Fostemsavir

Phase 3Small molecule

GSK

Fostemsavir is one of 112 small molecule programs targeting Immunodeficiency. It is currently in Phase 3.

Indications

Total Trials

Active Trials

111

Competitors

Pipeline

Status by Indication[3][1]

Indication

ImmunodeficiencyActive, not recruiting

HIV InfectionsRecruiting

Systemic InflammationRecruiting

AdolescentActive, not recruiting

HIVActive, not recruiting

ImmunodeficiencyPreclinical

Active, not recruiting

HIV InfectionsPhase 3

Recruiting

Systemic InflammationPhase 2

Recruiting

AdolescentPhase 2

Active, not recruiting

HIVPhase 3

Active, not recruiting

Competition

Competitive Landscape

53 competitors in Immunodeficiency

#DrugCompanyPhaseTrials

Fuzeon

CConrado Roberto Hoffmann Filho

Approved

7 2

Adenocard

Busulfex

1 4

Rayos

RRoxane Laboratories

Approved

1 5

Viramune

Boehringer Ingelheim

Approved

1 6

Cabenuva

GSK

Phase 3

5 7

Edurant Ped

WWim Janssens

Phase 3

8 8

B/F/TAF

Gilead

Phase 3

7 9

Immunoglobulin

Sanofi

Phase 3

2 10

Cellcept

Roche

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 1Active, not recruiting

HIV Infections

NCT07053384

Q4 2028

Phase 1/2Active, not recruiting

Adolescent

NCT04648280

Q1 2029

Phase 2Recruiting

Systemic Inflammation

NCT07030920

Q3 2032

Phase 3Recruiting

HIV Infections

NCT07393659

Clinical

Trials by Indication[1]

HIV Infections2 trials

A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment

Recruiting· GSK logo

GSK·Phase 3·NCT07393659·181 enrolled

An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1

Active, not recruiting· GSK logo

GSK·Phase 1·NCT07053384·130 enrolled

Adolescent1 trial

Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance

Active, not recruiting·PPENTA Foundation·Phase 1/2·NCT04648280·60 enrolled

Immunodeficiency1 trial

Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)

Available· GSK logo

GSK··NCT04233047

HIV1 trial

Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study

Active, not recruiting·OOrlando Immunology Center·Phase 4·NCT05220358·25 enrolled

Systemic Inflammation1 trial

Reducing Systemic Inflammation in People on Antiretroviral Therapy

Recruiting·—·Phase 2·NCT07030920·150 enrolled

1 more indication

Unspecified1 trial

Low-dose Fostemsavir Extended Release Relative Bioavailability Study

Completed· GSK logo

GSK·Phase 1·NCT04757974·32 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Fostemsavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fostemsavir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fostemsavir. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GSK

Fostemsavir

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q4 2028

Q1 2029

Q3 2032

Trials by Indication[1]

HIV Infections2 trials

Adolescent1 trial

Immunodeficiency1 trial

HIV1 trial

Systemic Inflammation1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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