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更新于：2025-10-30
BI-764198
更新于：2025-10-30
概要
基本信息
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 |
特殊审评孤儿药 (日本) |
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关联
12
项与 BI-764198 相关的临床试验NCT07220083
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants
NCT06955754
Relative Bioavailability of Three Different Oral Formulations of BI 764198 Including the Investigation of Food Effect on the Tablet Formulation in Healthy Male and Female Subjects (an Open-label, Randomised, Four-way Crossover Trial)
CTIS2022-502327-22-00
- 1434-0016
100 项与 BI-764198 相关的临床结果
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100 项与 BI-764198 相关的转化医学
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100 项与 BI-764198 相关的专利（医药）
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2
项与 BI-764198 相关的文献（医药）2025-05-04EXPERT OPINION ON INVESTIGATIONAL DRUGS
A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men
Article
作者: Tachibana, Yoshifumi ; Retlich, Silke ; Soleymanlou, Nima ; Sarashina, Akiko ; Yonemura, Takuma
BACKGROUND:
BI 764198 is a selective, oral transient receptor potential cation channel, subfamily C, member 6 inhibitor under investigation for focal segmental glomerulosclerosis.
RESEARCH DESIGN AND METHODS:
Phase I study in 44 Japanese male volunteers. Single dose part: BI 764198 20 mg (n = 6) vs. placebo (n = 2); multiple dose part: BI 764198 40, 80, or 160 mg (n = 9 each) or placebo (n = 9) as a single dose then multiple daily dosing for 2 weeks. Primary endpoint: participants with drug-related adverse events (DRAEs); secondary endpoints: pharmacokinetic.
RESULTS:
DRAEs were reported in 20.5% (9/44) of participants (total BI 764198 21.2% [7/33]; placebo 18.2% [2/11]), mostly diarrhea (total BI 764198 15.2% [5/33]; placebo 18.2% [2/11]) and headache (BI 764198 80 mg 11.1% [1/9]; BI 764198 160 mg 33.3% [3/9]). BI 764198 exposure increased near dose proportionally to 80 mg and was slightly higher than anticipated with 160 mg. Pharmacokinetics were similar in Asians and non-Asians after accounting for body weight. Limitations include small sample size per dose and short trial duration.
CONCLUSIONS:
BI 764198 was well tolerated; exposure increased near dose proportionally to 80 mg, as previously observed in predominantly White volunteers.
CLINICAL TRIAL REGISTRATION:
This study was registered on Clinical Trials.gov, identifier NCT04665700.
2023-08-01Thorax
TRPC6 inhibitor (BI 764198) to reduce risk and severity of ARDS due to COVID-19: a phase II randomised controlled trial
Article
作者: Diaz, George A ; Welte, Tobias ; Estrada, Vicente ; Soleymanlou, Nima ; Lacamera, Peter ; Gupta, Abhya ; McAuley, Danny Francis ; Ware, Lorraine B ; Kaste, Renee ; Choi, Wansuk
Background:
Despite the availability of COVID-19 vaccinations, there remains a need to investigate treatments to reduce the risk or severity of potentially fatal complications of COVID-19, such as acute respiratory distress syndrome (ARDS). This study evaluated the efficacy and safety of the transient receptor potential channel C6 (TRPC6) inhibitor, BI 764198, in reducing the risk and/or severity of ARDS in patients hospitalised for COVID-19 and requiring non-invasive, supplemental oxygen support (oxygen by mask or nasal prongs, oxygen by non-invasive ventilation or high-flow nasal oxygen).
Methods:
Multicentre, double-blind, randomised phase II trial comparing once-daily oral BI 764198 (n=65) with placebo (n=64) for 28 days (+2-month follow-up). Primary endpoint: proportion of patients alive and free of mechanical ventilation at day 29. Secondary endpoints: proportion of patients alive and discharged without oxygen (day 29); occurrence of either in-hospital mortality, intensive care unit admission or mechanical ventilation (day 29); time to first response (clinical improvement/recovery); ventilator-free days (day 29); and mortality (days 15, 29, 60 and 90).
Results:
No difference was observed for the primary endpoint: BI 764198 (83.1%) versus placebo (87.5%) (estimated risk difference –5.39%; 95% CI –16.08 to 5.30; p=0.323). For secondary endpoints, a longer time to first response (rate ratio 0.67; 95% CI 0.46 to 0.99; p=0.045) and longer hospitalisation (+3.41 days; 95% CI 0.49 to 6.34; p=0.023) for BI 764198 versus placebo was observed; no other significant differences were observed. On-treatment adverse events were similar between trial arms and more fatal events were reported for BI 764198 (n=7) versus placebo (n=2). Treatment was stopped early based on an interim observation of a lack of efficacy and an imbalance of fatal events (Data Monitoring Committee recommendation).
Conclusions:
TRPC6 inhibition was not effective in reducing the risk and/or severity of ARDS in patients with COVID-19 requiring non-invasive, supplemental oxygen support.
Trial registration number:
NCT04604184.
100 项与 BI-764198 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 |
|---|---|---|---|---|
| 局灶性节段性肾小球硬化症 | 临床3期 | 美国 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 中国 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 日本 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 阿根廷 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 澳大利亚 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 比利时 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 巴西 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 克罗地亚 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 丹麦 | 2025-12-05 | |
| 局灶性节段性肾小球硬化症 | 临床3期 | 法国 | 2025-12-05 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 54 | 糧醖餘願築獵憲積夢醖(窪艱衊簾廠糧壓壓範齋) = 1 participant (16.7%) experienced diarrhea 鬱鏇繭膚繭壓蓋齋繭鏇 (淵醖願醖鬱觸醖襯製獵 ) 更多 | 积极 | 2025-06-08 | |||
Placebo | |||||||
临床1期 | TRPC6 | 44 | 餘壓憲廠醖繭觸獵遞繭(獵製艱糧夢遞艱膚積壓) = 觸繭鏇艱觸憲獵壓鏇觸 鏇膚構構鑰糧獵網簾衊 (壓壓衊繭鏇鑰觸選鹹製 ) 更多 | - | 2025-05-04 | ||
Placebo | 餘壓憲廠醖繭觸獵遞繭(獵製艱糧夢遞艱膚積壓) = 繭積蓋鏇遞顧醖選鑰鑰 鏇膚構構鑰糧獵網簾衊 (壓壓衊繭鏇鑰觸選鹹製 ) 更多 | ||||||
临床2期 | - | 衊糧廠壓廠遞廠艱廠鏇(鹽淵觸艱齋觸觸衊製簾): days = 3.41 (95% CI, 0.49 ~ 6.34) 更多 | 不佳 | 2023-04-06 | |||
Placebo | |||||||
临床2期 | 133 | (BI 764198 Treatment Group) | 構窪製齋構繭顧範膚廠 = 範齋醖觸艱夢願鏇衊積 積鹽醖糧鏇壓醖鹽窪淵 (鹹鬱願醖網衊夢蓋窪積, 夢艱齋範鏇願膚糧積顧 ~ 範壓觸蓋範構夢廠齋鹽) 更多 | - | 2022-04-11 | ||
Placebo (Placebo) | 構窪製齋構繭顧範膚廠 = 鑰壓膚艱積鏇蓋淵鏇齋 積鹽醖糧鏇壓醖鹽窪淵 (鹹鬱願醖網衊夢蓋窪積, 築憲鏇襯衊醖築願遞窪 ~ 餘鏇範鑰鏇淵壓選鹽襯) 更多 |
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