A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS).
Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution.
Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo.

开始日期2025-05-29

申办/合作机构

Napo Therapeutics SpA

NCT06721871

/ Active, not recruiting临床2/3期

Evaluation of Safety, Tolerability and Efficacy of Crofelemer Following Multiple Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Participants With Microvillus Inclusion Disease (MVID)

A study that will evaluate the safety, tolerability and preliminary efficacy of multiple ascending doses of crofelemer, compared to placebo, using a randomized cross-over design within each dose level, when administered to participants with MVID receiving parenteral support (PS, defined as TPN with or without supplementary IV fluid requirements). Blinded study drug will be administered as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Assigned study drug will be reconstituted and administered orally (or enterally) three times daily (TID) as a concentrated liquid formulation in each of the three dose levels.

开始日期2025-05-01

申办/合作机构

Napo Pharmaceuticals, Inc.

NCT06326645

/ Active, not recruiting早期临床1期IIT

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .

开始日期2025-03-03

申办/合作机构

The Cleveland Clinic Foundation

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100 项与克罗非莫相关的临床结果

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100 项与克罗非莫相关的转化医学

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100 项与克罗非莫相关的专利（医药）

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项与克罗非莫相关的文献（医药）

2026-07-03·EXPERT OPINION ON PHARMACOTHERAPY

Crofelemer for chronic noninfectious diarrhea in adults with HIV/AIDS receiving antiretroviral therapy: a review of plant-derived antisecretory pharmacotherapy

Review

作者: Haneef, Anam ; Amin, Adnan ; Altaf, Sidra ; Rasny, M. R. M.

INTRODUCTION:

Chronic noninfectious diarrhea remains a clinically important but often underrecognized complication in patients receiving long-term antiretroviral therapy (ART). Although modern human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) treatment has transformed survival, gastrointestinal adverse effects can impair adherence, quality of life, nutrition, social functioning, and treatment satisfaction. Crofelemer is an oral, plant-derived botanical drug developed as a non-systemic antisecretory therapy for noninfectious diarrhea in adults with HIV/AIDS receiving ART.

AREAS COVERED:

This review evaluates crofelemer as a plant-derived pharmacotherapy for chronic noninfectious diarrhea. It discusses the clinical need, limitations of current antidiarrheal approaches, botanical origin, chloride-channel mechanism, pharmacology, clinical efficacy evidence, safety and tolerability, practical prescribing considerations, real-world positioning, and investigational expansion into cancer therapy-related diarrhea and rare intestinal-failure disorders.

EXPERT OPINION:

Crofelemer offers a mechanistically distinct option for selected patients with chronic watery, noninfectious diarrhea whose symptoms remain burdensome despite appropriate clinical evaluation and supportive care. However, its use should be guided by realistic expectations, careful patient selection, and recognition that response is not universal. Future clinical value will depend on phenotype-based prescribing, real-world effectiveness data, comparative studies, affordability, and patient-reported outcomes.

2023-10-16·The Journal of clinical investigation

Patient-derived enteroids provide a platform for the development of therapeutic approaches in microvillus inclusion disease

Article

作者: Kalashyan, Meri ; Thiagarajah, Jay R ; Bayer, Marie-Theres ; Oller, Haley ; Shub, Mitchell D ; Roland, Joseph T ; Kolobova, Elena ; Goldsmith, Jeffrey D ; Raghunathan, Krishnan ; Jimenez, Lissette ; Hagen, Susan J ; Kaji, Izumi ; Goldenring, James R

