预约演示
更新于：2026-10-21
Balcinrenone
更新于：2026-10-21
概要
基本信息
药物类型 小分子化药 |
别名 AZD 9977、AZD-9977 |
靶点 |
作用方式 调节剂 |
作用机制 MR调节剂(盐皮质激素受体调节剂) |
治疗领域 |
在研适应症 |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C20H18FN3O5 |
InChIKeyMBKYLPOPYYLTNW-ZDUSSCGKSA-N |
CAS号1850385-64-6 |
关联
14
项与 Balcinrenone 相关的临床试验ChiCTR2500095453
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
NCT06388616
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
NCT05884866
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.
100 项与 Balcinrenone 相关的临床结果
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100 项与 Balcinrenone 相关的转化医学
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100 项与 Balcinrenone 相关的专利（医药）
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32
项与 Balcinrenone 相关的文献（医药）2026-10-01BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone
Article
作者: Ericsson, Hans ; Karsanji, Deeyen ; Pawlik, Tadeusz ; Hartleib‐Geschwindner, Judith ; Tuyishimire, Bonifride ; Parkinson, Joanna ; Leonsson‐Zachrisson, Maria ; Eriksson, Anna L. ; Heijer, Maria
Abstract:
Aim:
Balcinrenone (previously AZD9977) is a novel selective non‐steroidal mineralocorticoid receptor antagonist (MRA) with a differential mechanism of action relative to approved MRAs. The aim of this trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone in participants with mild and moderate hepatic impairment versus participants with normal hepatic function.
Methods:
Participants with mild and moderate hepatic impairment (Child–Pugh Class A [
n
= 8] and Child–Pugh Class B [
n
= 8]) were compared with group matched controls with normal hepatic function [
n
= 9]. Eligible participants received a single oral dose of 50‐mg balcinrenone. Blood and urine samples were collected. Safety and tolerability were monitored.
Results:
In participants with mild hepatic impairment, balcinrenone exposure (area under the plasma concentration–time curve [AUC] and maximum plasma concentration [
Cmax
]) was similar compared with participants with normal hepatic function. In participants with moderate hepatic impairment,
Cmax
was similar, but there was a slight and statistically significant 30% (90% CI 4%–61%) increase in AUC compared with participants with normal hepatic function. Balcinrenone was well tolerated. All reported adverse events were of mild to moderate intensity.
Conclusions:
Compared with participants with normal hepatic function, balcinrenone exposure was similar in participants with mild hepatic impairment. AUC, but not
Cmax
, was slightly increased in participants with moderate hepatic impairment. We do not consider the minor AUC increase seen in participants with moderate hepatic impairment to be clinically relevant. Thus, we would not recommend any dose adjustment for patients with mild or moderate hepatic impairment.
2026-09-01JOURNAL OF CLINICAL PHARMACOLOGY
Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P‐gp Inhibitor
Article
作者: Karsanji, Deeyen ; Austin, Edward ; Leonsson‐Zachrisson, Maria ; Shi, Amy H. ; Vedin‐Nilsson, Charlotta ; Parkinson, Joanna ; Eriksson, Anna L. ; Ericsson, Hans ; Lindmark, Bosse ; Heijer, Maria ; Hartleib‐Geschwindner, Judith
Abstract:
Balcinrenone (AZD9977) is a novel selective non‐steroidal mineralocorticoid receptor antagonist with a distinct mode of action being developed as a fixed‐dose combination with the sodium–glucose cotransporter‐2 inhibitor dapagliflozin for the treatment of heart failure with impaired kidney function, and chronic kidney disease. In this Phase 1 randomized open‐label three‐way crossover study we investigated the effect of food on balcinrenone/dapagliflozin pharmacokinetics, and the pharmacokinetics of balcinrenone when dosed with a P‐glycoprotein (P‐gp) inhibitor. Fourteen healthy participants were administered an oral capsule of balcinrenone/dapagliflozin 40 mg/10 mg in three dosing periods: fasted (reference), fed (high‐fat, high‐calorie meal) and with a P‐gp inhibitor (quinidine 300 mg × 2). Balcinrenone exposure was comparable in the fed and fasted states (geometric mean ratios [GMRs] [90% CI]: maximum plasma concentration [C
max
] 1.05 [0.88, 1.25]; area under the plasma concentration–time curve from time 0 to infinity [AUC
inf
] 1.12 [1.06, 1.19]). In the fed state, dapagliflozin AUC
inf
was comparable to the fasted state (GMR [90% CI] 1.05 [1.01, 1.09]), whereas C
max
was decreased (GMR [90% CI] 0.59 [0.51, 0.69]), in line with previous dapagliflozin food interaction studies. Co‐administration with quinidine increased balcinrenone exposure: GMRs (90% CI) 1.48 (1.24, 1.76) and 1.24 (1.17, 1.31) for C
max
and AUC
inf
, respectively, but AUC fold increase was <2, the level used for classification of sensitive P‐gp substrates. All interventions were well tolerated. In conclusion, this study supports dosing of balcinrenone/dapagliflozin without regard to food. Balcinrenone is not considered a sensitive P‐gp substrate. No P‐gp based dosing precautions are warranted based on this study.
