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 Date01 Dec 2024

Sponsor / Collaborator

The Cleveland Clinic Foundation

[+1]

NCT04538625 / Active, not recruitingPhase 3

A Phase 3 Multicenter, Randomized, Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy

A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I.
After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.

Start Date07 Oct 2020

Sponsor / Collaborator

Napo Pharmaceuticals, Inc.

NCT04486326 / TerminatedPhase 4

Crofelemer for Functional Diarrhea

The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.

Start Date20 Aug 2020

Sponsor / Collaborator

Beth Israel Deaconess Medical Center, Inc.

100 Clinical Results associated with Crofelemer

100 Translational Medicine associated with Crofelemer

100 Patents (Medical) associated with Crofelemer

Literatures (Medical) associated 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 ; Shub, Mitchell D ; Oller, Haley ; 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.

01 Dec 2022·Breast cancer research and treatment

HALT-D: a randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane

Article

Author: Lynce, Filipa ; Mainor, Candace ; Graham, Deena ; Tan, Ming ; Ottaviano, Yvonne ; Rao, Suman ; Warren, Robert ; Mohebtash, Mahsa ; McNamara, Donna ; Dilawari, Asma ; Kurian, Shweta ; Swanson, Nicole ; Isaacs, Claudine ; Pohlmann, Paula R ; Swain, Sandra M ; Wu, Tianmin

Abstract:

Purpose:

To assess whether crofelemer would prevent chemotherapy-induced diarrhea (CID) diarrhea in patients with HER2-positive, any-stage breast cancer receiving trastuzumab (H), pertuzumab (P), and a taxane (T; docetaxel or paclitaxel), with/without carboplatin (C; always combined with docetaxel rather than paclitaxel).

Methods:

Patients scheduled to receive ≥ 3 consecutive TCHP/THP cycles were randomized to crofelemer 125 mg orally twice daily during chemotherapy cycles 1 and 2 or no scheduled prophylactic medication (control). All received standard breakthrough antidiarrheal medication (BTAD) as needed. The primary endpoint was incidence of any-grade CID for ≥ 2 consecutive days. Secondary endpoints were incidence of all-grade and grade 3/4 CID by cycle/stratum; time to onset and duration of CID; stool consistency; use of BTAD; and quality of life (Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea [FACIT-D] score).

Results:

Fifty-one patients were randomized to crofelemer (n = 26) or control (n = 25). There was no statistically significant difference between arms for the primary endpoint; however, incidence of grade ≥ 2 CID was reduced with crofelemer vs control (19.2% vs 24.0% in cycle 1; 8.0% vs 39.1%, in cycle 2). Patients receiving crofelemer were 1.8 times more likely to see their diarrhea resolved and had less frequent watery diarrhea.

Conclusion:

Despite the choice of primary endpoint being insensitive, crofelemer reduced the incidence and severity of CID in patients with HER2-positive breast cancer receiving P-based therapy. These data are supportive of further testing of crofelemer in CID.

Trial registration:

Clinicaltrials.gov, NCT02910219, prospectively registered September 21, 2016.

139

News (Medical) associated with Crofelemer

26 Jun 2024

·www.biospace.com

Jaguar Health Regains Compliance with Nasdaq's Bid Price Requirement - June 26, 2024

JAGX's securities continue to be listed and traded on Nasdaq Jaguar to report pivotal phase 3 OnTarget trial results for its cancer supportive care drug crofelemer on or before July 23, 2024 SAN FRANCISCO, CA / ACCESSWIRE / June 26, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that on June 25, 2024 the Company received formal notice from The Nasdaq Stock Market LLC ("Nasdaq") that Jaguar has regained compliance with Nasdaq's minimum bid price requirement. "We are very happy that Jaguar has regained compliance with Nasdaq. We consider our Nasdaq listing an asset of the Company," said Lisa Conte, Jaguar's president and CEO. "A Jaguar investor webcast held on or before July 23, 2024 will provide updates on Jaguar's advancing cancer supportive care portfolio, and will include members of Jaguar's scientific team, patient advocates, and leading oncology experts on two of the most common and intolerable side effects of cancer therapy: CTD and oral mucositis." 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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Crofelemer also is the subject of Napo's phase 3 OnTarget clinical trial for preventive treatment of cancer therapy-related diarrhea (CTD). Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar will report the results of the OnTarget trial on or before July 23, 2024, and the expectation that Jaguar will hold an investor webcast on or before July 23, 2024 regarding updates on the Company's cancer supportive care portfolio. 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 View the original press release on accesswire.com

