Tivicay
(Dolutegravir)ApprovedSmall molecule
GSKDolutegravir is used to treat HIV infection by helping to stop the virus from multiplying in the body, usually taken as part of a combination therapy with other HIV medications.[2] Tivicay is currently approved and in use across 16 indications[4].[1]
Tivicay is one of 418 small molecule programs targeting AIDS. It is currently in Approved.
16
Indications
155
Total Trials
20
Active Trials
417
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
1
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 16 indications
Competition
Competitive Landscape
326 competitors in HIV Infection
#DrugCompanyPhaseTrials
1Tivicay
GSKApproved
Leukine
SanofiPhase 3
Intron a
Merck & Co.Phase 3
Sunlenca
GileadPhase 3
Hivid
CConrado Roberto Hoffmann Filho
Phase 3
Praluent
RegeneronPhase 3
Betaseron
BayerPhase 3
Megace
Bristol-Myers SquibbPhase 3
Proleukin
IIovance Biotherapeutics, Inc.
Phase 3
Foscavir
NNational Institute of Allergy and Infectious Diseases (NIAID)
Phase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Treatment11 trials
Show 8 more trials
Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients
Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT02582684·122 enrolled
Immunodeficiency7 trials
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Interaction7 trials
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HIV infection6 trials
HIV-16 trials
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A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05406583·48 enrolled
70 more indications
Pilot Study4 trials
Tuberculosis4 trials
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A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT07124559·144 enrolled
LAM4 trials
REal-Life Cohort With DOlutegravir + LAmivudina
Completed·IInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz··NCT04638686·185 enrolled
Itching3 trials
Efficacy and Safety3 trials
EFFICACY AND SAFETY OF A SIMPLIFICATION STRATEGY BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS OPTIMIZED TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS CARRYING ARCHIVED MULTIDRUG RESISTANCE MUTATIONS
Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT03683524·96 enrolled
Children3 trials
Adult Subject3 trials
Antiretroviral Treatment3 trials
Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
Unknown status·IInstituto de Investigación Hospital Universitario La Paz·Phase 2·NCT03539224·41 enrolled
HIV3 trials
Drug3 trials
Tics3 trials
Trial3 trials
Resistance2 trials
Amyotrophic Lateral Sclerosis2 trials
Toxicity2 trials
Efficacy2 trials
HIV-1 infection2 trials
ESS2 trials
Drug Interactions2 trials
Pregnancy2 trials
Hepatic Impairment2 trials
Pediatric2 trials
TED2 trials
ISS1 trial
HIV-Infected Individuals1 trial
PLWH1 trial
Metabolic Disease1 trial
Imaging1 trial
Observational Study1 trial
ART1 trial
Tenofovir1 trial
Women1 trial
Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
Completed·—··NCT03336346·148 enrolled
Contraception1 trial
Infants1 trial
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
Completed·—··NCT04862975·164 enrolled
Remission1 trial
Gastrointestinal1 trial
Advanced1 trial
End-Stage Renal Disease1 trial
First-line1 trial
Prevention1 trial
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Recruiting·—·Phase 1·NCT06281834·25 enrolled
Treatment Failure1 trial
Single Dose1 trial
Cardiovascular Disease1 trial
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
Completed·—·Phase 4·NCT04340388·10 enrolled
Neurocognitive Dysfunction1 trial
Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT02519777·191 enrolled
Solid Organ Transplant1 trial
Randomised Controlled Trial1 trial
Low Bone Mineral Density1 trial
Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Protease Inhibitors To Dolutegravir In HIV-1-Infected Subjects With Low Bone Mineral Density
Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 3·NCT01966822·75 enrolled
Effectiveness1 trial
Prophylaxis1 trial
Insulin Sensitivity1 trial
Pulmonary Tuberculosis1 trial
Monotherapy1 trial
Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients
Terminated·—·Phase 3·NCT02596334·158 enrolled
Prospective1 trial
Gut Microbiota1 trial
Gut Microbiota, PGx and INSTIs Response
Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain··NCT04805944·180 enrolled
Cardiovascular1 trial
Central Nervous System1 trial
Weight Gain1 trial
Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study
Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05652478·120 enrolled
Unspecified11 trials
Show 8 more trials
Regulatory
FDA Approval Timeline[5]
Jun 9, 2016
TIVICAY
NDA NDA204790
Jun 12, 2020
TIVICAY PD
NDA NDA213983
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Tivicay drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Dolutegravir. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]