预约演示
更新于：2025-04-06
Apraglutide
阿帕拉格鲁肽
更新于：2025-04-06
概要
基本信息
原研机构 |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)无进展 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 631317673
来源: *****
关联
19
项与 阿帕拉格鲁肽 相关的临床试验NCT06002555
A Randomized Open-label, Single Dose, 3-Period, 6-Sequence, Cross-Over Trial With Washout Periods of at Least 14 Days to Investigate the Relative Bioavailability of Apraglutide in Dual Chamber Syringes Versus the Reference Formulation in Vials Following Subcutaneous Administrations in Healthy Subjects
CTIS2023-504430-22-00
- TA799-018
JPRN-jRCT2031220579
A Phase 1 Study of Apraglutide (Single Dose Study)
100 项与 阿帕拉格鲁肽 相关的临床结果
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100 项与 阿帕拉格鲁肽 相关的转化医学
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100 项与 阿帕拉格鲁肽 相关的专利（医药）
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18
项与 阿帕拉格鲁肽 相关的文献（医药）2024-12-01CLINICAL NUTRITION
Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon–in–continuity: A multicenter, open-label, metabolic balance study
Article
作者: Youssef, Nader N. ; Vermeersch, Pieter ; Bhatnagar, Gauraang ; Peeters, Ronald ; Youssef, Nader N ; Sartoris, Riccardo ; Joly, Francisca ; Jeppesen, Palle Bekker ; Verbiest, Astrid ; Verbeke, Kristin ; Huh, Susanna ; Bolognani, Federico ; Vanslembrouck, Ragna ; Vanuytsel, Tim ; Li, Carrie ; Wauters, Lucas ; Hvistendahl, Mark Krogh ; Menys, Alex
BACKGROUND:
Apraglutide is a novel long-acting GLP-2 analog in development for short bowel syndrome with intestinal failure (SBS-IF). This multicenter, open-label, phase 2 study in SBS-IF and colon-in-continuity (CiC) investigates the safety and efficacy of apraglutide.
METHODS:
This was a 52-week phase 2 metabolic balance study (MBS) in 9 adult patients with SBS-IF-CiC receiving once-weekly subcutaneous apraglutide injections. Safety was the primary endpoint. Secondary endpoints included changes in absorption parameters (MBS at baseline, after 4 weeks with stable parenteral support (PS), and 48 weeks), PS needs (48-week PS adjustment period based on monthly 48-h fluid balances) and intestinal morphology and motility (static and cine MRI at baseline and 4, 24 and 48 weeks).
RESULTS:
PS volume decreased by -4702 mL/week (-52 %; p < 0.001) at week 52. Seven patients (78 %) achieved ≥1 day off PS at week 52. At 4 weeks, fecal output was reduced by 253 g/day (p = 0.013). At 48 weeks, increases in wet weight absorption by 316 g/day (p = 0.039), energy absorption by 1134 kJ/day (p = 0.041) and carbohydrate absorption by 56.1 g/day (p = 0.024) were observed. Moreover, small bowel length increased from 29.7 to 40.7 cm (p = 0.012), duodenal wall thickness increased by 0.8 mm (p = 0.02) and motility in the proximal colon was reduced (p = 0.031). A total of 127 adverse events was reported, which were mostly mild to moderate.
CONCLUSION:
Apraglutide had an acceptable safety profile and was associated with significant reductions in PS needs and days off PS, improvements in intestinal absorption, and structural and functional intestinal changes in patients with SBS-IF-CiC.
CLINICALTRIALS:
gov, Number NCT04964986.
2024-11-05Annals of Transplantation
The Long-Acting Glucagon-Like Peptide-2 Analog Apraglutide Enhances Intestinal Protection and Survival After Chemotherapy and Allogeneic Transplantation in Mice.
