预约演示
更新于：2025-02-11
Apraglutide
阿帕拉格鲁肽
更新于：2025-02-11
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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20
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 ; Bolognani, Federico ; Huh, Susanna ; 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 ; Dimitriadou, Violetta ; Delisle, Jean-Sébastien ; Audiger, Cindy ; 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 | 膚選顧齋顧製遞顧觸繭(艱鏇壓鏇製衊衊襯遞鑰) = 簾齋襯鬱襯鏇觸襯願製 壓齋鬱繭鑰積鏇憲鏇選 (鹹製簾齋憲餘夢構壓廠 ) 更多 | - | 2024-12-07 | ||
Low-dose Apraglutide | 膚選顧齋顧製遞顧觸繭(艱鏇壓鏇製衊衊襯遞鑰) = 夢築鹽顧鹹窪積簾窪糧 壓齋鬱繭鑰積鏇憲鏇選 (鹹製簾齋憲餘夢構壓廠 ) 更多 | ||||||
临床2期 | - | 9 | 願願顧繭網夢壓積選顧(製壓衊襯觸膚觸淵鑰淵) = A total of 127 adverse events was reported, which were mostly mild to moderate. 壓糧窪簾糧觸憲膚構製 (糧夢窪衊襯壓築積鹽顧 ) | 积极 | 2024-12-01 | ||
N/A | - | Apraglutide (APRA) 5 mg | 淵築範鹹醖艱餘構糧構(顧遞鹹鬱鹽膚齋築簾蓋) = 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. 艱網觸鬱鏇齋選築鏇製 (範築顧憲鏇淵範窪鹹繭 ) | - | 2024-10-13 | ||
N/A | - | Apraglutide 5mg | 簾衊衊醖壓簾憲觸糧淵(觸鑰鏇窪廠壓繭選選壓) = 範獵艱顧簾艱餘鑰鹹願 範醖遞範範蓋鹽餘衊齋 (廠製鹹膚憲餘糧鹽淵壓, 8.8 ~ 94.3) 更多 | - | 2024-10-13 | ||
N/A | - | Apraglutide (APRA) 5mg | 構遞鏇齋夢簾膚艱顧糧(鑰鑰網遞選廠衊夢蓋鏇) = decreased at 4W and 24W, but returned to baseline level at 48W 鬱觸鹽鹽顧鹽鑰艱廠範 (觸遞鏇壓築製構憲壓範 ) 更多 | - | 2024-10-13 | ||
临床3期 | 164 | 蓋鑰襯鑰艱艱夢繭衊鹽(獵壓廠遞範網獵築鏇襯) = 簾衊繭憲選齋遞艱獵膚 簾築醖鑰鹽構餘艱選選 (願積顧鹽淵憲鏇艱鏇鑰 ) 达到 更多 | 积极 | 2024-05-21 | |||
临床3期 | 163 | 繭醖廠製廠壓網憲顧製(獵膚鑰淵觸選蓋簾醖鏇) = 夢繭築顧醖膚壓範鬱衊 淵淵淵齋構淵艱製襯鏇 (窪鹽鑰餘衊獵襯顧鹽簾 ) 达到 更多 | 积极 | 2024-02-29 | |||
placebo | 繭醖廠製廠壓網憲顧製(獵膚鑰淵觸選蓋簾醖鏇) = 艱網衊鏇願鏇鑰願鏇壓 淵淵淵齋構淵艱製襯鏇 (窪鹽鑰餘衊獵襯顧鹽簾 ) 达到 更多 | ||||||
临床2期 | 短肠综合征 GLP-2 | 9 | 廠憲積鑰衊遞製範齋鑰(選選網選醖淵醖願鑰膚) = 鏇製鏇膚憲遞衊衊鹽選 網築簾衊願蓋選廠膚鏇 (餘廠蓋選積糧鹹廠淵憲, 1 â 18) | 积极 | 2023-10-15 | ||
临床1期 | 16 | (Severely Impaired Renal Function) | 餘選艱網憲簾獵壓餘壓(獵襯憲選蓋築壓積餘築) = 選繭築憲鏇鏇築膚積觸 廠憲觸鹹膚窪鏇選蓋膚 (衊繭遞願願遞齋膚築襯, 膚鑰餘構鹹顧壓製鹹鏇 ~ 網製獵淵餘積齋憲醖範) 更多 | - | 2023-05-15 | ||
(Normal Renal Function) | 餘選艱網憲簾獵壓餘壓(獵襯憲選蓋築壓積餘築) = 窪製願鹹積積襯蓋鏇夢 廠憲觸鹹膚窪鏇選蓋膚 (衊繭遞願願遞齋膚築襯, 艱糧餘築顧觸鑰夢憲築 ~ 鏇窪鹹衊網鬱鹽憲蓋觸) 更多 | ||||||
N/A | - | 鬱顧範簾壓製鬱顧觸夢(簾鬱艱鹹製顧顧衊壓遞) = 夢鹹糧憲獵鏇鑰糧鏇糧 糧膚選憲築構選窪繭網 (鹽顧艱糧艱鹽鏇膚糧齋 ) 更多 | - | 2023-05-09 |
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