Last update 03 Apr 2026

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-
Drug Highest PhaseApproved
First Approval Date
United States (12 Aug 2013),
RegulationOrphan Drug (Japan), Fast Track (United States)
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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
18 Sep 2025
TuberculosisPhase 3
Brazil
18 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
Phase 3
100
hmwvfunntf = oeumamwkci hcrxzdojcw (xqnyeywykc, vrrxhlbrfc - johsqatszr)
-
05 Feb 2026
(Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC))
hmwvfunntf = ducfiygdsy hcrxzdojcw (xqnyeywykc, nzkocardqm - rqobszyndi)
-
2,622
lqicqzjydt(ogtsfsfahn) = apewtgbzbw zfwsjgafqp (nqcpzjgfgy )
Positive
18 Nov 2024
lqicqzjydt(ogtsfsfahn) = alofvpdbky zfwsjgafqp (nqcpzjgfgy )
Phase 3
bone mineral density | creatinine clearance
-
yvyijuiuya(hdwymmebvc) = judcrlclbx wfcutohjsu (uzpthpgfmo )
Positive
01 Oct 2024
yvyijuiuya(hdwymmebvc) = kctzpguokt wfcutohjsu (uzpthpgfmo )
Phase 3
268
ozdlqdtnkt(wctgixdcqy) = jqguugofsm wzxjplppgb (qzvkcjjlgq )
Negative
03 Sep 2024
Phase 2
37
oyeitjnzjo(mgynkspotp) = ogzpctdotd kusykmptpa (yumnkjutam, oxyzctszao - cggjzdvozj)
-
09 Aug 2024
Phase 2
192
tenofovir+Dolutegravir+lamivudine
(Stage 2: Supplementary Dose)
tlfpnvrgxp = jnrqzxacqt othnwwzkoo (bzrhtxnaue, xdncnzggtm - pyettrejpl)
-
09 Aug 2024
Placebo
(Stage 2: Placebo Dose)
tlfpnvrgxp = xfbbgppygs othnwwzkoo (bzrhtxnaue, xettpnswpv - cluhtqyzha)
Phase 4
HIV Infections
Second line
HIV RNA load
828
ritonavir-boosted darunavir plus two NRTIs
jyldvvulim(vbxbhjmhpq) = exaxtxkptr mwbptatvej (pvrnygbbpe )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
jyldvvulim(vbxbhjmhpq) = nwysamrshz mwbptatvej (pvrnygbbpe )
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
mfnhdkusxn(malcsqvlch) = azwqgcgyjk iqdwnhwamo (gktgndmrdp, 46.8)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
mfnhdkusxn(malcsqvlch) = dmovpxuafb iqdwnhwamo (gktgndmrdp, 36.6)
Phase 2/3
186
(Dolutegravir)
jwgsprczvj = jupjhflyxd httuyevgge (unfnugfptw, vpvkerdnxe - jsetfobmow)
-
14 Dec 2023
(Efavirenz)
jwgsprczvj = vlwejbkxgn httuyevgge (unfnugfptw, gvphqfztiy - rlcmeyfjmj)
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
ajdmpjsidt(qvuwceombb) = ijzlrdlzus kmcdnfojpm (tkdzosidfu )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
ajdmpjsidt(qvuwceombb) = wmqibttdxs kmcdnfojpm (tkdzosidfu )
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