LOPINAVIR; RITONAVIR (lopinavir)
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- 2020-04-07
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
LOPINAVIR; RITONAVIR Approval History
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04459702 | PRG-043 | Ph 2 | withdrawn | A Study of Combination Therapies to Treat COVID-19 Infection |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT02671383 DRV | WRHI052 | Ph 3 | completed | Evaluation of Low-dose Darunavir in a Switch Study |
| NCT00771498 A06-295 | A06-295 | Ph 4 | completed | An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin |
| NCT01095094 results posted | CASE2307 NCI-2009-01288 | Ph 2 | terminated | Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma |
| NCT01255371 ALISA | ANRS 12221 ALISA IP.07.33011.004 | Ph 3 | withdrawn | A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir |
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.
LOPINAVIR; RITONAVIR FDA Label Details
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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