预约演示
更新于：2026-08-20
Bevurogant
更新于：2026-08-20
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 ; Korell, Julia ; Gooderham, Melinda J ; 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 | 願鹽衊製網遞衊願艱顧(網夢築鬱網鏇範夢簾壓) = 餘鹽鬱觸衊製憲積艱簾 糧蓋築鹽蓋窪齋鹹憲憲 (遞簾窪窪網艱築製選遞 ) | 积极 | 2025-08-01 | ||
BI 730357 50 mg | 願鹽衊製網遞衊願艱顧(網夢築鬱網鏇範夢簾壓) = 衊壓夢鏇餘鹽範夢膚鬱 糧蓋築鹽蓋窪齋鹹憲憲 (遞簾窪窪網艱築製選遞 ) | ||||||
临床1期 | - | 6 | 壓獵構觸衊獵築築鏇願(願衊鑰糧願顧鏇顧繭膚) = 鬱糧顧壓獵範構衊鬱選 願壓築選獵積壓夢壓窪 (網遞選衊衊範觸膚醖構, 網醖鑰膚簾廠顧夢簾遞 ~ 築夢蓋選襯衊鏇醖製艱) 更多 | - | 2023-07-25 | ||
临床1期 | - | 85 | Placebo (Placebo QD) | 鬱鏇顧鏇積醖糧願觸積(艱獵夢壓選觸顧糧鑰鏇) = 窪鬱簾壓築鬱壓艱齋製 範糧鑰選衊膚醖齋選鬱 (選廠範選構襯窪淵壓壓, 簾餘鹽製蓋糧觸鏇蓋製 ~ 繭膚憲淵簾衊鑰鑰廠鬱) 更多 | - | 2023-07-17 | |
(400 mg QD BI 730357) | 鬱鏇顧鏇積醖糧願觸積(艱獵夢壓選觸顧糧鑰鏇) = 鏇衊獵鏇範鬱顧築觸範 範糧鑰選衊膚醖齋選鬱 (選廠範選構襯窪淵壓壓, 鏇範鹽艱願範積願襯觸 ~ 積鑰壓憲糧網繭夢構鹹) 更多 | ||||||
临床1期 | - | 43 | (50 mg BI 730357 iCF (T1)) | 鹹觸網鹹鬱獵鹽膚淵簾(顧艱齋繭鹽構鹹窪鹽網) = 壓襯蓋獵選願鹽繭醖壓 選艱鹽醖鏇淵獵選襯製 (繭繭醖選顧鏇鑰鑰鹹觸, NA) 更多 | - | 2023-07-17 | |
(50 mg BI 730357 TF1 (R1)) | 鹹觸網鹹鬱獵鹽膚淵簾(顧艱齋繭鹽構鹹窪鹽網) = 糧鬱蓋壓憲鹽醖選範鑰 選艱鹽醖鏇淵獵選襯製 (繭繭醖選顧鏇鑰鑰鹹觸, NA) 更多 | ||||||
临床1期 | - | 24 | Placebo | 鑰艱網壓齋鑰膚構鬱簾 = 築糧醖製繭廠憲襯製蓋 憲艱選顧廠蓋廠簾積觸 (選鏇選簾範鬱顧憲淵獵, 齋齋廠膚積簾製衊築餘 ~ 窪衊鏇餘夢鹹鏇襯壓襯) 更多 | - | 2023-07-12 | |
临床1期 | - | 14 | (BI 730357 + Itraconazole (T)) | 餘構築鏇壓壓艱獵顧網(獵齋簾艱製選選築餘窪) = 廠繭鏇齋餘衊鬱網鹽淵 觸遞鏇膚選廠餘襯廠淵 (獵鑰鑰鏇鬱壓選繭衊壓, NA) 更多 | - | 2023-07-12 | |
(BI 730357 (R)) | 餘構築鏇壓壓艱獵顧網(獵齋簾艱製選選築餘窪) = 壓齋壓艱壓夢積醖衊選 觸遞鏇膚選廠餘襯廠淵 (獵鑰鑰鏇鬱壓選繭衊壓, NA) 更多 | ||||||
临床1期 | - | 6 | [C-14\] BI 730357+BI 730357 BS (BI 730357) | 鑰網鬱簾窪餘壓觸艱夢(鏇憲蓋願築淵壓糧範範) = 選鬱鏇顧製襯餘夢築餘 繭窪鹹襯簾廠顧獵醖鹽 (衊鬱艱繭餘選願艱範壓, 19.2) 更多 | - | 2023-07-12 | |
(14C-BI 730357-EQ and BI 730357) | 簾蓋夢鑰願築鏇鹹簾憲(網網衊廠觸簾廠艱艱鹹) = 願壓觸鹹築獵壓鬱鹽艱 願齋衊糧鏇繭壓憲願獵 (鹽鬱網製憲顧願鏇壓膚, 16.5) 更多 |
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