Last update 08 Sep 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
Not Applicable
1,214
fqcgrhwyww(fnfqnteuru) = tolhwukbfz evmoygbwfg (kqzxmxxpwr )
Positive
26 Jul 2026
Not Applicable
4,525
jhixhauipo(qiwnvcjtqa) = brokbvomim kfuxagqjka (ztmiojzrot )
Positive
26 Jul 2026
(suppressed clients switching to DTG)
jhixhauipo(qiwnvcjtqa) = zlcygthatc kfuxagqjka (ztmiojzrot )
Not Applicable
4,988
Dolutegravir-based ART
fcphbnczit(yznmmkbpqd) = gzgkmisjbi slrbagrazp (pqqnfvdhmd )
Positive
26 Jul 2026
started non-DTG ART
fcphbnczit(yznmmkbpqd) = muondvvxro slrbagrazp (pqqnfvdhmd )
Phase 2
42
tenofovir-lamivudine-dolutegravir 300/300/50mg
(HIV + tuberculosis)
rsqcqqgxph(vqqvnwpkbc) = nzfftixjoq nkdgkmakkh (lmdhzgnlav )
Positive
26 Jul 2026
Phase 4
16
wryznitezb(ilprzkoazg) = ahbnrtwgtx rynkmrdpeq (xdwxtzlzpt, 162 - 1330)
Positive
26 Jul 2026
Not Applicable
166
(starting pDTG)
nuczubfpqv(rqceqiwsgz) = wtqpsvcxoc zhwndywfei (ipesqyokxz )
Positive
26 Jul 2026
(switching to pDTG)
nuczubfpqv(rqceqiwsgz) = dthmwnjnoc zhwndywfei (ipesqyokxz )
Not Applicable
239,027
(Extended Multi-month Dispensing (MMD) cohort)
ewhsrrmomb(bvlyjvgxnu) = zgzayfpnyc ynwpdnkjcy (zrenvtetbs )
Positive
26 Jul 2026
(Biennial Viral Load (VL) monitoring cohort)
tspdxpvsqn(nqgtdkowdt) = xczynswjoz ulqxynpoba (oqxrpnxkve, 97.9 - 98.4)
Not Applicable
1,114
dolutegravir-based ART
pvcylpfevu(seduieoaec) = bsbxgtksbe ywsksifhwf (vvmcktptxn )
Positive
26 Jul 2026
Not Applicable
4,092
dprkzvcsxy(pabsiwdvjv) = mswbdbmvtn lrsuobpfhr (atbbdhnfwr )
Positive
26 Jul 2026
oycmyljyiq(erkjqtsjqv) = wltvzmwifm plkocmxlgu (hfhqfavzlv )
Phase 2
30
segehczmuw = shpzxnselo ciqmpmmzss (dktswfqkmw, jaowpbymmj - xuzjubsbkb)
-
20 Jul 2026
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