INDAPAMIDE · ANI PHARMS
INDICATIONS Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Usage in Pregnancy : The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Details
- Status
- Prescription
- First Approved
- 1983-07-06
- Routes
- ORAL
- Dosage Forms
- TABLET
INDAPAMIDE Approval History
What INDAPAMIDE Treats
4 indicationsINDAPAMIDE 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
INDAPAMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INDAPAMIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INDAPAMIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INDAPAMIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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)INDICATIONS Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy : The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Ed...
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Full clinical data, patents, trials, and competitive landscape for indapamide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.