An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide.
Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment.
Participants will be in the study for about 65 weeks.

开始日期2025-06-26

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

ChiCTR2500095623

/ Not yet recruiting临床4期IIT

Efficacy of Teduglutide in the treatment of acute myocardial infarction: a prospective single-center randomized controlled study

开始日期2025-01-01

申办/合作机构

安徽医科大学第一附属医院

[+1]

NCT05371028

/ CompletedN/A

A Non-interventional, Multicentre Retrospective Study of the Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada

The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada.
This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study.
The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.

开始日期2023-09-23

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与替度格鲁肽相关的临床结果

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100 项与替度格鲁肽相关的转化医学

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100 项与替度格鲁肽相关的专利（医药）

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268

项与替度格鲁肽相关的文献（医药）

2025-11-01·Endocrinologia Diabetes y Nutricion

3, 2, 1! From GLP-2 to GLP-1 analog over a 10-year journey

Review

作者: Tapia-Sanchiz, María Sara ; Jiménez-Blanco, Sara ; Molina-Baena, Begoña ; Sampedro-Núñez, Miguel Antonio

Short bowel syndrome (SBS) represents one of the central conditions in clinical nutrition, with a complex and challenging management. Teduglutide, an analog of human glucagon-like peptide-2 (GLP-2), is the first approved long-term, non-symptomatic treatment for SBS. We present the case of a 62-year-old woman with SBS who required prolonged home parenteral nutrition (HPN). Following clinical stabilization, teduglutide was initiated, leading to significant clinical and nutritional improvement, including spontaneous closure of enterocutaneous fistulas and a 70% reduction in parenteral nutrition requirements. This allowed for a surgical reconstruction, after which she achieved full enteral autonomy, later developing grade 1 obesity. This case highlights the therapeutic potential of teduglutide as a bridging therapy and the remaining uncertainties regarding its long-term management.

2025-11-01·JPGN reports

Delayed presentation of a retained colonic segment in a child with intestinal failure on teduglutide

Article

作者: Bordelon, Rachel C. ; Speer, Allison L. ; Tammisetti, Varaha S. ; Tchakarov, Amanda ; Shahin, Mohamed M. ; Imseis, Essam ; Varalla, Sarah J.

Abstract:

Teduglutide is a glucagon‐like peptide 2 (GLP‐2) analogue that was approved by the United States Food and Drug Administration for the treatment of pediatric (>1 year) intestinal failure due to short bowel syndrome in 2019. GLP‐2 analogues promote rapid intestinal adaptation, increasing the absorptive capacity of residual intestine after surgical resection to aid the achievement of enteral autonomy or reduce parenteral nutrition requirements. Despite relatively few reported side effects, there is a theoretical risk of proliferative complications. Here we present an intriguing case of a pediatric patient found to have a decade‐long retained, discontinuous segment of colon from a surgical procedure performed in infancy, which became clinically significant after a period of treatment with teduglutide.

2025-10-01·JOURNAL OF PARENTERAL AND ENTERAL NUTRITION

Teduglutide in adults with short bowel syndrome and intestinal failure: A descriptive cohort study

Article

作者: Testro, Adam ; Chapman, Brooke ; Low, Elizabeth S. L. ; Wong, Darren ; Burrell, Kathryn ; Tan, Katrina

Abstract:

Background:

International evidence supports the efficacy of teduglutide in reducing parenteral support requirements, or achieving enteral autonomy, in patients with short bowel syndrome–intestinal failure. This is a multicenter observational study presenting the real‐world experience with teduglutide in Australia.

Materials and Methods:

11 of 12 Australian intestinal rehabilitation units submitted data for 19 adult patients with short bowel syndrome–intestinal failure prescribed teduglutide from November 2020 to August 2023. Patient and clinical characteristics, including teduglutide dosing and parenteral support prescriptions, were collected at 3‐month intervals for 12 months from teduglutide initiation and finally at study termination. Univariate analysis was conducted and results presented as medians with interquartile ranges (IQRs).

