Drugs / FIPRAVIRIMAT
last change Oct 2025 re-read 9 days ago

FIPRAVIRIMAT

Small molecule

Developed for
HIV infectious disease
Investigated by
ViiV Healthcare · GlaxoSmithKline · Syneos Health

Trials 15

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 112 trials
Phase 1 NCT04857892 Apr → Sep 2021 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04425902 Dec 2020 → Mar 2021 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04563845 Nov 2020 → Oct 2021 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04630002 Oct 2020 → Oct 2021 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04507321 Sep → Nov 2020 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04263142 Jan → Mar 2020 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT04128293 Oct → Nov 2019 HIV infectious disease ViiV Healthcare Terminated No outcome recorded
Phase 1 NCT03984825 Jun → Aug 2019 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT03836729 Feb → Mar 2019 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT03816696 Jan → Mar 2019 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 23 trials
Phase 2 NCT04900038 Aug 2021 → Nov 2022 HIV infectious disease ViiV Healthcare Terminated No outcome recorded Stop: Business
Phase 2 NCT04493216 Nov 2020 → Sep 2022 HIV infectious disease ViiV Healthcare Terminated No outcome recorded Stop: Business
Phase 2 NCT03784079 Jan 2019 → Feb 2020 HIV infectious disease ViiV Healthcare Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2024-02-28 GlaxoSmithKline Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
Next-generation maturation inhibitor GSK3640254 showed broad spectrum potency without MI resistance
2021-03-09 GlaxoSmithKline Results ViiV Healthcare presents positive proof-of-concept findings for GSK3640254, a novel, investigational maturation inhibitor for the treatment of HIV gsk.com ↗
The study showed the antiviral activity of GSK’254, establishing a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA.
2021-03-09 ViiV Healthcare Results ViiV Healthcare presents positive proof-of-concept findings for GSK3640254, a novel, investigational maturation inhibitor for the treatment of HIV viivhealthcare.com ↗
The study showed the antiviral activity of GSK’254, establishing a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA.

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as FIPRAVIRIMAT ChEMBL registry synonym — accepted as the source's own label CHEMBL5201510 ↗
Known as [14C]-GSK3640254 “\[14C\]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.” NCT04507321 ↗
Known as FIPRAVIRIMAT MESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL5201510 ↗
Known as GSK'254 “The DYNAMIC study evaluated the efficacy and safety of the maturation inhibitor GSK3640254 (GSK'254) plus dolutegravir (DTG) in adults naive to antiretroviral therapy.” PMID 41357331 ↗ Oct 2025
2

“GSK3640254 (GSK'254) is a next-generation human immunodeficiency virus type 1 (HIV-1) maturation inhibitor with pharmacokinetics (PK) supporting once-daily therapy.” PMID 34996113 ↗ Sep 2022

“GSK3640254 (GSK'254) is a novel HIV-1 maturation inhibitor” PMID 37961928 ↗ Dec 2023

Known as GSK-3640254A ChEMBL registry synonym — accepted as the source's own label CHEMBL5201510 ↗
Known as GSK-3640254D ChEMBL registry synonym — accepted as the source's own label CHEMBL5201510 ↗
Known as GSK3640254 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04493216 ↗
14

NCT03836729 ↗

NCT04900038 ↗

NCT03575962 ↗

NCT04128293 ↗

NCT04630002 ↗

NCT03784079 ↗

NCT04263142 ↗

NCT04507321 ↗

NCT03984825 ↗

NCT04425902 ↗

Show 4 more sources

Known as GSK3640254 mesylate “This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and...” NCT04128293 ↗
Known as GSK3640254/DTG ClinicalTrials.gov intervention name — accepted as the source's own label NCT04857892 ↗
Action Inhibit “GSK3640254 is a next-generation maturation inhibitor” PMID 34995417 ↗ Jan 2022
Modality Small molecule — CHEMBL5201510 ↗
Route Oral “GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.” NCT03231943 ↗