VIRACEPT (nelfinavir mesylate)
Viracept is used to manage HIV-1 infection in combination with other antiretroviral medications. It helps patients by controlling the virus as part of a multi-drug regimen. This medication belongs to a group of drugs known as protease inhibitors and is prescribed to help manage the progression of the infection.
How VIRACEPT Works
This drug works by targeting and inhibiting the HIV-1 protease enzyme. By blocking this specific enzyme, the medication interferes with the viral life cycle. This action helps manage the infection by limiting the virus's ability to function.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1997-03-14
- Routes
- ORAL
- Dosage Forms
- TABLET, POWDER
VIRACEPT Approval History
What VIRACEPT Treats
1 indicationsVIRACEPT is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
VIRACEPT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VIRACEPT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03077451 results posted | AMC-098 NCI-2016-00071, AMC 098 | Ph 2 | completed | Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma |
| NCT03829020 | MC1811 NCI-2019-00466, MC1811 | Ph 1 | completed | Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT01959672 results posted | 0441-13-FB NCI-2013-02273, NCI-2013-02118 | Ph 2 | completed | Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer |
| NCT03050060 results posted | 9712 NCI-2016-01816, 9712 | Ph 2 | terminated | Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer |
| NCT01164709 | SAKK 65/08 SWS-SAKK-65/08, EU-21051 | Ph 1 | completed | Nelfinavir Mesylate and Bortezomib in Treating Patients With Relapsed or Progressive Advanced Hematologic Cancer |
| NCT00915694 | CDR0000644278 UPCC-01309, IRB#809463 | Ph 1 | terminated | Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIRACEPT FDA Label Details
Indications & Usage
FDA Label (PDF)VIRACEPT is indicated for the treatment of HIV-1 Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment