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

NCT04595370

/ CompletedPhase 2

A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60 mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).

Start Date26 Jan 2021

Sponsor / Collaborator

AstraZeneca PLC

NCT04686591

/ CompletedPhase 1

A Phase I, Open-label Study of Absolute Bioavailability and Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]AZD9977 in Healthy Male Subjects

Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose Oral Administration

Start Date21 Dec 2020

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Balcinrenone

100 Translational Medicine associated with Balcinrenone

100 Patents (Medical) associated with Balcinrenone

Literatures (Medical) associated with Balcinrenone

01 Feb 2025·European Journal of Heart Failure

Can the novel aldosterone inhibiting drug balcinrenone reduce hyperkalaemia and worsening renal function compared to steroidal mineralocorticoid receptor antagonists in heart failure?

Author: Heerspink, Hiddo J.L. ; Beldhuis, Iris E. ; Voors, Adriaan A.

A review.Mineralocorticoid receptor antagonists (MRAs) are recommended for patients with HF with reduced ejection fraction (HFrEF) and may be considered for patients with a mildly reduced ejection fraction to reduce HF hospitalizations and improve survival.There is an important need for aldosterone inhibitors that have similar or better cardiac effects but less often cause hyperkalemia or WRF. In this issue of the journal, clin. data are presented of the novel selective mineralocorticoid receptor (MR) partial antagonist, balcinrenone (formerly AZD997).Thus novel aldosterone inhibiting drug balcinrenone reduce hyperkalemia and worsen renal function compared to steroidal mineralocorticoid receptor antagonists in heart failure.

01 Feb 2025·CPT: Pharmacometrics & Systems Pharmacology

Concentration–QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval

Article

Author: Sundell, Jesper ; Johansson, Susanne ; Parkinson, Joanna ; Melin, Johanna ; Rekic, Dinko ; Dota, Corina ; Ebrahimi, Ahmad

AbstractBalcinrenone (AZD9977) is a selective mineralocorticoid receptor modulator in development in combination with dapagliflozin for treatment of heart failure with impaired kidney function and chronic kidney disease. A prespecified concentration–QT analysis was performed based on data from a phase I single ascending dose study prospectively designed as a thorough QT study substitute. Oral single doses of balcinrenone of 5–800 mg, plus fractionated doses of 800 and 1200 mg, were evaluated in 62 healthy male participants. Time‐matched 12‐lead digital electrocardiogram and plasma concentrations were measured pre‐dose and up to 48 h postdose in the participants. Analysis was performed using a linear mixed‐effect model, where baseline‐adjusted Fridericia‐corrected QT interval (ΔQTcF) was a dependent variable and time‐matched balcinrenone concentration an independent variable. The model fit was deemed adequate by evaluation of goodness‐of‐fit plots, and the slope of the concentration–ΔQTcF relationship was nonsignificant (−0.003 ms/μmol/L; 95% confidence interval [CI]: −0.181, 0.176). The high clinical exposure scenario was defined as the maximum concentration (2.156 μmol/L) following the highest expected therapeutic dose (40 mg once daily) under fed conditions and in presence of a strong cytochrome P450 3A4 inhibitor. Estimated baseline‐adjusted and placebo‐corrected QTcF interval (ΔΔQTcF) at this concentration was 0.35 ms (90% CI: −1.29, 2.00). Furthermore, the upper 90% ΔΔQTcF CI was estimated to be below the threshold of regulatory concern of 10 ms at all observed concentrations (up to 16.7 μmol/L). Hence, it can be concluded that balcinrenone does not induce QTcF prolongation at the high clinical exposure scenario.

20 Dec 2024·Organic Process Research & Development

A Journey through Process Development Enhanced by Kinetic Modeling: An Efficient Manufacturing Route to Balcinrenone

Author: Page, Alice ; Cox, Robert J. ; Dave, David ; Ronson, Thomas O. ; Foulkes, Matthew J. ; García-Morales, Cristina ; Neouchy, Zeina ; Pointon, Helen

This work focuses on the accelerated development of a versatile process for synthesizing a key amide intermediate en route to the active pharmaceutical ingredient balcinrenone.The process development was facilitated by the implementation of predictive kinetic models at the early stages of development.The predictive kinetic models effectively guided and expedited route design, process design, and process optimization for both batch and continuous manufacturing of a telescoped asym. reduction/amidation process using methylamine in methanol.The implementation of the telescoped batch process led to significant enhancements in throughput, sustainability, and economic efficiency of the synthesis of balcinrenone, resulting in the successful manufacture of the key amide intermediate.Addnl., the utilization of a multilinear regression (MLR)-Kinetics hybrid model enabled the rapid development of an alternative process using methylamine in water, providing a contingency plan for manufacturing campaigns in the event of shortage of methylamine in methanol.In addition to the primary focus, this study expanded the application of kinetic modeling to guide process design and optimization for a second intermediate obtained via pH-controlled addition/cyclization, thereby enhancing understanding and throughput for this step.Finally, the use of a structured experimentation design involving initial kinetic studies led to the discovery of improved conditions for the final amide bond formation to produce balcinrenone.

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

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 2	Italy	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Sweden	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Czechia	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	United States	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Canada	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Poland	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	Denmark	AstraZeneca PLC	26 Jan 2021
Chronic Kidney Diseases	Phase 2	Taiwan Province	AstraZeneca PLC	26 Jan 2021

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03682497 (Pubmed) Manual	Phase 1	Heart Failure \| Renal Insufficiency	68	AZD9977	gqdxxczasv(ojkprcgumn) = dglsapqukr stwrukgfim (dljcdjislg, -5.3 to 4.4)	Positive	15 Aug 2022
				spironolactone	gqdxxczasv(ojkprcgumn) = inrregsoel stwrukgfim (dljcdjislg, -0.8 to 7.5)
NCT03435276 (Pubmed) Manual	Phase 1	Hyperkalemia	27	AZD9977	(vgzluwbawv) = ipphjforwg nvemjtpluk (fakotlvogw )	Positive	01 Mar 2020
				Placebo	(vgzluwbawv) = dowyxupghx nvemjtpluk (fakotlvogw )
NCT03682497 (ESC2019)	Phase 1	Heart failure with normal ejection fraction	27	AZD9977	(lljsfjftgi) = 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 phdcpbykxg (hgmotsqyya )	-	03 Sep 2019
				Placebo
ASN2016	Not Applicable	-	-	AZD9977	yxadapfucn(yiqvlyvnbn) = xahhloqrbi njaysnejbu (tsfefdigzq, 0.02)	-	15 Nov 2016
				Eplerenone	yxadapfucn(yiqvlyvnbn) = ylmhzpllnk njaysnejbu (tsfefdigzq, 0.05)

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