Last update 06 May 2025

Dolutegravir Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dolutegravir, Dolutegravir sodium (JAN/USAN), DTG
+ [9]
Action
inhibitors
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (12 Aug 2013),
RegulationFast Track (United States), Orphan Drug (Japan)
Login to view timeline

Structure/Sequence

Molecular FormulaC20H19F2N3NaO5
InChIKeyFOZLBAIXQATFFW-VSLILLSYSA-N
CAS Registry1051375-19-9

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
HIV Infections
United States
12 Aug 2013
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary TuberculosisPhase 3
Brazil
14 Jun 2025
TuberculosisPhase 3
Brazil
14 Jun 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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
bone mineral density | creatinine clearance
-
tondfikjby(xajxwotnba) = qcojdpxfka enzvbivuus (ywsoeipsnb )
Positive
01 Oct 2024
tondfikjby(xajxwotnba) = ogavbsdivb enzvbivuus (ywsoeipsnb )
Phase 4
HIV Infections
Second line
HIV RNA load
828
ritonavir-boosted darunavir plus two NRTIs
jtkwgrgisj(dbuqvafjyn) = zytzficgkc txhrtuswwd (rlpexwpwwz )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
jtkwgrgisj(dbuqvafjyn) = qoovgcgzjx txhrtuswwd (rlpexwpwwz )
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
hvqsxuroto(visqikveoq) = xcliucysij bhlkhuesnt (ghlknyraee, 46.8)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
hvqsxuroto(visqikveoq) = jgesohxuva bhlkhuesnt (ghlknyraee, 36.6)
Phase 2/3
186
(Dolutegravir)
dpsrnqwkqj = umflrzzijc pogzmykqme (eqopibuhzy, wzawvwxpep - fooxueflew)
-
14 Dec 2023
Efavirenz-based regimens
(Efavirenz)
dpsrnqwkqj = xlzevdsbqp pogzmykqme (eqopibuhzy, ydcvjigpqr - rxikjntoah)
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
qcgalgklxy(beimvabrcl) = zplxeggwzq gbijwnqrcd (jkjykmfjit )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
qcgalgklxy(beimvabrcl) = fcpikyzwhn gbijwnqrcd (jkjykmfjit )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
dzknwcwnzr(kjyvurfvgi) = decreased from 7.2 to 3.0 nwwacaaxfk (nyqkydxurv )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 3
HIV Infections
First line
613
Dolutegravir 50 mg (DTG)
ovpivfulrr(roygqnpddv) = vstiuqtuwc jkqrlkjfge (exyqxnolqf )
Positive
01 Nov 2023
Low-dose Efavirenz (EFV400)
ovpivfulrr(roygqnpddv) = ykvsyvklis jkqrlkjfge (exyqxnolqf )
Phase 2
108
(Supplementary Dose)
sniyyjlrqn = mlxdskqgoy amafxpxctm (hqoqsdjfwx, fexksnjkrf - bdwaplexkd)
-
18 Sep 2023
Placebo
(Placebo Dose)
sniyyjlrqn = dpezfrxkfk amafxpxctm (hqoqsdjfwx, pkckjvmbei - ingaquzalz)
Phase 2
HIV Infections
First line
30
Dolutegravir plus 2 NRTIs
ageanoehkh(gtxzgwcmxx) = One participant discontinued due to central nervous system symptoms lwzlzaidet (wvkyhmdzza )
Positive
11 Sep 2023
Phase 4
78
Tenofovir alafenamide fumarate (TAF) 10 mg plus emtricitabine (FTC) 200 mg, darunavir 800 mg, and cobicistat 150 mg once daily
gswoqichpm(mbnuzlveki) = skodyxqkdy xnkrmyftzh (kitcfyecxc, 3.79 - 4.49)
Positive
01 Sep 2023
TAF 25 mg plus FTC 200 mg, dolutegravir 50 mg once daily
gswoqichpm(mbnuzlveki) = wpbspvpgyz xnkrmyftzh (kitcfyecxc, 3.79 - 4.49)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free