Drugs / PEGLOXENATIDE
PEGLOXENATIDE
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT02461914 | Aug → Dec 2015 | — | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02472236 | Jun → Sep 2015 | — | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02451527 | May → Sep 2015 | — | First Affiliated Hospital Xi'an Jiaotong University | Completed | No outcome recorded |
| Phase 1 | NCT02447601 | Mar → May 2015 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02467790 | Feb 2015 → Mar 2016 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01965496 | Mar 2012 → Mar 2013 | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01976858 | Jun → Sep 2011 | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01965509 | May 2012 → Aug 2013 | type 2 diabetes mellitus | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02477865 | Mar 2014 → May 2016 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02477969 | Feb 2014 → Jun 2016 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-05-11 | Hansoh BioMedical R&D Company | Results 翰森制药 | 孚来美®两项研究成果亮相欧洲内分泌学大会，心肾获益再添实证 hansoh.cn ↗
研究提示，在真实世界中，对于已合并心血管疾病或高危因素的T2DM患者，采用孚来美®联合SGLT2i方案较SGLT2i单药可进一步改善心血管结局. |
| 2026-03-30 | Hansoh BioMedical R&D Company | Results ECIM 2026 | 孚来美®两项心血管研究入选，中国原研GLP-1RA优势显著 hansoh.cn ↗
洛塞那肽显著降低主要不良心血管事件（3P-MACE，包括全因死亡、非致死性心肌梗死、非致死性卒中）风险达42%（HR=0. 58，p=0. 007）. |
| 2025-05-16 | Hansoh BioMedical R&D Company | Results J Diabetes Investig | 研究首次阐明孚来美®改善T2DM胰岛素抵抗和脂质代谢紊乱分子机制 hansoh.cn ↗
结果发现，孚来美®具有显著改善胰岛素抵抗、纠正脂质代谢紊乱、抑制炎症与氧化应激等作用，并可通过调控SRA/CNBP/ROCK2轴改善T2DM. |
| 2025-03-31 | Hansoh BioMedical R&D Company | Results INT J MOL SCI |翰森制药孚来美®通过双重机制加速糖尿病伤口愈合 hansoh.cn ↗
然而，接受孚来美®治疗的糖尿病小鼠相比未接受治疗的糖尿病小鼠的愈合速度明显提升. |
| 2024-08-08 | Hansoh BioMedical R&D Company | Results GLP-1RA真实世界研究成果在国际期刊发表，翰森制药孚来美®为DKD患者带来更优选择 hansoh.cn ↗
值得注意的是，尽管使用聚乙二醇洛塞那肽治疗的患者数量最多，但其胃肠道反应的总发生率（17. 6%vs30. 6%~51%）和低血糖发生率（3. 1%vs8. 2%~11. 5%）均低于其它GLP-1RA. |
| 2024-07-22 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results HANSOH PHARMA PUBLISHED THE FIRST RANDOMIZED CLINICAL EVIDENCE OF FULAIMEI IN TREATING DIABETIC KIDNEY DISEASE hspharm.com ↗
The data showed that PEG loxenatide is as effective as dapagliflozin in improving urine protein levels in patients with mild-to-moderate DKD and offers superior benefits in improving lipid profiles. |
| 2024-07-22 | Hansoh BioMedical R&D Company | Results 翰森制药创新药孚来美®首个治疗糖尿病肾病的临床证据发表 hansoh.cn ↗
临床研究结果显示，治疗24周后，聚乙二醇洛塞那肽组和达格列净组的UACR自基线分别平均下降29. 3%和31. 8%，无统计学显著差异（p = 0. 336），意味着两者在改善尿蛋白方面的疗效相当. |
| 2023-01-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S SEVERAL INNOVATIVE DRUGS AND NEW INDICATIONS WERE ADDED TO THE 2022 NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
Hansoh Pharma's first Chinese original chronic myeloid leukemia (CML) drug Hansoh Xinfu (Flumatinib Mesylate Tablets) and first Chinese original long-acting GLP-1 hypoglycemic drug Fulaimei (Polyethylene Glycol Loxenatide Injection) have been successfully renewed in the National Reimbursement Drug List through negotiation. |
| 2020-12-28 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory PROMISING PROSPECTS: HANSOH PHARMA'S CLASS 1 INNOVATIVE DRUGS, AMEILE, HANSOH XINFU AND FULAIMEI, INCLUDED IN CHINA’S NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
Hansoh Pharma's Ameile (Almonertinib Mesylate Tablets), Hansoh Xinfu (Flumatinib Mesylate Tablets) and Fulaimei (Polyethylene Glycol Loxenatide Injection) are included. |
All press releases naming this drug 9 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PEGLOXENATIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802213 ↗ |
| Known as | Peg-40 kd-loxenatide | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802213 ↗ |
| Known as | PEGylated Loxenatide | “Evaluating PEGylated Loxenatide Injection（PEX168）in Monotherapy of Type 2 Diabetes Mellitus” NCT02477865 ↗ |
| Known as | PEX168 | “Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM.” PMID 31396983 ↗ Dec 2019 |
| Known as | Polyethylene Glycol Loxenatide | “Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).” NCT01976858 ↗2“Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM.” PMID 31396983 ↗ Dec 2019 “Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue” NCT01965509 ↗ |
| Modality | Peptide | “a new human glucagon-like peptide 1 (GLP-1) analogue” NCT01965496 ↗ |
| Route | Subcutaneous | “A injection administered subcutaneously” NCT01965496 ↗ |