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
| 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 | NCT02480881 | Jul 2015 → Jan 2016 | 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 | 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02467335 Comparator | Jan → Oct 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
Fostemsavir CD4 T-cell, CD4/CD8 ratio improvement and a general reduction in inflammatory biomarkers with low-level viremia (LLV) up to Week 192 with fostemsavir (FTR)-based regimens in individuals with multidrug-resistant (MDR) HIV-1 |
| 2024-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024 gsk.com ↗
CD4 T-cell, CD4/CD8 Ratio Improvement and a General Reduction in Inflammatory Biomarkers with Low-Level Viremia (LLV) up to Week 192 with Fostemsavir (FTR)-Based Regimens in Individuals with Multidrug-Resistant (MDR) HIV-1 |
| 2024-02-28 | GlaxoSmithKline | Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
Temsavir treatment enhances bNAb recognition and subsequent clearance of HIV-1 infected cells |
| 2023-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023 gsk.com ↗
Durable efficacy and robust CD4+ T-cell count improvement observed among age, race, sex, and geographic subgroups of heavily treatment-experienced people with multidrug-resistant HIV-1 after 240 weeks of fostemsavir treatment |
| 2022-07-29 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS POSITIVE FIVE-YEAR DATA AT AIDS 2022, DEMONSTRATING THE DURABILITY OF FOSTEMSAVIR IN PEOPLE LIVING WITH HIV WHO ARE HEAVILY TREATMENT-EXPERIENCED viivhealthcare.com ↗
Study findings showed that people living with multidrug-resistant HIV-1 treated for approximately five years with fostemsavir-based regimens experienced durable virologic responses and continued clinically meaningful improvements in CD4+ cell count and CD4+/CD8+ ratio. |
| 2021-02-08 | GlaxoSmithKline | Regulatory ViiV Healthcare receives Marketing Authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV gsk.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the European Marketing Authorisation of Rukobia (fostemsavir) 600mg extended-release tablets, for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. |
| 2021-02-08 | ViiV Healthcare | Regulatory ViiV Healthcare receives Marketing Authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV viivhealthcare.com ↗ |
| 2020-12-11 | GlaxoSmithKline | Regulatory ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available gsk.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Rukobia (fostemsavir) 600 mg extended-release tablets, a novel attachment inhibitor for the treatment of HIV-1 infection. |
| 2020-12-11 | ViiV Healthcare | Regulatory ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available viivhealthcare.com ↗
today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Rukobia (fostemsavir) 600 mg extended-release tablets, a novel attachment inhibitor for the treatment of HIV-1 infection. |
| 2020-07-02 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available gsk.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. |
| 2020-07-02 | ViiV Healthcare | Regulatory ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available viivhealthcare.com ↗
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. |
| 2020-01-10 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available gsk.com ↗ |
| 2020-01-10 | ViiV Healthcare | Regulatory ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available viivhealthcare.com ↗
today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of fostemsavir |
| 2019-12-05 | GlaxoSmithKline | Regulatory ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available gsk.com ↗
today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir |
| 2019-12-05 | ViiV Healthcare | Regulatory ViiV Healthcare submits New Drug Application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available viivhealthcare.com ↗ |
| 2019-07-22 | GlaxoSmithKline | Results ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019 gsk.com ↗
In the randomised cohort, rates of virologic suppression and immunologic response increased from Week 48 to Week 96 in this difficult-to-treat population with multidrug resistant HIV-1. |
| 2019-07-22 | ViiV Healthcare | Results ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019 viivhealthcare.com ↗
In the randomised cohort, rates of virologic suppression and immunologic response increased from Week 48 to Week 96 in this difficult-to-treat population with multidrug resistant HIV-1. |
| 2018-10-31 | GlaxoSmithKline | Results ViiV Healthcare announces positive phase 3 results from the BRIGHTE study of fostemsavir at 48 weeks in heavily treatment-experienced patients with HIV gsk.com ↗
ViiV Healthcare today announced 48-week results from the phase III BRIGHTE study of investigational fostemsavir in heavily treatment-experienced (HTE) patients with HIV-1 infection. |
| 2017-10-27 | GlaxoSmithKline | Results ViiV Healthcare announces positive phase 3 results from the BRIGHTE study of fostemsavir in heavily treatment-experienced patients with HIV gsk.com ↗
54% of patients in the randomised cohort achieved virologic suppression (<40 c/mL) at 24 weeks of treatment with fostemsavir plus optimised background therapy. |
| 2015-07-21 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for Investigational HIV-1 Attachment Inhibitor for Heavily Treatment-Experienced Patients bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. |
| 2015-02-25 | Bristol-Myers Squibb | Results 48-Week Analysis of Investigational HIV-1 Attachment Inhibitor Paves Way for Phase III Trial Initiation bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. |
| 2014-03-05 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Presents Promising Phase IIb Data for Novel, Investigational Attachment Inhibitor for HIV-1 Infected Treatment-Experienced Patients bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today presented 24-week Phase IIb data that demonstrated similar response rates (HIV-1 RNA < 50 c/mL) for its investigational compound, BMS-663068, when compared to a boosted protease inhibitor, Reyataz ® (atazanavir sulfate) with ritonavir. |
| 2011-02-28 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Posts New Data on Pharmacodynamics, Safety, and Pharmacokinetics of Investigational Compound BMS-663068 for the Treatment of HIV-1 Infection bms.com ↗
The data were presented today at the 18 th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. |
All press releases naming this drug 23 releases
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 ↗17“Fostemsavir (BMS-663068/GSK3684934)” NCT02362503 ↗ |
| 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 |