Results:

Seventy‐four percent of the cohort (median age 58 [IQR 44–67] years) were female. The median residual small bowel length was 85 cm (IQR 60–118), with 53% having colon in continuity. Prior to teduglutide commencement, median parenteral support duration was 3.8 (IQR 1.1–11.0) years, with weekly parenteral support volumes of 11.5 (IQR 6.2–15.3) L/week. Seven patients (37%) achieved enteral autonomy, with five weaned off by 12 months and the remaining between 12–42 months from teduglutide initiation. 79% achieved ≥20% parenteral support volume reductions, with overall median parenteral support volume reductions of 28% after 12 months. Baseline quality‐of‐life assessments suggested that sexual function, travel ability, and sleep patterns were areas of greatest disease burden.

Conclusion:

Within an Australian cohort, teduglutide is effective at reducing parenteral support requirements in patients with short bowel syndrome–intestinal failure, although the effect onset and range remains heterogenous.

105

项与替度格鲁肽相关的新闻（医药）

2025-10-30

·动脉网

武田药品·韦伯总裁CEO：从信达生物引进包括ADC在内的后期开发产品，强化2030年以后的增长驱动力武田薬品・ウェバー社長CEO Innovent社からADC含む後期開発品強化 2030年以降の成長ドライバーに

武田薬品のクリストフ・ウェバー代表取締役社長兼CEOは10月30日、2025年度第2四半期決算説明会に臨み、中国Innovent Biologics社との戦略的提携により後期開発段階にある次世代型固形腫瘍治療薬のパイプラインが強化されたと期待感を表明した。グローバルオンコロジービジネスユニットのテレサ・ビテッティ・プレジデントも米ボストンからオンラインで参加し、「2030年以降に向けた重要な成長ドライバーになる」と強調。戦略提携品のうち、非小細胞肺がんや大腸がんを標的とする「IBI363」は初期適応症で400億米ドル以上、胃がんや膵管腺がんを標的とする「IBI343」は約80億ドル以上の潜在市場が見込めると強調し、「オンコロジー領域での将来のリーダーとしての地位を強化する」と意欲を示した。. 武田药品的克里斯托夫·韦伯代表董事长兼CEO于10月30日出席2025财年第二季度财报说明会时表示，通过与中国信达生物制药的战略合作，有望增强处于后期开发阶段的下一代实体肿瘤治疗药物的研发管线。全球肿瘤业务部门总裁特蕾莎·比泰蒂也从美国波士顿在线参与会议，并强调“这是面向2030年以后的重要增长驱动力”。在战略合作产品中，针对非小细胞肺癌和结直肠癌的“IBI363”初期适应症市场预计超过400亿美元，而针对胃癌和胰管腺癌的“IBI343”潜在市场预计超过80亿美元。她还表示，“这将巩固我们在肿瘤领域作为未来领导者的地位”，展现了强烈的发展意愿。武田薬品とInnovent Biologics社は10月21日に、PD-1/IL-2α Biased二重特異性抗体融合タンパク質の「IBI363」と、CLDN18.2を標的とする抗体薬物複合体（ADC）「IBI343」の2剤について、中国・香港・マカオ・台湾以外の全世界におけるライセンスおよび提携契約を締結した。