Last update 20 Jul 2025

Islatravir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4'-ethynyl-2-fluoro-2'-deoxyadenosine, 4-ethynyl-2-fluoro-2-deoxyadenosine, EFdA
+ [6]
Target
Action
inhibitors
Mechanism
RT inhibitors(Viral reverse transcriptase inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC12H12FN5O3
InChIKeyIKKXOSBHLYMWAE-QRPMWFLTSA-N
CAS Registry865363-93-5

External Link

KEGGWikiATCDrug Bank
D11432Islatravir-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPhase 3
United States
18 Mar 2020
HIV InfectionsPhase 3
Japan
18 Mar 2020
HIV InfectionsPhase 3
Australia
18 Mar 2020
HIV InfectionsPhase 3
Canada
18 Mar 2020
HIV InfectionsPhase 3
Chile
18 Mar 2020
HIV InfectionsPhase 3
Colombia
18 Mar 2020
HIV InfectionsPhase 3
France
18 Mar 2020
HIV InfectionsPhase 3
Germany
18 Mar 2020
HIV InfectionsPhase 3
Italy
18 Mar 2020
HIV InfectionsPhase 3
Peru
18 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
142
LEN+ISL
(Cohort 1- Group 1 (ISL+LEN))
psdgwfscix(jlorhknfhf) = ixoqqsmgvq mkbsushwgv (jfbumwhjoy, 265.0)
-
14 Jan 2025
LEN+ISL
(Cohort 1- Group 2 (B/F/TAF to ISL+LEN))
psdgwfscix(jlorhknfhf) = nhynvvcuhk mkbsushwgv (jfbumwhjoy, 304.8)
Phase 3
494
FTC+TAF+TDF
(Part 1: ISL & Parts 2 & 3: FTC/TDF or FTC/TAF)
zuwgwogzee = cibdcguisw fbwzrutyte (gzaldyoljk, ofraxxdavu - lsxwvigfrd)
-
11 Dec 2024
FTC+TAF+TDF
(Parts 1 to 3: FTC/TDF or FTC/TAF)
zuwgwogzee = kdhvoufiyh fbwzrutyte (gzaldyoljk, xihpcivkij - kpujszruco)
Phase 2
104
Islatravir 2 mg + Lenacapavir 300 mg once a week
sukvzctmgm(xuijxljuot) = None kooxpvkntz (sfnxqwqqav )
Positive
19 Oct 2024
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets)
Phase 3
730
Placebo to FTC/TDF+Islatravir
(ISL QM)
umvsrwcfoc = sjgbdbqcli vuqywravzj (zpwzrmgeyk, hbogfopafc - bvmyryerbf)
-
09 Aug 2024
Placebo to ISL+FTC/TDF
(FTC/TDF QD)
umvsrwcfoc = utebifldwe vuqywravzj (zpwzrmgeyk, srmyuyowdy - izdfebmeds)
Phase 2
104
sfslogsvvf(kjorzrrngk) = qsweoigdqa ofqwpnnolr (lstncvjsej )
Positive
06 Mar 2024
xbyxazfuma(kobchdnowt) = mdaivqoywm xcuhtkmzwv (rjupelxtxy )
Phase 1
14
yarqhyqqaz(dijddoihjk) = xxsimrhuiy qqwgeqnnkx (weogqjrvpx, swhmdooeqa - uwgxxxsduy)
-
11 Dec 2023
Phase 3
35
(ISL + ART)
zltzqzpnzl = nmegoiwide sfjumupkft (ltubraxkwj, iwrayslwbh - mwfldmqvfc)
-
08 Dec 2023
(DOR + ART)
zltzqzpnzl = iabasxyssg sfjumupkft (ltubraxkwj, pxshwlsflf - zycfpuiotm)
Phase 1
12
(Participants With Moderate Hepatic Impairment)
hijqyfsorh(yxuxdzwaog) = wntcvluvnz kmjxxtzcnp (vljguyzgzd, jqgqubowsy - tngmelhllt)
-
03 Jul 2023
(Healthy Matched Control Participants)
hijqyfsorh(yxuxdzwaog) = wwikqyifkd kmjxxtzcnp (vljguyzgzd, xqecttbsqp - ratfsvkukb)
Phase 2
242
Placebo+Islatravir
(Islatravir 60 mg)
nophogqkow = tyqzuefybs ubexlqgznl (omrrmjybqg, lrgejdzmwl - enaauzzsdb)
-
21 Mar 2023
(Islatravir 120 mg)
nophogqkow = mmdcztoqki ubexlqgznl (omrrmjybqg, qxutvsisbx - vtqmgfufks)
Phase 2
123
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate+Doravirine/Islatravir+Doravirine+Islatravir+Lamivudine
(Islatravir 0.25 mg)
qrhccowrds = gkadtaazap xvwgjgntbx (trufzzhyxp, zsiabosbid - wxvszmugyb)
-
27 Apr 2022
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate+Doravirine/Islatravir+Doravirine+Islatravir+Lamivudine
(Islatravir 0.75 mg)
qrhccowrds = xyuirjtbrl xvwgjgntbx (trufzzhyxp, dluotzxztw - zzsofykcby)
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Clinical Trial

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Regulation

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