TheraRadar
Data updated: May 26, 2026

INDAPAMIDE

Cardiovascular Approved 1995-07-27

INDAPAMIDE is indicated for the treatment of Hypertension; Fluid Retention; Congestive Heart Failure; Edema.

Source: FDA Label • ANI PHARMS
8
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Discontinued
First Approved
1995-07-27
Routes
ORAL
Dosage Forms
TABLET

INDAPAMIDE Approval History

1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
140 FDA actions from 1995 to 2024
Aug 2024 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label · Labeling
Sep 2023 SUPPL
Label · Labeling

What INDAPAMIDE Treats

4 indications

INDAPAMIDE is approved for 4 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Fluid Retention
  • Congestive Heart Failure
  • Edema
Source: FDA Label

INDAPAMIDE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to INDAPAMIDE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
3 shared
WATSON LABS
INZIRQO
HYDROCHLOROTHIAZIDE
3 shared
NOVITIUM PHARMA
METOLAZONE
METOLAZONE
3 shared
Novartis
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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

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

INDAPAMIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

INDAPAMIDE is indicated for the treatment of Hypertension; Fluid Retention; Congestive Heart Failure; Edema.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.