TheraRadar
Data updated: May 26, 2026

PRAVACHOL (pravastatin sodium)

Trial Activity: Declining
Cardiovascular Approved 1991-10-31
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections conducting 2 trials (40%)
18 indications explored (Broad Platform)
→ hiv-1 infection (2 trials)
→ leukemia (1 trials)
→ liver cancer (1 trials)
14
Indications
--
Phase 3 Trials
1
Priority Reviews
34
Years on Market

Details

Status
Discontinued
First Approved
1991-10-31
Routes
ORAL
Dosage Forms
TABLET

Companies

Bristol-Myers Squibb
Active Ingredient: PRAVASTATIN SODIUM

PRAVACHOL Approval History

1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
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2015
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2021
2022
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2024
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2026
Original
New Indication
New Form
Label Update
228 FDA actions from 1991 to 2022 · 12 indication expansions
May 2022 SUPPL
Label · Labeling
FDA Letter Label
Sep 2020 SUPPL
Label · Labeling
FDA Letter Label
Jan 2017 SUPPL
Mfg · Manufacturing (CMC)

What PRAVACHOL Treats

14 FDA approvals

Originally approved for its first indication in 1991 . Covers 14 distinct patient populations.

  • Other (14)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT00840177 results posted S0919 S0919, U10CA032102 Ph 2 completed S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
NCT01075555 CDR0000666232 FFCD-PRODIGE-11, FFCD-0803 Ph 3 completed Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
NCT01342887 results posted 2409.00 NCI-2011-00657 Ph 1, Ph 2 terminated Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01515813 ACTG A5292 1U01AI068636 Ph 2 withdrawn Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PRAVACHOL FDA Label Details

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Data Sources

FDA Approval: NDA019898 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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