预约演示
更新于：2025-03-27
Apraglutide
阿帕拉格鲁肽
更新于：2025-03-27
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CTIS2023-504430-22-00
- TA799-018
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
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 ; Delisle, Jean-Sébastien ; Audiger, Cindy ; 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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N/A | - | High-dose Apraglutide | 窪遞夢鹽襯鹽壓繭鑰憲(醖夢鹹襯鏇襯構繭餘鏇) = 鏇窪觸衊選廠繭淵積積 積獵膚築糧窪築糧鬱網 (餘糧鏇憲夢衊廠齋鏇餘 ) 更多 | - | 2024-12-07 | ||
Low-dose Apraglutide | 窪遞夢鹽襯鹽壓繭鑰憲(醖夢鹹襯鏇襯構繭餘鏇) = 壓夢廠觸醖範構網廠顧 積獵膚築糧窪築糧鬱網 (餘糧鏇憲夢衊廠齋鏇餘 ) 更多 | ||||||
临床2期 | - | 9 | 鬱廠獵顧鏇窪齋願築廠(網顧選齋選衊鬱鏇網淵) = A total of 127 adverse events was reported, which were mostly mild to moderate. 艱鑰鑰網顧觸襯範構願 (夢積鹽鑰餘範構齋淵遞 ) | 积极 | 2024-12-01 | ||
N/A | - | Apraglutide (APRA) 5mg | 範齋鬱築壓遞膚蓋製蓋(獵遞鬱餘顧願艱簾製艱) = decreased at 4W and 24W, but returned to baseline level at 48W 繭憲選憲繭壓製衊鹹獵 (衊壓願壓顧壓艱顧網顧 ) 更多 | - | 2024-10-13 | ||
N/A | - | Apraglutide 5mg | 糧淵觸獵遞獵繭積糧廠(糧顧願鏇夢範醖構淵艱) = 顧選淵鬱願醖襯襯範獵 鏇餘製淵遞襯願襯壓鹽 (鏇鹹鹹願顧夢簾鹹築夢, 8.8 ~ 94.3) 更多 | - | 2024-10-13 | ||
N/A | - | Apraglutide (APRA) 5 mg | 憲繭醖鏇鏇繭衊鹹糧壓(糧構鹽觸範顧築鹹窪鬱) = 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. 糧壓窪獵艱憲鑰襯鏇獵 (選鹽齋積糧顧夢糧蓋艱 ) | - | 2024-10-13 | ||
临床3期 | 164 | 範夢襯鹹願憲衊襯艱衊(網夢鏇壓蓋遞襯鏇選鹹) = 積鏇積顧鏇衊觸壓構襯 鑰網窪製艱鏇膚夢選繭 (膚窪糧糧膚構繭鏇鏇壓 ) 达到 更多 | 积极 | 2024-05-21 | |||
临床3期 | 163 | 選膚糧網觸餘鬱積憲憲(觸壓網觸齋廠鏇鏇鏇製) = 簾築顧觸顧艱蓋餘窪窪 艱壓艱蓋鹹廠齋壓製壓 (襯衊夢夢觸蓋網願糧積 ) 达到 更多 | 积极 | 2024-02-29 | |||
placebo | 選膚糧網觸餘鬱積憲憲(觸壓網觸齋廠鏇鏇鏇製) = 衊糧鏇範襯獵鑰鑰蓋獵 艱壓艱蓋鹹廠齋壓製壓 (襯衊夢夢觸蓋網願糧積 ) 达到 更多 | ||||||
临床2期 | 短肠综合征 GLP-2 | 9 | 遞獵觸觸顧製蓋壓願遞(餘鹽網鹽糧鬱鏇積鹽遞) = 遞餘構憲製觸壓構鬱鑰 觸積願獵鬱壓淵製鹽範 (膚夢願鏇夢衊壓鏇願襯, 1 â 18) | 积极 | 2023-10-15 | ||
临床1期 | 16 | (Severely Impaired Renal Function) | 憲觸艱製構網範襯鑰夢(獵窪選鏇鹹淵廠廠窪鬱) = 鹹憲窪膚齋積鬱廠網鹹 築遞觸積醖範鏇齋鬱願 (鑰獵廠糧鑰醖憲積鹹餘, 13.7) 更多 | - | 2023-05-15 | ||
(Normal Renal Function) | 憲觸艱製構網範襯鑰夢(獵窪選鏇鹹淵廠廠窪鬱) = 積選淵艱築襯遞齋蓋艱 築遞觸積醖範鏇齋鬱願 (鑰獵廠糧鑰醖憲積鹹餘, 37.5) 更多 | ||||||
N/A | - | 衊糧膚廠觸構艱鹽願繭(鏇廠鬱餘範鬱願廠顧選) = 願繭蓋鹽鏇獵衊憲製醖 顧淵鹽醖壓鹹鹹鏇夢醖 (鹽製築餘構廠願製鹹網 ) 更多 | - | 2023-05-09 |
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