Summary
Valsartan 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 Valsartan to Hypertension: 1 is currently recruiting; 7 have completed. The most advanced is Phase 4 (NCT01241487). The largest enrolment is 1438 participants (NCT01785472). Registration activity spans 2005 to 2025. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2024 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 | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 7 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 systematic reviews, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01241487 | A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy 2009 | completed | Phase 4 | 150 |
| NCT00699192 | Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension 2008 | completed | Phase 3 | 965 |
| NCT01785472 | Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension 2013 | completed | Phase 3 | 1,438 |
| NCT00386607 | A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. 2006 | completed | Phase 3 | 601 |
| NCT00413049 | Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension 2007 | completed | Phase 3 | 698 |
| NCT00254475 | A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia 2005 | completed | Phase 3 | 871 |
| NCT06863987 | A Phase III Clinical Study of Valsartan Oral Solution for the Treatment of Hypertension in Children and Adolescents 2025 | enrolling by invitation | Phase 3 | 342 |
| NCT01878201 | A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension 2013 | completed | Phase 2 | 75 |
Published literature
- Clinical trial publication Efficacy and Safety of SPH3127 Tablet, a Novel Direct Renin Inhibitor, in Patients with Mild-to-Moderate Essential Hypertension: A Phase III Randomised TrialLv Q, Ma C, Wang F et al. · Drugs · 2026 · PMID 42165988
- Clinical trial publication Sexual function among controlled and uncontrolled hypertensive females receiving beta-blockers or ACEI/ARB and thiazides: a prospective randomized controlled studyGamalEl Din SF, Elyamani E, Bushra MT et al. · Scientific reports · 2026 · PMID 41844720
- Clinical trial publication Effects of different antihypertensive drug classes on central and ambulatory blood pressure in resistant hypertension: A randomized clinical trialYugar-Toledo JC, Minari TP, de Mello PG et al. · British journal of clinical pharmacology · 2026 · PMID 40859651
- Cochrane review Angiotensin receptor neprilysin inhibitor for the treatment of hypertension: a systematic review and meta-analysisNoe HM, Sujarit AS, Chongmelaxme B et al. · Hypertension research : official journal of the Japanese Society of Hypertension · 2026 · PMID 41145713
- Clinical trial publication On-treatment systolic blood pressure and preserved kidney function in hypertensive patients with proteinuria. The VALUE TrialOlsen E, Mariampillai JE, Schmieder RE et al. · Blood pressure · 2025 · PMID 40765469
- Clinical trial publication Effects of sacubitril/valsartan on hypertensive heart disease: the REVERSE-LVH randomized phase 2 trialLee V, Dalakoti M, Zheng Q et al. · Nature communications · 2025 · PMID 40739095
- 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
- Cochrane review Efficacy and safety of sacubitril-valsartan in hypertension patients with end-stage kidney disease on maintenance dialysis: a meta-analysisNguyen DV, Pham GT, Pham SN et al. · Journal of hypertension · 2025 · PMID 39927814
- 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
- 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
- Systematic review 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
- Systematic review Comparison of sacubitril/valsartan with olmesartan for hypertension: A meta-analysis of randomized controlled trialsSun Y, Yang H · Medicine · 2024 · PMID 38579097
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 Valsartan approved for Hypertension?
Valsartan 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 Valsartan in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Valsartan to Hypertension: 1 is currently recruiting; 7 have completed. The most advanced is Phase 4 (NCT01241487). The largest enrolment is 1438 participants (NCT01785472). Registration activity spans 2005 to 2025.
What does the evidence show for Valsartan in Hypertension?
Valsartan 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.