TheraRadar
Data updated: May 26, 2026

LOZOL (indapamide)

Trial Activity: Mature
Cardiovascular Approved 1983-07-06
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Alnylam Pharmaceuticals conducting 1 trials (33%)
3 indications explored (Focused)
→ hypertension (3 trials)
→ renal insufficiency (1 trials)
→ type 2 diabetes mellitus (1 trials)
2
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Discontinued
First Approved
1983-07-06
Routes
ORAL
Dosage Forms
TABLET

Companies

Sanofi
Active Ingredient: INDAPAMIDE

LOZOL Approval History

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Original
New Indication
New Form
Label Update
60 FDA actions from 1983 to 2021 · 1 indication expansions
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label
Sep 2009 SUPPL
Label · Labeling
FDA Letter Label
Oct 2000 SUPPL
Label · Labeling

What LOZOL Treats

2 FDA approvals

Originally approved for its first indication in 1983 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05103332 KARDIA-2 results posted ALN-AGT01-003 2021-003776-13 Ph 2 completed Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
NCT01172431 WestChinaH Ph 4 completed Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
NCT00980187 AISHA RO-SCL-IQ v 1.0/04.07 Ph 4 completed A Comparison of Indapamide SR 1.5 mg With HCTZ 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate AHT and Type 2 DM
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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.

LOZOL FDA Label Details

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Data Sources

FDA Approval: NDA018538 → 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