Article
作者: Lesage, Sylvie ; Audiger, Cindy ; Delisle, Jean-Sébastien ; Dimitriadou, Violetta ; Minden, Mark D ; Biemans, Barbara ; Chabot-Roy, Geneviève
BACKGROUND The gastrointestinal (GI) barrier can be damaged by chemotherapy or radiation therapy, causing fatigue, malnutrition, sepsis, dose-limiting toxicity, and, occasionally, death. Glucagon-like peptide-2 (GLP-2) promotes mucosal epithelium growth and repair in the GI tract. Here, we examined the GI-protective effects of apraglutide, a long-acting peptide GLP-2 analog, in murine models of chemotherapy, and total body irradiation followed by allogeneic transplantation. MATERIAL AND METHODS The impact of apraglutide on cytarabine or melphalan chemotherapy-induced intestinal damage was assessed in BALB/c mice, and the effect on allogeneic transplantation in BALB/cJ and C57BL/6J mice. Outcomes included survival, and changes in body weight, intestinal function and morphology, including colon length and bacterial composition of the intestinal microbiota. RESULTS Adding apraglutide to chemotherapy significantly improved survival rates and reduced weight loss, with no impact on leukocyte counts (and, therefore, no effect on chemotherapy-induced immunosuppression), compared with chemotherapy alone in mice. These benefits were associated with preservation of the morphological integrity of the GI mucosa, attenuation of the negative impact of cytarabine on the intestinal microbiota, and significant improvement in plasma levels of citrulline. In addition, in a model of irradiation followed by allogeneic transplantation, mice in groups receiving apraglutide had improved survival, reduced weight loss, and increased colon length compared with those that did not. CONCLUSIONS Apraglutide protects intestinal function and improves survival in mice following allogeneic transplantation or chemotherapy with cytarabine or melphalan. The potential effect of apraglutide on chemotherapy efficacy and on engraftment following allogeneic transplantation has been investigated in a parallel manuscript.
2024-09-01CURRENT OPINION IN CLINICAL NUTRITION AND METABOLIC CARE
Intestinal adaptation and rehabilitation in adults with short bowel syndrome
Review
作者: Pironi, Loris
Purpose of review:
Over the past decade, trophic gastrointestinal hormonal factors have been included in the intestinal rehabilitation programs for short bowel syndrome (SBS). Up today the only trophic factor approved for clinical practice is the glucagon-like peptide-2 (GLP-2) analogue, teduglutide. A literature review on the last 2-year data on GLP-2 analogues for the treatment of SBS in adults has been performed.
Recent findings:
Several reports on real-world data on the efficacy and safety of teduglutide treatment for SBS, some case-reports on the use of teduglutide in non-SBS conditions as well as phase 2 trials on new GL-2 analogues on patients with SBS have been retrieved,
Summary:
Real-world data confirmed the teduglutide efficacy not only in weaning off IVS in accurately selected patients but also increased the alert on the risk of development of gastrointestinal polyps related to the drug; the impact of the therapy on patients’ QoL deserves further studies and the cost-utility of the treatment is still uncertain. Some case reports highlighted the potential benefit of treatment with teduglutide in non-SBS gastrointestinal diseases, such as graft-versus-host disease, primary amyloidosis and refractory microscopic colitis. Phase 2 RCTs on safety and efficacy of two new long-acting GLP-2 analogues, glepaglutide and apraglutide, were published, and phase 3 RCTs have been completed.