Microvillus inclusion disease (MVID), caused by loss-of-function mutations in the motor protein myosin Vb (MYO5B), is a severe infantile disease characterized by diarrhea, malabsorption, and acid/base instability, requiring intensive parenteral support for nutritional and fluid management. Human patient-derived enteroids represent a model for investigation of monogenic epithelial disorders but are a rare resource from MVID patients. We developed human enteroids with different loss-of function MYO5B variants and showed that they recapitulated the structural changes found in native MVID enterocytes. Multiplex immunofluorescence imaging of patient duodenal tissues revealed patient-specific changes in localization of brush border transporters. Functional analysis of electrolyte transport revealed profound loss of Na+/H+ exchange (NHE) activity in MVID patient enteroids with near-normal chloride secretion. The chloride channel-blocking antidiarrheal drug crofelemer dose-dependently inhibited agonist-mediated fluid secretion. MVID enteroids exhibited altered differentiation and maturation versus healthy enteroids. γ-Secretase inhibition with DAPT recovered apical brush border structure and functional Na+/H+ exchange activity in MVID enteroids. Transcriptomic analysis revealed potential pathways involved in the rescue of MVID cells including serum/glucocorticoid-regulated kinase 2 (SGK2) and NHE regulatory factor 3 (NHERF3). These results demonstrate the utility of patient-derived enteroids for developing therapeutic approaches to MVID.

2023-10-01·Clinical breast cancer

Crofelemer for the Management of Neratinib-Associated Diarrhea in Patients With HER2+ Early-Stage Breast Cancer

Article

作者: Melisko, Michelle ; Quintal, Laura ; Rugo, Hope S ; Johnson, MacKenzie ; Jacob, Saya ; Chien, Amy Jo ; Roque, Brianna

BACKGROUND:

To evaluate the efficacy of crofelemer, a first in class anti-secretory anti-diarrheal agent, to manage neratinib-induced diarrhea in patients with early-stage breast cancer taking adjuvant neratinib.

PATIENTS AND METHODS:

This single center, open label trial enrolled patients with Stage 2 to 3 HER2+ breast cancer taking adjuvant neratinib. One cohort took prophylactic crofelemer 125 mg bid and loperamide in the first 2 cycles, and as needed in subsequent cycles. The second cohort took dose-escalated neratinib with loperamide as needed (DE cohort). The primary endpoint was incidence of grade ≥ 3 diarrhea in the first 2 cycles.

RESULTS:

Seven patients in the crofelemer cohort and 4 in the DE cohort were enrolled. In the first 2 cycles, 2 patients (29%) in the crofelemer cohort and 2 patients (50%) in the DE cohort experienced grade 3 diarrhea lasting 1 day on average. After cycle 2, no additional patients in either cohort had grade 3 diarrhea. Five of 7 patients controlled diarrhea with crofelemer alone. There were no grade 4 diarrhea events in either cohort. Three patients in the crofelemer cohort dose-reduced neratinib due to diarrhea in the first 2 cycles. Patients in the crofelemer cohort had an average of 0.58 diarrhea episodes/day. 82% experienced constipation, all grade 1.

CONCLUSIONS:

This is the first study to investigate crofelemer for neratinib-induced diarrhea and demonstrates crofelemer activity in this setting. Further investigation of crofelemer for diarrhea secondary to cancer treatment is needed.

355

项与克罗非莫相关的新闻（医药）

2026-10-13

·BioSpace

Reminder: Today, October 13, 2026, is the Record Date for Jaguar Health’s Special Stock Dividend

