BalanceD-HF: A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Start Date01 Jul 2024

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

NCT06388616

/ CompletedPhase 1

A Phase I, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.

Start Date02 May 2024

Sponsor / Collaborator

AstraZeneca PLC

NCT05884866

/ CompletedPhase 2IIT

Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate the Mechanistic Effects of Dapagliflozin, Dapagliflozin + Balcinrenone, Balcinrenone and Placebo on Body Solute and Water Homeostasis and Energy Metabolism in Male and Female Participants Over 50 Years of Age With Chronic Kidney Disease.

The purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease.
The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies.
In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites.
In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.

Start Date13 Jul 2023

Sponsor / Collaborator

Klinikum Nürnberg

100 Clinical Results associated with Balcinrenone

100 Translational Medicine associated with Balcinrenone

100 Patents (Medical) associated with Balcinrenone

Literatures (Medical) associated with Balcinrenone

07 Apr 2026·ENDOCRINOLOGY

Balcinrenone Shows a Unique Regulation of Potassium Excretion in Streptozotocin-induced Diabetes in Male Mice

Article

Author: Kanki, Monica ; Donner, Daniel G ; de Haan, Judy ; Bamberg, Krister ; Cole, Timothy J ; Fuller, Peter J ; Vivekanantham, Elliott ; Kiriazis, Helen ; Young, Morag J ; Tesch, Gregory H ; Parslow, Adam C ; Sun, June M

Abstract:

Patients with diabetes are disproportionately affected by cardiovascular and kidney disease. Mineralocorticoid receptor (MR) antagonists show organ protection against cardiovascular and renal injury; however, major side effects including hyperkalemia and reduced renal function limit their use in individuals with diabetic complications. The nonsteroidal MR modulator balcinrenone may offer end-organ protection with fewer side effects. We compared responses to balcinrenone and eplerenone delivered from 8 weeks postinduction of streptozotocin (STZ)-induced type 1 diabetes in male mice. RNA sequencing revealed diabetes induced modulation of immune function, and metabolic and vascular targets in the kidney, which were similarly attenuated by balcinrenone or eplerenone treatment. Urine K+ excretion was lower following eplerenone treatment, but not balcinrenone treatment, compared to diabetes without treatment. We identified a 5.90-fold increase in the expression of K+ transporter G protein-activated inward rectifier potassium channel 1 in eplerenone- but not balcinrenone-treated diabetic mice. Balcinrenone and eplerenone similarly attenuated the diabetes-induced reduction in peak E-wave/A-wave velocity compared to mice without treatment at 15 weeks post-STZ. Gene markers of cardiac injury, B-type natriuretic peptide, and β-myosin heavy chain protein were higher in diabetic vs nondiabetic left ventricles (LVs). Conversely, gene expression of Ca2+ ion channel subunits, voltage-dependent L type, calcium channel subunit α 1C, and ryanodine receptor 2 in LV was lower in diabetic but not eplerenone- or balcinrenone-treated diabetic mice. Although balcinrenone and eplerenone similarly modified cardiac changes, potassium excretion was greater with balcinrenone, consistent with a reduced risk of hyperklemia with the nonsteroidal MR modulator.

03 Mar 2026·ESC Heart Failure

Established and emerging pharmacologic options and unmet needs in HFpEF and HFmrEF

Review

Author: ter Maaten, Jozine M ; Savarese, Gianluigi ; Sauer, Andrew J

Abstract:

