预约演示
更新于：2026-04-02
Bevurogant
更新于：2026-04-02
概要
基本信息
权益机构- |
最高研发阶段临床前 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评- |
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结构/序列
分子式C26H28N8O3S |
InChIKeyHVVHIBHBDCYLDI-HNNXBMFYSA-N |
CAS号1817773-66-2 |
关联
15
项与 Bevurogant 相关的临床试验NCT04680676
A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Proof-of-concept Trial of BI 730357 Given for 12 Weeks in Patients With Active Psoriatic Arthritis
NCT04679948
The Effect of Multiple Doses of BI 730357 on the Single Dose Pharmacokinetics of Caffeine, Warfarin, Omeprazole and Midazolam Administered Orally as a Cocktail in Healthy Subjects (an Open-label, Two-period Fixed Sequence Design Trial)
EUCTR2019-001684-77-HU
A 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis
100 项与 Bevurogant 相关的临床结果
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100 项与 Bevurogant 相关的转化医学
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100 项与 Bevurogant 相关的专利（医药）
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7
项与 Bevurogant 相关的文献（医药）2025-08-01JOURNAL OF INVESTIGATIVE DERMATOLOGY
Phase II Randomized Trial of BI 730357, an Oral RORγt Inhibitor, for Moderate-to-Severe Plaque Psoriasis
Article
作者: Papp, Kim A ; Gooderham, Melinda J ; Korell, Julia ; Mrowietz, Ulrich ; Sofen, Howard ; Drda, Kristin ; Flack, Mary ; Gu, Hui ; Kadus, Werner ; Vangerow, Harald
TRIAL DESIGN:
This 2-part, double-blinded trial assessed the RORγt inhibitor BI 730357 in plaque psoriasis.
METHODS:
In part 1, patients were randomized 2:2:2:2:1 to 25, 50, 100, and 200 mg BI 730357 or placebo once daily (fasting conditions); nonresponders were switched to higher doses. In part 2, a separate patient set was randomized 4:4:1 to receive BI 730357 (400 mg once daily, 200 mg twice daily) or a placebo (fed conditions). Patients from parts 1 and 2 could enter a long-term extension trial. Coprimary endpoints included ≥75% reduction from baseline in PASI75 and static Physician's Global Assessment score of 0/1 (clear/almost clear) at week 12.
RESULTS:
In total, 274 patients were treated (178 [part 1] and 96 [part 2]). In part 1, 12 (30.0%) patients achieved PASI75 (P = .0062), and 11 (27.5%) achieved static Physician's Global Assessment of 0/1 (P = .0095) with BI 730357 200 mg versus none receiving placebo. Exposure-response relationship plateaued at ≥200 mg once daily BI 730357. Drug-related adverse events occurred in ≤15.8% of patients. Of 165 patients who entered the long-term extension, 93 (56.4%) achieved PASI75 during treatment, and ≤18.5% experienced a drug-related adverse event.
CONCLUSIONS:
BI 730357 was well tolerated, with moderate efficacy versus placebo in plaque reduction (clinicaltrials.gov: NCT03635099 and NCT03835481).
