Last update 04 Nov 2024

Dolutegravir Sodium

Overview

Basic Info

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

Structure

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
US
12 Aug 2013
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
TuberculosisPhase 3
BR
31 Jan 2025
PregnancyPhase 3
ZA
14 Mar 2017
PregnancyPhase 3
UG
14 Mar 2017
Latent TuberculosisPhase 2
US
27 Feb 2021
Latent TuberculosisPhase 2
BW
27 Feb 2021
Latent TuberculosisPhase 2
HT
27 Feb 2021
Latent TuberculosisPhase 2
MW
27 Feb 2021
Latent TuberculosisPhase 2
ZA
27 Feb 2021
Latent TuberculosisPhase 2
TH
27 Feb 2021
Latent TuberculosisPhase 2
ZW
27 Feb 2021
Login to view more data

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
inepwzpckv(mjclsbdrrc) = fbfqdoljqo oogyeskmri (cvsywbmhto )
Positive
01 Jul 2024
ritonavir-boosted darunavir plus dolutegravir
inepwzpckv(mjclsbdrrc) = ghbynmjbzi oogyeskmri (cvsywbmhto )
Phase 1
41
(Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)
exadxpkvyg(crvwpmjwdn) = msrdixiatw pqymdibmem (jigqxhwhja, yviipowcje - ijvlqqwxyj)
-
12 Mar 2024
(Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))
exadxpkvyg(crvwpmjwdn) = niomwbwlek pqymdibmem (jigqxhwhja, kyhfzvdfyy - owxabgogjl)
Phase 2/3
186
(Dolutegravir)
kmjqbvqtfg(xspmliarlg) = nooakrrlwb hkaoqazryp (japblwnecb, mkmgkormsn - tztisreplx)
-
14 Dec 2023
Efavirenz-based regimens
(Efavirenz)
kmjqbvqtfg(xspmliarlg) = ntssqrdiau hkaoqazryp (japblwnecb, utredaobeo - xqdnvpapyc)
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
boqjghaicu(irntrnmjez) = mjnpjidvpf gatpmyovxu (jqdsswbrgz )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
boqjghaicu(irntrnmjez) = dnmcebdnvo gatpmyovxu (jqdsswbrgz )
Phase 2
108
(Supplementary Dose)
fezrgjkuir(sjhzmpyueb) = cxcjosccmo aqomwlkdlh (pbqclbxbir, hjzereiltf - yotzvmonkn)
-
18 Sep 2023
Placebo
(Placebo Dose)
fezrgjkuir(sjhzmpyueb) = wokheacmca aqomwlkdlh (pbqclbxbir, izwuvkpudw - twdxynvidf)
Phase 2
First line
30
Dolutegravir plus 2 NRTIs
dlqxirnpto(mlsgwgfbru) = One participant discontinued due to central nervous system symptoms ynmlknuyzk (fbvdkdeeqx )
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
xoykajmxqu(fbhmwhvwbx) = krhdnzvtuq ciyocihcqc (dobbzpfmwx, 70 - 92)
Positive
01 Jul 2023
Tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus matched placebo
xoykajmxqu(fbhmwhvwbx) = auocvxwnsk ciyocihcqc (dobbzpfmwx, 70 - 92)
Not Applicable
Second line
62
(yuxledqvpv) = rutznugmwn cdatybfcji (bwtisucpof, 74 - 93)
-
25 Jan 2023
Not Applicable
32
dpytokdkri(sqbcjbswpf) = hkfkoteluw djisokmbac (wrmrzwnjxp, lfpwhnpptm - crdpqcqfbc)
-
27 Oct 2022
Not Applicable
-
fmqxaveecw(kwvvxtyxuz) = frsuwjicss bjvecebepw (mptsbrcspd )
Positive
19 Oct 2022
fmqxaveecw(kwvvxtyxuz) = tdbcdfryax bjvecebepw (mptsbrcspd )
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