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.

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.

NCT03953170

/ Withdrawn临床3期IIT

Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.

开始日期2022-06-02

申办/合作机构

Allegheny-Singer Research Institute

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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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290

项与替度格鲁肽相关的文献（医药）

2025-07-01·CLINICAL NUTRITION

Identification of Pappalysin-2 (PAPP-A2), a modulator of Insulin-like Growth Factor-1 pathway, as a potential marker of teduglutide efficacy in patients with short bowel syndrome

Article

作者: Cros, Jérôme ; Le Beyec-Le Bihan, Johanne ; Le Gall, Maude ; Joly, Francisca ; Nicolle, Rémy ; de Dreuille, Brune ; Chassac, Anaïs ; Cazals-Hatem, Dominique ; Bado, André ; Poté, Nicolas

BACKGROUND:

Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, is indicated to treat short bowel syndrome (SBS) since 2015. It has been shown to reduce parenteral support (PS) in SBS patients, although patients' response is quite heterogeneous. The exact mechanisms of action of GLP-2 on intestinal cells are still poorly understood. The aim of this study was to explore the intestinal action of teduglutide to identify molecular mechanisms underlying response heterogeneity.

METHODS:

A retrospective study was conducted in 39 SBS patients treated with teduglutide for at least 6 months. Intestinal biopsy specimens collected before and after treatment initiation were selected and analyzed by RNA sequencing to identify genes differentially expressed and pathways regulated following teduglutide treatment.

RESULTS:

Of the 39 patients included in the study, 29 (74%) had a colon in continuity. The overall response to teduglutide was a reduction by 75% (interquartile range: 42-100) in PS volume. Among the genes differentially expressed in the small bowel during teduglutide treatment, the most significantly upregulated gene was PAPPA2 (q-value < 0.0001), encoding the metalloproteinase Pappalysin-2 (PAPPA-2) involved in Insulin-like Growth Factor (IGF) bioavailability. The best responders to teduglutide showed a lower PAPPA2 expression at baseline (p < 0.01). PAPPA2 expression at baseline also correlated positively with the percentage of remnant colon (p < 0.001).

CONCLUSION:

We identified a new stakeholder, PAPPA-2, known to modulate IGF bioavailability, as playing a possible role in GLP-2 mechanism of action in human with SBS. We showed by association the existence of a greater spontaneous intestinal adaptation in SBS patients with a colon in continuity that could reduce sensitivity to teduglutide. Additionally, we suggest that initial PAPPA2 expression could serve as a predictive biomarker for teduglutide efficacy.

2025-07-01·EClinicalMedicine

Predictors of response and enteral autonomy in children with short bowel syndrome treated with teduglutide: a real-life multicentre cohort study

Article

作者: Hilberath, Johannes ; Hojsak, Iva ; Ghirardi, Arianna ; Lezo, Antonella ; Sacristán, Rocío González ; Guerra, Paula ; Norsa, Lorenzo ; D'Antiga, Lorenzo ; Poinsot, Pierre ; Ramos Boluda, Esther ; Lambe, Cecile ; Guz-Mark, Anat ; Broekaert, Ilse Juia

Background:

Teduglutide (TED), a glucagon-like peptide 2 analogue licensed for children with short bowel syndrome (SBS), is increasingly used in the attempt to augment intestinal absorption and lower parenteral nutrition (PN) needs. Data from real-life studies on TED efficacy and predictors of response in children with SBS are limited. This study aimed to define pre-treatment and on-treatment predictors of response, in terms of PN reduction and weaning, in TED treated children with SBS.

Methods:

In this multicenter cohort study, we collected retrospective and prospective data of children with SBS undergoing TED treatment in 7 countries in Europe (Italy, Spain, Croatia, Germany, France, Israel, Portugal). All children with SBS starting TED treatment and not included in clinical trials were eligible. Information on patients' post-surgical anatomy, amount of PN calories and volume required at baseline and at 3, 6 and 12 months after TED start, along with biochemical markers of PN tolerance and complications, were recorded. The main outcome was predicting factors of 1 year response to TED treatment defined as a reduction of ≥20% of PN needs.

Findings:

Between 01.06.2021 and 31.05.2023, we collected information on 104 children (64 males, 61.5%; 40 females, 38.5%) the median age at enrolment was 6.7 years old (IQR: 3.6-10.4); at 12 months' follow up after TED start 68 children achieved response (cumulative incidence: 70%, 95% CI 61%-79%), whereas complete PN weaning was achieved in 21 children (cumulative incidence: 22%, 95% CI 15%-31%). Multivariable logistic regression analysis showed that predictors of response were longer residual small bowel length (p = 0.027), higher weight Z-score at baseline (p = 0.0061) and normal liver enzymes (p = 0.010). Pre-treatment PN calories <35 kcal/kg/day (p = 0.044) and citrulline ≥14 μmol/L (p = 0.047) predicted complete PN weaning, as well as haemoglobin and citrulline rise in the first 6 months of treatment (p = 0.014 and p = 0.044 respectively).