Phase 3Drug Approval

21 Jun 2024

·www.biospace.com

Jaguar Health Reports Approval of All Proposals at June 2024 Annual Meeting of Stockholders

Jaguar to report pivotal phase 3 OnTarget trial results for its cancer supportive care drug crofelemer on or before July 23, 2024 Investor webcast on or before July 23 will include updates on Jaguar's cancer supportive care portfolio, including participation from Jaguar scientific team, patient advocates, and leading oncology experts on cancer therapy-related diarrhea and oral mucositis In honor of World Rainforest Day (June 22), Jaguar is proud to share RealPharma podcast interview with ethnobotanist Dr. Steven King SAN FRANCISCO, CA / ACCESSWIRE / June 21, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Annual Meeting of Stockholders held June 21, 2024 (the "Annual Meeting"). Five proposals were submitted to and approved by the stockholders of the Company at the Annual Meeting. The proposals are described in detail in the Company's definitive proxy statement on Schedule 14A relating to the Annual Meeting on May 21, 2024 and supplemental information filed with the Securities and Exchange Commission. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at . The proxy statement is also available on the Company's corporate website. "In honor of World Rainforest Day (June 22), we are proud to share the link to RealPharma's recent podcast interview with ethnobotanist Steven King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research, and IP Officer," said Lisa Conte, the Company's founder, president and CEO. "The RealPharma podcast series is hosted by Dr. Na-Ri Oh and Ian Wendt, Jaguar's Chief Commercial Officer. In the interview, Dr. King shares incredible stories from his journey - like living with indigenous communities in the Amazon and learning about their medicinal uses of plants. He also discusses the powerful impact these natural resources can have on global health, all while preserving the cultures that discovered them. It's a testament to how ancient wisdom and cutting-edge science can work hand-in-hand. The podcast episode can be accessed at this link: From the Forest to your Pharmacy: Dr. Steven King's Ethnobotanical Journey." 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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Crofelemer also is the subject of Napo's phase 3 OnTarget clinical trial for preventive treatment of cancer therapy-related diarrhea (CTD). Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar will provide the results of the OnTarget trial and updates on the Company's cancer supportive care portfolio on or before July 23, 2024, and the expectation that Jaguar will hold an investor webcast on or before July 23, 2024. 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 accesswire.com

Phase 3Drug Approval

12 Jun 2024

·www.biospace.com

Jaguar Health to Report Pivotal Phase 3 OnTarget Trial Results for its Cancer Supportive Care Drug Crofelemer on or Before July 23, 2024

