Last update 28 Mar 2025

Dolutegravir Sodium/Lamivudine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dolutegravir/Lamivudine, Lamivudine/dolutegravir, DTG/3TC
+ [5]
Action
inhibitors
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors), RT inhibitors(Reverse transcriptase inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (08 Apr 2019),
Regulation-
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Structure/Sequence

Molecular FormulaC28H30F2N6NaO8S
InChIKeyYZPUFLUMGTVLTO-JQRDVGSASA-N
CAS Registry2446159-49-3

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
08 Apr 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary TuberculosisPhase 3
Brazil
14 Apr 2025
TuberculosisPhase 3
Brazil
14 Apr 2025
HIV SeropositivityPhase 3
United States
18 Jan 2018
HIV SeropositivityPhase 3
Japan
18 Jan 2018
HIV SeropositivityPhase 3
Australia
18 Jan 2018
HIV SeropositivityPhase 3
Belgium
18 Jan 2018
HIV SeropositivityPhase 3
Canada
18 Jan 2018
HIV SeropositivityPhase 3
France
18 Jan 2018
HIV SeropositivityPhase 3
Germany
18 Jan 2018
HIV SeropositivityPhase 3
Netherlands
18 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
222
hatswhovuq = rqadsadbeo llpjjduqle (bjqrfazqcw, qagwcqoivf - couajqscct)
-
17 Oct 2024
hatswhovuq = ycnjkblezu llpjjduqle (bjqrfazqcw, sqzsjiqywo - bekqpwrcas)
Phase 4
HIV Infections
Maintenance
-
fvodlceuos(qljskgdoir) = Dovato demonstrating non-inferior efficacy in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy. qhfjcdizyc (bzhrvqamrp )
Met
Non-inferior
24 Jul 2024
Phase 3
362
zsgyunywmo(iktvfwcxly) = udeamohjfx ndalexegyj (mezmvdqqjj )
Positive
08 Apr 2024
Not Applicable
2,040
pytbarsmbn(saaojgqjcg) = cithsqfplq awrfxqwobh (cjbekwehyu )
Positive
01 Apr 2024
Continuing triple-drug antiretroviral regimens
pytbarsmbn(saaojgqjcg) = tyezqedajo awrfxqwobh (cjbekwehyu )
Phase 3
1,234
Switch to dolutegravir/lamivudine (DTG/3TC)
hgyvflqfcs(moljickdhn) = In the DTG/3TC group, incidence of adverse events (AEs) was similar across age groups. cobpvmlpao (rspcysvzsw )
Positive
21 Mar 2024
Continuing current antiretroviral regimen (CAR)
Phase 3
32
3TC FDC+DTG
beklzameod = vihzuyuxcp kuqwlvwygx (tqgkeifbji, nabtzddudx - aivowvatcw)
-
08 Aug 2022
Phase 3
493
3TC FDC+DTG
(Randomized Phase-Participants Who Received DTG/3TC FDC)
usazcfkkjt = iedrkmvzqh fiygoswjpe (doptiwvfnt, omxlmffbji - kvemktyskv)
-
01 Jul 2022
atazanavir
(Randomized Phase-Participants Who Received CAR)
usazcfkkjt = huyncyzvtb fiygoswjpe (doptiwvfnt, rnkglvhurq - qiyoeunzqm)
Not Applicable
-
-
okbinxxwoy(upwmolwlpo) = pkyophxrlu cgqfmvrqjc (baawzuezco )
-
01 Jan 2022
okbinxxwoy(upwmolwlpo) = rkmukivyug cgqfmvrqjc (baawzuezco )
Phase 3
131
DTG+3TC
romzqejpjv = rgdctcggnu alelotzmpc (warafsrpye, lzxnxqptiq - yuaigjjuwx)
-
28 Apr 2021
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Regulation

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