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Livalo

(Pitavastatin 4 Mg Oral Tablet)

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

HIV Infections

NCT06317051

Clinical

Trials by Indication[1]

HIV Infections1 trial

A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk

Active, not recruiting·KKirby Institute·Phase 3·NCT06317051·300 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 3, 2009

LIVALO

NDA NDA022363

Jul 14, 2017

ZYPITAMAG

NDA NDA208379

Aug 4, 2017

NIKITA

NDA NDA209875

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Pitavastatin 4 Mg Oral Tablet. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pitavastatin 4 Mg Oral Tablet compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA209875). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Medicure company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: MMedicure

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