Data updated: May 26, 2026
RALTEGRAVIR POTASSIUM
Infectious Disease
Approved 2024-12-19
2
Indications
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET
RALTEGRAVIR POTASSIUM Approval History
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2025
May 2025 ORIGINAL
Update
What RALTEGRAVIR POTASSIUM Treats
2 FDA approvalsOriginally approved for its first indication in 2024 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 2024)Letter
- • Approved indication (May 2025)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01022476 LIVERAL | ANRS 148 LIVERAL 2009-014616-36 | Ph 1, Ph 2 | completed | Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
RALTEGRAVIR POTASSIUM FDA Label Details
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ISENTRESS
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.