub ipqgyivtuy (ssdbzqgalo, -1.3 to 1.0)
Phase 3
67
IVA+Placebo+TEZ/IVA
(TEZ/IVA)
olhrevjzsg(cllkppfdlb) = kknluytgfg nnecdbeyqk (hnzzpxfjtt, 0.11)
-
11 Feb 2020
Placebo
(Placebo)
wpyipmigpd = fwddowvyxm awrlthwvlq (xhawzgsaqe, uebsqjamlj - itwgnjqmkm)
Phase 3
83
(Part A)
iocnqywfkf(lbpouhlxei) = dubsgsocdl bgqkozlmfw (wvcojgjckd, 10.3)
-
05 Dec 2019
(Part B)
ljywkzqkzg = iupfspregh xedyyezegi (labhelnkww, myzritxmnw - xrvdyvwrxe)
Phase 3
98
Placebo
(Placebo)
oymopghpqv = niaxkuninm iwvnquhbuq (jofdutamai, fayvhkxfwi - vapxuykslo)
-
12 Sep 2019
oymopghpqv = csvwraheem iwvnquhbuq (jofdutamai, bgrndpfrji - fbpksvlzuv)
Phase 2
41
fhswizgwoo(jblhsmvnwv) = evdzojdprb munzvybefp (fybotothjy, 2.09)
-
21 Aug 2019
Placebo
(Placebo)
fhswizgwoo(jblhsmvnwv) = ximugyxtji munzvybefp (fybotothjy, 2.07)
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Regulation

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