This section highlights FDA-related milestones and regulatory updates for drugs developed by Jaguar Animal Health (JAGX).
Over the past two years, Jaguar Animal Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Canalevia-CA1, Crofelemer, Crofelemer, Gelclair, NP300, and NP-300. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Canalevia-CA1 - FDA Regulatory Timeline and Events
Canalevia-CA1 is a drug developed by Jaguar Animal Health for the following indication: For the treatment of chemotherapy-induced diarrhea (CID) in dogs.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Canalevia-CA1
- Announced Date:
- June 11, 2025
- Indication:
- For the treatment of chemotherapy-induced diarrhea (CID) in dogs.
Announcement
Jaguar Health, Inc. announced that the first study site has been established for Jaguar's field study of Canalevia-CA1, Jaguar's U.S. Food and Drug Administration (FDA) conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs.
AI Summary
Jaguar Health, Inc. announced that the first study site has been established for its field study of Canalevia-CA1. This prescription drug is currently conditionally approved by the U.S. FDA for treating chemotherapy-induced diarrhea (CID) in dogs. The study will involve dogs undergoing chemotherapy across the United States, where they will be randomly assigned to receive either Canalevia-CA1 or serve as members of a control group. The goal of this field study is to collect real-world evidence to support the drug’s clinical effectiveness for CID.
Gathering this data is an important step toward obtaining full FDA approval for Canalevia-CA1. The study also highlights Jaguar’s commitment to addressing unmet medical needs in veterinary care, where effective treatment options for chemotherapy-induced diarrhea in dogs are limited. This progress is seen as a significant milestone in advancing the use of Canalevia-CA1 in veterinary medicine.
Read Announcement
Crofelemer - FDA Regulatory Timeline and Events
Crofelemer is a drug developed by Jaguar Animal Health for the following indication: Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Crofelemer
- Announced Date:
- June 25, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. announced that the company plans to pursue approval from the European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP) for Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs.
AI Summary
Jaguar Health, Inc. announced plans to pursue approval from the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) for Canalevia (crofelemer delayed-release tablets) to treat general diarrhea in dogs. The company aims to use statistically significant data from a completed study to support this application within the European Union.
Jaguar plans to submit a detailed dossier to the EMA summarizing an updated analysis of the study results, which showed that dogs treated with Canalevia experienced fewer watery stools and improved fecal scores compared to placebo. If the EMA finds the data acceptable and approves the marketing application, Canalevia could be sold in all 27 EU member countries. The move also comes as Jaguar engages in discussions with potential partners to advance regulatory approval and commercialization globally, addressing an unmet need in treating general canine diarrhea.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- June 23, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. today provided updates on the company's orphan disease intestinal failure program. Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting two independent proof-of-concept investigator-initiated trials (IITs), and conducting two placebo-controlled Phase 2 studies, of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, in patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) in the United States, European Union, and/or Middle East/North Africa regions.
AI Summary
Jaguar Health, Inc. provided an update on its orphan disease intestinal failure program. Through its family companies, Napo Pharmaceuticals and Napo Therapeutics, the company is advancing two independent investigator-initiated trials (IITs) as well as two placebo-controlled Phase 2 studies. These studies are evaluating crofelemer—a novel plant-based anti-secretory prescription drug—for its potential benefits in patients with intestinal failure caused by microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) in the United States, European Union, and Middle East/North Africa regions.
Preliminary data from the ongoing IIT in Abu Dhabi indicate that crofelemer may reduce the need for total parenteral nutrition in affected patients, with notable decreases observed in early cases. Additionally, enrollment in the first Phase 2 study for pediatric MVID patients has reached approximately 25%, and patient screening continues.
Read Announcement - Drug:
- Crofelemer
- Announced Date:
- June 9, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. today provided a recap on the company's assessment of the in-person Type C Meeting on May 28, 2025 with the Division of Gastroenterology of the U.S. Food and Drug Administration (FDA) to discuss the statistically significant responder analysis results for adult patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial.
