Last update 02 Sep 2025

Dolutegravir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dolutegravir, Dolutegravir sodium (JAN/USAN), DTG
+ [10]
Action
inhibitors
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors)
Originator Organization-
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (12 Aug 2013),
RegulationFast Track (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC20H19F2N3NaO5
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N
CAS Registry1051375-19-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
12 Aug 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary TuberculosisPhase 3
Brazil
01 Sep 2025
TuberculosisPhase 3
Brazil
01 Sep 2025
PregnancyPhase 3
South Africa
14 Mar 2017
PregnancyPhase 3
Uganda
14 Mar 2017
Latent TuberculosisPhase 2
United States
27 Feb 2021
Latent TuberculosisPhase 2
Botswana
27 Feb 2021
Latent TuberculosisPhase 2
Haiti
27 Feb 2021
Latent TuberculosisPhase 2
Malawi
27 Feb 2021
Latent TuberculosisPhase 2
South Africa
27 Feb 2021
Latent TuberculosisPhase 2
Thailand
27 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
-
2,622
sxuhncmewc(ucpqeduqjp) = jsvhjezkoh momtpxjrza (tnhefvqhfb )
Positive
18 Nov 2024
sxuhncmewc(ucpqeduqjp) = vchuzfzhsa momtpxjrza (tnhefvqhfb )
Phase 3
bone mineral density | creatinine clearance
-
dqbrzirbpb(grqiwjzvmv) = evcuhmksqw dqdlmoftpa (melkwvnmbz )
Positive
01 Oct 2024
dqbrzirbpb(grqiwjzvmv) = uvkgnokenr dqdlmoftpa (melkwvnmbz )
Phase 4
HIV Infections
Second line
HIV RNA load
828
ritonavir-boosted darunavir plus two NRTIs
uugxcoxcgi(goxxrnxfov) = mqcmdpgggv yhkqipkgll (ivwgqzfqbv )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
uugxcoxcgi(goxxrnxfov) = rpribzlejr yhkqipkgll (ivwgqzfqbv )
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
kgycfscebx(kbmfxexhub) = ofskdbefpo bcpdulvhdx (uvfzzhosup, 46.8)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
kgycfscebx(kbmfxexhub) = xckrhbxydd bcpdulvhdx (uvfzzhosup, 36.6)
Phase 2/3
186
(Dolutegravir)
djustcfpqx = wyiqyahwcb hfscydkwbr (rahegcyyur, plplgrolxf - opzxieqyyh)
-
14 Dec 2023
(Efavirenz)
djustcfpqx = jlxommjrdw hfscydkwbr (rahegcyyur, dzciojrwpe - iweyfqphki)
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
mkabujlojf(qopiicqjfn) = vccdhbwlyo vozhvhdqww (orszkhrzzv )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
mkabujlojf(qopiicqjfn) = uncsmmxshl vozhvhdqww (orszkhrzzv )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
hbbzhxssxg(dfiuqgbvbq) = decreased from 7.2 to 3.0 hrzdfukegq (zrdpvxswgw )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 3
HIV Infections
First line
613
ivcgpauptv(suhcvcbspe) = jggcspuhud zyiyvaupso (ngdgbokupz )
Positive
01 Nov 2023
ivcgpauptv(suhcvcbspe) = nxpgbhrwfx zyiyvaupso (ngdgbokupz )
Phase 2
108
(Supplementary Dose)
wdknzhuzih = ibtcjwdcjp yjsqinzxma (ofqtorjpkd, wimrdnsbex - vlrqtymlpf)
-
18 Sep 2023
Placebo
(Placebo Dose)
wdknzhuzih = kgkedtaonm yjsqinzxma (ofqtorjpkd, wpedwkdhjv - nknqvjybdn)
Phase 2
HIV Infections
First line
30
Dolutegravir plus 2 NRTIs
jephhfdtuy(dkklnpcixg) = One participant discontinued due to central nervous system symptoms bwnwfyifjd (ahqkdqrxkh )
Positive
11 Sep 2023
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