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Fuzeon

(Enfuvirtide)

ApprovedPeptide

CConrado Roberto Hoffmann Filho

Enfuvirtide is used to treat HIV infection by blocking the virus from entering and infecting CD4 cells, which are important immune cells. It is typically used in combination with other HIV medications, especially for patients whose virus has become resistant to other drugs.[2] Fuzeon is currently approved and in use across 6 indications[4].[1]

Fuzeon is one of 199 small molecule programs targeting AIDS. It is currently in Approved.

6

Indications

30

Total Trials

0

Active Trials

198

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AIDSApproved

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

EncephalopathyActive, not recruiting

ImmunodeficiencyActive, not recruiting

AIDSApproved

Approved

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

EncephalopathyPhase 2

Active, not recruiting

ImmunodeficiencyApproved

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Fuzeon

CConrado Roberto Hoffmann Filho

Sunlenca

Hivid

CConrado Roberto Hoffmann Filho

Praluent

Betaseron

PEG-Intron

Megace

Bristol-Myers Squibb

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Buprenorphine/naloxone

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

Clinical

Trials by Indication[1]

Immunodeficiency7 trials

QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

Completed· Roche logo

Roche·Phase 4·NCT00232908·361 enrolled

A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Completed· Roche logo

Roche·Phase 2·NCT00089492·64 enrolled

A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 2·NCT00128830·211 enrolled

Show 4 more trials

A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection

Completed· Roche logo

Roche·Phase 4·NCT02569502·6 enrolled

A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience

Completed· Roche logo

Roche·Phase 4·NCT00487188·47 enrolled

A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

Completed· Roche logo

Roche·Phase 4·NCT02582983·23 enrolled

Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

Completed· Roche logo

Roche·Phase 3·NCT02733419·84 enrolled

Treatment4 trials

BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

Completed· Roche logo

Roche·Phase 4·NCT00326963·142 enrolled

A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

Terminated· Roche logo

Roche·Phase 4·NCT00488059·29 enrolled

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00537394·517 enrolled

Show 1 more trial

Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00051831·19 enrolled

Adult3 trials

A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

Completed· Roche logo

Roche·Phase 2·NCT00002239·68 enrolled

Study of Valproic Acid to Treat HIV Infected Adults

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT00312546·14 enrolled

A Study of T-20 in HIV-Positive Adults

Completed·TTrimeris·Phase 2·NCT00002228·78 enrolled

HIV2 trials

WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

Completed· Roche logo

Roche·Phase 4·NCT00233883·58 enrolled

Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00302822·195 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT01836068·11 enrolled

13 more indications

Drug1 trial

Adding New Drugs for HIV Infected Patients Failing Current Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00031044·50 enrolled

Efficacy1 trial

A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00344760·2 enrolled

HIV-11 trial

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.

Completed· Roche logo

Roche·Phase 2·NCT00615134·29 enrolled

HIV infection1 trial

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Completed·KKirby Institute·Phase 4·NCT00192660·80 enrolled

AIN1 trial

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.

Withdrawn· Roche logo

Roche·Phase 4·NCT00461266

HIV-1 infection1 trial

BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

Completed· Roche logo

Roche·Phase 4·NCT00337701·326 enrolled

Children1 trial

Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001118·24 enrolled

Adolescent1 trial

T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

Completed· Roche logo

Roche·Phase 2·NCT00022763·52 enrolled

Combination Therapy1 trial

T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs

Completed· Roche logo

Roche·Phase 3·NCT00008528·525 enrolled

Resistance1 trial

T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs

Completed· Roche logo

Roche·Phase 3·NCT00021554·525 enrolled

Encephalopathy1 trial

Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00120367·30 enrolled

Pilot Study1 trial

Fuzeon Viral Decay Pilot Study

Completed·CCanadian Immunodeficiency Research Collaborative·N/A·NCT00334022·18 enrolled

Unspecified1 trial

Metabolic Effects of Enfuvirtide in Healthy Volunteers

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00657761·15 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 13, 2003

FUZEON

NDA NDA021481

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Enfuvirtide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Fuzeon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Enfuvirtide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Enfuvirtide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021481). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Transmembrane Glycoprotein Gp41 Inhibitor[3]
Modality: Peptide[3]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

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