Investor webcast on or before July 23 will include updates on Jaguar's cancer supportive care portfolio, including participation from Jaguar scientific team, patient advocates, and leading oncology experts on cancer therapy-related diarrhea (CTD) and oral mucositis Cancer patients with diarrhea are 40% more likely to discontinue their therapy, and up to 40% of cancer patients experience the painful side effect of oral mucositis SAN FRANCISCO, CA / ACCESSWIRE / June 12, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it will hold an investor webcast on or before July 23, 2024 to provide results for the company's pivotal phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy, with or without standard chemotherapy. The webcast, which will provide updates on Jaguar's advancing cancer supportive care portfolio, will include members of Jaguar's scientific team, patient advocates, and leading oncology experts on two of the most common and intolerable side effects of cancer therapy: CTD and oral mucositis. "Patients are the heart of our mission at Jaguar," said Lisa Conte, the company's president and CEO. "The thorough and exhaustive OnTarget prophylactic protocol allowed for the inclusion of all treatment needs for participating patients with solid tumors and targeted therapy, including any supportive care. We look forward to receiving and providing the results with the anticipation we know all our stakeholders share. As with many pharmaceutical companies involved with an expansive global pivotal study, we use several third-party contractors. In order to address the complexity of OnTarget's statistical programming needs - as the trial involves multiple solid tumor types, 23 targeted therapies, six countries, daily patient-reported outcomes covering anywhere from 90 to 180 days with multiple entries a day, and concomitant medications - we retained a clinically experienced biostatistics and programming expert to review and lead the statistical programming and the implementation of the statistical analysis plan submitted to the FDA. The third-party vendors who are conducting the analysis of patient data for the OnTarget trial have identified the key necessary steps required to share results with Jaguar on or before July 23, allowing us to set a date for the findings." "While cancer treatments have advanced considerably since the advent and availability of targeted therapies, significant short- and long-term treatment side effects can be challenging or even devastating to an individual's quality of life," said Stacey Tinianov, 11-year cancer survivor and founder of Advocates for Collaborative Education who serves on the company's Scientific Advisory Board. "Supportive care during treatment is crucial for maintaining dignity and well-being. No side effect, whether extreme fatigue, severe diarrhea, mouth sores, chronic pain, or anything else, should ever be considered ‘acceptable' or ‘tolerable.'" In addition to the forthcoming OnTarget data, the following advances in Jaguar's cancer supportive care portfolio will be discussed during the webcast on or before July 23: In April 2024, Jaguar entered into an exclusive 5-year U.S. in-license agreement for the FDA-approved oral mucositis prescription product, Gelclair®. Jaguar's promotion of Gelclair began at this year's Oncology Nursing Society (ONS) Congress and the American Society of Clinical Oncology (ASCO) Annual Meeting. In March 2024, Jaguar signed a binding term sheet with Turkish specialty pharmaceutical company GEN related to the commercialization of crofelemer in Turkey and eight neighboring countries following GEN's receipt of regulatory approval for crofelemer for specified indications, including CTD. In December 2023 and April 2024, Jaguar supported the patient led advocacy program - "Make Cancer Less Shitty" - at the San Antonio Breast Cancer Symposium (SABCS) and ONS Congress, respectively. The program is designed to provide a voice to cancer survivors who are no longer willing to accept debilitating side effects of cancer treatments as an acceptable trade-off for survival. Visit the Make Cancer Less Shitty program at makecancerlessshitty.com and on X, Facebook & Instagram. In January 2024, a study published in the peer-reviewed journal PLOS ONE showed statistically significant results for use of crofelemer for preventive treatment of CTD in dogs. On December 21, 2021, the U.S. Food and Drug Administration conditionally approved Canalevia®-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea (CID) in dogs. About Crofelemer Crofelemer is the only oral prescription drug approved under FDA botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. Jaguar family company 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. The OnTarget study is testing whether crofelemer (versus placebo) can prevent (or substantially reduce) diarrhea when any one of the selected 23 targeted therapies (that are associated with diarrhea in at least 50% of patients) is initiated. Image of Croton lechleri tree, the source of crofelemer About Cancer Therapy-Related Diarrhea (CTD) Diarrhea is a common side effect of targeted therapies and new treatments are needed. Up to 95% of patients on tyrosine kinase inhibitors (TKIs) suffer from diarrhea, depending on the TKI used.1 More than 2 million people are expected to be diagnosed with cancer in 2024 in the U.S., according to the American Cancer Society.2 Cancer patients with diarrhea have been shown to be 40% more likely to discontinue their targeted therapy.3 About Oral Mucositis Oral mucositis is a common, painful, and debilitating cancer treatment-related side effect.4 Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy.5 Of the latter, 19% may end up being hospitalized, which may negatively impact quality of life and increase healthcare utilization costs.5 Oral mucositis can cause an inability to eat or talk, and an increased risk of infection. It may also result in treatment delays or dose reductions to manage symptoms.4 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, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Crofelemer also is the subject of Napo's phase 3 OnTarget clinical trial for preventive treatment of cancer therapy-related diarrhea (CTD). Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Jaguar will provide the results of the OnTarget trial and updates on the company's cancer supportive care portfolio on or before July 23, 2024, and the expectation that Jaguar will hold an investor webcast on or before July 23, 2024. 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. 1 Moschen AR, Sammy Y, Marjenberg Z, Heptinstall AB, Pooley N, Marczewska AM. The Underestimated and Overlooked Burden of Diarrhea and Constipation in Cancer Patients. Curr Oncol Rep. 2022;24(7):861-874. doi:10.1007/s11912-022-01267-3 2 American Cancer Society. Cancer Facts & Figures 2024. Available: Accessed June 10, 2024. 3 Okhuysen PC, Schwartzberg LS, Roeland E, et al. The impact of cancer-related diarrhea on changes in cancer therapy patterns. J Clin Oncol. 2021; 39:15_suppl, 12111-12111. 4 The Oral Cancer Foundation. Mucositis. Accessed March 26, 2024. Available at 5 Pulito C, Cristaudo A, Porta CL, et al. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 39, 210 (2020). Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View the original press release on accesswire.com

