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 and randomization will be stratified by baseline PS volume (≤4 or >4 L/week).

Start Date29 May 2025

Sponsor / Collaborator

Napo Therapeutics SpA

NCT06721871

/ RecruitingPhase 2

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 32-week 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

Start Date01 May 2025

Sponsor / Collaborator

Napo Pharmaceuticals, Inc.

NCT06326645

/ RecruitingEarly Phase 1IIT

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. .

Start Date03 Mar 2025

Sponsor / Collaborator

The Cleveland Clinic Foundation

[+1]

100 Clinical Results associated with Crofelemer

100 Translational Medicine associated with Crofelemer

100 Patents (Medical) associated with Crofelemer

Literatures (Medical) associated with Crofelemer

01 Apr 2024·American journal of medical genetics. Part A

Clinical course and therapeutic trial for a case of congenital secretory diarrhea due to novel GUCY2C variant

Author: Horton, Darlene ; Teng, Ru-Jeng ; Wong, Ian Guo Yi ; Teng, Ru‐Jeng ; Scott, William ; Cramer, Jesse ; Muriello, Michael ; Basel, Donald ; Elkadri, Abdul

Abstract:

Chronic diarrhea presents a significant challenge for managing nutritional and electrolyte deficiencies, especially in children, given the higher stakes of impacting growth and developmental consequence. Congenital secretory diarrhea (CSD) compounds this further, particularly in the case of the activating variants of the guanylate‐cyclase 2C (GUCY2C) gene. GUCY2C encodes for the guanylate‐cyclase 2C (GC‐C) receptor that activates the downstream cystic fibrosis transmembrane receptor (CFTR) that primarily drives the severity of diarrhea with an unclear extent of influence on other intestinal channels. Thus far, management for CSD primarily consists of mitigating nutritional, electrolyte, and volume deficiencies with no known pathophysiology‐driven treatments. For activating variants of GUCY2C, experimental compounds have shown efficacy in vitro for direct inhibition of GC‐C but are not currently available for clinical use. However, Crofelemer, a CFTR inhibitory modulator with negligible systemic absorption, can theoretically help to treat this type of CSD. Herein, we describe and characterize the clinical course of a premature male infant with a de novo missense variant of GUCY2C not previously reported and highly consistent with CSD. With multi‐disciplinary family‐directed decision‐making, a treatment for CSD was evaluated for the first time to our knowledge with Crofelemer.

16 Oct 2023·The Journal of clinical investigation

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

Article

Author: Kalashyan, Meri ; Thiagarajah, Jay R ; Bayer, Marie-Theres ; Roland, Joseph T ; Oller, Haley ; Shub, Mitchell D ; 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.

01 Oct 2023·Clinical breast cancer

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

Article

Author: 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.

302

News (Medical) associated with Crofelemer

18 Mar 2026

·jaguarhealth.gcs-web.com

FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with significant toxicities; PS reduction could potentially reduce co-morbidities and improve clinical benefit, as no approved therapies exist for MVID Jaguar launches news alert text service for investors - click here to sign up for text alerts SAN FRANCISCO, CA / ACCESS Newswire / March 18, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support (PS) requirements, which may result in disease progression-modification of MVID. "We are pleased to have the opportunity to continue treatment with crofelemer powder for oral solution in our ongoing clinical trial of crofelemer in pediatric MVID patients," said Pravin Chaturvedi , PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board . "This would allow patients who have completed their double-blind treatment period to be eligible for the single-blind phase of continued treatment with crofelemer for further assessment of clinical benefit through reduction of PS for a longer period. PS reduction could potentially reduce co-morbidities associated with the disease and TPN; thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID." The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee (DMC), which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately 30% of the participating MVID patients have completed the study's double-blind treatment phase and the clinical investigators are supporting the patients' participation in the single-blind extended phase. This trial of crofelemer in MVID patients has clinical sites in the US, Italy and the UAE , and the consent from the FDA, the European Medicines Agency (EMA), The Ministry of Health and Prevention (MOHAP), and the Institutional Review Boards (IRBs) for each site. "Our development plan for this ultrarare disease, with an expected improved clinical benefit from the longer treatment in the extension phase, may also support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval for this ultrarare pediatric disorder," said Lisa Conte , Jaguar's founder, president, and CEO. "The extremely low incidence and prevalence of MVID, its lethal natural history and the fact that no therapies are available for MVID other than lifelong PS, underscores the need for new therapies. Together with the support of MVID clinical key opinion leaders (KOLs), we are exploring expedited regulatory pathways for crofelemer." 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 (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 MVID and short bowel syndrome. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.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 Napo will initiate a single-blind extension phase for its MVID trial, the expectation that PS reduction could potentially reduce co-morbidities associated with MVID and TPN, thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID, and Jaguar's expectation that its development plan for MVID may support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval. 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.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

