Approval Probability
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Also known as enfuvirtide [Fuzeon], Fuzeon
Enfuvirtide · 6 trials · 1 indication
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
| Arm | Type | Description |
|---|---|---|
| Enfuvirtide + OB (Not Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 milligram (mg) twice daily (b.i.d.) and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants not meeting the randomization criteria will receive enfuvirtide 90 mg b.i.d and OB for next 24 weeks (up to Week 52). |
| Enfuvirtide + OB (Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive enfuvirtide 90 mg b.i.d. and OB for next 24 weeks (up to Week 52). |
| OB alone (Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive OB alone for next 24 weeks (up to Week 52). |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Enfuvirtide | DRUG | Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d. |
| Optimized background antiretroviral regimen (OB) | DRUG | Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs. |
| enfuvirtide [Fuzeon] | DRUG | 90mg sc bid |
| Optimized background ARV therapy | DRUG | As prescribed |
| Ritonavir | DRUG | - |
| Abacavir sulfate | DRUG | - |
| Amprenavir | DRUG | - |
| Efavirenz | DRUG | - |
Inclusion Criteria: * Participants with HIV-1 infection * Female participants without any risk of pregnancy * Participants previously treated with drugs of 2 or 3 different antiretroviral classes * Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and wi...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Enfuvirtide is used for the treatment of HIV Infections. It is studied in treatment-experienced patients with human immunodeficiency virus type 1 (HIV-1), including those with prior drug treatment or resistance to multiple classes of antiretroviral drugs. It is given in combination with an optimized background antiretroviral regimen.
Enfuvirtide is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the company associated with the drug's clinical development and the Fuzeon brand name.
Enfuvirtide is in Phase 3 clinical development. It is investigational and is not stated to be approved. The clinical program includes six completed trials, with no active trials currently listed, and a total enrollment of 1,283 participants across the studies.
Enfuvirtide has been studied in completed trials including NCT02733419, a Phase 3 study in treatment-experienced HIV-1 participants in France; NCT00021554, a Phase 3 trial in patients with prior drug treatment or resistance across multiple countries; NCT00615134, a Phase 2 induction study; and NCT00022763, a Phase 2 trial in HIV-infected children and adolescents.
Yes, enfuvirtide is also known as Fuzeon. Fuzeon is the brand name for enfuvirtide, and the two names refer to the same drug. The INNOVE study, for example, is listed as a study of Fuzeon (enfuvirtide) plus optimized background versus optimized background alone.
Enfuvirtide is a peptide, belonging to the -tide (peptide) target class. It is a small molecule in modality terms. The supplied information identifies its target class as -tide (peptide), which reflects its peptide-based structure rather than a specific molecular target.