Dividend intended to provide dilution protection to Jaguar shareholders as company continues evaluation of strategic alternatives Jaguar's rare disease intestinal failure development program for microvillus inclusion disease (MVID) and short bowel syndrome for crofelemer powder for oral solution is expected to continue to provide clinical milestones, including a planned New Drug Application (NDA) filing for crofelemer for MVID in mid-2027 SAN FRANCISCO, CA / ACCESS Newswire / October 13, 2026 / Jaguar Health, Inc. ( NASDAQ:JAGX ) ("Jaguar" or "the Company") today issued a reminder that today, October 13, 2026, is the Record Date for the Company's special stock dividend (the "Special Stock Dividend"). As announced , Jaguar's Board of Directors declared a Special Stock Dividend to holders of Jaguar Common Stock and certain outstanding warrants as of record on October 13, 2026. The Special Stock Dividend consists of the Company's Series R Convertible Preferred Stock (the "Preferred Stock"). The payment date for the Special Stock Dividend is October 15, 2026, two days after the Record Date. Only persons who own shares of the Company's voting common stock (the "Common Stock"), or certain warrants to purchase Common Stock with dividend rights, at the close of business on the Record Date will be entitled to receive shares of the Preferred Stock. Each share of Preferred Stock will convert into five shares of Common Stock on November 2, 2026. "Jaguar is issuing the Special Stock Dividend to reward and recognize our passionate and supportive stockholders and provide protection against potential dilution as we continue evaluation of strategic alternatives," said Lisa Conte, Jaguar's founder, president, and CEO. "We remain sharply focused on our ongoing global development program for oral crofelemer as adjunctive therapy to parenteral support for rare intestinal failure diseases, including microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) for crofelemer powder for oral solution. Jaguar's intestinal failure program is expected to continue to provide clinical milestones, including a planned New Drug Application (NDA) filing for crofelemer for MVID in mid-2027." For additional information about the Special Stock Dividend and terms of the Preferred Stock and associated risk factors, please refer to the Form 8-K the Company filed with the U.S. Securities and Exchange Commission on October 5, 2026, which can be viewed on the Company's website by clicking here . About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding payment of dividends, conversion of the Preferred Stock, Jaguar's expectation that its intestinal failure program will continue to provide clinical proof-of-concept milestones, and Jaguar's expectation that the Company will NDA with the U.S. Food and Drug Administration for the MVID indication in mid-2027. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