2026-03-03ESC Heart Failure
Established and emerging pharmacologic options and unmet needs in HFpEF and HFmrEF
Review
作者: 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.
100 项与 Balcinrenone 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 心脏衰竭 | 临床3期 | 中国 | 2024-07-01 | |
| 慢性肾病 | 临床2期 | 美国 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 日本 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 比利时 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 保加利亚 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 加拿大 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 捷克 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 丹麦 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 德国 | 2021-01-26 | |
| 慢性肾病 | 临床2期 | 匈牙利 | 2021-01-26 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 153 | 膚襯廠鏇獵積窪鑰願醖(築獵願積簾築觸簾積蓋) = 製願觸築餘範鹽構鹹鏇 構顧範網構簾鹹獵選鹹 (觸憲願獵廠製壓膚壓蓋, 醖蓋夢淵襯獵鑰窪範選 ~ 襯網鹹齋顧願選繭醖繭) 更多 | - | 2024-11-19 | |||
临床1期 | 68 | 製衊艱蓋艱襯築窪衊膚(範艱範壓構鏇鏇鑰鑰餘) = 廠襯積獵觸糧襯積鑰顧 觸艱艱製窪鏇餘艱蓋壓 (範簾構醖衊願觸糧鬱顧, -5.3 ~ 4.4) | 积极 | 2022-08-15 | |||
製衊艱蓋艱襯築窪衊膚(範艱範壓構鏇鏇鑰鑰餘) = 艱齋餘鏇範壓鏇蓋顧餘 觸艱艱製窪鏇餘艱蓋壓 (範簾構醖衊願觸糧鬱顧, -0.8 ~ 7.5) | |||||||
临床1期 | 27 | 選壓積選鬱襯鑰築襯築(膚壓蓋窪窪製憲廠網鏇) = 顧鏇築壓壓選憲鏇遞糧 範願鹽積齋蓋廠壓鬱襯 (淵鹽網醖簾襯糧網製餘 ) | 积极 | 2020-03-01 | |||
Placebo | 選壓積選鬱襯鑰築襯築(膚壓蓋窪窪製憲廠網鏇) = 餘淵淵淵鹹選簾鑰醖蓋 範願鹽積齋蓋廠壓鬱襯 (淵鹽網醖簾襯糧網製餘 ) | ||||||
临床1期 | 27 | 廠蓋繭淵艱糧鹽鏇糧範(餘構夢築膚願襯鹹蓋憲) = 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 鏇獵網製蓋齋膚淵積憲 (齋艱艱憲鑰鏇積憲鏇膚 ) | - | 2019-09-03 | |||
Placebo | |||||||
临床1期 | - | 40 | (Treatment C) | 製鬱簾簾齋艱積積齋獵(鹹艱範鏇艱簾艱憲願鹽) = 淵襯鏇艱衊蓋簾築齋鏇 鏇餘襯襯醖淵糧窪艱夢 (淵積衊簾觸膚糧遞廠鏇, 1.19) 更多 | - | 2017-03-29 | |
(Treatment D) | 製鬱簾簾齋艱積積齋獵(鹹艱範鏇艱簾艱憲願鹽) = 構鹹壓簾積窪網積醖艱 鏇餘襯襯醖淵糧窪艱夢 (淵積衊簾觸膚糧遞廠鏇, 1.18) 更多 |
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