Summary
Mirabegron has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Heart Failure would be drug repurposing rather than first-in-human development. This does not mean it is approved for Heart Failure. ClinicalTrials.gov lists 4 registered trials linking Mirabegron to Heart Failure: 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02599480). It plans or enrolled 296 participants. Registration activity spans 2013 to 2017. The literature layer holds 7 publications for this pair: 2 meta-analyses and 5 clinical trial publications. Publication years run from 2022 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 Heart Failure ranks 616 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: Annual mortality ~22% on standard care; only 5-11% of HFrEF patients achieve normalisation of ejection fraction (HFrecEF) with GDMT; HFpEF has no disease-modifying therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 49.5 (trials 11.5, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 7 (5 clinical trial publications, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | agonist; agonist |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRB3 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01876433 | Beta 3 Agonist Treatment in Heart Failure 2013 | completed | Phase 2 | 70 |
| NCT02599480 | Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure 2016 | completed | Phase 2 | 296 |
| NCT02775539 | Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure 2016 | status unknown | Phase 2 | 80 |
| NCT03926754 | Beta 3 Agonist Treatment in Heart Failure-2 2017 | completed | PHASE2, PHASE3 | 56 |
Published literature
- Meta-analysis Efficacy and Safety of the β 3 -Adrenergic Agonist Mirabegron in Patients With Heart Failure: An Updated Systematic Review and Meta-AnalysisAbdelhamid A, Arabi A, Rajha H et al. · Journal of cardiovascular pharmacology · 2026 · PMID 41949490
- Meta-analysis Is Mirabegron-the novel beta 3 agonist-effective in patients with heart failure? A systematic review and meta-analysis of efficacy and safetyElrosasy A, Abo Zeid M, Aldemerdash MA et al. · Irish journal of medical science · 2026 · PMID 41491862
- Clinical trial publication Exploring the impact of metabolic comorbidities on epicardial adipose tissue in heart failure with preserved ejection fractionMenghoum N, Badii MC, Leroy M et al. · Cardiovascular diabetology · 2025 · PMID 40121452
- Clinical trial publication First-In-Man Trial of β3-Adrenoceptor Agonist Treatment in Chronic Heart Failure: Impact on Diastolic FunctionBahrami HSZ, Hasselbalch RB, Søholm H et al. · Journal of cardiovascular pharmacology · 2024 · PMID 38452283
- Clinical trial publication Repurposing the β3-Adrenergic Receptor Agonist Mirabegron in Patients With Structural Cardiac Disease: The Beta3-LVH Phase 2b Randomized Clinical TrialBalligand JL, Brito D, Brosteanu O et al. · JAMA cardiology · 2023 · PMID 37728907
- Clinical trial publication β3 adrenergic agonist treatment in chronic pulmonary hypertension associated with heart failure (SPHERE-HF): a double blind, placebo-controlled, randomized clinical trialGarcía-Álvarez A, Blanco I, García-Lunar I et al. · European journal of heart failure · 2023 · PMID 36404400
- Clinical trial publication Hemodynamic Effects of Cyclic Guanosine Monophosphate-Dependent Signaling Through β3 Adrenoceptor Stimulation in Patients With Advanced Heart Failure: A Randomized Invasive Clinical TrialBundgaard H, Axelsson Raja A, Iversen K et al. · Circulation. Heart failure · 2022 · PMID 35758031
Mechanism and notes
Recorded mechanism or class: agonist; agonist.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRB3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Mirabegron approved for Heart Failure?
Mirabegron has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Heart Failure would be drug repurposing rather than first-in-human development. This does not mean it is approved for Heart Failure. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Mirabegron in clinical trials for Heart Failure?
ClinicalTrials.gov lists 4 registered trials linking Mirabegron to Heart Failure: 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02599480). It plans or enrolled 296 participants. Registration activity spans 2013 to 2017.
What does the evidence show for Mirabegron in Heart Failure?
Mirabegron has both completed registered trials and synthesis-level publications linked to Heart Failure. 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 DGIdb, in this case via the biomarker or target ADRB3. 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.