2025-08-01JOURNAL OF INVESTIGATIVE DERMATOLOGY
Revisiting RORγt Inhibition in Plaque Psoriasis: Lessons Learned from BI 730357
Article
作者: Bunick, Christopher G ; Akbarialiabad, Hossein
2024-02-01Clinical pharmacology in drug development
The Effect of BI 730357 (Retinoic Acid‐Related Orphan Receptor Gamma t Antagonist, Bevurogant) on the Pharmacokinetics of a Transporter Probe Cocktail, Including Digoxin, Furosemide, Metformin, and Rosuvastatin: An Open‐Label, Non‐randomized, 2‐Period Fixed‐Sequence Trial in Healthy Subjects
Article
作者: Fenglei Huang ; Mary Flack ; HeeJae Choi
Abstract:
Evaluating Drug‐Drug Interactions (DDIs) for new investigational compounds requires several trials evaluating different drugs with different transporter specificities. By using a cocktail of drugs with different transporter specificities, a single trial could evaluate the pharmacokinetics (PKs) of each cocktail drug simultaneously, reducing the number of clinical DDI trials required for clinical development. We aimed to investigate the effect of steady‐state Boehringer Ingelheim (BI) 730357 (bevurogant) on the PKs of a validated and optimized 4‐component transporter cocktail. This open‐label, non‐randomized, 2‐period fixed‐sequence phase I trial compared transporter cocktail (0.25 mg digoxin/1 mg furosemide/10 mg metformin hydrochloride/10 mg rosuvastatin) with and without BI 730357 in healthy subjects aged 18‐55 years with body mass index 18.5‐29.9 kg/m2. During reference treatment/period 1, transporter cocktail was administered 90 minutes after breakfast. After a washout period, during test treatment/period 2, BI 730357 was dosed twice daily for 13 days, with transporter cocktail administered on day 1. The primary endpoints were the area under the concentration‐time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0‐∞) and the maximum measured concentration of the analyte in plasma (Cmax), and the secondary endpoint was the area under the concentration‐time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0‐tz). Steady‐state BI 730357 increased digoxin (+48% to +94%), minimally affected metformin (−2% to −9%), furosemide (+12% to +18%), and rosuvastatin (+19% to +39%) exposure. Therefore, no clinically relevant inhibition of transporters OCT2/MATE‐1/MATE‐2K, OAT1/OAT3, OATP1B1/OATP1B3 was observed. Potential inhibition of breast cancer resistance protein noted as PK parameters of coproporphyrin I/III (OATP1B1/OATP1B3 biomarkers) remained within bioequivalence boundaries while rosuvastatin PK parameters (AUC0‐∞/Cmax/AUC0‐tz) exceeded the bioequivalence boundary. BI 730357 was safe and well tolerated. This trial confirms the usefulness and tolerability of the transporter cocktail consisting of digoxin, furosemide, metformin, and rosuvastatin in assessing drug‐transporter interactions in vivo.
