FUZEON
LOE ApproachingNDASUBCUTANEOUSINJECTABLEPriority Review
Approved
Mar 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FUZEON (enfuvirtide) is a fusion inhibitor subcutaneous injection approved in 2003 for HIV infection and AIDS. It works by blocking HIV's ability to fuse with and enter CD4+ T cells, representing a novel mechanism in antiretroviral therapy. Administered via subcutaneous injection, it is typically reserved for treatment-experienced patients with HIV resistant to other antiretrovirals.
$0.001BPart D
LOE ApproachingDeclining
Minimal commercial activity with only 258 Part D claims in 2023 indicates a heavily contracted franchise nearing end-of-life with likely small, defensive team focus.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules
Started Jun 2009
4 enrolled
HIV1 InfectionHIV Infections
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.
Started Jan 2008
29 enrolled
HIV Infections
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
Started Jun 2007
29 enrolled
HIV Infections
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Started Apr 2007
0HIV Infections
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
Started Jun 2006
326 enrolled
HIV Infections
Worked on FUZEON at Roche? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.