また、初期開発段階のEGFR/B7H3二重特異性抗体薬物複合体（ADC）「IBI3001」のライセンスオプションも取得した。この戦略的提携により武田薬品は、固形がん領域で次世代のがん免疫療法におけるバックボーンおよび抗体薬物複合体（ADC）の後期開発段階のパイプラインを強化することができた。. 武田药品与Innovent Biologics公司于10月21日就PD-1/IL-2α偏向性双特异性抗体融合蛋白“IBI363”和靶向CLDN18.2的抗体药物偶联物（ADC）“IBI343”这两种药物，签订了除中国、香港、澳门和台湾以外的全球许可与合作协议。此外，还获得了处于早期开发阶段的EGFR/B7H3双特异性抗体药物偶联物（ADC）“IBI3001”的许可选项。通过这一战略合作，武田药品加强了在实体瘤领域下一代癌症免疫疗法的支柱地位，并充实了抗体药物偶联物（ADC）的后期开发管线。◎テレサ・ビテッティ・プレジデントは、「このディールは戦略的に重要だ」 ◎特蕾莎·维泰蒂总裁表示：“这项协议具有战略重要性。”テレサ・ビテッティ・プレジデントは、「このディールは戦略的に重要だ。中核となる最先端の候補物質を獲得した」と強調する。同社のオンコロジー注力領域は、血液がん・骨髄系腫瘍（AML/MDS、CML/MF、PV）が中心だったが、今回の戦略的提携により、非小細胞肺がん、頭頸部扁平上皮がん、小細胞肺がん、さらに大腸がん、胃がん、膵がん、肝細胞がんなど幅広い固形がん領域で、ADCを含む次世代型モダリティのパイプラインを強化することができた。テレサ・ビテッティ・プレジデントは、「この提携に含まれるプログラムは、タケダが目指すオンコロジー戦略に完全に合致している」と語り、「オンコロジー領域での将来のリーダーとしての地位を強化する」と強調した。. 特蕾莎·比泰蒂总裁强调：“这项交易在战略上非常重要，我们获得了核心的前沿候选药物。”该公司以往的肿瘤学重点领域主要是血液癌和骨髓系肿瘤（如AML/MDS、CML/MF、PV），但通过此次战略合作，公司在非小细胞肺癌、头颈部鳞状细胞癌、小细胞肺癌以及结直肠癌、胃癌、胰腺癌、肝细胞癌等广泛的实体瘤领域中，得以强化包括ADC在内的下一代治疗模式的研发管线。特蕾莎·比泰蒂总裁表示：“此次合作包含的项目完全符合武田的肿瘤学战略目标”，并强调“这将巩固我们在肿瘤学领域作为未来领导者的地位”。◎「IBI363」の市場ポテンシャルは400億ドル「IBI343」で約80億ドル ◎「IBI363」的市场潜力为400亿美元，「IBI343」约为80亿美元。一方で、市場ポテンシャルについては、「IBI363」の初期適応症となる2次治療/がん免疫療法難治性非小細胞肺がんで140億米ドル、1次治療非小細胞肺がんで230億米ドル、1次治療大腸がんで90億米ドルをし、あわせて400億ドルの潜在市場があるとした。また、「IBI343」の対象となる胃がん、膵管腺がん（PDAC）で約80億ドルを見込み、今後、開発を加速させ、2030年以降の成長ドライバーとしての期待感を表明した。一方面，关于市场潜力，预计“IBI363”在作为二线治疗/癌症免疫疗法难治性非小细胞肺癌的初期适应症中将达到140亿美元，在一线治疗非小细胞肺癌中为230亿美元，在一线治疗大肠癌中为90亿美元，合计潜在市场达400亿美元。此外，针对“IBI343”的胃癌和胰管腺癌（PDAC）目标市场预计约为80亿美元，并表示未来将加速开发，期待其成为2030年以后的增长驱动力。◎ビバンセのGE影響は「上半期がピーク」細胞療法中止の関連で減損損失582億円 ◎贝班赛的GE影响“上半年达到峰值” 因细胞疗法中止相关减损损失582亿日元古田未来乃チーフフィナンシャルオフィサー25年度第2四半期決算について、ビバンセの米国での特許切れ（2023年8月）に伴いジェネリック品の影響から1000億円の減収になったと報告。一方で効率化による営業コストの削減などで、「コア営業利益への影響は一部軽減できた」と強調した。またビバンセのジェネリック影響については、「上半期がピーク」と見通し、通期については「成長が改善の見込み」と述べた。このほか財務ベースの営業利益は、細胞療法の取り組みの中止に関連する無形資産の減損損失582億円が影響した。