2
项与 Bevurogant 相关的新闻（医药）2024-11-21
·精准药物
孤儿药临床结果信使RNA
100 项与 Bevurogant 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 银屑病关节炎 | 临床2期 | - | 2022-05-02 | |
| 强直性脊柱炎 | 临床2期 | 匈牙利 | 2020-12-07 | |
| 中轴性脊柱关节炎 | 临床2期 | 匈牙利 | 2020-12-07 | |
| 慢性大斑块银屑病 | 临床2期 | 美国 | 2018-09-17 | |
| 慢性大斑块银屑病 | 临床2期 | 加拿大 | 2018-09-17 | |
| 慢性大斑块银屑病 | 临床2期 | 德国 | 2018-09-17 | |
| 斑块状银屑病 | 临床2期 | 美国 | 2018-09-17 | |
| 斑块状银屑病 | 临床2期 | 加拿大 | 2018-09-17 | |
| 斑块状银屑病 | 临床2期 | 德国 | 2018-09-17 | |
| 自身免疫性疾病 | 临床前 | 美国 | 2021-01-05 |
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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 | 274 | BI 730357 25 mg | 艱餘餘窪獵製積製獵衊(襯築餘鑰蓋網鬱糧簾構) = 構遞築簾壓繭衊製醖網 繭齋膚選憲選鹽範窪網 (觸網膚築鑰醖淵遞選齋 ) | 积极 | 2025-08-01 | ||
BI 730357 50 mg | 艱餘餘窪獵製積製獵衊(襯築餘鑰蓋網鬱糧簾構) = 鬱壓憲衊憲窪製蓋範蓋 繭齋膚選憲選鹽範窪網 (觸網膚築鑰醖淵遞選齋 ) | ||||||
临床1期 | - | 6 | 築願築簾鑰鏇築蓋製鹽(夢繭蓋餘願壓廠憲廠壓) = 鑰衊鏇顧鹹顧壓獵顧糧 膚構網餘顧醖襯襯鏇積 (製遞夢範顧憲餘簾窪簾, 醖膚觸積顧築齋壓廠襯 ~ 衊構衊膚築鹽遞蓋壓遞) 更多 | - | 2023-07-25 | ||
临床1期 | - | 43 | (50 mg BI 730357 iCF (T1)) | 糧築鏇窪窪構艱獵積顧(構淵觸襯鹹艱膚鬱鹽鹹) = 積選餘觸顧憲鹽積簾壓 範齋築衊齋襯觸範構遞 (壓繭廠憲蓋憲夢鑰鹽艱, NA) 更多 | - | 2023-07-17 | |
(50 mg BI 730357 TF1 (R1)) | 糧築鏇窪窪構艱獵積顧(構淵觸襯鹹艱膚鬱鹽鹹) = 齋廠製鬱蓋艱壓鬱獵憲 範齋築衊齋襯觸範構遞 (壓繭廠憲蓋憲夢鑰鹽艱, NA) 更多 | ||||||
临床1期 | - | 85 | Placebo (Placebo QD) | 構積膚淵窪範醖餘選夢(構壓積顧願蓋鹹壓簾鑰) = 憲構憲壓夢餘範願觸醖 遞窪鹹蓋範鏇廠鏇獵簾 (夢淵遞鬱獵構窪衊鑰廠, 簾窪衊齋遞繭襯膚構窪 ~ 醖簾顧壓蓋齋鬱選鹹餘) 更多 | - | 2023-07-17 | |
(400 mg QD BI 730357) | 構積膚淵窪範醖餘選夢(構壓積顧願蓋鹹壓簾鑰) = 窪衊窪鏇積窪範築醖齋 遞窪鹹蓋範鏇廠鏇獵簾 (夢淵遞鬱獵構窪衊鑰廠, 築網憲鹽糧蓋鏇夢遞壓 ~ 鏇選鏇淵觸網襯製齋選) 更多 | ||||||
临床1期 | - | 14 | (BI 730357 + Itraconazole (T)) | 積構糧壓膚構憲鏇醖艱(廠觸淵廠鬱範構顧獵壓) = 壓蓋鹽積鬱鑰鬱範網簾 壓襯糧餘糧願憲壓淵齋 (鬱鑰遞鏇網鏇構淵廠願, NA) 更多 | - | 2023-07-12 | |
(BI 730357 (R)) | 積構糧壓膚構憲鏇醖艱(廠觸淵廠鬱範構顧獵壓) = 壓淵壓壓獵襯膚餘遞夢 壓襯糧餘糧願憲壓淵齋 (鬱鑰遞鏇網鏇構淵廠願, NA) 更多 | ||||||
临床1期 | - | 6 | [C-14\] BI 730357+BI 730357 BS (BI 730357) | 遞鑰蓋糧蓋鬱築糧鹹廠(簾鏇餘蓋淵築蓋衊艱範) = 積築壓顧鹹觸顧構鹹廠 顧顧夢衊壓繭觸夢獵選 (遞鬱壓糧夢壓憲遞憲選, 19.2) 更多 | - | 2023-07-12 | |
(14C-BI 730357-EQ and BI 730357) | 衊餘製憲鑰鬱膚鑰構選(衊壓鹽網鹹築膚積遞衊) = 衊構鬱積積壓憲繭醖製 齋鏇鹹蓋蓋積膚醖顧窪 (衊醖醖製顧壓鑰壓鑰艱, 16.5) 更多 | ||||||
临床1期 | - | 24 | Placebo | 簾齋餘構廠獵簾構鬱襯 = 醖壓蓋遞鬱築糧網齋衊 餘壓憲淵簾顧餘繭鏇淵 (齋餘繭鹹衊齋衊網蓋鏇, 壓構齋夢襯鹽廠鑰網願 ~ 膚願夢艱範鹹餘鹹鬱糧) 更多 | - | 2023-07-12 |
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