AI Summary
Jaguar Health, Inc. recapped its recent in-person Type C Meeting held on May 28, 2025, with the FDA’s Division of Gastroenterology. At the meeting, the company discussed the statistically significant responder analysis results from Napo Pharmaceuticals’ Phase 3 OnTarget trial in adult breast cancer patients. The data showed promising improvements in managing cancer therapy-related diarrhea, highlighting a positive outcome for a subgroup of patients. Company leadership expressed satisfaction over the constructive discussion, seeing the results as a strong foundation for moving forward with crofelemer’s development. They emphasized that the findings provide an important signal in addressing unmet needs in metastatic breast cancer patients. This productive dialogue with the FDA supports Jaguar Health’s plans to submit further protocols aimed at confirming the clinical benefits of crofelemer for these patients, paving the way for potential new treatment pathways.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- April 30, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. announced initial proof-of-concept results showing that a novel liquid formulation of crofelemer reduced the required TPN and/or supplementary intravenous fluids, collectively referred to as parenteral support (PS) in patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) by up to 27% and 12.5% respectively.
AI Summary
Jaguar Health, Inc. announced promising initial proof-of-concept results for a new liquid formulation of crofelemer in treating patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). The study showed that the treatment reduced the need for total parenteral nutrition (TPN) and supplementary intravenous fluids—collectively referred to as parenteral support (PS)—by up to 27% in MVID patients and 12.5% in SBS-IF patients. The liquid formulation also appeared to improve nutrient absorption by lowering stool volume and frequency while increasing urine output. These early findings suggest that crofelemer could offer a much-needed alternative to reduce the lifelong reliance on TPN, which is associated with risks such as infections and organ complications, potentially leading to an improved quality of life for patients with these challenging conditions.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- April 28, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. announced that Jaguar is hosting an investor webcast on Wednesday, April 30, 2025 at 8:30 AM Eastern to review the initial results of the proof-of-concept (POC) investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's plant-based anti-secretory prescription drug, in patients with the rare diseases microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) that were presented by Dr. Mohamad Miqdady on April 26, 2025 at the 11th Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates.
AI Summary
Jaguar Health, Inc. announced an investor webcast scheduled for Wednesday, April 30, 2025 at 8:30 AM Eastern. During the webcast, the company will review the initial results from a proof-of-concept investigator-initiated trial (IIT) for a novel liquid formulation of its plant-based anti-secretory drug, crofelemer. The trial, led by Dr. Mohamad Miqdady, focused on patients with microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF), two rare conditions where treatment options are very limited. The discussion will cover patient experiences, the drug’s impact on disease progression and quality of life, as well as possible expedited regulatory pathways specifically for crofelemer in MVID. Dr. Miqdady presented the preliminary data at the Annual ELITE PED-GI Congress in Abu Dhabi, highlighting important findings in these challenging pediatric conditions.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- April 17, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. and Napo Therapeutics announced that preliminary results from the ongoing pediatric investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for various congenital diarrheal disorders (CDD), including MVID and SBS with intestinal failure (SBS-IF), will be presented by Dr. Mohamad Miqdady at the April 24-26, 2025 Annual ELITE PED-GI Congress in Abu Dhabi in the United Arab Emirates.
AI Summary
Jaguar Health, Inc. and Napo Therapeutics announced that preliminary results from an ongoing pediatric investigator-initiated trial evaluating a novel liquid formulation of crofelemer will be presented at the Annual ELITE PED-GI Congress in Abu Dhabi from April 24-26, 2025. The study targets various congenital diarrheal disorders, including microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF), both of which have severe impacts on children’s health and require intensive parenteral nutrition.