古田未来首席财务官就25财年第二季度财报报告称，由于万珂在美国的专利到期（2023年8月），受仿制药影响，收入减少了1000亿日元。同时，她强调通过提高效率削减营业成本等措施，“对核心营业利润的影响得到了部分缓解”。关于万珂仿制药的影响，她预计“上半年将达到峰值”，并表示全年“有望实现增长改善”。此外，与终止细胞疗法相关的工作导致无形资产减值损失582亿日元，影响了基于财务基础的营业利润。【連結業績（前年同期比） 25年度通期予想（前期比）】【链接业绩（与前年同期比） 25年度全年预测（与前期比）】売上高 2兆2194億8100万円（6.9％減） 4兆5000億円（1.8％減）←修正前４兆5300億円销售额 2兆2194亿8100万日元（减少6.9%） 4兆5000亿日元（减少1.8%）←修正前4兆5300亿日元営業利益 2535億6100万円（27.7％減） 4000億円（16.8％増）←修正前4750億円营业利润 2535亿6100万日元（减少27.7%） 4000亿日元（增长16.8%）←修正前4750亿日元親会社帰属純利益 1124億4100万円（40.0％減） 1530億円（41.8％増）←修正前2280億円母公司归属净利润 1124亿4100万日元（减少40.0%） 1530亿日元（增加41.8%）←修正前2280亿日元【グローバル主要製品売上（前年同期実績）通期予想億円】【全球主要产品销售额（去年同期实际业绩）全年预测亿日元】【消化器系疾患】【消化系统疾病】ENTYVIO 4792（4732）9550←修正前9820 ENTYVIO 4792（4732）9550←修正前9820GATTEX/レベスティブ 716（733）1450 GATTEX/雷贝斯蒂布 716（733）1450タケキャブ/VOCINTI 689（643）1400←修正前1380 竹出租车/VOCINTI 689（643）1400←修正前1380PANTOLOC/CONTROLOC 212（225）440←修正前410 PANTOLOC/CONTROLOC 212（225）440←修正前410 DEXILANT 164（198）360←修正前350 DEXILANT 164（198）360←修正前350リアルダ/MEZAVANT 138（134）270 瑞尔达/MEZAVANT 138（134）270RESOLOR/MOTEGRITY 36（113）70←修正前130 RESOLOR/MOTEGRITY 36（113）70←修正前130EOHILIA 42（23）>100%←修正前>190% EOHILIA 42（23）>100%←修正前>190%【希少疾患】【罕见疾病】タクザイロ 1133（1110）2300 塔库赛罗 1133（1110）2300アドベイト 536（588）1550←修正前1610（予想はアディノベイト計）阿德贝特 536（588）1550←修正前1610（预想为阿迪诺贝特合计）アディノベイト/ADYNOVI 288（345）阿迪诺韦特/ADYNOVI 288（345）エラプレース 491（531）960←修正前880 错误位置 491（531）960←修正前880リプレガル 387（413）810←修正前830 里普雷加尔 387（413）810←修正前830ビプリブ 283（270）550←修正前530 比普里布 283（270）550←修正前530リブテンシティ 221（155）450 肋骨城市 221（155）450ボンベンディ 114（104）250←修正前240 邦贝迪 114（104）250←修正前240フィラジル 86（98）130←修正前120 菲拉吉尔 86（98）130←修正前120アジンマ 48（24）>60%←修正前>50% 阿珍马 48（24）>60%←修正前>50%【血漿分画製剤】【血浆分离制剂】免疫グロブリン製剤 3871（3910）1桁台半ば％の成⻑免疫球蛋白制剂 3871（3910）增长百分之十几中期アルブミン製剤 661（703）1桁台後半％の成⻑←修正前 1桁台半ば％の成⻑白蛋白制剂 661（703）个位数后半段%的增长←修正前个位数中段%的增长ファイバ 174（236）320←修正前350 光纤 174（236）320←修正前350HEMOFIL/IMMUNATE /IMMUNINE 126（146）240 HEMOFIL/IMMUNATE /IMMUNINE 126（146）240CINRYZE 72（82）140←修正前120 CINRYZE 