drugset
Drugs / Delstrigo
last change Jun 2026 re-read 3 minutes ago

Delstrigo

Developed for
HIV infectious disease
Investigated by
Africa Health Research Institute · Merck Sharp & Dohme LLC · Professor Francois Venter

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Delstrigo — 2018-11-22 europa.eu ↗
Approved US (FDA) DELSTRIGO — 2018-08-30 fda.gov ↗

Trials 1

today
US approved 2018
EU approved 2018
NCT05924438 · Ph 3
20192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT05924438 Nov 2023 → Jun 2026 overdue HIV infectious disease Professor Francois Venter Active not recruiting No outcome recorded

Press releases naming this drug 7 releases

DateIssuerRelease
2019-09-20 Merck Sharp & Dohme LLC Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed merck.com ↗
2019-01-22 Merck Sharp & Dohme LLC U.S. FDA Accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) merck.com ↗
2018-11-28 Merck Sharp & Dohme LLC European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in… merck.com ↗
2018-10-04 Merck Sharp & Dohme LLC Merck’s HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens merck.com ↗
2018-10-04 Merck Sharp & Dohme LLC Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-AHEAD Study Evaluating DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Treatment-Naïve Patients merck.com ↗
2018-09-20 Merck Sharp & Dohme LLC Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection merck.com ↗
2018-08-30 Merck Sharp & Dohme LLC FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients merck.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Delstrigo ClinicalTrials.gov intervention name — accepted as the source's own label NCT05924438 ↗
Route Oral “Treatment Group 1 Participants will receive Doravirine, as part of a fixed-dose oral combination with lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF,...” NCT05924438 ↗