Dr. Mohamad Miqdady, the principal investigator, will share early proof-of-concept data assessing crofelemer’s ability to improve stool formation, enhance nutrient absorption, and potentially reduce the dependency on total parenteral nutrition (TPN). These findings could pave the way for regulatory pathways that may offer new treatment options for patients suffering from these rare, debilitating conditions.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- March 28, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc nnounced the results of a new survey of 27 board certified veterinary oncologists practicing in the U.S. regarding Canalevia-CA1 and the treatment of chemotherapy-induced diarrhea (CID) in dogs.
AI Summary
Jaguar Health, Inc. recently released the results of a new survey involving 27 board-certified veterinary oncologists from across the U.S. regarding the use of Canalevia-CA1 in treating chemotherapy-induced diarrhea (CID) in dogs. According to the survey, a significant majority (83.33%) of the veterinarians emphasized the importance of using a non-antimicrobial treatment for CID, citing concerns over antibiotic resistance. Many noted that managing diarrhea is essential not only for the dog’s quality of life but also for allowing them to stay on their cancer treatment regimens. Veterinary experts, including Christine Swanson, DVM, highlighted that Canalevia-CA1 helps control gastrointestinal upset, making it easier to continue necessary chemotherapy. Overall, the survey reflects a growing appreciation for Canalevia-CA1 as a targeted, plant-based treatment option that addresses an important unmet need in the management of CID in dogs.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- February 19, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, announced that the clinical protocol for Napo's Phase 2 study to evaluate the efficacy of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for the indication of SBS-IF in adults has received regulatory clearance from health authorities in Italy and Germany, where the trial will be conducted.
AI Summary
Jaguar Health’s family companies, Napo Pharmaceuticals and Napo Therapeutics, announced a key milestone for their novel plant-based drug, crofelemer. The clinical protocol for Napo’s Phase 2 study—designed as a double blind, placebo-controlled trial to test crofelemer’s efficacy for treating short bowel syndrome-induced intestinal failure (SBS-IF) in adults—has received regulatory clearance from health authorities in Italy and Germany. The study marks a significant step in the company’s multiple clinical efforts aimed at addressing rare gastrointestinal disorders. Crofelemer, already recognized for its potential through Orphan Drug Designation, is being evaluated in several trials across regions including the US, EU, and MENA. This regulatory green light in Europe underscores the growing confidence in crofelemer as a promising treatment option, potentially offering new hope and improved quality of life for patients battling this debilitating condition.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- January 29, 2025
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health announced Napo's filing of a broad defining provisional patent application with the U.S. Patent and Trademark Office (USPTO) for crofelemer, Jaguar's novel plant-based FDA-approved gastrointestinal normalizing prescription drug, to mitigate the gastrointestinal side effects associated with glucagon-like peptide-1 (GLP-1) receptor agonists and antagonists, together with other incretin-based therapies including glucose-dependent insulinotropic polypeptide (GIP) agonists and antagonists, and glucagon-agonist drugs.
AI Summary
Jaguar Health’s family company, Napo Pharmaceuticals, has filed a broad provisional patent application with the U.S. Patent and Trademark Office for crofelemer. Crofelemer is a novel, plant-based, FDA-approved prescription drug already marketed under the name Mytesi for HIV-related diarrhea. The company aims to expand its use to mitigate gastrointestinal side effects commonly seen in patients treated with GLP-1 receptor agonists and antagonists, as well as other incretin-based therapies like glucose-dependent insulinotropic polypeptide (GIP) agents and glucagon agonists.
These therapies often cause gastrointestinal issues, including diarrhea, abdominal pain, bloating, and discomfort in a significant percentage of patients, potentially affecting treatment adherence. By seeking protection for crofelemer’s application in this supportive role, Jaguar Health is positioning the drug as a valuable option to improve patient comfort and enable continued use of crucial obesity and metabolic therapies.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- December 17, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to crofelemer, the company's novel plant-based prescription drug, for treatment of diarrhea in cholera.