申请上市

2026-10-11

·杏林统计与生信之家

一滴“龙血”如何变成FDA新药：Crofelemer的研发故事

作者按：Crofelemer的成功告诉我们：植物药现代化并不意味着把复杂体系拆解成某一个“明星成分”。它以人用经验为起点，以生物活性为纽带，以临床疗效为最终评价标准，在尊重植物复方复杂性的基础上建立现代药物研发体系。2012年，Crofelemer 获得FDA批准上市（FDA正式批准的处方植物药botanical drug products来源混合物数量非常有限，共4个），成为“不唯成分论”的植物复方药走向国际监管体系的成功案例，其研发经验对中药新药创新具有重要启示意义。2022年5月5日：国家药监局药审中心（CDE）发布了两项关键试行指导原则，标志着“三结合”体系开始进入实际操作阶段。Crofelemer的研发故事符合中药新药审评“三结合”中，新的中药注册分类不再以物质基础作为划分依据，并淡化了对“有效成分”和“有效部位”等化学成分含量的硬性要求。复杂植物药并非不能进入现代药物监管体系，关键在于建立从物质基础、生物活性到临床疗效的完整证据链，而不是简单追求单一有效成分。在南美洲亚马逊地区，有一种叫Croton lechleri 的植物。当树皮被划开时，会流出一种暗红色的汁液，当地人形象地把它称为：“龙血”（Dragon's blood）。几个世纪以来，当地居民一直把这种红色树汁用于腹泻、伤口等疾病。如果故事停在这里，它不过是一味传统植物药。但几十年后，这种来自亚马逊森林的红色树汁，却一步步走进现代实验室、临床试验和美国FDA，最终变成了一种正式批准的新药——Crofelemer。它的故事，非常值得今天的中药研发者思考。一、不是先发现一个化合物，而是先发现“人们真的在用它” 现代新药研发，我们熟悉的路径通常是：发现靶点→ 筛选化合物 → 动物实验 → 临床试验。Crofelemer却走了另一条路。上世纪，美国一家名为 Shaman Pharmaceuticals 的公司把注意力放到了传统医学和民族植物学上。他们提出一个很朴素的问题：如果一种植物已经被当地居民使用了几百年，我们是不是可以先看看，它为什么有效？于是，研究人员注意到了 Croton lechleri。当地居民长期用它治疗腹泻。这相当于大自然已经提供了一个非常粗糙、但很有价值的“临床信号”。研究人员并没有停留在：“祖祖辈辈都这么用，所以它一定有效。”而是继续追问：它里面到底有什么？为什么能够止泻？能不能把它做成一个质量稳定、疗效可靠的现代药物？真正的药物研发，从这里才开始。二、麻烦来了：它根本不是一个单一化合物研究人员从植物中得到了一类富含原花青素的成分。后来，这种药物被命名为Crofelemer。但它和我们熟悉的很多西药不一样。阿司匹林有明确的化学结构。二甲双胍也有明确的化学结构。而 Crofelemer 呢？它实际上是由多种原花青素寡聚体组成的复杂混合物。换句话说：它不是“一个分子”，而是一群结构相近的分子。这一下，问题就复杂了。FDA自然会问：你今天生产的这一批，和明天生产的那一批，是同一个药吗？如果连每一种成分都无法完全分离和定量，又怎么保证质量？这也是所有复杂植物药都会面对的问题。三、研究人员换了一个思路：不要求每一个分子完全一样，但要证明“这个药始终还是那个药” Crofelemer研发中最有意思的一点，就发生在这里。对于这样一个复杂植物药，如果要求每一批产品的所有化学分子都完全相同，几乎不现实。于是问题被重新定义了：我们不一定要求每一个成分绝对一致，但必须证明不同批次的产品，在关键质量特征、生物活性和最终治疗效果上是一致的。这就是后来植物药研发中非常重要的一个思想：therapeutic consistency——治疗一致性。为了做到这一点，质量控制不能只从药片开始。研究人员要一路往前追：植物是不是同一个物种？生长在哪里？什么时候采集？原料怎么保存？怎么提取？怎么纯化？不同批次的化学指纹是不是相似？原花青素的组成和分布是不是稳定？也就是说，质量控制从：植物→ 原料 → 工艺 → 中间体 → 成品建立了一条完整链条。这和简单检测一个“指标成分含量”完全不是一回事。四、更关键的一步：科学家终于弄明白它为什么能止泻 Crofelemer并不是让肠道“少动一点”。它作用的关键位置，是肠道上皮细胞上的离子通道。正常情况下，某些腹泻患者的肠道会大量向肠腔分泌氯离子。氯离子出去以后，钠和水也会跟着进入肠腔。结果就是：水越来越多，形成水样腹泻。研究发现，Crofelemer可以抑制两个重要的氯离子通道：CFTR 和 CaCC。于是：氯离子分泌减少→ 水进入肠腔减少 → 水样腹泻减轻。突然之间，一味传统的“止泻植物药”，有了现代生理学解释。更加巧妙的是，Crofelemer口服以后几乎不需要大量进入血液。因为它要作用的地方，本来就在肠道。所以它可以理解为：药物到了该去的地方，在局部发挥作用，然后尽量少进入全身。这也为它相对良好的全身安全性提供了一个重要基础。五、但是，故事差一点在半路结束新药研发从来不是直线前进。Crofelemer早期做过多项临床研究，也曾看到治疗腹泻的积极信号。然而，开发它的 Shaman Pharmaceuticals 最终没有撑下去。公司陷入财务困境，并在2001年前后进入破产程序。一个已经研究了多年的植物药，差一点就此消失。后来，Napo Pharmaceuticals 接手了这个项目。Crofelemer又重新回到了研发轨道。所以今天回头看，它的成功绝不是：发现植物→ 做实验 → FDA批准。真实的路径更像是：传统经验→ 药物发现 → 早期临床 → 公司失败 → 项目转手 → 重新研发 → 再做临床 → 最终获批。这是一场持续二十多年的长跑。六、最后一关，还是要靠临床试验说话无论植物使用了几百年，机制研究多么漂亮，最后都绕不开一个问题：病人吃了以后，到底有没有真正获益？Crofelemer最终开展了关键的随机、双盲、安慰剂对照临床试验。研究对象并不是笼统的“所有腹泻患者”。开发团队把适应症不断缩小、定义清楚，最终聚焦于：接受抗逆转录病毒治疗的 HIV/AIDS 成人患者的非感染性腹泻。这一点非常重要。因为腹泻背后的原因很多。感染性腹泻、炎症性腹泻、药物相关腹泻，治疗完全不同。药物研发不是适应证越宽越好，而是：找到最合适的患者。关键研究中，Crofelemer组达到预设临床应答标准的患者比例约为：17.6%；而安慰剂组约为：8.0%。差别并不是惊天动地。但结合患者的未满足临床需求、严格的疗效定义、相对良好的安全性，以及此前积累的大量药学和药理证据，FDA最终认为：获益大于风险。2012年12月，Crofelemer获得FDA批准。一个来自亚马逊传统医学的植物，终于成为了现代处方药。七、Crofelemer真正值得中药学习的，并不是“植物药也能被FDA批准” 如果只得到这个结论，反而把这个故事看简单了。Crofelemer真正重要的地方是，它回答了一个复杂中药同样必须回答的问题：当一个药不是单一化学分子，而是复杂混合物时，我们怎样证明它是一个可以信赖的现代药物？答案不是：一定要把它拆成一个单体。也不是：祖先用了几百年，所以不需要现代证据。而是建立一条完整证据链：传统人用经验→明确适应证→稳定原料和生产工艺→化学特征可表征→生物活性可解释→不同批次具有治疗一致性→随机临床试验证明患者获益。最终，我们真正需要证明的并不是：“每一批药的每一个化学成分都完全一样。”而是：今天生产出来的药，仍然是临床试验中那个安全、有效、值得患者信赖的药。这也许就是 Crofelemer 的故事给中药现代化最重要的启示。复杂，并不可怕。真正困难的是：如何用现代科学证明这种复杂是可认识的、可控制的、可重复的，最终也是可以给患者带来稳定获益的。从亚马逊森林里的一滴“龙血”，到FDA批准的新药，Crofelemer用了二十多年。它证明了一件事：传统经验可以成为现代新药研发的起点，但绝不能成为终点。它也提出一个中药创新评价方法学问题：chemical fingerprint；CQAs（关键质量属性）；therapeutic consistency；totality of evidence；中药复方整体疗效评价。

