Drugs / Fostemsavir
Fostemsavir
English name fostemsavir
also known as
BMS-663068 · FTR · GSK3684934 · Rukobia · Bms-663068 free acid · BMS-663068 TROMETHAMINE · BMS-663068-03 · Fostemsavir trometamol · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Rukobia | — | 2021-02-04 | europa.eu ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07053384 | Jul 2025 → Jan 2027 expected | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04757974 | Mar → Jul 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02859259 | Aug 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02805556 | Mar → May 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02674581 | Feb → May 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02666053 | Jan → Feb 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02666001 | Jan → Jun 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02508064 | Aug → Nov 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02480894 | Jul → Sep 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02480881 | Jul 2015 → Jan 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02277600 | Nov 2014 → Jan 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02234882 | Sep → Oct 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02164045 | Jun → Jul 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02138084 | May → Jul 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02063360 | Feb → May 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04648280 | Jun 2022 → Dec 2028 expected | — | PENTA Foundation | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07030920 | Sep 2025 → Oct 2028 expected | HIV infectious disease | University of Montreal Hospital Centre (CHUM) | Recruiting | No outcome recorded |
| Phase 2 | NCT01384734 | Jul 2011 → Feb 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT01009814 | Nov 2009 → Jun 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07393659 | May 2026 → Dec 2030 expected | HIV infectious disease | ViiV Healthcare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02362503 | Feb 2015 → Aug 2016 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05220358 | Jun 2022 → Feb 2026 overdue | HIV infectious disease | Orlando Immunology Center | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04233047 | — | HIV infectious disease | ViiV Healthcare | Available | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02467335 Comparator | Jan → Oct 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fostemsavir | “Fostemsavir (BMS-663068/GSK3684934)” NCT02362503 ↗ |
| Known as | BMS-663068 | “Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are...” NCT04233047 ↗ |
| Known as | Bms-663068 free acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | BMS-663068 TROMETHAMINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | BMS-663068-03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | Fostemsavir trometamol | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | FOSTEMSAVIR TROMETHAMINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | FTR | “relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR” NCT04757974 ↗2“In July 2020 the FDA approved fostemsavir (FTR), a prodrug of its active moiety temsavir” NCT05220358 ↗ “Fostemsavir (FTR)” NCT07053384 ↗ |
| Known as | GSK-3684934A | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301594 ↗ |
| Known as | GSK3684934 | “Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are...” NCT04233047 ↗1“Fostemsavir (BMS-663068/GSK3684934)” NCT02362503 ↗ |
| Known as | Rukobia | “The intervention will be either the addition of fostemsavir (Rukobia 600 mg daily) to the patient's current ART regimen, or the participant receiving the standard of care.” NCT07030920 ↗1“Fostemsavir 600 MG [Rukobia]” NCT05220358 ↗ |
| Action | Inhibit | “blocking initial viral attachment and entry into host CD4+ T-cells” PMID 27922453 ↗ Dec 2016 |
| Modality | Other / unclassified | “a first-in-class attachment inhibitor” PMID 35315687 ↗ Mar 2022 |
| Route | Oral | “BMS-663068, an oral HIV-1 attachment inhibitor” PMID 22896665 ↗ Aug 2012 |