72（82）140←修正前120【オンコロジー】【肿瘤学】アドセトリス 745（682）1420←修正前1380 阿德塞特里斯 745（682）1420←修正前1380リュープリン/ENANTONE 586（604）1160←修正前1150 亮丙瑞林/ENANTONE 586（604）1160←修正前1150ニンラーロ 414（474）800←修正前810 尼拉洛 414（474）800←修正前810アイクルシグ 345（354）690←修正前720 艾克鲁西格 345（354）690←修正前720FRUZAQLA 273（231）>10％←修正前>20％ FRUZAQLA 273（231）>10％←修正前>20％アルンブリグ 178（182）390←修正前410 阿尔布里格 178（182）390←修正前410ベクティビックス 136（135）260←修正前270 贝克蒂维克斯 136（135）260←修正前270ゼジューラ 73（72）150←修正前140 泽朱拉 73（72）150←修正前140カボメティクス 44（44）80 卡博梅蒂克斯 44（44）80【ニューロサイエンス】【神经科学】VYVANSE/ELVANSE 1066（2032）2270←修正前2410 VYVANSE/ELVANSE 1066（2032）2270←修正前2410トリンテリックス 570（641）1220←修正前1250 特林特里克斯 570（641）1220←修正前1250インチュニブ 230（198）430←修正前420 英特尼布 230（198）430←修正前420ADDERALL XR 106（168）210←修正前190 专注达 XR 106（168）210←修正前190【ワクチン】【疫苗】QDENGA 211（199）550←修正前570 QDENGA 211（199）550←修正前570【その他】【其他】アジルバ 25（58）70←修正前60 阿吉尔巴 25（58）70←修正前60ホスレノール 48（39）90←修正前70 霍斯勒诺尔 48（39）90←修正前70【国内主要製品売上（前年同期比）億円】【国内主要产品销售额（与去年同期相比）亿日元】ENTYVIO 96（11.9 %増） ENTYVIO 96（11.9 %增加）GATTEX/レベスティブ 49 （7.6 %増） GATTEX/雷贝斯蒂布 49（增加7.6%）タケキャブ/VOCINTI 514（4.1%増）竹出租车/VOCINTI 514（增长4.1%）タクザイロ 18（9.7 %増）托克赛罗 18（增加9.7%）アドベイト 13（11.2 %減）广告费 13（减少11.2%）アディノベイト/ADYNOVI 65（7.7 %減）阿迪诺贝特/ADYNOVI 65（减少7.7%）エラプレース３（－）错误位置 3（-）リプレガル 40（5.5 %減）瑞普莱加尔 40（减少5.5%）ビプリブ７（14.9 %増）比普里布 7（增长14.9%）リブテンシティ 14（1,197.0 %増）肋板城市 14（增长1,197.0%）ボンベンディ５（3.4％増）邦贝迪 5（增长3.4%）フィラジル 11（12.9 %減）菲拉吉尔 11（减少12.9%）アジンマ 10（99.0％増）阿津马 10（增加99.0％）ファイバ２（24.4％減）光纤 2（减少24.4%）アドセトリス 62（5.6 %増）阿德赛曲斯 62（增加5.6%）リュープリン/ENANTONE 144（2.7 %増）亮丙瑞林/ENANTONE 144（增加2.7%）ニンラーロ 31（4.8 %増）尼拉洛 31（增加4.8%）FRUZAQLA（国内製品名：フリュザクラ） 32（－） FRUZAQLA（国内制品名：弗鲁扎克拉） 32（－）アルンブリグ 11（15.2 %減）阿鲁布里格 11（减少15.2%）ベクティビックス 136（0.8 %増）贝克蒂维克斯 136（增长0.8%）ゼジューラ 56（3.4 %減）泽朱拉 56（减少3.4%）カボメティクス 44（1.4 %減）卡波梅蒂克斯 44（减少1.4%）VYVANSE/ELVANSE 18（27.1 %増） VYVANSE/ELVANSE 18（增加27.1%）トリンテリックス 72（15.0 %増）特林特里克斯 72（增加15.0%）インチュニブ 154（18.1 %増）因图尼布 154（增加18.1%）アジルバ 25（57.1％減）阿吉利巴 25（减少57.1%）