2026-10-06

·BioSpace

Napo Pharmaceuticals, a Jaguar Health Family Company, Sponsoring Intestinal Failure Panel Discussion at Pediatric Gastroenterology Conference in Abu Dhabi

Company remains sharply focused on its ongoing rare disease intestinal failure global development program for microvillus inclusion disease (MVID) and short bowel syndrome (SBS) for crofelemer powder for oral solution, targeting an NDA filing for MVID mid-2027 A recent Rareatives article shares the story of a young child living with MVID, highlighting the importance of family perspectives, supportive communication, and collaboration with clinicians in addressing rare intestinal diseases SAN FRANCISCO, CA / ACCESS Newswire / October 6, 2026 / Jaguar Health, Inc. ( Nasdaq:JAGX ) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is a sponsor of the 2nd Best of Elite Ped-GI meeting in Abu Dhabi in the United Arab Emirates and is also sponsoring a panel discussion titled Intestinal Barrier Beyond Total Parenteral Nutrition (TPN) on October 30, 2026 at the meeting. Participants in the panel discussion include Dr. Mohamad Miqdady, Dr. Christos Tzivinikos, and Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board. Dr. Miqdady is the Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City , a flagship tertiary hospital in the UAE and the largest teaching medical center in Abu Dhabi. He is also a Clinical Professor at Khalifa University’s medical school in Abu Dhabi, and completed his Fellowship in Pediatric Gastroenterology at Baylor College of Medicine and Texas Children's Hospital in Houston. Dr. Christos Tzivinikos, MD DCH FRCPCH MSc CEBP, Chairman of the 2nd Best of Elite Ped-GI meeting, is a Consultant Pediatric Gastroenterologist and Founder of the Pediatric GI Department at Al Jalila Children’s Specialty Hospital in Dubai, and Clinical Associate Professor at Mohammed Bin Rashid University of Medicine and Health Sciences in Dubai. Napo remains sharply focused on its ongoing global development program for oral crofelemer as adjunctive therapy to parenteral support (PS) for rare IF diseases, including MVID and SBS-IF. In June 2026, as announced , data was presented at the 58 th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in Lille, France from ongoing investigational studies with oral liquid crofelemer in pediatric patients with IF due to MVID and SBS-IF. The results of ongoing investigations of liquid oral crofelemer formulations demonstrate substantial reductions in weekly PS needs as well as in PS normalized to body weight in pediatric IF patients dosed orally for more than one year, with no significant clinical or laboratory abnormalities. Jaguar's IF program is expected to continue to provide clinical milestones, including a planned New Drug Application (NDA) filing for MVID in mid-2027. A recent Rareatives article shares the story of a young child living with MVID, highlighting the importance of family perspectives, supportive communication, and collaboration with clinicians in addressing rare intestinal diseases. Dr. Miqdady is a member of Napo's Scientific Advisory Board. Dr. Miqdady and Dr. Tzivinikos are involved is clinical evaluations of crofelemer powder for oral solution for treatment of IF in pediatric IF patients. The 2nd Best of Elite Ped-GI meeting is dedicated to advancing clinical knowledge and best practices in pediatric gastroenterology and nutrition, with a particular emphasis on parenteral nutrition in children with complex gastrointestinal disorders. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals, Inc. (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit napopharma.com Napo Therapeutics, visit napotherapeutics.com Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the company will New Drug Application (NDA) for crofelemer for MVID in mid-2027. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on ACCESS Newswire