Interpretation:

In children with SBS, longer residual small bowel, better nutritional status and absence of liver disease were associated with response to teduglutide. Complete PN weaning was predicted by lower calories needs and higher citrulline at baseline. An increase of haemoglobin and citrulline in the first 6 months of treatment were further predictors of complete PN weaning. Even if limited by the real-life design of the study, these findings may guide a tailored indication for the use of teduglutide in children with short bowel syndrome.

Funding:

The European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Networking grant.

2025-06-01·United European Gastroenterology Journal

European Consensus on Malabsorption—UEG & SIGE, LGA, SPG, SRGH, CGS, ESPCG, EAGEN, ESPEN, and ESPGHAN

Article

作者: Lenti, Marco Vincenzo ; Fonseca, Jorge ; Keller, Jutta ; Mendive, Juan ; Gasbarrini, Antonio ; Broekaert, Ilse ; Laterza, Lucrezia ; Corazza, Gino Roberto ; Kyselova, Denisa ; Lionis, Christos ; Surdea‐Blaga, Teodora ; Arvanitakis, Marianna ; Dolinsek, Jernej ; Schneider, Stephane ; Di Sabatino, Antonio ; Dumitrascu, Dan Lucian ; Hammer, Heinz Florian ; Pironi, Loris ; Nicolau, Adrien ; Foteini, Anastasiou ; Derovs, Aleksejs ; Hammer, Johann ; Segarra‐Cantón, Oscar ; Sonyi, Marc ; Nunes, Gonçalo ; Sabo, Cristina Maria ; Tacheci, Ilja ; Krznarić, Željko ; Burgos, Rosa ; Pokrotnieks, Juris

ABSTRACT:

Malabsorption is a complex and multifaceted condition characterised by the defective passage of nutrients into the blood and lymphatic streams. Several congenital or acquired disorders may cause either selective or global malabsorption in both children and adults, such as cystic fibrosis, exocrine pancreatic insufficiency (EPI), coeliac disease (CD) and other enteropathies, lactase deficiency, small intestinal bacterial overgrowth (SIBO), autoimmune atrophic gastritis, Crohn's disease, and gastric or small bowel resections. Early recognition of malabsorption is key for tailoring a proper diagnostic work‐up for identifying the cause of malabsorption. Patient's medical and pharmacological history are essential for identifying risk factors. Several examinations like endoscopy with small intestinal biopsies, non‐invasive functional tests, and radiologic imaging are useful in diagnosing malabsorption. Due to its high prevalence, CD should always be looked for in case of malabsorption with no other obvious explanations and in high‐risk individuals. Nutritional support is key in management of patients with malabsorption; different options are available, including oral supplements, enteral or parenteral nutrition. In patients with short bowel syndrome, teduglutide proved effective in reducing the need for parenteral nutrition, thus improving the quality of life of these patients. Primary care physicians have a central role in early detection of malabsorption and should be involved into multidisciplinary teams for improving the overall management of these patients. In this European consensus, involving 10 scientific societies and several experts, we have dissected all the issues around malabsorption, including the definitions and diagnostic testing (Part 1), high‐risk categories and special populations, nutritional assessment and management, and primary care perspective (Part 2).

102

项与替度格鲁肽相关的新闻（医药）

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

2025-07-08

·opko.com

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 and JERUSALEM, July 08, 2025 (GLOBE NEWSWIRE) -- 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 47th 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 minerals1. 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. Cautionary Statement Regarding Forward Looking Statements Various statements in this presentation are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward-looking statements include, among others: results of our clinical trials; the anticipated benefits of an oral tablet for the treatment of SBS; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10-K filed with the SEC, as well as the companies’ respective subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward-looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. 1 https://rarediseases.org/rare-diseases/short-bowel-syndrome/ 2 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. Released July 8, 2025