抗体药物偶联物免疫疗法财报

2025-09-16

·GlobeNewswire-Health Care

Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress

Preclinical Data for OPK-8801003 Demonstrate Substantially Longer Biological Half-Life with Peak Plasma Levels Comparable to Gattex®, the Only Approved GLP-2 Therapy Oral GLP-2 Tablet Could Transform Treatment Paradigm for 30,000 Short Bowel Syndrome (SBS) Patients Currently Dependent on Daily Injections of the Peptide Sept. 15, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, today announced the presentation of a poster titled "A First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” at the 47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress in Prague, Czech Republic, highlighting pharmacokinetic (PK) data relating to its oral GLP-2 analog program. Entera and OPKO Health, Inc. entered into a research collaboration in 2023 to develop oral peptide candidates for intestinal malabsorption syndromes, combining OPKO's proprietary long-acting GLP-2 analog (OPK-8801003) with Entera's N-Tab™ oral peptide platform. Currently, the only approved GLP-2 therapy is Gattex® (teduglutide), which generates approximately $800 million in annual sales despite requiring daily subcutaneous injections with challenging compliance rates and limited patient access. "The pharmacokinetic data presented at ESPEN represent a significant milestone in our journey to develop the first oral GLP-2 therapy and an incremental milestone in validating our N-Tab™ oral peptide platform," said Miranda Toledano, Chief Executive Officer of Entera. "Given the robust oral bioavailability demonstrated in our preclinical studies, we believe this daily GLP-2 tablet candidate could fundamentally change how SBS patients are treated, offering a less-invasive administration that can be titrated to enable personalized dosing in this rare and heterogeneous condition." Extended Half-Life: OPK-8801003 GLP-2 tablet demonstrated a plasma half-life of approximately 15 hours in minipigs, representing an approximate 18-fold improvement over teduglutide, which has a half-life of only 0.85 hours in the same species. Robust Oral Bioavailability: Following oral administration of OPK-8801003 tablets in minipigs, peak plasma concentrations reached ~200 ng/ml (Cmax), substantially exceeding the reported Cmax of 36.8 ng/ml for daily 0.05 mg/kg teduglutide subcutaneous injection in humans. Sustained Exposure: Systemic exposure (AUC ~2 h*μg/ml) was maintained for more than 24 hours with relatively low variability, supporting once-daily oral dosing. Favorable Safety Profile: No signs of toxicity were observed in the preclinical studies. Short bowel syndrome is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the U.S. and EU are living with SBS, and current annual sales of GATTEX® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals.1 SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children.1 Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. 1 Zhu C, Li Y. An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults. J Int Med Res. 2022 Mar;50(3):3000605221086145. doi: 10.1177/03000605221086145. PMID: 35343263; PMCID: PMC8966062. The content above comes from the network. if any infringement, please contact us to modify.

上市批准临床结果

2025-07-09

·PipelineReview

OPKO Health and Entera Bio Announce Abstract on PK/PD of Oral GLP-2 Tablet for the Treatment of Short Bowel Syndrome Selected for 2025 ESPEN Congress