Clinical StudyBreakthrough Therapy

18 Mar 2026

·www.biospace.com

FDA Feedback Supports Extension Phase for Jaguar Health’s Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with significant toxicities; PS reduction could potentially reduce co-morbidities and improve clinical benefit, as no approved therapies exist for MVID Jaguar launches news alert text service for investors - click here to sign up for text alerts SAN FRANCISCO, CA / ACCESS Newswire / March 18, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support (PS) requirements, which may result in disease progression-modification of MVID. "We are pleased to have the opportunity to continue treatment with crofelemer powder for oral solution in our ongoing clinical trial of crofelemer in pediatric MVID patients," said Pravin Chaturvedi, PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board. "This would allow patients who have completed their double-blind treatment period to be eligible for the single-blind phase of continued treatment with crofelemer for further assessment of clinical benefit through reduction of PS for a longer period. PS reduction could potentially reduce co-morbidities associated with the disease and TPN; thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID." The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee (DMC), which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately 30% of the participating MVID patients have completed the study's double-blind treatment phase and the clinical investigators are supporting the patients' participation in the single-blind extended phase. This trial of crofelemer in MVID patients has clinical sites in the US, Italy and the UAE, and the consent from the FDA, the European Medicines Agency (EMA), The Ministry of Health and Prevention (MOHAP), and the Institutional Review Boards (IRBs) for each site. "Our development plan for this ultrarare disease, with an expected improved clinical benefit from the longer treatment in the extension phase, may also support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval for this ultrarare pediatric disorder," said Lisa Conte, Jaguar's founder, president, and CEO. "The extremely low incidence and prevalence of MVID, its lethal natural history and the fact that no therapies are available for MVID other than lifelong PS, underscores the need for new therapies. Together with the support of MVID clinical key opinion leaders (KOLs), we are exploring expedited regulatory pathways for crofelemer." 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 (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 MVID and short bowel syndrome. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit 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 Napo will initiate a single-blind extension phase for its MVID trial, the expectation that PS reduction could potentially reduce co-morbidities associated with MVID and TPN, thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID, and Jaguar's expectation that its development plan for MVID may support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval. 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

Clinical StudyBreakthrough Therapy

09 Mar 2026

·jaguarhealth.gcs-web.com

Jaguar Health Strengthens Company's Balance Sheet by Restructuring and Reducing Royalty and Debt Obligations and Extinguishing Warrants

Strengthening balance sheet and capitalization is a key Jaguar priority Company continues its sharp, strategic focus on global development program for crofelemer for rare-disease intestinal failure indications SAN FRANCISCO, CA / ACCESS Newswire / March 9, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or "the Company") today announced that the Company has strengthened its balance sheet by restructuring and reducing its royalty obligations and debt held by affiliates of Chicago Venture Partners L.P. , including the extinguishment of 48,212 warrants. The restructuring consisted of an initial reduction of approximately 10% (amounting to a reduction of approximately $3 million ) of royalty obligations and debt; extending the maturity date by three years for a secured revolving line of credit for approximately $7 million put in place in November 2025 ; and ensuring that there are no maturity dates before July 2026 for any debt held by affiliates of Chicago Venture Partners L.P. "We are very pleased to have completed this debt restructuring, and we plan to pursue additional potential opportunities to further restructure and reduce debt over the coming months in agreement with the debt holder," said Lisa Conte , Jaguar's founder, president, and CEO. "Strengthening Jaguar's balance sheet and capitalization is a key priority. Operationally, we continue to sharply focus on our ongoing global development program for our crofelemer powder-for-oral-solution formulation for rare-disease intestinal failure indications. Our intestinal failure program is expected to continue to provide clinical proof-of-concept milestones and is the subject of business development discussions with the potential to bring in non-dilutive funds from potential licensee partners." 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 https://jaguar.health 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 it will pursue additional potential opportunities to further restructure and reduce debt over the coming months, Jaguar's expectation that its intestinal failure program will continue to provide clinical proof-of-concept milestones, and Jaguar's expectation that the opportunity may exist to bring in non-dilutive funds from potential licensee partners to support the intestinal failure program. 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.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