Phase 3Drug ApprovalLicense out/in

100 Deals associated with Crofelemer

External Link

KEGG	Wiki	ATC	Drug Bank
D03605	Crofelemer	A07XA06	DB04941

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	US	Napo Pharmaceuticals, Inc.	07 Oct 2020
Solid tumor	Phase 3	AR	Napo Pharmaceuticals, Inc.	07 Oct 2020
Solid tumor	Phase 3	GE	Napo Pharmaceuticals, Inc.	07 Oct 2020
Solid tumor	Phase 3	RS	Napo Pharmaceuticals, Inc.	07 Oct 2020
Solid tumor	Phase 3	TW	Napo Pharmaceuticals, Inc.	07 Oct 2020
HIV Enteropathy	Phase 3	US	Bausch Health Americas, Inc.	01 Oct 2007
HIV Enteropathy	Phase 3	PR	Bausch Health Americas, Inc.	01 Oct 2007
Acquired Immunodeficiency Syndrome	Phase 3	US	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Acquired Immunodeficiency Syndrome	Phase 3	PR	Shaman Pharmaceuticals, Inc.	31 Aug 2001
Irritable bowel syndrome with diarrhea	Phase 2	US	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 (Company_Website) Manual	Phase 4	Diarrhea	-	Crofelemer	ogyvnkjvgs(zdxnjfxmzp) = statistically meaningful reduction ybbdichftf (fmigmvmsgx )	Positive	28 May 2024
				Placebo
NCT02910219 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	51	crofelemer	sdphousqvj(brcqpruhxs) = hkbppyiirf vcrkwrbkve (nwoxcddtnw ) View more	Negative	25 Oct 2022
				no scheduled prophylactic medication	sdphousqvj(brcqpruhxs) = btihfzrilz vcrkwrbkve (nwoxcddtnw ) View more
NCT02910219 (HALT-D, CTgov)	Phase 2	Diarrhea \| HER2 Positive Breast Cancer	53	Crofelemer (Crofelemer)	vtexdsnjux(jpkambuydk) = lowmqmstmr bljumilbnn (kqudjyjvdi, fupdmsxdzi - hpnwmkyssf) View more	-	24 Oct 2022
				TCHP+THP (Control)	vtexdsnjux(jpkambuydk) = rsnuweswxp bljumilbnn (kqudjyjvdi, iqlkudxeko - yfiqbrptpm) View more
NCT00547898 (CTgov)	Phase 3	HIV Enteropathy	374	placebo (Placebo)	angzvchxmg(vvrujbixqa) = qgdljlibyq kuhjiwmkei (uvbkglbivw, rrawquxnyx - kmskxlatpe) View more	-	03 Sep 2020
				Crofelemer 125 mg (Crofelemer 125 mg)	angzvchxmg(vvrujbixqa) = onhbettkbu kuhjiwmkei (uvbkglbivw, cntvevuxmy - fujpfrncvh) View more
NCT01374490 (CTgov)	Phase 3	Diarrhea \| HIV Enteropathy	250	Crofelemer	kacbsnnipa(rjamluyxef) = xlmdejlsvn cunmumosxm (cnlovemuve, vyinmpwkya - laxcbjpibs) View more	-	17 Aug 2020
IAS2017	Not Applicable	HIV Enteropathy	274	Crofelemer 125mg bid	tcmbucqljs(bectirislc) = jrofmawjlm jepbyflckb (mnglmghejg )	-	01 Jan 2017

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