A decline in mortality due to heart failure (HF) with reduced ejection fraction (HFrEF) has been attributed to effective guideline-directed medical therapies. But few effective therapies are available for HF with preserved ejection fraction (HFpEF), despite a high burden of HF events, or for HF with mildly reduced ejection fraction (HFmrEF). Novel therapies are needed for these HF subtypes.Clinical trials have demonstrated the efficacy of sodium–glucose cotransporter 2 inhibitors for improving outcomes in HFpEF and HFmrEF. While renin–angiotensin system inhibitors, angiotensin receptor/neprilysin inhibitors, and steroidal mineralocorticoid receptor antagonists for HFpEF or HFmrEF have not demonstrated effects on primary trial outcomes, sub-analyses from large HF trials suggest they may reduce the risk of hospitalization for HF or mortality. Beta blockers may be beneficial for HFmrEF. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, reduced HF events and cardiovascular deaths in participants with HF and ejection fraction ≥40% in the FINEARTS-HF trial, and is under evaluation for HFpEF and HFmrEF in the REDEFINE-HF and CONFIRMATION-HF trials.As treatment for HFpEF and HFmrEF may be impacted by comorbidities, novel treatments could be tailored to specific phenotypes such as obesity and chronic kidney disease. Trials of glucagon-like peptide-1 receptor agonist (GLP-1 RA), semaglutide, and dual glucose-dependent insulinotropic polypeptide receptor agonist/GLP-1 RA, tirzepatide, for HFpEF with obesity, observed an impact on HF hospitalization events and quality of life.Trials of selective mineralocorticoid modulator, balcinrenone, and aldosterone synthase inhibitor, vicadrostat, will address key evidence gaps and help improve outcomes for patients with HFpEF and HFmrEF.

26 Nov 2025·NEPHROLOGY DIALYSIS TRANSPLANTATION

Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial

Article

Author: Mark, Patrick B ; Miller, Matthew T ; Jiang, Yunyun ; Leonsson-Zachrisson, Maria ; Guzman, Nicolas J ; De Sousa-Amorim, Erika ; Eriksson, Anna L ; Heerspink, Hiddo J L

ABSTRACT:

Background and hypothesis:

Despite benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) being recommended for treatment of chronic kidney disease (CKD), there is still an unmet need for managing renal residual risk. Based on pre-clinical data, balcinrenone is a novel mineralocorticoid receptor antagonist that maintains cardio-renal benefits without increasing hyperkalaemia risk. Use of balcinrenone and dapagliflozin is expected to provide complementary and additive kidney and cardiovascular protection. The MIRO-CKD study tests the hypothesis that balcinrenone with dapagliflozin is superior to dapagliflozin alone in reducing albuminuria in patients with CKD.

Methods:

MIRO-CKD is a double-blind, active-controlled, phase 2b study evaluating the efficacy and safety of balcinrenone/dapagliflozin in 300 adults (planned) with CKD, estimated glomerular filtration rate (eGFR) 25–60 mL/min/1.73 m2 and serum potassium within normal range. Participants are being randomized 1:1:1 to balcinrenone/dapagliflozin 15 mg/10 mg, 40 mg/10 mg or placebo/dapagliflozin 10 mg for 12 weeks, followed by an 8-week wash-out period to assess off-drug effects. The primary endpoint is the change in log-transformed urinary albumin-to-creatinine ratio (UACR) from baseline to Week 12. Other outcomes include pharmacokinetics, safety and tolerability.

Results:

A total of 614 patients were screened and 324 were randomized across 15 countries in Asia, Europe, and North and South America. There were 56.2% of participants taking SGLT2i and 87.1% renin–angiotensin–aldosterone system inhibitors at enrolment. The patient population are at increased risk of CKD progression by having CKD stage 3/4 and albuminuria (median UACR: 365.5 mg/g; mean eGFR: 42.2 mL/min/1.73 m2). 56.5% of participants had type 2 diabetes mellitus.

Conclusions:

MIRO-CKD is a fully recruited global trial enrolling a contemporary CKD population at increased risk of progression and with an increased risk of hyperkalaemia based on their reduced kidney function. The study will assess the efficacy, safety and tolerability of the combination of balcinrenone and dapagliflozin to identify an optimal dose for a future phase 3 study in patients with CKD.

Clinical Trial Registration Number:

NCT06350123.

