TheraRadar
Data updated: Jul 17, 2026

IRBESARTAN; HYDROCHLOROTHIAZIDE (irbesartan: hydrochlorothiazide) · MACLEODS PHARMS LTD

Trial Activity: Declining 4 active trials
Cardiovascular Approved 2012-09-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Handok Inc. conducting 4 trials (14%)
23 indications explored (Broad Platform)
→ hypertension (8 trials)
→ focal segmental glomerulosclerosis (2 trials)
→ immunoglobulin a nephropathy (2 trials)
3
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2012-09-27
Routes
ORAL
Dosage Forms
TABLET

Companies

MACLEODS PHARMS LTD CHARTWELL RX Apotex ZYDUS PHARMS USA
Active Ingredient: IRBESARTAN: HYDROCHLOROTHIAZIDE

IRBESARTAN; HYDROCHLOROTHIAZIDE Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2012 to 2025
Nov 2025 SUPPL
Label · Labeling
Nov 2025 SUPPL
Label · Labeling
Jun 2022 SUPPL
Label · Labeling

What IRBESARTAN; HYDROCHLOROTHIAZIDE Treats

3 FDA approvals

Originally approved for its first indication in 2012 . Covers 3 distinct patient populations.

  • Other (3)
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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.

IRBESARTAN; HYDROCHLOROTHIAZIDE FDA Label Details

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Data Sources

FDA Approval: ANDA202414 → 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