临床结果上市批准临床2期

2025-06-09

·药时空

此前FDA拒绝批准！长效GLP-2类似物欧洲递交上市许可

6月2日（当地时间），丹麦制药公司Zealand Pharma A/S宣布向EMA（欧洲药品管理局）递交长效GLP-2(胰高血糖素样肽-2）类似物Glepaglutide上市许可申请（MAA），适应症：治疗短肠综合征（SBS )成人患者。新闻稿称，EMA递交MAA依据来自Glepaglutide每周二次治疗SBS的关键3期临床研究（EASE-1）和两项进行中长期扩展研究（EASE-2和EASE-3）以及机制研究（EASE-4）的支持。EASE-1研究（NCT03690206）是一项随机、双盲3期试验，共招募了106例每周至少3天依赖肠外支持（PS）肠衰竭SBS患者。患者随机接受10 mg Glepaglutide治疗（每周一次或两次）或安慰剂治疗。主要终点24周时每周肠外支持量相对于基线的绝对变化。研究结果显示，24周时每周两次Glepaglutide每周PS总体积减少5.13L/周，而安慰剂组每周减少2.85L/周（p=0.0039）。当每周给药一次时，Glepaglutide每周PS降低3.13L/周，较安慰剂未达到统计学意义。共有9例接受Glepaglutide治疗患者完全停用PS（实现肠内自主），而安慰剂组患者无法停止PS。对于每周两次接受Glepaglutide治疗患者，14%患者（n=5）实现肠自主。106例患者中102例完成EASE-1研究，其中96例继续为期两年的长期安全性和有效性扩展试验EASE-2研究。EASE-2研究（NCT03905707）是一项随机、双盲试验，其中SBS患者继续EASE-1治疗，Glepaglutide10 mg（每周一次或两次）。EASE-1研究安慰患者被重新随机分配接受10 mg Glepaglutide治疗（每周一次或每周两次）。治疗至少6个月后中期分析，关键疗效终点对Glepaglutide临床反应总体上保持不变或显示持续改善，包括更多两种剂量的停止PS患者。完成EASE-2研究患者有资格参加EASE-3 （NCT04881825），评估使用自动注射器每周给药一次Glepaglutide。首个57例从EASE-2研究转入EASE-3研究患者期中分析表明，PS减少保持不变。EASE-4研究（NCT04991311）是一项3b期试验，旨在评估Glepaglutide对肠液和能量摄取的机制影响，试验提供Glepaglutide在改善肠道吸收方面的药效学作用的证据。Glepaglutide为一款潜在治疗SBS的长效GLP-2类似物液体制剂，并将配备可皮下注射的自动给药装置，旨在降低或消除SBS患者的肠外营养支持，FDA曾授予孤儿药资格。2024年12月，其SBS的NDA被FDA出具完整回复函（CRL），FDA要求增加临床试验提供更多有效性和安全性证据。新闻稿中，Zealand Pharma A/S表示将于2025年下半年启动3期临床（EASE-5）以支持FDA的审批。2024年2月，日本武田制药注射用替度格鲁肽（Teduglutide）正式获得中国国家药品监督管理局（NMPA）批准（商品名：瑞唯抒/Revestive），适用于治疗短肠综合征（Short bowel syndrome，简称SBS）成人和1岁及以上儿童患者。此外，VectivBio和杭州泰格医药在2021年向CDE递交了GLP-2R激动剂注射用阿帕拉格鲁肽（Apraglutide）治疗SBS的IND申请（受理号：JXHL2100112），但未见开展临床试验信息。金赛生物和重庆派金生物在国内实施了3项针对SBS的临床试验，对应的产品分别为生长激素和重组替度格鲁肽（日本武田替度格鲁肽生物类似药）。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

孤儿药临床3期上市批准临床结果临床2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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临床结果