AI Summary
Jaguar Health recently announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to its novel plant-based prescription drug, crofelemer. This important milestone is aimed at developing a treatment for diarrhea caused by cholera, a condition that can be particularly severe in areas with limited medical resources.
The orphan-drug designation is significant because it provides the company with financial incentives, such as tax credits and priority review, to help expedite the drug’s development and regulatory process. Jaguar Health views this as a promising step toward addressing a critical unmet medical need by offering a potentially effective therapy for cholera-induced diarrhea. This decision by the FDA reflects confidence in the drug’s potential and supports further research to bring new treatment options to patients in need.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- December 9, 2024
- Estimated Event Date Range:
- December 11, 2024 - December 11, 2024
- Target Action Date:
- December 11, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. announced that the data from the recently conducted analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicate that crofelemer achieved significant results in this subgroup, will be the subject of a poster presentation on December 11, 2024 during the 12:30 - 2:00 p.m. CST Poster Session 1 at the San Antonio Breast Cancer Symposium (SABCS), which takes place December 10-13, 2024 in San Antonio, Texas.
AI Summary
Jaguar Health, Inc. announced that results from its Phase 3 OnTarget trial, focusing on adult breast cancer patients, will be shared during a poster presentation at the San Antonio Breast Cancer Symposium (SABCS). The analysis showed that crofelemer achieved significant results in this subgroup, suggesting its potential benefit for breast cancer patients experiencing chemotherapy-induced diarrhea.
The poster is scheduled for December 11, 2024, between 12:30 and 2:00 p.m. CST during Poster Session 1 at SABCS, which will run from December 10-13, 2024, in San Antonio, Texas. Jaguar plans to use the data from this significant subgroup analysis as part of a briefing package for the U.S. Food and Drug Administration, aiming to discuss faster pathways for making crofelemer available. A complete study report is expected to be submitted to a peer-reviewed journal, with additional subgroup analyses possibly leading to more future submissions.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- December 5, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, announced that an article about Canalevia-CA1 (crofelemer delayed-release tablets), Jaguar's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, has been published in PetVet Magazine Inc.
AI Summary
Jaguar Health announced that an article highlighting Canalevia‑CA1 has been published in PetVet Magazine. Canalevia‑CA1 is Jaguar Health’s canine-specific formulation of crofelemer, a novel plant-based drug designed to treat chemotherapy‑induced diarrhea (CID) in dogs. The drug, which is conditionally approved by the U.S. Food and Drug Administration, is the first approved treatment of its kind for dogs experiencing CID. The featured article details how the medication works to improve the health and quality of life in canine cancer patients by addressing diarrhea, a common complication of chemotherapy. By sharing this news in PetVet Magazine, Jaguar Health aims to educate veterinarians and pet owners about the benefits of Canalevia‑CA1 and reinforce their commitment to advancing treatments that support both animal and human health in the challenging arena of cancer care.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- August 1, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. announced that the results of two independent investigator-initiated studies of crofelemer, Napo's novel, plant-based oral prescription drug, showed a benefit in patients with chronic refractory diarrhea and have been accepted for poster presentations at the American College of Gastroenterology Annual Scientific Meeting, which takes place October 25-30, 2024 at the Pennsylvania Convention Center in Philadelphia.
AI Summary
Jaguar Health, Inc. announced that two independent investigator-initiated studies on crofelemer—a plant-based oral prescription drug developed by Napo Pharmaceuticals—show promising benefits for patients suffering from chronic refractory diarrhea. The studies involved patients with functional diarrhea and chronic idiopathic diarrhea. In one study, crofelemer significantly reduced stool looseness and abdominal pain in patients with functional diarrhea, while in the other, nearly 60% of chronic idiopathic diarrhea patients experienced improvement in their symptoms.