100 项与克罗非莫相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03605	克罗非莫	A07XA06	DB04941

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
腹泻	美国	Napo Pharmaceuticals, Inc.	2012-12-31

未上市

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适应症	最高研发状态	国家/地区	公司	日期
微绒毛包涵体病	临床3期	美国	Napo Pharmaceuticals, Inc.	2025-05-01
微绒毛包涵体病	临床3期	意大利	Napo Pharmaceuticals, Inc.	2025-05-01
微绒毛包涵体病	临床3期	阿拉伯联合酋长国	Napo Pharmaceuticals, Inc.	2025-05-01
HIV肠病	临床3期	美国	Bausch Health Americas, Inc.	2007-10-01
获得性免疫缺陷综合征	临床3期	美国	Shaman Pharmaceuticals, Inc.	2001-08-31
获得性免疫缺陷综合征	临床3期	波多黎各	Shaman Pharmaceuticals, Inc.	2001-08-31
短肠综合征	临床2期	德国	Napo Therapeutics SpA	2025-05-29
短肠综合征	临床2期	意大利	Napo Therapeutics SpA	2025-05-29
腹泻型肠易激综合征	临床2期	美国	Bausch Health Americas, Inc.	2004-12-01
急性腹泻	临床1期	美国	Napo Pharmaceuticals, Inc.	2022-01-30

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临床结果

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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