MIAMI, FL, USA and JERUSALEM, Israel I July 08, 2025 I OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47 th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic. Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome Poster Viewing Date & Time: September 13, 2025, 3:30 – 4:00 p.m. local time & Welcome Reception Poster Topic: Poster Session 1 – Liver and gastrointestinal tract Location of Display: Forum Hall Foyer 3 The oral GLP-2 tablet program combines a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist, which is marketed under the brand GATTEX ® (teduglutide), requires daily subcutaneous injections. “Given the heterogeneity of patients with SBS and challenging compliance rates attributed to injectable GLP-2 therapy, we believe a daily tablet format may enable more personalized care of this peptide and individualize titration,” said Miranda Toledano, Entera Chief Executive Officer. About Short Bowel Syndrome Short bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the US and EU are living with SBS, and current annual sales of GATTEX ® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals 1 . SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children. 2 About Entera Bio Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n=161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn , Twitter , Facebook , Instagram . About OPKO Health OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com . SOURCE: OPKO Health

临床结果上市批准临床2期临床3期

100 项与替度格鲁肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	替度格鲁肽	A16AX08	DB08900

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
短肠综合征	欧盟	Takeda Pharmaceuticals International AG	2012-08-30
短肠综合征	冰岛	Takeda Pharmaceuticals International AG	2012-08-30
短肠综合征	列支敦士登	Takeda Pharmaceuticals International AG	2012-08-30
短肠综合征	挪威	Takeda Pharmaceuticals International AG	2012-08-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
术后并发症	临床3期	美国	Shire Plc	2022-06-02
瘘	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2019-01-31
克罗恩病	临床2期	美国	Shire Plc	2003-11-12
克罗恩病	临床2期	加拿大	Shire Plc	2003-11-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