The positive findings have been accepted for poster presentations at the upcoming American College of Gastroenterology Annual Scientific Meeting in Philadelphia, scheduled for October 25-30, 2024. This research supports crofelemer’s potential in addressing unmet needs in gastrointestinal care, particularly for patients with diarrhea-predominant irritable bowel syndrome and related conditions.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- June 12, 2024
- Estimated Event Date Range:
- July 23, 2024 - July 23, 2024
- Target Action Date:
- July 23, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, Inc. 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.
AI Summary
Jaguar Health, Inc. has announced that it will hold an investor webcast on or before July 23, 2024. During this webcast, the company will share results from its pivotal phase 3 OnTarget trial, which is studying crofelemer for the prevention of diarrhea in adult cancer patients with solid tumors. These patients are receiving targeted therapy, with or without standard chemotherapy.
The OnTarget trial is significant because diarrhea is a common and severe side effect of cancer treatments, often leading patients to discontinue therapy. The webcast will offer key insights and updates on how effectively crofelemer may help manage this side effect. Additionally, the event will feature presentations from Jaguar’s scientific team, as well as contributions from patient advocates and leading oncology experts, highlighting the company’s commitment to improving supportive care for cancer patients.
Read Announcement- Drug:
- Crofelemer
- Announced Date:
- May 6, 2024
- Indication:
- Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder
Announcement
Jaguar Health, announced that it has established a new Investigational New Animal Drug (INAD) file with the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) for the company's novel plant-based prescription drug crofelemer to treat general, non-infectious diarrhea in dogs. Inc.
AI Summary
Jaguar Health has established a new Investigational New Animal Drug (INAD) file with the U.S. Food and Drug Administration’s Center for Veterinary Medicine. This new file is part of the company’s efforts to develop its novel plant-based prescription drug, crofelemer. The drug is aimed at treating general, non-infectious diarrhea in dogs. By initiating this regulatory process, Jaguar Health plans to gather essential safety and efficacy data to support further development of crofelemer for canine patients.
This important move reflects the company’s dedication to advancing veterinary medicine with innovative treatments. By complying with FDA regulations, Jaguar Health is working to ensure that new therapeutic options are both scientifically supported and safe for animal use. The establishment of the INAD file is a significant step toward addressing the needs of dogs experiencing digestive issues and could lead to more effective management options in the future.
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Crofelemer (SBS) - FDA Regulatory Timeline and Events
Crofelemer (SBS) is a drug developed by Jaguar Animal Health for the following indication: Short Bowel Syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Crofelemer (SBS)
- Announced Date:
- August 27, 2024
- Indication:
- Short Bowel Syndrome
Announcement
Jaguar Health, announced that the country of Jordan's Industrial Property Protection Directorate has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar's novel plant-based prescription drug. Inc.
AI Summary
Jaguar Health recently announced that Jordan’s Industrial Property Protection Directorate issued a new patent to Jaguar’s family company, Napo Pharmaceuticals. The patent protects methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea following small intestine resection or gallbladder removal when used with an inhibitor of chloride-ion transport such as crofelemer, Jaguar’s unique plant-based prescription drug.
Jaguar’s CEO, Lisa Conte, stated that this new patent further strengthens the intellectual property protection for crofelemer in addressing SBS. Jaguar is also supporting independent, investigator-initiated proof-of-concept studies in the US, EU, and Middle East/North Africa regions to explore the use of crofelemer for SBS and other rare diseases, with results expected in late 2024 and throughout 2025.
Read Announcement- Drug:
- Crofelemer (SBS)
- Announced Date:
- July 18, 2024
- Estimated Event Date Range:
- July 23, 2024 - July 23, 2024
- Target Action Date:
- July 23, 2024
- Indication:
- Short Bowel Syndrome
Announcement
Jaguar Health, announced that it will hold an investor webcast on Tuesday, July 23, 2024 at 8:30 AM Eastern to review 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. Inc.
