[{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA approves ViiV Healthcare\u2019s Tivicay to treat HIV in children","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Gets FDA Approval of an Expanded Indication for Dovato (dolutegravir\/lamivudine)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Viatris","sponsor":"Clinton Health Access Initiative","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Groundbreaking Agreement Reduces by 75% the Cost of HIV Treatment for Children in Low-and Middle-Income Countries","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Viatris","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Receives EU Marketing Authorisation for the First-Ever Dispersible-Tablet Formulation of Dolutegravir, Tivicay","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Tentative U.S. FDA Approval for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets under PEPFAR","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Presents Data From Second Dovato (dolutegravir\/lamivudine) Switch Study","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare To Present Key Data that Provides Further Support for The Use of 2-Drug Regimens, Including Long-Term Efficacy, Alongside New Insights Into Living With HIV at IDWeek 2021","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Presents Three-Year Switch Data for Dovato (dolutegravir\/lamivudine) Confirming Long-Term, Non-Inferior Efficacy with No Virologic Failure versus Continuation of Taf-Based Regimens of At Least Three Drugs","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Submits FDA Application for First Dispersible Single Tablet Regimen Containing Dolutegravir (DTG) For Children Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare to Present New Long-term Findings From its Innovative 2-Drug and Long-acting Hiv Medicines Portfolio at CROI 2022","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Viiv Healthcare Announces US FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-daily Treatment for Children Living With HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Announces U.S.FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-daily Treatment for Children Living With HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare to Present New Data From Innovative HIV treatment and Prevention Portfolio at AIDS 2022","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir and Rilpivirine Tablets","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Tentative Approval From U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Gets US FDA Tentative Approval for Dolutegravir Tablets for Oral Suspension","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Viatris","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)\/Dolutegravir (DTG)\/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"AIDS Healthcare Foundation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AHF Praises Colombia's Stand for Accessible HIV Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ACTG","sponsor":"ViiV Healthcare","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ACTG Announces Launch of Clinical Trial Evaluating Drug-Drug Interaction in Shortened Tuberculosis Regimen Among People Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Strides Receives Tentative USFDA Approval for Dolutegravir Tablets","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Strides Pharma Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Strides Receives Tentative USFDA Approval for Dolutegravir\/ Lamivudine\/Tenofovir Disproxil Fumurate Tablets","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Dolutegravir
USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.
USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.
Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for the treatment of HIV-associated tuberculosis.
Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.
Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcriptase.
Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.
Dovato (dolutegravir sodium), is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen.
In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs.