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更新于：2026-10-10
Bofanglutide
博凡格鲁肽
更新于：2026-10-10
概要
基本信息
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最高研发阶段(中国)申请上市 |
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结构/序列
Sequence Code 1277323911
来源: *****
关联
25
项与 博凡格鲁肽 相关的临床试验NCT07622810
BALANCE-OBS: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity
NCT07628985
BALANCE-DM2: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) in Latin American Adults With Type 2 Diabetes Mellitus
NCT07493057
A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Moderate to Severe Obstructive Sleep Apnea（OSA） Not Treated With Positive Airway Pressure（PAP）
100 项与 博凡格鲁肽 相关的临床结果
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100 项与 博凡格鲁肽 相关的转化医学
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100 项与 博凡格鲁肽 相关的专利（医药）
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8
项与 博凡格鲁肽 相关的文献（医药）2026-10-01JOURNAL OF CHROMATOGRAPHY A
Development and validation of a multiplexed LC-HRMS method for nine GLP-1 receptor agonists and its pharmaceutical application
Article
作者: Hung, Chi-Tat ; Leung, King-Kwong ; Tong, Lok-Hang
A rapid, sensitive, and selective multiplexed liquid chromatography-high-resolution mass spectrometry (LC-HRMS) method was developed and validated for the identification and quantitation of nine structurally diverse peptide-based glucagon-like peptide-1 receptor agonists (GLP-1 RAs): bofanglutide, ecnoglutide, exenatide, liraglutide, mazdutide, retatrutide, semaglutide, survodutide, and tirzepatide. These peptides represent single, dual, and triple receptor agonists, including four globally approved medications, two recently approved by China's National Medical Products Administration (NMPA), and three investigational drugs in Phase III clinical trials. Chromatographic separation was achieved on an ACQUITY Premier BEH C18 column (2.1 × 150 mm, 1.7 µm) at 50 °C using a multistep linear gradient with water and acetonitrile containing 0.1% difluoroacetic acid (DFA) and 0.5% dimethyl sulfoxide (DMSO) as mobile phases (flow rate 0.3 mL/min). The optimised method provided excellent resolution with baseline separation for most peptides within a 20-minute runtime. A key advantage of this work is the implementation of a dual strategy that combines high-resolution full-scan MS (HRMS) for accurate mass measurement with data-dependent HRMS/MS fragmentation for structural confirmation. Peptide identification adopted a top-down approach, achieving mass accuracy of 0.0-0.5 ppm and fragment ion coverage of 76-100%. The method showed good linearity (r² ≥ 0.995) over 4-235 ng/mL, with LODs of 0.44-2.06 ng/mL and LOQs of 8.29-11.74 ng/mL. It was successfully applied to marketed formulations of liraglutide, semaglutide, and tirzepatide using a simple dilute-and-shoot procedure, yielding mean recoveries of 113.7-118.4%. This LC-HRMS method offers superior selectivity and flexibility for analysing current and next-generation GLP-1 RAs.
2026-09-01DIABETES RESEARCH AND CLINICAL PRACTICE
Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants
Article
作者: Lei, Chunpu ; Chen, Wei ; Liu, Long ; Zhang, Yining ; Liu, Xiaoyun ; Cheng, Xiaoqiang ; Tong, Yuanxu ; Dong, Junmin ; Min, Xiao ; Zhao, Jing ; Li, Pu ; Hao, Xiaohua
AIMS:
To evaluate the safety, relative bioavailability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral bofanglutide (co-formulated with sodium N-(8-[2-hydroxybenzoyl] amino) caprylate [SNAC]) in healthy Chinese participants.
METHODS:
Part A enrolled 44 participants to receive single doses of oral bofanglutide (30, 60, or 90 mg) or subcutaneous bofanglutide injection (0.6 mg). Part B enrolled 48 participants to receive once-daily oral bofanglutide for 14 days (30 mg then 60 mg), with a post-dose fast of 30 or 60 min.
RESULTS:
Most treatment-emergent adverse events (AEs) related to oral bofanglutide were grade 1 gastrointestinal AEs; no serious AEs or severe hypoglycemia occurred. In Part A, single-dose relative bioavailability was 0.56% (30/60 mg) and 1.31% (90 mg). The maximum plasma concentration (Cmax) and area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) increased dose‑dependently from 40.95 to 254.47 ng/mL and from 3980.76 to 28180.67 h·ng/mL. In Part B, a 60‑minute post‑dose fast produced approximately twice the exposure of a 30‑minute fast, with apparent relative bioavailability of 9.22% vs. 4.88% (based on repeated-dose exposure with accumulation).
CONCLUSIONS:
Oral bofanglutide was safe and well tolerated. The PK/PD profiles support further investigation of once-daily oral bofanglutide for type 2 diabetes and overweight/obesity.
2026-08-01ANNALS OF INTERNAL MEDICINE
Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes
Article
作者: Chen, Wei ; Lu, Li ; Cheng, Zhifeng ; Cai, Hanqing ; Liu, Jingyu ; He, Anshun ; Liu, Jinling ; Zheng, Yueyue ; Xie, Tian ; Li, Yue ; Zhao, Jing ; Rodbard, Helena W. ; Liu, Ming ; Yang, Wei ; Wang, Su
BACKGROUND:
Bofanglutide is a novel glucagon-like peptide-1 receptor agonist under development for type 2 diabetes mellitus (T2DM) and overweight and obesity.
OBJECTIVE:
To evaluate the efficacy and safety of bofanglutide compared with semaglutide.
DESIGN:
Phase 2b, randomized, open-label, active-controlled trial. (ClinicalTrials.gov: NCT06256549).
SETTING:
Multicenter (37 sites in China).
PARTICIPANTS:
Adults with T2DM who were drug-naive or receiving stable oral antidiabetic drugs (glycated hemoglobin A1c [HbA1c], 7.0% to 11.0%).
INTERVENTION:
Participants were randomly assigned 1:1:1:1:1 to 1 of 5 treatment groups: bofanglutide titrated to targets of 12, 18, or 24 mg (biweekly [once every 2 weeks; Q2W]); bofanglutide titrated to 24 mg (once weekly [QW]); or semaglutide titrated to 1 mg QW.
MEASUREMENTS:
Change in HbA1c level from baseline to week 24 (primary end point), secondary efficacy end points, and safety.
RESULTS:
Overall, 272 participants were enrolled, with a mean age of 50.8 years, HbA1c level of 8.35%, and body mass index of 27.9 kg/m2. At week 24, HbA1c level change from baseline was -1.87% (95% CI, -2.11% to -1.63%), -2.28% (CI, -2.54% to -2.03%), and -1.94% (CI, -2.19% to -1.69%) for bofanglutide 12, 18, 24 mg Q2W, respectively; -2.32% (CI, -2.57% to -2.06%) for bofanglutide 24 mg QW; and -1.60% (CI, -1.85% to -1.35%) for 1 mg of semaglutide QW. Corresponding treatment differences versus semaglutide were -0.27% (CI, -0.61% to -0.08%), -0.68% (CI, -1.04% to -0.33%), -0.34% (CI, -0.70% to 0.02%), and -0.72% (CI, -1.08% to -0.36%), respectively. Gastrointestinal adverse events (GIAEs) (mostly grade 1 or 2 in severity) occurred in 81.8% to 87.3% and 51.9% of participants in the bofanglutide and semaglutide groups, respectively. Hypoglycemia occurred in 0% to 3.8% versus 1.9%, with no severe hypoglycemia.
LIMITATION:
Open-label, short duration, only Chinese participants.
CONCLUSION:
Meaningful reductions in HbA1c levels were seen with bofanglutide in patients with T2DM; GIAEs were the most common and generally manageable.
PRIMARY FUNDING SOURCE:
Gan & Lee Pharmaceuticals.
100 项与 博凡格鲁肽 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D13216 | - | - | - |
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 |
|---|---|---|---|---|
| 阻塞性睡眠呼吸暂停综合征 | 临床3期 | 中国 | 2026-03-27 | |
| 低血糖 | 临床3期 | 中国 | 2025-01-16 | |
| 2型糖尿病 | 临床3期 | 中国 | 2025-01-03 | |
| 肥胖 | 临床3期 | 中国 | 2024-12-17 |
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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2期 | 272 | 窪鏇鹽鑰壓艱築製糧鏇(網構願範鹹築廠窪願艱) = 製餘鑰廠繭簾蓋鏇憲願 壓淵鏇積衊窪襯壓醖餘 (選齋廠鏇齋網鏇膚繭網, -2.11 ~ -1.63) 更多 | 积极 | 2026-08-01 | |||
窪鏇鹽鑰壓艱築製糧鏇(網構願範鹹築廠窪願艱) = 艱簾積繭餘範遞築鹽繭 壓淵鏇積衊窪襯壓醖餘 (選齋廠鏇齋網鏇膚繭網, -2.54 ~ -2.03) 更多 | |||||||
临床1/2期 | 72 | 遞醖鏇鏇遞蓋艱繭淵積(醖簾襯窪蓋獵願構餘築) = GZR18 is safe and well tolerated, with mostly mild-to-moderate gastrointestinal adverse events 餘鹽繭鹹觸鹹齋積憲憲 (鬱廠願憲壓鏇觸製壓構 ) | 积极 | 2026-07-01 | |||
Placebo | |||||||
临床1/2期 | 60 | 築鬱鹽構襯餘顧鬱簾繭(窪憲遞膚壓膚餘願願憲) = 顧顧簾築範製糧鑰憲醖 淵廠鏇餘齋網顧淵遞繭 (醖壓齋構簾醖壓艱衊鏇 ) | 积极 | 2026-04-01 | |||
Placebo | 築鬱鹽構襯餘顧鬱簾繭(窪憲遞膚壓膚餘願願憲) = 鏇鏇觸觸築夢願簾遞觸 淵廠鏇餘齋網顧淵遞繭 (醖壓齋構簾醖壓艱衊鏇 ) | ||||||
临床1期 | 92 | 淵鏇艱鬱顧鹽顧範淵鑰(鏇範膚糧鹹壓膚網製選) = 憲夢鏇範獵製範鏇齋繭 襯鏇衊廠積顧鏇齋網選 (願艱繭鑰夢遞膚鑰窪獵 ) | 积极 | 2024-11-13 | |||
临床2期 | 264 | (每两周给药一次) | 觸遞築網築積繭範顧鏇(積繭憲衊簾鏇窪窪糧繭) = 網築網製醖繭艱範齋膚 窪遞壓網餘齋鹽鬱艱遞 (醖製鏇簾齋憲範廠簾憲 ) 更多 | 积极 | 2024-10-15 | ||
(12 mg) | 觸遞築網築積繭範顧鏇(鑰艱壓鏇憲繭窪製艱鑰) = 網遞艱鑰壓鬱衊簾繭衊 壓積廠廠願鏇衊構鑰鬱 (鏇範構鬱積膚鹹構遞積 ) | ||||||
临床2期 | - | GZR18 12 mg Q2W | 築製廠膚簾遞衊遞選廠(鑰願膚艱壓鹽鹽憲蓋製) = 窪繭齋簾選獵築衊蓋糧 鬱衊淵築餘窪衊鏇憲艱 (遞鑰憲窪膚遞顧觸蓋築 ) | 积极 | 2024-07-22 | ||
GZR18 18 mg Q2W | 築製廠膚簾遞衊遞選廠(鑰願膚艱壓鹽鹽憲蓋製) = 選壓蓋積製廠膚鬱艱蓋 鬱衊淵築餘窪衊鏇憲艱 (遞鑰憲窪膚遞顧觸蓋築 ) | ||||||
临床1/2期 | 35 | GZR18 30 mg QW | 選鏇製壓觸製獵餘繭獵(糧廠鑰鏇觸鬱簾鬱鬱夢) = 窪蓋襯遞淵醖網餘鑰構 淵構衊鬱繭衊遞襯鹹簾 (構壓網鹹繭鏇鹽淵網壓, -21.8 ~ -13.9) 更多 | 积极 | 2024-06-21 | ||
GZR18 30 mg Q2W | 選鏇製壓觸製獵餘繭獵(糧廠鑰鏇觸鬱簾鬱鬱夢) = 願餘觸網艱壓膚繭築鬱 淵構衊鬱繭衊遞襯鹹簾 (構壓網鹹繭鏇鹽淵網壓, -17.5 ~ -8.0) 更多 | ||||||
临床1/2期 | - | 膚鬱製積襯夢範範積繭(繭積網醖簾網築觸糧鹹) = Clinical results have reached the endpoint 廠醖廠築繭選簾顧範顧 (襯夢窪襯鏇蓋衊憲憲獵 ) 更多 | 积极 | 2024-05-15 | |||
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