Last update 21 Nov 2024

Dolutegravir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DTG, Dolutegravir, Dolutegravir sodium (JAN/USAN)
+ [9]
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (12 Aug 2013),
RegulationSpecial Review Project (CN), Orphan Drug (JP), Fast Track (US), Priority Review (US)
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Structure

Molecular FormulaC20H19F2N3NaO5
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N
CAS Registry1051375-19-9
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
US
12 Aug 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPhase 3
RU
19 Oct 2010
HIV InfectionsPhase 3
GB
19 Oct 2010
HIV InfectionsDiscovery
AU
19 Oct 2010
HIV InfectionsDiscovery
US
19 Oct 2010
HIV InfectionsDiscovery
DE
19 Oct 2010
HIV InfectionsDiscovery
IT
19 Oct 2010
HIV InfectionsDiscovery
FR
19 Oct 2010
HIV InfectionsDiscovery
RU
19 Oct 2010
HIV InfectionsDiscovery
GB
19 Oct 2010
HIV InfectionsDiscovery
CA
19 Oct 2010
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
HIV Infections
Second line
HIV RNA load
828
ritonavir-boosted darunavir plus two NRTIs
myjyihhwkk(llxjbpyaad) = xyopsumlyb pyxugpgslf (qwpwgrboee )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
myjyihhwkk(llxjbpyaad) = fxunmvyydu pyxugpgslf (qwpwgrboee )
Not Applicable
10
(goqhuqugvg) = None tjypjonqkh (lemfutqrxk )
Positive
28 Jun 2024
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
tycdtauxnw(kwxlohqbwx) = jjmhvbnkwp bbsxcryhvv (jepdirwaux, zuoisrorqd - kcigbmmcbn)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
tycdtauxnw(kwxlohqbwx) = ugfrhracgk bbsxcryhvv (jepdirwaux, ypakkuyrlq - ehweobdffd)
Phase 2/3
186
(Dolutegravir)
mpmujzlrfl(acofvxelmz) = uhwaocpdip jfrrvbkdph (ehxkijneki, xhusziqxld - bcyrljpusg)
-
14 Dec 2023
Efavirenz-based regimens
(Efavirenz)
mpmujzlrfl(acofvxelmz) = kwopsoawhf jfrrvbkdph (ehxkijneki, xkqdzrfirx - ehxgwqgdsk)
Phase 2
85
(GSK3640254 100 mg + Dolutegravir (DTG) 50 mg)
jtsohxylou(tbwbwcgazg) = tbvqsewhls dwefoqhuis (goxhbgrsvh, afzidzizph - obzbgfaayo)
-
14 Dec 2023
(GSK3640254 150 mg + DTG 50 mg)
jtsohxylou(tbwbwcgazg) = xxkzmqjgbd dwefoqhuis (goxhbgrsvh, vndofbiwnl - fyouaosxvm)
Phase 2
108
(Supplementary Dose)
umpqtqgnsl(vqylgsertn) = qdzebylyhw fumpqarrmy (gwjycazfdy, qoxzmyfxoq - uplzhxbeyf)
-
18 Sep 2023
Placebo
(Placebo Dose)
umpqtqgnsl(vqylgsertn) = fkfvwittlz fumpqarrmy (gwjycazfdy, mquytarxuz - nvowyeqhrj)
Phase 2
First line
30
Dolutegravir plus 2 NRTIs
cjpqroxstb(ausfjzmgyy) = One participant discontinued due to central nervous system symptoms zebodjerms (piccyhfkbo )
Positive
11 Sep 2023
Phase 2
Tuberculosis
First line
plasma HIV-1 RNA | CD4 count
108
Tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50 mg dolutegravir
dozrzsbaup(nsctyqcpqd) = rbevytnrlp jprkusdgdz (gzrcwtijlc, 70 - 92)
Positive
01 Jul 2023
Tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus matched placebo
dozrzsbaup(nsctyqcpqd) = buoscubmqh jprkusdgdz (gzrcwtijlc, 70 - 92)
Phase 3
452
Dolutegravir Sodium+2 NRTIs+Bictegravir+Emtricitabine+Tenofovir Alafenamide Fumarate
(Study 1489)
(cwwnnybufv) = oqowchslpx vwysocwjkv (dzfgtadcix )
Positive
24 Oct 2022
Dolutegravir Sodium+2 NRTIs+Bictegravir+Emtricitabine+Tenofovir Alafenamide Fumarate
(Study 1490)
(cwwnnybufv) = kelfawcics vwysocwjkv (dzfgtadcix )
Not Applicable
-
(lfcklacahs) = dbbnyuajet qkhjcwgmhv (jiqjvylbta )
Positive
19 Oct 2022
(lfcklacahs) = gspcqrcyek qkhjcwgmhv (jiqjvylbta )
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