100 项与 阿帕拉格鲁肽 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 短肠综合征 | 申请上市 | 美国 | 2025-01-29 | |
| 肠衰竭 | 临床3期 | 美国 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 日本 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 阿根廷 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 比利时 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 捷克 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 丹麦 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 法国 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 德国 | 2021-01-26 | |
| 肠衰竭 | 临床3期 | 匈牙利 | 2021-01-26 |
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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 | - | High-dose Apraglutide | 製餘襯襯襯築鹽鏇獵膚(製襯遞構範蓋顧顧憲願) = 願範鏇醖遞夢齋壓築獵 鏇醖觸願願醖築鏇衊鹹 (襯鬱觸製艱繭鹽艱繭蓋 ) 更多 | - | 2024-12-07 | ||
Low-dose Apraglutide | 製餘襯襯襯築鹽鏇獵膚(製襯遞構範蓋顧顧憲願) = 餘餘窪簾網觸遞鹹鹽壓 鏇醖觸願願醖築鏇衊鹹 (襯鬱觸製艱繭鹽艱繭蓋 ) 更多 | ||||||
临床2期 | 9 | 簾窪構觸積廠襯鬱鏇膚(網鏇膚積餘鏇範選窪襯) = A total of 127 adverse events was reported, which were mostly mild to moderate. 衊範鹽範簾網鏇顧淵窪 (鬱顧窪蓋襯繭窪顧鹹願 ) | 积极 | 2024-12-01 | |||
N/A | - | Apraglutide 5mg | 簾積衊齋窪獵獵選簾廠(製鬱襯顧醖構窪廠齋衊) = 壓築鏇築醖壓繭窪積糧 遞淵憲網蓋繭顧網鏇獵 (鹽顧鏇網鏇糧蓋積積夢, 8.8 ~ 94.3) 更多 | - | 2024-10-13 | ||
N/A | - | Apraglutide (APRA) 5mg | 膚齋鏇鑰顧鏇襯遞遞鹽(願鬱獵選壓顧齋積範鏇) = decreased at 4W and 24W, but returned to baseline level at 48W 鏇艱淵廠遞簾鏇鬱鹹夢 (願獵願廠鏇積鑰製膚鬱 ) 更多 | - | 2024-10-13 | ||
N/A | - | Apraglutide (APRA) 5 mg | 餘網壓觸糧鬱鹹鬱網餘(鏇艱餘膚鑰淵餘餘壓醖) = All pts experienced â¥1 adverse event (AE); a total of 127 AEs were reported. Three pts experienced serious AEs. APRA was interrupted for 1 week in one pt with acute cholangitis and restarted successfully to trial completion. 醖網構艱餘膚築艱鑰範 (襯觸淵淵憲蓋壓窪選襯 ) | - | 2024-10-13 | ||
临床3期 | 164 | 範鬱願觸顧獵夢夢鏇憲(遞網製窪鏇觸選顧醖衊) = 簾鹹壓醖窪構艱齋築積 鬱網顧窪鹽鏇鬱積夢鹹 (蓋齋製鏇構膚壓觸鏇廠 ) 达到 更多 | 积极 | 2024-05-21 | |||
临床3期 | 163 | 築糧憲鏇簾襯膚鏇築艱(廠膚獵餘糧鬱膚鹽壓積) = 襯醖醖蓋選鬱簾顧襯鹽 齋憲鹽艱襯艱鹽糧網範 (選壓鏇網製積憲艱衊蓋 ) 达到 更多 | 积极 | 2024-02-29 | |||
placebo | 築糧憲鏇簾襯膚鏇築艱(廠膚獵餘糧鬱膚鹽壓積) = 遞餘齋膚齋鹽構觸膚遞 齋憲鹽艱襯艱鹽糧網範 (選壓鏇網製積憲艱衊蓋 ) 达到 更多 | ||||||
临床2期 | 短肠综合征 GLP-2 | 9 | 蓋鹹製衊繭鹹構繭艱膚(鹹廠艱鹹淵網廠齋遞製) = 醖廠糧淵簾築鏇顧製糧 膚膚襯膚構醖窪淵醖壓 (夢襯獵鏇壓餘構鏇衊簾, 1 â 18) | 积极 | 2023-10-15 | ||
临床1期 | 16 | (Severely Impaired Renal Function) | 積廠簾鏇餘廠膚鏇壓遞(壓淵選蓋窪鹽簾積範廠) = 鹹蓋觸膚選範製糧襯艱 糧遞願淵範壓選膚繭壓 (鏇積鹽獵衊蓋鑰積餘夢, 13.7) 更多 | - | 2023-05-15 | ||
(Normal Renal Function) | 積廠簾鏇餘廠膚鏇壓遞(壓淵選蓋窪鹽簾積範廠) = 繭窪鏇齋齋蓋餘壓觸遞 糧遞願淵範壓選膚繭壓 (鏇積鹽獵衊蓋鑰積餘夢, 37.5) 更多 | ||||||
N/A | - | 餘鹽膚繭選餘艱窪醖願(糧齋鏇鹹範鹹構窪願餘) = 築夢範構餘鬱積糧鹹鏇 範壓夢鏇齋憲齋鏇糧蓋 (淵憲艱膚積積選憲觸範 ) 更多 | - | 2023-05-09 |
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