IRBESARTAN
IRBESARTAN is indicated for the treatment of Hypertension; Diabetic Nephropathy.
Details
- Status
- Prescription
- First Approved
- 2012-03-30
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
IRBESARTAN Approval History
What IRBESARTAN Treats
2 indicationsIRBESARTAN is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Diabetic Nephropathy
IRBESARTAN Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 ) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue irbesartan ta...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 ) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue irbesartan tablets as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )
IRBESARTAN 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 IRBESARTAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IRBESARTAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IRBESARTAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
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.
IRBESARTAN FDA Label Details
Indications & Usage
IRBESARTAN is indicated for the treatment of Hypertension; Diabetic Nephropathy.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warni...
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Full clinical data, patents, trials, and competitive landscape for irbesartan.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.