UEGW2024	N/A	肠衰竭	-	TEDUGLUTIDE	範鑰蓋簾簾鏇憲繭繭鬱(鏇範鹹構廠鑰構衊製窪) = 淵淵選壓願鏇製簾壓構襯蓋醖繭鏇製艱醖醖願 (顧繭鏇選窪糧鬱鑰憲淵 ) 更多	-	2024-10-13
				Placebo	範鑰蓋簾簾鏇憲繭繭鬱(鏇範鹹構廠鑰構衊製窪) = 簾簾糧構鏇鑰醖艱簾廠襯蓋醖繭鏇製艱醖醖願 (顧繭鏇選窪糧鬱鑰憲淵 ) 更多
UEGW2024	N/A	失盐型肾上腺皮质综合症	-	TEDUGLUTIDE	顧艱蓋構築齋壓選製餘(鑰窪繭顧餘膚醖築繭壓) = 窪願憲蓋獵餘齋獵蓋淵繭鹽衊網窪鹹蓋積窪積 (壓積繭窪範鏇積夢積遞 )	-	2024-10-13
NCT05027308 (CTgov)	临床3期	短肠综合征	3	Teduglutide	築醖窪糧觸夢積製醖廠 = 蓋窪鏇願選膚願獵壓製遞壓繭積鹽艱選選憲鹽 (壓積蓋願網選衊艱鏇觸, 製網積簾壓鹽鹹積蓋觸 ~ 觸積醖獵鹽夢鬱襯製築) 更多	-	2024-05-16
NCT02682381 \| NCT01952080 (SBS-IF, Pubmed \| J Pediatr Gastroenterol Nutr)	临床3期	肠衰竭	101	Teduglutide	餘廠艱齋壓鏇壓遞蓋夢(簾網鑰簾窪簾齋獵鏇鏇) = Safety assessments included gastrointestinal adverse event reporting 顧襯廠膚齋獵餘獵顧糧 (獵願鏇繭夢構鹽構壓衊 )	积极	2023-11-01
				Teduglutide (Standard of care)
NCT03268811 \| NCT03571516 \| NCT02980666 (Pubmed)	临床3期	短肠综合征	-	Teduglutide	繭淵築鏇顧選衊製醖繭(齋構淵獵鬱願繭膚構夢) = All adverse events were in line with known impacts of SBS-IF and adverse reactions to teduglutide. Only one serious adverse event (abdominal pain) was considered related to teduglutide. 選鏇夢鹽願鑰簾簾繭膚 (艱積餘遞願襯艱鹹觸壓 )	积极	2023-06-27
				Teduglutide (Standard of care)
NCT02431325 (CTgov)	临床2期	动脉炎 \| HIV感染	32	Teduglutide (Teduglutide)	襯製範選遞獵觸構網鏇(衊糧鹹構遞艱簾築醖艱) = 齋淵齋鑰廠廠淵顧遞鹽遞餘顧範鹽鬱積獵觸鏇 (範廠廠繭淵顧鏇鏇淵壓, 0.29) 更多	-	2023-06-12
				Placebo (Placebo)	襯製範選遞獵觸構網鏇(衊糧鹹構遞艱簾築醖艱) = 壓窪襯範觸顧鬱觸餘簾遞餘顧範鹽鬱積獵觸鏇 (範廠廠繭淵顧鏇鏇淵壓, 0.35) 更多
NCT03562130 (Pubmed \| Am J Clin Nutr)	临床4期	短肠综合征	25	Teduglutide	醖壓構衊鬱選顧艱遞積(鑰糧遞鹽艱廠簾簾鬱觸) = Mild abdominal pain at the early phase of treatment, stoma changes, and redness at the injection site were commonly reported 廠廠壓鑰淵醖廠壓齋窪 (簾壓廠憲願構窪構夢襯 )	-	2023-06-01
NCT03596164 (CTgov)	临床3期	短肠综合征	11	SHP633-306 (SHP633-306: Teduglutide 0.05 mg/kg)	餘齋糧淵齋積膚窪鹽醖 = 鏇範積餘遞蓋淵廠夢範願鹹膚鑰糧選簾範鬱獵 (積夢廠觸顧醖壓膚鬱鑰, 鹽顧窪艱窪夢築願鏇鬱 ~ 範鬱積獵觸繭網範醖壓) 更多	-	2023-03-15
				TED-C14-004+Teduglutide (TED-C14-004: Teduglutide 0.05 mg/kg)	餘齋糧淵齋積膚窪鹽醖 = 製構衊餘糧網鹹餘積選願鹹膚鑰糧選簾範鬱獵 (積夢廠觸顧醖壓膚鬱鑰, 膚廠鹽廠願顧獵鏇憲蓋 ~ 製襯積衊範衊願繭廠繭) 更多
NCT03268811 (CTgov)	临床3期	短肠综合征	9	teduglutide (Total Children (Aged: 1 to 15 Years))	鏇醖艱壓齋夢襯網繭窪 = 構鏇糧繭膚衊獵壓積壓壓糧齋淵壓製衊鏇艱襯 (網網願廠醖鏇膚膚範糧, 顧築製願鏇觸構鏇遞鹹 ~ 範醖選衊壓淵壓廠鬱觸) 更多	-	2022-05-24
				teduglutide (Infants (Corrected Gestational Age: 4 to < 12 Months))	鏇醖艱壓齋夢襯網繭窪 = 選襯窪廠鹽積製簾遞憲壓糧齋淵壓製衊鏇艱襯 (網網願廠醖鏇膚膚範糧, 遞壓築選齋鑰鏇構鑰餘 ~ 積鏇鬱壓窪壓艱繭築鬱) 更多
NCT02954458 (CTgov)	临床3期	短肠综合征	61	NTT+teduglutide (Non-teduglutide/Non-teduglutide Treatment (NTT/NTT))	憲鹽遞觸觸築網糧製顧 = 壓憲襯網獵齋鬱鏇窪衊簾築壓蓋範壓築糧遞築 (範廠築鏇醖夢獵蓋壓壓, 夢獵鹽鏇範夢餘鑰鬱鏇 ~ 壓醖鹹襯窪齋願選鹹願) 更多	-	2021-10-13
				NTT+Teduglutide (Non-teduglutide/Teduglutide Treatment (NTT/TED))	憲鹽遞觸觸築網糧製顧 = 齋廠蓋願遞鏇餘膚齋網簾築壓蓋範壓築糧遞築 (範廠築鏇醖夢獵蓋壓壓, 積積遞糧網鬱簾願觸網 ~ 遞觸獵鑰醖觸衊鬱蓋鹹) 更多