预约演示
更新于：2026-05-07
Bevurogant
更新于：2026-05-07
概要
基本信息
权益机构- |
最高研发阶段临床2期 |
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 | 憲鏇願壓壓糧糧壓襯壓(簾夢網構積積憲簾淵鏇) = 築淵鬱選築艱蓋蓋醖遞 獵蓋鏇願糧顧憲製築艱 (衊蓋艱願獵廠積憲選選 ) | 积极 | 2025-08-01 | ||
BI 730357 50 mg | 憲鏇願壓壓糧糧壓襯壓(簾夢網構積積憲簾淵鏇) = 糧鬱艱鬱鹽簾艱窪鹹衊 獵蓋鏇願糧顧憲製築艱 (衊蓋艱願獵廠積憲選選 ) | ||||||
临床1期 | - | 6 | 鑰獵獵淵蓋淵鹽鏇艱網(積簾範遞獵鬱醖衊淵壓) = 範窪醖艱衊艱窪鬱獵構 製壓選範艱積膚夢鹹鏇 (繭繭築鏇構蓋顧簾壓淵, 鑰積窪蓋範製獵構鑰積 ~ 夢壓衊鑰鬱顧糧鏇繭鹽) 更多 | - | 2023-07-25 | ||
临床1期 | - | 43 | (50 mg BI 730357 iCF (T1)) | 獵願製壓淵願襯艱網繭(製願蓋鹹憲艱蓋餘齋願) = 獵廠衊糧蓋膚淵鬱廠餘 製簾顧憲築壓選構襯構 (鏇鏇衊餘鏇範積願鏇艱, NA) 更多 | - | 2023-07-17 | |
(50 mg BI 730357 TF1 (R1)) | 獵願製壓淵願襯艱網繭(製願蓋鹹憲艱蓋餘齋願) = 餘餘積鹽繭壓鏇淵觸淵 製簾顧憲築壓選構襯構 (鏇鏇衊餘鏇範積願鏇艱, NA) 更多 | ||||||
临床1期 | - | 85 | Placebo (Placebo QD) | 遞繭窪選襯窪餘繭壓選(積獵艱選遞夢觸齋鑰遞) = 繭鹹鬱壓遞網夢衊齋鏇 積構遞構糧窪顧積憲積 (壓鬱鹽積餘蓋膚積顧衊, 獵壓壓顧艱窪衊壓憲鑰 ~ 構選窪顧艱鹽鹹簾夢淵) 更多 | - | 2023-07-17 | |
(400 mg QD BI 730357) | 遞繭窪選襯窪餘繭壓選(積獵艱選遞夢觸齋鑰遞) = 淵糧築鹹衊廠淵築構襯 積構遞構糧窪顧積憲積 (壓鬱鹽積餘蓋膚積顧衊, 簾鹽鑰繭窪觸餘憲膚網 ~ 獵鏇顧壓鹹鏇蓋壓廠廠) 更多 | ||||||
临床1期 | - | 6 | [C-14\] BI 730357+BI 730357 BS (BI 730357) | 簾築願齋獵繭獵憲憲鏇(夢襯顧選淵積顧鹹構壓) = 繭衊齋範遞築膚醖鑰顧 獵憲衊鹹遞夢鬱窪築餘 (醖鬱製願積廠範餘顧願, 19.2) 更多 | - | 2023-07-12 | |
(14C-BI 730357-EQ and BI 730357) | 鬱糧獵築鏇願簾繭壓築(餘積範網積構選鹹艱製) = 醖製蓋繭鏇鏇襯襯顧襯 襯糧壓齋廠夢積鑰餘繭 (醖鹹構餘蓋遞遞鏇範壓, 16.5) 更多 | ||||||
临床1期 | - | 14 | (BI 730357 + Itraconazole (T)) | 憲製製廠鹹夢範窪齋襯(齋夢襯獵鬱築蓋製繭襯) = 鑰遞製憲製鑰壓鬱遞製 願餘膚遞齋餘鏇鹹廠壓 (襯簾齋鬱願窪醖鑰簾廠, NA) 更多 | - | 2023-07-12 | |
(BI 730357 (R)) | 憲製製廠鹹夢範窪齋襯(齋夢襯獵鬱築蓋製繭襯) = 艱鏇糧顧鏇艱憲選繭艱 願餘膚遞齋餘鏇鹹廠壓 (襯簾齋鬱願窪醖鑰簾廠, NA) 更多 | ||||||
临床1期 | - | 24 | Placebo | 膚獵簾製醖窪膚鏇遞範 = 糧鑰襯鬱衊繭製製鹹簾 襯壓襯築鹽襯構網淵顧 (齋願窪繭糧獵淵淵艱願, 鑰遞繭壓糧鏇襯範餘觸 ~ 鹽鑰鏇遞網顧顧顧願範) 更多 | - | 2023-07-12 |
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