Summary
Irbesartan has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. ClinicalTrials.gov lists 8 registered trials linking Irbesartan to Hypertension: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2008 to 2023. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2023 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Essential Hypertension ranks 376 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not well-characterized as population baseline; routinely framed as irreversible in clinical culture despite contrary trial evidence.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 72.0 (trials 22.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00741585 | Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment 2008 | completed | Phase 4 | 21,983 |
| NCT01238705 | Combined Antihypertensive Therapy and Sexual Dysfunction 2008 | status unknown | Phase 4 | 280 |
| NCT05476354 | Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients 2022 | completed | Phase 3 | 271 |
| NCT00950066 | Irbesartan and Amlodipine Combination in Controlling Blood Pressure 2009 | completed | Phase 2 | 270 |
| NCT04488978 | Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension 2020 | completed | Phase 2 | 440 |
| NCT01082835 | Jiangzhuo Qinggan Prescription and Irbesartan in the Treatment of Essential Hypertension(Hepatogastric Damp-heat)Clinical Study 2010 | status unknown | Not applicable | 240 |
| NCT06208072 | The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone. 2023 | status unknown | Not applicable | 50 |
| NCT00742066 | Role of AT1-receptor Blockers in Insulin-induced Vasodilation. 2008 | status unknown | Not applicable | 32 |
Published literature
- Clinical trial publication Pharmacogenomics-Guided Precision Therapy for Chronic Kidney Disease with Resistant Hypertension: A Prospective Cohort StudyHa X, Gao X, Teng W et al. · Kidney & blood pressure research · 2026 · PMID 41363682
- Clinical trial publication Pooled randomised QUARTET trials assessing effectiveness of a single pill for hypertensionMarschner S, Huffman MD, Quintans D et al. · Open heart · 2025 · PMID 41419232
- Clinical trial publication Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): a randomized, blinded, crossover trialZhao X, Liu T, Yang Q et al. · BMC medicine · 2025 · PMID 39881316
- Cochrane review Primary aldosteronism: pharmacotherapy vs surgery vs embolization efficacy - systematic review and network meta-analysis of studies predominantly conducted in ChinaLi G, Xu W, Li C et al. · Frontiers in endocrinology · 2025 · PMID 41334444
- Cochrane review Antihypertensive drugs for hyperuricemia in patients with hypertension: a systematic review and network meta-analysis of Chinese trialsWu J, Di H, Zhang Y et al. · BMC cardiovascular disorders · 2025 · PMID 41331424
- Cochrane review Renin inhibitors versus angiotensin receptor blockers for primary hypertensionWang GM, Li LJ, Fan L et al. · The Cochrane database of systematic reviews · 2025 · PMID 40013543
- Meta-analysis Systolic Blood Pressure and Pulse Pressure in Heart Failure: Pooled Participant-Level Analysis of 4 TrialsLu H, Kondo T, Claggett BL et al. · Journal of the American College of Cardiology · 2025 · PMID 39745404
- Systematic review A systematic review of commencing full-dose antihypertensives in newly diagnosed hypertensionKaravadra B, D Elia A, Shantsila A et al. · Blood pressure · 2025 · PMID 41351601
- Clinical trial publication The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan MonotherapyLee HY, Min KW, Han KA et al. · Clinical therapeutics · 2024 · PMID 38704294
- Clinical trial publication Ambulatory blood pressure after 12 weeks of quadruple combination of quarter doses of blood pressure medication vs. standard medicationNolde JM, Atkins E, Marschner S et al. · Journal of hypertension · 2024 · PMID 38501351
- Cochrane review Comparative efficacy and safety of six angiotensin II receptor blockers in hypertensive patients: a network meta-analysisZhang Z, Yang H, Guo H · International journal of clinical pharmacy · 2024 · PMID 38861046
- Meta-analysis A Systematic Literature Review and Network Meta-analysis of Azilsartan Medoxomil Compared to Other Anti-hypertensives Efficacy in Lowering Blood Pressure Amongst Mild to Moderate Hypertensive PatientsQian J, Zhang M, Chen Z · Advances in therapy · 2024 · PMID 39412629
- Cochrane review Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysisXie M, Tang T, Liang H · Clinical cardiology · 2023 · PMID 37432701
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Irbesartan approved for Hypertension?
Irbesartan has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Irbesartan in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Irbesartan to Hypertension: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00741585). It plans or enrolled 21983 participants. Registration activity spans 2008 to 2023.
What does the evidence show for Irbesartan in Hypertension?
Irbesartan has both completed registered trials and synthesis-level publications linked to Hypertension. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.