Data updated: May 26, 2026
IRBESARTAN; HYDROCHLOROTHIAZIDE (irbesartan)
Trial Activity: Declining 4 active trials
Cardiovascular
Approved 2012-09-27
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
Website: ↗
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
Apr 2022 SUPPL
Label
Jun 2021 SUPPL
Label
Feb 2019 SUPPL
Label
Dec 2018 SUPPL
Label
Sep 2016 SUPPL
Label
Sep 2016 SUPPL
Label
Mar 2015 SUPPL
Label
Feb 2015 SUPPL
Label
Feb 2015 SUPPL
Label
Feb 2013 ORIGINAL
Update
Dec 2012 SUPPL
Label
Oct 2012 ORIGINAL
Update
Sep 2012 ORIGINAL
Update
What IRBESARTAN; HYDROCHLOROTHIAZIDE Treats
3 FDA approvalsOriginally approved for its first indication in 2012 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Sep 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Feb 2013)
📋
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07555054 | HS-10390-202 | Ph 2 | not yet recruiting | A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease |
| NCT03762850 PROTECT results posted | 021IGAN17001 2017-004605-41 | Ph 3 | active not recruiting | A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy |
| NCT03493685 DUPLEX results posted | 021FSGS16010 | Ph 3 | completed | Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) |
| NCT05056727 STABILIZE-CKD results posted | D9488C00001 2021-001911-96 | Ph 3 | terminated | A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia |
| NCT01613118 DUET results posted | RET-D-001 | Ph 2 | completed | Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis |
| NCT00152698 | Retina-Irbesartan | Ph 3 | withdrawn | Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia |
| NCT00933231 | FKC-014 | Ph 3 | completed | Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts |
| NCT06660940 | BOJI2022080XY | Ph 4 | not yet recruiting | Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy |
| NCT06635772 | HS-10390-201 | Ph 2 | not yet recruiting | A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy |
| NCT02597361 ARCADE | P140918 2015-001065-76 | Ph 3 | completed | Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE) |
| NCT05663073 | HD-AI-101 | Ph 1 | completed | Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers |
| NCT05475665 | HD-AI-302 | Ph 3 | completed | Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients |
| NCT05688098 | HD-AI-102 | Ph 1 | completed | Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers |
| NCT05476354 | HD-AI-301 | Ph 3 | completed | Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients |
| NCT05243199 | (2020)(137) | Ph 4 | completed | Sacubitril/Valsartan for CKD5 Stage Dialysis Patients |
| NCT04606563 ARBs CORONA II | H20-01984 | Ph 3 | terminated | Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? |
| NCT03934307 | ALN-AGT01-001 2019-000129-39 | Ph 1 | completed | A Study to Evaluate ALN-AGT01 in Patients With Hypertension |
| NCT03147677 | 320.6750.16025 | Ph 4 | completed | Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan |
| NCT01825850 | LG-GBCL001 | Ph 1 | completed | Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects |
| NCT00987662 OBI | AUTH170909 | Ph 4 | withdrawn | Irbesartan Versus Amlodipine: The OBI Study |
| NCT01442987 | HM-IBAT-301 | Ph 3 | completed | Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia |
| NCT00791830 SAFIR | EudraCT no: 2008-001267-11 | Ph 3 | completed | Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan |
| NCT00660309 results posted | CSPP100A2329 | Ph 4 | completed | A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus |
| NCT00635232 results posted | PCO-C-006 | Ph 2 | completed | A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension |
| NCT00957554 I-ADD | IRBAM_R_04219 | Ph 3 | completed | Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
IRBESARTAN; HYDROCHLOROTHIAZIDE FDA Label Details
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Data Sources
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