NCT04486326 (CTgov)	临床4期	腹泻	17	Crofelemer (Crofelemer)	選壓鹽願淵鏇淵範廠製(簾衊遞壓築網壓鹹鏇淵) = 齋餘選繭製鹹構鹹齋憲簾製壓齋繭壓廠繭餘壓 (積繭築鹹構窪製醖蓋齋, 0.72) 更多	-	2026-03-10
				Placebo (Placebo)	選壓鹽願淵鏇淵範廠製(簾衊遞壓築網壓鹹鏇淵) = 蓋糧夢簾衊願糧窪齋築簾製壓齋繭壓廠繭餘壓 (積繭築鹹構窪製醖蓋齋, 0.79) 更多
NCT03898856 (CTgov)	临床4期	慢性腹泻	93	Diagnostic tests for cause of chronic diarrhea+Crofelemer	積憲衊廠簾艱觸夢鏇蓋 = 鏇製範鏇範壓簾淵遞築鑰顧網醖淵鹽遞繭積鬱 (齋糧獵鹽願窪艱糧鏇壓, 願鹹積醖顧繭憲膚衊觸 ~ 蓋觸蓋壓鹹糧顧膚蓋選) 更多	-	2026-02-12
Company_Website 人工标引	N/A	微绒毛包涵体病	1	Crofelemer	壓壓廠顧製齋壓壓構壓(觸鏇鬱艱獵範鬱蓋膚壓) = 簾襯鹹鹽鑰窪餘膚夢鏇積窪範選壓積窪窪觸艱 (餘憲艱範鹹壓遞製鏇鹹 )	积极	2025-05-20
NCT04538625 (OnTARGET, Company_Website) 人工标引	临床3期	腹泻	287	crofelemer	顧製廠範艱鬱積鏇鏇齋(醖蓋觸製醖選獵繭獵鹹) = crofelemer prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo. Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients 壓構獵構願夢積簾鹽鏇 (蓋積選製糧繭鏇築淵窪 ) 达到	积极	2025-03-27
				Placebo
NCT04538625 (OnTarget, Company_Website) 人工标引	临床3期	腹泻	287	Crofelemer	壓觸積鹹廠鑰製窪簾齋(淵顧網夢繭淵製淵觸積) = 淵簾鹹齋艱衊憲鏇艱範衊窪鹽鹽選襯衊築艱夢 (襯餘膚鑰顧壓積構鏇壓 )	积极	2024-12-12
				Placebo	壓觸積鹹廠鑰製窪簾齋(淵顧網夢繭淵製淵觸積) = 淵願醖鹹簾鹹蓋顧鏇夢衊窪鹽鹽選襯衊築艱夢 (襯餘膚鑰顧壓積構鏇壓 )
NCT04486326 (Company_Website) 人工标引	临床4期	腹泻	-	Crofelemer	顧淵夢鏇願鬱膚蓋獵鬱(顧構艱製構觸構膚選構) = statistically meaningful reduction 襯憲壓製艱憲鹹餘鏇願 (壓鹽餘構廠網遞製築顧 )	积极	2024-05-28
				Placebo
NCT02910219 (Pubmed) 人工标引	临床2期	HER2阳性乳腺癌 HER2 Positive	51	crofelemer	齋願壓鏇蓋簾鬱構襯廠(鏇遞獵範廠簾窪憲獵鹹) = 鑰齋膚鹽齋製鏇積糧衊簾鑰鏇觸製顧鹽憲遞鑰 (簾膚構壓糧選齋簾鑰淵 ) 更多	不佳	2022-10-25
				no scheduled prophylactic medication	齋願壓鏇蓋簾鬱構襯廠(鏇遞獵範廠簾窪憲獵鹹) = 觸齋醖膚觸鑰築糧蓋壓簾鑰鏇觸製顧鹽憲遞鑰 (簾膚構壓糧選齋簾鑰淵 ) 更多
NCT02910219 (HALT-D, CTgov)	临床2期	腹泻	53	Crofelemer (Crofelemer)	襯蓋顧選蓋製艱鹽壓壓 = 壓鏇簾遞鹽餘鏇顧艱艱簾憲願廠積顧積膚鬱簾 (壓繭窪糧鏇夢壓艱繭鏇, 醖夢衊膚鏇壓廠鹹簾壓 ~ 鬱膚淵膚醖繭鬱簾窪醖) 更多	-	2022-10-24
				THP (Control)	襯蓋顧選蓋製艱鹽壓壓 = 衊構鑰襯繭築觸衊膚膚簾憲願廠積顧積膚鬱簾 (壓繭窪糧鏇夢壓艱繭鏇, 築淵積醖夢衊範積選淵 ~ 糧醖窪艱願蓋網醖鏇醖) 更多
NCT02910219 (Halt-d, SABCS2022)	临床2期	乳腺癌新辅助 \| 辅助 HER2+	53	Crofelemer	醖醖膚積鬱窪鹹積願遞(鏇選獵製鏇製積廠繭夢) = 觸製鹽餘積艱鑰壓構衊鏇觸觸襯窪淵鹽廠鑰壓 (顧衊襯壓繭鑰夢壓繭餘 ) 更多	积极	2022-02-15
				Control	醖醖膚積鬱窪鹹積願遞(鏇選獵製鏇製積廠繭夢) = 築選鏇艱鏇衊網艱製餘鏇觸觸襯窪淵鹽廠鑰壓 (顧衊襯壓繭鑰夢壓繭餘 ) 更多
NCT02910219 (HALT-D, Company_Website) 人工标引	临床2期	腹泻	51	Crofelemer	夢淵範鑰憲製窪獵憲鏇(範構簾壓齋衊獵鏇醖獵) = not statistically different for the two groups 選蓋遞鬱艱糧蓋願鹽鬱 (鏇積蓋觸製鑰積鹹構醖 )	不佳	2021-12-10
				standard of care