Summary
Bisoprolol Fumarate 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trials linking Bisoprolol Fumarate to Hypertension: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05880056). The largest enrolment is 2000 participants (NCT01742702). Registration activity spans 1999 to 2024. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 1995 to 2013. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 58.0 (trials 30.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 4 (4 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03276598 | A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension 1999 | completed | Phase 4 | 233 |
| NCT02398929 | BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study) 2013 | completed | Phase 4 | 100 |
| NCT01251146 | A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension 2010 | completed | Phase 4 | 177 |
| NCT01762436 | Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension 2010 | completed | Phase 4 | 109 |
| NCT05880056 | Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension 2024 | recruiting | Phase 4 | 406 |
| NCT01977794 | Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension 2014 | completed | Phase 3 | 200 |
| NCT05288400 | Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension. 2018 | completed | Phase 3 | 150 |
| NCT01742702 | HaemoDYNAMICs in Primary and Secondary Hypertension 2006 | status unknown | Not applicable | 2,000 |
Published literature
- Clinical trial publication Comparison of efficacy and safety between bisoprolol transdermal patch (TY-0201) and bisoprolol fumarate oral formulation in Japanese patients with grade I or II essential hypertension: randomized, double-blind, placebo-controlled studyMatsuoka H, Kuwajima I, Shimada K et al. · Journal of clinical hypertension (Greenwich, Conn.) · 2013 · PMID 24119112
- Clinical trial publication [Efficacy of a cardioselective beta1-adrenoblocker bisoprolol in patients with chronic obstructive pulmonary disease in combination with ischemic heart disease]Tsvetkova OA, Veselovskaia MV · Terapevticheskii arkhiv · 2007 · PMID 17526191
- Clinical trial publication Beta-blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trialSorof JM, Cargo P, Graepel J et al. · Pediatric nephrology (Berlin, Germany) · 2002 · PMID 12042891
- Clinical trial publication First-line therapy option with low-dose bisoprolol fumarate and low-dose hydrochlorothiazide in patients with stage I and stage II systemic hypertensionFrishman WH, Burris JF, Mroczek WJ et al. · Journal of clinical pharmacology · 1995 · PMID 7751430
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 Bisoprolol Fumarate approved for Hypertension?
Bisoprolol Fumarate 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 Bisoprolol Fumarate in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Bisoprolol Fumarate to Hypertension: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05880056). The largest enrolment is 2000 participants (NCT01742702). Registration activity spans 1999 to 2024.
What does the evidence show for Bisoprolol Fumarate in Hypertension?
Bisoprolol Fumarate has 6 completed trials and 4 linked publications for Hypertension. Completed trials may or may not have posted results; follow the NCT links to check. 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.