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Drug

Dolutegravir

Approved · EMA
Emerging researchLate-stage development

Also known as Dovato, Juluca, Tivicay, Triumeq.

RxNorm1433868ChEMBLCHEMBL1229211UNIIDKO1W9H7M1
3
Research papers
14
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir

Clinical trial2026-07-21Primary completion · ClinicalTrials.gov

Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Clinical trial2026-06-17Results expected Q1 2028 · ClinicalTrials.gov

Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

Clinical trial2026-06-12Results expected Q1 2028 · ClinicalTrials.gov

Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.

Clinical trial2026-06-02Results expected Q2 2028 · ClinicalTrials.gov

Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Use of Antiretrovirals

Clinical trial2026-06-01Results expected Q1 2027 · ClinicalTrials.gov

Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial.

Research2022-09-01The lancet. HIV

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.

Research2021-12-01The New England journal of medicine

Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial.

Research2021-04-01Lancet (London, England)

Drug Safety Update: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects

Regulatory2020-10-22MHRA

Drug Safety Update: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception

Regulatory2018-06-22MHRA

Approval: Tivicay (EMA)

Regulatory2014-01-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dolutegravir
Aliases & brands
DovatoJulucaTivicayTriumeq
RxNorm CUI
1433868
ChEMBL ID
CHEMBL1229211
UNII
DKO1W9H7M1
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-01-16
Latest approval
2014-01-16
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2014-01-16Approval
Approval: Tivicay (EMA)
Indication: Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children… Show full indication

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2020-10-22Safety communicationSafety
Drug Safety Update: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects
Evidence ↗
2018-06-22Safety communicationSafety
Drug Safety Update: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

96 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
96
registered trials across all phases
LATEST COMPLETION 2024
14
Active studies
10
Recruiting
50
Late-stage (III+)
62
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 96
Early Phase 11Phase 123Phase 1 / 25Phase 217Phase 2 / 33Phase 319Phase 423Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Doravirine Dose Optimisation in Pregnancy

RecruitingPH IVUniversity of Liverpooln=762028

Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection

Active, not recruitingPH IVUniversity of California, San Franciscon=742028

Effect of Dolutegravir + Tenofovir Disoproxil Fumarato/Emtricitabina Compared With Darunavir/Cobicistat + Tenofovir Disoproxil/Fumarato /Emtricitabina on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults With HIV-1 Infection

Not yet recruitingPH IVInstituto Mexicano del Seguro Socialn=1402026

An Open-label, Sequential Non-randomised Pharmacokinetics Study of DTG Plasma Exposure When Given as Twice or Once Daily DTG in the Presence of Rifampicin in Children With HIV and TB Between 20-35kgs in SA

Unknown statusPH IVUniversity of KwaZulun=202025

Contraceptives and Dolutegravir-based ART

Unknown statusPH IVBotswana Harvard AIDS Institute Partnershipn=1402024

Recent completions

Trials that read out recently, adding to the completed evidence base.

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

CompletedPH IVHelen Reynoldsn=362024

Body Composition Sub-study of the D2EFT Trial

CompletedPH IVKirby Instituten=1552024

The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

CompletedPH IChelsea and Westminster NHS Foundation Trustn=162024

A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line ART

CompletedPH II/IIIPENTA Foundationn=7922023

Dolutegravir in Pregnant HIV Mothers and Their Neonates

CompletedPH IIIUniversity of Liverpooln=2682023

HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

CompletedPH INational Institute of Neurological Disorders and Stroke (NINDS)n=1222023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20212022
Major research themes3
Anti-HIV Agents1HIV Infections1HIV-11
Journals, researchers & institutions
Top journals
  • Lancet (London, England)1
  • The lancet. HIV1
  • The New England journal of medicine1
Leading researchers
  • Ali S2
  • Amuge P2
  • Archary M2
  • Atwine L2
  • Bbuye D2
  • Ford D2
  • Giaquinto C2
  • Gibb DM2
Leading institutions
free-text, unnormalised
  • University of the Witwatersrand2
  • Baylor College of Medicine Children's Foundation1
  • Baylor College of Medicine Children's Foundation-Uganda1
  • Brigham and Women's Hospital1
  • Center for Biostatistics in AIDS Research1
  • Centre for the AIDS Programme of Research in South Africa1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.