适应症

分期

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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	失盐型肾上腺皮质综合症	-	TEDUGLUTIDE	夢繭鹽蓋選鏇築鹹鹹鏇(壓齋鹽鏇獵膚構選艱顧) = 鬱艱蓋糧觸選膚淵選構襯觸鑰鏇餘糧觸積築繭 (鏇壓簾觸襯築繭構鹽膚 )	-	2024-10-13
UEGW2024	N/A	肠衰竭	-	TEDUGLUTIDE	獵繭鹹簾鏇壓襯襯鑰餘(憲艱鏇觸膚衊繭範廠鹹) = 餘顧構鏇選膚鬱夢鬱醖憲顧遞膚鹹壓壓餘鏇廠 (範簾構餘網廠夢餘製餘 ) 更多	-	2024-10-13
				Placebo	獵繭鹹簾鏇壓襯襯鑰餘(憲艱鏇觸膚衊繭範廠鹹) = 築積憲鹽願選醖餘艱壓憲顧遞膚鹹壓壓餘鏇廠 (範簾構餘網廠夢餘製餘 ) 更多
NCT05027308 (CTgov)	临床3期	短肠综合征	3	Teduglutide	顧齋製蓋築選鹹網蓋襯 = 膚淵壓窪願鹹醖構積鏇蓋廠繭製餘製繭願餘範 (製範積蓋憲壓鏇鹹壓蓋, 繭憲顧壓膚積鏇積觸壓 ~ 構獵夢醖構鏇鑰壓願糧) 更多	-	2024-05-16
NCT02682381 \| NCT01952080 (SBS-IF, Pubmed \| J Pediatr Gastroenterol Nutr)	临床3期	肠衰竭	101	Teduglutide	構觸願齋鹽鏇獵簾醖壓(顧範觸鹹鑰構窪簾膚網) = Safety assessments included gastrointestinal adverse event reporting 顧蓋餘製鬱網糧築淵衊 (衊糧鑰積遞遞蓋積壓壓 )	积极	2023-11-01
				Teduglutide (Standard of care)
NCT03268811 \| NCT03571516 \| NCT02980666 (Pubmed)	临床3期	短肠综合征	-	Teduglutide	糧選鏇鏇艱淵餘鏇憲齋(製範積壓蓋簾壓願糧膚) = 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. 獵製衊壓衊繭選窪壓餘 (遞壓醖選餘糧鬱觸廠壓 )	积极	2023-06-27
				Teduglutide (Standard of care)
NCT02431325 (CTgov)	临床2期	动脉炎 \| HIV感染	32	Teduglutide (Teduglutide)	膚淵鑰鏇窪夢淵鬱夢獵(鏇齋鏇艱醖範鹹鏇繭鹽) = 築齋鹹淵餘憲蓋蓋窪鹹鹽鬱醖觸顧築遞襯壓選 (醖淵積襯憲衊憲鬱夢糧, 0.29) 更多	-	2023-06-12
				Placebo (Placebo)	膚淵鑰鏇窪夢淵鬱夢獵(鏇齋鏇艱醖範鹹鏇繭鹽) = 夢艱構醖觸鬱觸夢齋醖鹽鬱醖觸顧築遞襯壓選 (醖淵積襯憲衊憲鬱夢糧, 0.35) 更多
NCT03562130 (Pubmed \| Am J Clin Nutr)	临床4期	短肠综合征	25	Teduglutide	窪鏇鑰積糧蓋築衊繭艱(憲鬱遞糧觸選廠膚艱憲) = Mild abdominal pain at the early phase of treatment, stoma changes, and redness at the injection site were commonly reported 鹹積艱憲窪窪繭襯膚蓋 (網鹽遞蓋築蓋夢糧觸鑰 )	-	2023-06-01
NCT03596164 (CTgov)	临床3期	短肠综合征	11	SHP633-306 (SHP633-306: Teduglutide 0.05 mg/kg)	遞鑰壓淵鬱醖襯廠淵艱 = 窪構鹹鹹鏇夢願窪憲鹽壓範齋願襯蓋齋鬱膚夢 (積糧壓餘淵鹹窪蓋鑰鑰, 淵艱廠鹽蓋糧顧鑰糧鹹 ~ 鹽襯遞憲憲蓋廠鏇築膚) 更多	-	2023-03-15
				TED-C14-004+Teduglutide (TED-C14-004: Teduglutide 0.05 mg/kg)	遞鑰壓淵鬱醖襯廠淵艱 = 艱夢簾廠構顧積範簾窪壓範齋願襯蓋齋鬱膚夢 (積糧壓餘淵鹹窪蓋鑰鑰, 構鹹獵襯鑰獵網蓋襯鏇 ~ 網顧製簾範艱餘糧鏇膚) 更多
NCT03268811 (CTgov)	临床3期	短肠综合征	9	teduglutide (Total Children (Aged: 1 to 15 Years))	艱築製構餘鬱範鏇壓鹹 = 艱製網簾製齋淵憲蓋積襯簾構糧觸鏇願蓋艱鹹 (範壓築膚齋淵淵糧鏇鹽, 顧窪鹽鹽構願觸窪觸蓋 ~ 鹹憲願鏇網鹹夢餘網蓋) 更多	-	2022-05-24
				teduglutide (Infants (Corrected Gestational Age: 4 to < 12 Months))	艱築製構餘鬱範鏇壓鹹 = 鹽餘遞範顧膚夢糧衊獵襯簾構糧觸鏇願蓋艱鹹 (範壓築膚齋淵淵糧鏇鹽, 鹽齋構醖鑰築齋膚觸蓋 ~ 艱遞糧齋構鬱構構齋積) 更多
NCT02954458 (CTgov)	临床3期	短肠综合征	61	NTT+teduglutide (Non-teduglutide/Non-teduglutide Treatment (NTT/NTT))	淵鹽簾壓衊夢觸膚鏇衊 = 淵顧蓋觸鹽觸糧鏇糧鬱衊獵築襯願膚膚醖壓醖 (網壓糧壓餘選範遞壓夢, 窪醖衊餘網衊齋願襯遞 ~ 顧鹽觸獵鹹窪積築淵餘) 更多	-	2021-10-13
				NTT+Teduglutide (Non-teduglutide/Teduglutide Treatment (NTT/TED))	淵鹽簾壓衊夢觸膚鏇衊 = 構鑰獵簾範觸鑰襯選夢衊獵築襯願膚膚醖壓醖 (網壓糧壓餘選範遞壓夢, 淵襯夢觸願襯鏇築鏇觸 ~ 選積淵簾範鹽醖觸窪夢) 更多