News (Medical) associated with Balcinrenone

26 Jun 2024

·www.fiercepharma.com

New CKD drugs are promising, but need stronger efficacy data, kidney docs say: GlobalData

In total, the chronic kidney disease market is forecast to balloon in size from $2.2 billion last year to $13.5 billion by 2033, during which time a range of new treatments are on track to make their debuts. Though a host of drugs currently under development are poised to massively expand the existing market for chronic kidney disease (CKD) treatments, they’ll need to go further to win the support of doctors, according to a new report. The segment is expected to expand at a compound annual growth rate of nearly 20% over the course of a decade, according to GlobalData’s estimates. The report comprises the seven major markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan, though GlobalData noted that the U.S. will be a disproportionately large contributor to that growth, thanks to its higher prevalence of CKD and costs of prescription medications. In total, the CKD market is forecast to balloon in size from $2.2 billion last year to $13.5 billion by 2033, during which time a range of new treatments are on track to make their debuts. Among those now in development are ProKidney’s cell therapy rilparencel, also known as React, and AstraZeneca’s combinations of zibotentan and dapagliflozin, and balcinrenone and dapagliflozin—all of which are currently in clinical trials. Meanwhile, Novo Nordisk is also exploring a potential expanded indication for Ozempic in CKD. Just last month, Novo shared results from its FLOW study of once-weekly Ozempic’s ability to reduce the risk of major kidney disease events in patients with both CKD and Type 2 diabetes. With a median follow-up period of nearly three and a half years, the study found that participants treated with the GLP-1 had an average 24% risk reduction compared to those assigned to the placebo group, and their rate of kidney function decline was “significantly slower.” Additionally, semaglutide was shown to reduce the risk of major cardiovascular events by 18% and all-cause mortality by 20%. Following that data drop, Novo confirmed that it will pursue expanded approvals for Ozempic in the U.S. and Europe by the end of this year. Despite the promising results from the studies of those and other potential new CKD therapeutics so far, according to GlobalData, many kidney doctors have yet to be convinced to shake up their existing CKD treatment standards and have “mixed views” about tacking on another drug to their patients’ current regimens. “It will be easier for new drug entrants to capture CKD market share if they offer a novel mechanism of action or help to improve compliance,” Kajal Jaddoo, senior pharma analyst at GlobalData, said in the report. “Overall, nephrologists surveyed by GlobalData have indicated that the pipeline for CKD is somewhat promising, but a significant improvement in efficacy would have to be demonstrated by any therapy for it to become either a replacement or add-on to the existing therapies.”

Clinical ResultDrug ApprovalCell Therapy

05 May 2023

·www.prnewswire.com

Chronic Kidney Disease Competitive Landscape Report 2023: Comprehensive Insights About 75+ Companies and 95+ Drugs

DUBLIN, May 5, 2023 /PRNewswire/ -- The "Chronic Kidney Disease - Competitive landscape, 2023" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 75+ companies and 95+ drugs in Chronic Kidney Disease Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. In March 2023, POXEL SA, announced the publication of preclinical results in autosomal dominant polycystic kidney disease (ADPKD) for PXL770, a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. For the first time, POXEL SA showed beneficial effects of a direct and selective AMPK activator in preclinical ADPKD models from three species mouse, human, and dog. These results confirm the potential utility of AMPK activation for this disease and support the development of PXL770 in a Phase 2 clinical program for ADPKD. In February 2023, AstraZeneca announced the successful completion of the acquisition of CinCor Pharma, Inc. The acquisition bolsters AstraZeneca's cardiorenal pipeline by adding baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension, to its cardiorenal portfolio. In January 2023, The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced. In November 2022, The Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford, which designed, conducted and analyzed EMPA-KIDNEY in a scientific collaboration with Boehringer Ingelheim and Eli Lilly and Company, announced that EMPA-KIDNEY phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD). When treated with Jardiance (empagliflozin), the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P< 0.0001). In October 2022, Revelation Biosciences Inc. announced positive results in a preclinical model of acute kidney injury (AKI), chronic kidney disease (CKD). Treatment with REVTx-300 significantly reduced renal cortical fibrosis in a dose dependent manner in the medium and high dose groups (21.7% reduction (p < 0.05) and 29.3% (p < 0.05), respectively) and was comparable to a known TGF inhibitor of fibrosis used as a positive control (38.1% reduction (P < 0.05)). In October 2022, French Biopharma Company, Poxel SA announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator - and is also a phase 2 ready ADPKD asset, subject to additional financing. In-depth Commercial Assessment: Chronic Kidney Disease Collaboration Analysis by Companies The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. Current Treatment Scenario and Emerging Therapies: How many companies are developing Chronic Kidney Disease drugs? How many Chronic Kidney Disease drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Chronic Kidney Disease and their status? What are the key designations that have been granted to the emerging and approved drugs? Key Players Boehringer Ingelheim Eli Lilly and Company Reata Pharmaceuticals Novo Nordisk KBP Biosciences AstraZeneca Allena Pharmaceuticals SCOHIA PHARMA DiaMedica Therapeutics CinCor Pharma Galapagos NV Sentien Biotechnologies, Inc. Regeneron Pharmaceuticals UnicoCell Biomed OccuRx Pharmicell Lisata Therapeutics Unicycive Therapeutics Senda Biosciences Sarfez Pharmaceuticals Rege Nephro Orgenesis GNI Group Algomedix Maze Therapeutics Chinook Therapeutics Angion Biomedica Corp Arch Biopartners Scohia Pharma Algernon Pharmaceuticals TICEBA GmbH Key Products Empagliflozin Bardoxolone methyl Ziltivekimab KBP-5074 AZD9977 ALLN-346 BI-685509 SCO-792 DM199 Baxdrostat GLPG2737 SBI-101 REGN5459 ELIXCYTE FT011 Cellgram-CKD CLBS201 UNI-494 Research Program SZ007 Renal progenitor cells MSCKD F351 Research programme: TRPC6 antagonist APOL1 Programme Research and discovery programs: severe chronic kidney disease ROCK2 Inhibitor LSALT peptide SCO-116 Repirinast Polycystic kidney disease (PKD) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Clinical ResultAcquisitionPhase 2Phase 3Orphan Drug