100 Deals associated with Crofelemer

External Link

KEGG	Wiki	ATC	Drug Bank
D03605	Crofelemer	A07XA06	DB04941

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diarrhea	United States	Napo Pharmaceuticals, Inc.	31 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Enteropathy	Phase 3	United States	Bausch Health Americas, Inc.	01 Oct 2007
Acquired Immunodeficiency Syndrome	Phase 3	United States	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Acquired Immunodeficiency Syndrome	Phase 3	Puerto Rico	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Short Bowel Syndrome	Phase 2	Germany	Napo Therapeutics SpA	29 May 2025
Short Bowel Syndrome	Phase 2	Italy	Napo Therapeutics SpA	29 May 2025
Microvillus Inclusion Disease	Phase 2	United States	Napo Pharmaceuticals, Inc.	01 May 2025
Microvillus Inclusion Disease	Phase 2	Italy	Napo Pharmaceuticals, Inc.	01 May 2025
Microvillus Inclusion Disease	Phase 2	United Arab Emirates	Napo Pharmaceuticals, Inc.	01 May 2025
Irritable bowel syndrome with diarrhea	Phase 2	United States	Bausch Health Americas, Inc.	01 Dec 2004
Acute diarrhea	Phase 1	United States	Napo Pharmaceuticals, Inc.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04486326 (CTgov)	Phase 4	Diarrhea	17	Crofelemer (Crofelemer)	qsdfvlocya(cpgmifkagk) = ihymqpopes jgmydqqeuy (xqwyfulpeh, 0.72) View more	-	10 Mar 2026
				Placebo (Placebo)	qsdfvlocya(cpgmifkagk) = fftanphiir jgmydqqeuy (xqwyfulpeh, 0.79) View more
NCT03898856 (CTgov)	Phase 4	Chronic diarrhea	93	Diagnostic tests for cause of chronic diarrhea+Crofelemer	flormlbttq = acratmksqd oexrhjpxet (bjlldfrtad, ermcscfhfw - epakolujgf) View more	-	12 Feb 2026
Company_Website Manual	Not Applicable	Microvillus Inclusion Disease	1	Crofelemer	xgexsydszf(pgbqfqdwyr) = oishmosfgk hllghardff (unqdjscybd )	Positive	20 May 2025
NCT04538625 (OnTARGET, Company_Website) Manual	Phase 3	Diarrhea	287	crofelemer	ykmcfwxxyc(ylnrlittlh) = 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 uqcyhvlwos (oqkiruliqn ) Met	Positive	27 Mar 2025
				Placebo
NCT04538625 (OnTarget, Company_Website) Manual	Phase 3	Diarrhea	287	Crofelemer	kebbuwnrhb(iddemegpba) = ilhnssnnko nskurdcpqt (kgcdnwpilv )	Positive	12 Dec 2024
				Placebo	kebbuwnrhb(iddemegpba) = wrpjqffhtu nskurdcpqt (kgcdnwpilv )
NCT04486326 (Company_Website) Manual	Phase 4	Diarrhea	-	Crofelemer	dhetrechni(frpwjrdlpa) = statistically meaningful reduction ldszbhdqfb (jgfogyjnfa )	Positive	28 May 2024
				Placebo
NCT02910219 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	51	crofelemer	nffakdvtbr(gljcqmhcxd) = gmxvcefkjm nqolnhhvxp (kyothswlxr ) View more	Negative	25 Oct 2022
				no scheduled prophylactic medication	nffakdvtbr(gljcqmhcxd) = weetzoomae nqolnhhvxp (kyothswlxr ) View more
NCT02910219 (HALT-D, CTgov)	Phase 2	Diarrhea	53	Crofelemer (Crofelemer)	pfoxjbbafs = mzzmriudmk rgmxtvoszu (bbdxfycnhu, yfkjuxxtcr - mwdbhoiugi) View more	-	24 Oct 2022
				THP (Control)	pfoxjbbafs = vtzjjihors rgmxtvoszu (bbdxfycnhu, iwdvgosbub - nnwwqtxata) View more
NCT02910219 (Halt-d, SABCS2022)	Phase 2	Breast Cancer Neoadjuvant \| Adjuvant HER2+	53	Crofelemer	dyjjbcqfig(xjqfohbqam) = wyhxwgbooo ahsuurpwzd (tpdahkmpbf ) View more	Positive	15 Feb 2022
				Control	dyjjbcqfig(xjqfohbqam) = samgenthcn ahsuurpwzd (tpdahkmpbf ) View more
NCT02910219 (HALT-D, Company_Website) Manual	Phase 2	Diarrhea	51	Crofelemer	zqgsjoumfg(ixigjvhloy) = not statistically different for the two groups ydtsivhqyb (lofbiuxxqm )	Negative	10 Dec 2021
				standard of care

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