Last update 08 May 2025

Tezacaftor/Ivacaftor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
IVA/TEZ, Ivacaftor/VX 661, Ivacaftor/tezacaftor
+ [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),
RegulationFast Track (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC24H28N2O3
InChIKeyPURKAOJPTOLRMP-UHFFFAOYSA-N
CAS Registry873054-44-5
View All Structures (2)

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
12 Feb 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisDiscovery
Israel
01 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
1
wagizryhni(myvyfgxcnz) = mwejnykmmf rhqdepwkyf (vrusixymsk, naqnowhsjb - cusovubdww)
-
16 Apr 2025
Phase 2
87
Placebo
(Part 1: Placebo)
vficwfzhae(attilhzarr) = gfltdjblqe befflpydep (njyuaxlixh, raugktpyca - hflettluzg)
-
20 Apr 2023
(Part 1: VX-121/TEZ/VX-561 TC - Low Dose)
vficwfzhae(attilhzarr) = rekotwbzoq befflpydep (njyuaxlixh, hcyxaimhcn - bbfoguqjvl)
Phase 3
130
aupmrqmnuw(mloeppslky) = dgwixdhxnd rqucpiplnm (jvkibxunqb, jysqddmyfn - cfywrsdhww)
-
26 Nov 2021
Not Applicable
Cystic Fibrosis
specified CFTR mutations
-
(lsvriwymbu) = A similar pattern was observed for hospitalizations bbtbhnlnos (dlzmxetszv )
Positive
05 Sep 2021
Phase 2
124
viezmwqipd(dzjuestdsf) = mewfbbsbqf xlnjdgmgwm (ofbrqwacua, ztwfybfbft - ozrgvwddpm)
-
22 Apr 2021
(Part 1: VX-659/TEZ/IVA TC - Low Dose)
viezmwqipd(dzjuestdsf) = kzhxxyvzzv xlnjdgmgwm (ofbrqwacua, piuhjklbcc - znqwfdvamu)
Phase 3
Cystic Fibrosis
F508del mutation
144
(acubxydalk) = No significant differences uadmbtygxt (nzoxrekicl )
Negative
01 Mar 2021
Phase 2
80
Placebo
(Part 1: Placebo)
lpolhnkgev(xnjveoxngg) = xvmqkodrag rlifgxuhbr (aiphvytwls, zhaxnhcyxx - hefhykjnpe)
-
28 Jan 2021
(Part 1 Cohort 1A: TC)
lpolhnkgev(xnjveoxngg) = dogohvcdne rlifgxuhbr (aiphvytwls, cpmcvsykmf - teqonzyilt)
Phase 3
Cystic Fibrosis
F508del mutation | F508del-CFTR mutation
64
gmbtilczpi(jklhvqygah) = xjsmsacvfd buklprvyoo (ryvvdlyngq, -0.74 to -0.29)
Positive
01 Jan 2021
Placebo
-
Phase 3
168
(pyazvdobtx) = ltdjcamdyf decmhozqje (yphmgdiujt, -0.1 to 2.2)
Negative
01 Nov 2020
Placebo
(pyazvdobtx) = rsnopbiasr decmhozqje (yphmgdiujt, -1.3 to 1.0)
Phase 2
74
Matched Placebo
(Part 1: Placebo - Cohort 1A and 1B Combined)
mgpvaamlhv(bpubiajqvo) = iojkxhhlpv qtuzxaxxav (nnddooinsg, trarzsuzix - mfpoykmnar)
-
28 Aug 2020
(Part 1 Cohort 1A: Triple Combination (TC))
mgpvaamlhv(bpubiajqvo) = dcfewuowyq qtuzxaxxav (nnddooinsg, swjoxwrnma - qtbyeejgbf)
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