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Rukobia (FOSTEMSAVIR)
Rukobia works by blocking the potassium voltage-gated channel subfamily H member 2, which is involved in the replication of the human immunodeficiency virus 1.
At a glance
| Generic name | FOSTEMSAVIR |
|---|---|
| Sponsor | GSK |
| Target | Potassium voltage-gated channel subfamily H member 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
RUKOBIA is an HIV-1 antiretroviral agent [see Microbiology (12.4)].
Approved indications
- Human immunodeficiency virus I infection
Common side effects
- Nausea
- Diarrhea
- Headache
- Abdominal pain
- Dyspepsia
- Fatigue
- Rash
- Sleep disturbance
- Immune Reconstitution Inflammatory Syndrome
- Somnolence
- Vomiting
- ALT (>5.0 ULN)
Key clinical trials
- A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV (PHASE1)
- 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 (PHASE1,PHASE2)
- A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment (PHASE3)
- Reducing Systemic Inflammation in People on Antiretroviral Therapy (PHASE2)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
- Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients (PHASE3)
- Changes in Immunologic Parameters Following the Addition of Fostemsavir in Virologically Suppressed Immunologic Non-responders Living With HIV-the RECOVER Study (PHASE4)
- Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rukobia CI brief — competitive landscape report
- Rukobia updates RSS · CI watch RSS
- GSK portfolio CI