Drugs / Triumeq

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Triumeq — 2014-08-31 europa.eu ↗
Approved US (FDA) TRIUMEQ — 2014-08-22 fda.gov ↗

Trials 1

today
US approved 2014
EU approved 2014
NCT02354053 · Ph 4
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 41 trial
Phase 4 NCT02354053 Nov 2015 → Jul 2018 HIV infectious disease McGill University Health Centre/Research Institute of the McGill University Health Centre Completed No outcome recorded
Comparator or background therapy1 trial
Phase 4 NCT02924389 Background Sep 2016 → Sep 2019 HIV infectious disease Emory University Terminated No outcome recorded Stop: Enrollment

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2022-03-30 ViiV Healthcare Regulatory 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 viivhealthcare.com ↗
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.
2021-10-04 ViiV Healthcare Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗
2019-03-07 ViiV Healthcare Results ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5).

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Triumeq ClinicalTrials.gov intervention name — accepted as the source's own label NCT02354053 ↗
1

NCT02924389 ↗

Route Oral “Triumeq will be taken orally once daily.” NCT02924389 ↗