100 Deals associated with Balcinrenone

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 3	China	Astrazeneca /Cr/	01 Jul 2024
Chronic Kidney Diseases	Phase 2	United States	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Japan	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Belgium	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Bulgaria	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Canada	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Czechia	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Denmark	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Germany	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Hungary	AstraZeneca PLC	26 Jan 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04595370 (MIRACLE, CTgov)	Phase 2	Heart Failure \| Chronic Kidney Diseases	153	Dapagliflozin	tvugqlvxxa(vubhodveko) = uutdffsufd opyjizxnva (kgisetbqhs, iyiroscckf - lhqvxqvlgi) View more	-	19 Nov 2024
NCT03682497 (Pubmed) Manual	Phase 1	Renal Insufficiency \| Heart Failure	68	AZD9977	stouncwjqt(zvmxojfkxg) = dllghjirer rhwljjtlxk (zvjarpmaxg, -5.3 to 4.4)	Positive	15 Aug 2022
				spironolactone	stouncwjqt(zvmxojfkxg) = qqbygigdny rhwljjtlxk (zvjarpmaxg, -0.8 to 7.5)
NCT03435276 (Pubmed) Manual	Phase 1	Hyperkalemia	27	AZD9977	vhviucpfzj(biljzyqhry) = wiiujfrqfx czrntwyfbh (cflsbmjcng )	Positive	01 Mar 2020
				Placebo	vhviucpfzj(biljzyqhry) = phwahqbexw czrntwyfbh (cflsbmjcng )
NCT03682497 (ESC2019)	Phase 1	Heart failure with normal ejection fraction \| Heart failure with mid range ejection fraction	27	AZD9977	ybaszxxcla(booaaymwug) = A total of 7 adverse events occurred in 4 participants (22.2%) receiving AZD9977 and 8 events occurred in 6 participants (66.7%) receiving placebo, none severe or resulting in withdrawal from the study edgfyiauam (qdkhzbynuy )	-	03 Sep 2019
				Placebo
NCT02532998 (CTgov)	Phase 1	-	40	Placebo+fludrocortisone+eplerenone+AZD9977 (Treatment C)	novajgpxjh(qbplxlqbin) = kwrmyjsybe fjfmpbjltb (mfzhknorrx, 1.19) View more	-	29 Mar 2017
				fludrocortisone+eplerenone+AZD9977 (Treatment D)	novajgpxjh(qbplxlqbin) = xeufxdbogi fjfmpbjltb (mfzhknorrx, 1.18) View more

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