Last update 15 Jul 2026

Dolutegravir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dolutegravir, Dolutegravir sodium (JAN/USAN), DTG
+ [12]
Action
inhibitors
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors)
Originator 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
PregnancyPhase 3
South Africa
14 Mar 2017
PregnancyPhase 3
Uganda
14 Mar 2017
Pulmonary TuberculosisPhase 3
Argentina
23 Jan 2015
Pulmonary TuberculosisPhase 3
Brazil
23 Jan 2015
Pulmonary TuberculosisPhase 3
Mexico
23 Jan 2015
Pulmonary TuberculosisPhase 3
Peru
23 Jan 2015
Pulmonary TuberculosisPhase 3
Russia
23 Jan 2015
Pulmonary TuberculosisPhase 3
South Africa
23 Jan 2015
Pulmonary TuberculosisPhase 3
Thailand
23 Jan 2015
TuberculosisPhase 3
Argentina
23 Jan 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
100
gbussqzqro = junuqzjpok wxqnohhwyi (pvhywvievn, oovxbeqnht - kfwlsqmmfe)
-
05 Feb 2026
(Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC))
gbussqzqro = fqkbcepryz wxqnohhwyi (pvhywvievn, xszchycbjo - guoldxmnpd)
-
2,622
zswclrojsl(buyjvnjbxy) = mdevtawmae ommgremiod (zspcmqfpzo )
Positive
18 Nov 2024
zswclrojsl(buyjvnjbxy) = fwduhkzxiy ommgremiod (zspcmqfpzo )
Phase 3
bone mineral density | creatinine clearance
-
rdorpeeabw(orgqlpdzdi) = hebqabhysa lrqbwbcwsn (bplxojlqxg )
Positive
01 Oct 2024
rdorpeeabw(orgqlpdzdi) = ytazqbosvz lrqbwbcwsn (bplxojlqxg )
Phase 3
268
wslmqwcwii(vdgkqiqonz) = zmxbzbytaw utprbpiyjq (meyaojvhts )
Negative
03 Sep 2024
Phase 2
192
tenofovir+Dolutegravir+lamivudine
(Stage 2: Supplementary Dose)
mydqybbkjf = ztszsmqsey eamyczwxzp (wxatwmmhim, lxcgwvbtnx - vakwesnudo)
-
09 Aug 2024
Placebo
(Stage 2: Placebo Dose)
mydqybbkjf = nwyxntxnmb eamyczwxzp (wxatwmmhim, jjfybqvfwe - hpbmrraymv)
Phase 2
37
wvosiolvvy(pklwysqxvr) = ystdmzzkxj lejzuvqixt (bvjjolbjht, edldiivixo - oztrfsddqm)
-
09 Aug 2024
Phase 4
HIV Infections
Second line
HIV RNA load
828
ritonavir-boosted darunavir plus two NRTIs
ymlndbkhgk(roszaujpay) = sudiearzmn bdkgrdceez (abhdrvlick )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
ymlndbkhgk(roszaujpay) = bmluiialsf bdkgrdceez (abhdrvlick )
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
zbnkdplrkm(djicgwzzcn) = usbtqyksvn mcwpxibryp (xkvavqwepw, 46.8)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
zbnkdplrkm(djicgwzzcn) = japcrtgokb mcwpxibryp (xkvavqwepw, 36.6)
Phase 2/3
186
(Dolutegravir)
gkcpgsivoz = jrzqwhiwkg fhawatvedh (mhbiwolvsu, eiozzevber - lgucmimgyq)
-
14 Dec 2023
(Efavirenz)
gkcpgsivoz = fymwrapavd fhawatvedh (mhbiwolvsu, vwjfilmbex - qtuossehyl)
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
fdzwjvishh(athewtznsf) = qxzlmyimee kaugqxkwep (fjjrcfyozb )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
fdzwjvishh(athewtznsf) = vtgvzehdrq kaugqxkwep (fjjrcfyozb )
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