AI Summary
Jaguar Health announced that it will host an investor webcast on Tuesday, July 23, 2024, at 8:30 AM Eastern. During the webcast, the company plans to review the results of its pivotal Phase 3 OnTarget trial, which tested crofelemer for the prevention of diarrhea in adult cancer patients with solid tumors who are receiving targeted therapy, with or without standard chemotherapy.
A press release detailing the trial’s outcomes will be issued on the morning of the webcast. This study is a key part of Jaguar’s effort to improve cancer supportive care by addressing severe diarrhea—a side effect that often forces patients to stop their treatment. The results of the OnTarget trial could play an important role in helping to keep patients on cancer therapy and enhance overall treatment tolerability.
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Gelclair - FDA Regulatory Timeline and Events
Gelclair is a drug developed by Jaguar Animal Health for the following indication: For oral mucositis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Gelclair
- Announced Date:
- April 22, 2024
- Indication:
- For oral mucositis
Announcement
Jaguar Health, Inc. announced that Jaguar family company Napo Pharmaceuticals ("Napo") is exhibiting at the Oncology Nursing Society (ONS) Congress taking place April 24-28, 2024 in Washington, DC.
AI Summary
Jaguar Health, Inc. announced that its family company, Napo Pharmaceuticals, will exhibit at the Oncology Nursing Society (ONS) Congress, set for April 24-28, 2024, in Washington, DC. This event is a key stage for showcasing Jaguar’s expanding focus on cancer supportive care. At the congress, Napo will highlight the “Make Cancer Less Shitty” patient advocacy program, an initiative designed to raise awareness of the gaps in supportive care and emphasize the importance of addressing the side effects of cancer treatments.
Jaguar is broadening its care focus beyond HIV-related issues and is now set to launch Gelclair®, an FDA-approved gel for managing oral mucositis (“chemo mouth”), a common side effect of cancer therapy. The company’s presence at ONS underlines its commitment to improving the quality of life for cancer patients and supporting the oncology nursing community.
Read Announcement- Drug:
- Gelclair
- Announced Date:
- April 16, 2024
- Indication:
- For oral mucositis
Announcement
Jaguar Health, announced that it has signed an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC ("Venture Life"), an international consumer health company focused on the global self-care market, for Venture Life's FDA-approved oral mucositis prescription product, Gelclair, for the U.S. market.Inc
AI Summary
Jaguar Health has signed an exclusive five-year in-license agreement with United Kingdom-based Venture Life Group to market Gelclair in the U.S. Gelclair is an FDA‐approved prescription product designed to relieve oral mucositis, a common and painful side effect of cancer treatment. This condition, often referred to as “chemo mouth,” can greatly affect a patient’s ability to eat, speak, and maintain nutrition during therapy.
The product works as a protective gel that adheres to the mucosal surfaces in the mouth, soothing lesions without numbing or stinging, and it is intended to help minimize discomfort associated with oral mucositis. Jaguar Health’s planned commercial launch of Gelclair is set for Q3 2024, representing a key move into expanding their portfolio in cancer supportive care and offering a much-needed solution for patients undergoing cancer treatments.
Read Announcement
NP300 - FDA Regulatory Timeline and Events
NP300 is a drug developed by Jaguar Animal Health for the following indication: For Treatment of General Diarrhea in Dogs.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NP300
- Announced Date:
- November 22, 2024
- Indication:
- For Treatment of General Diarrhea in Dogs
Announcement
Jaguar Health, Inc. announced that it is seeking a partner to fund and execute the development and commercialization of NP300, the company's prescription drug candidate for the treatment of general, non-infectious diarrhea in dogs, in exchange for commercial rights to the product in the U.S.
AI Summary
Jaguar Health, Inc. announced it is looking for a partner to help fund and manage the development and commercialization of NP300, a new prescription drug candidate for treating general, non-infectious diarrhea in dogs. This unmet need is significant because diarrhea is a common issue that leads to millions of veterinary visits each year. NP300 is a novel antisecretory drug with a mechanism of action similar to Canalevia®-CA1, Jaguar’s approved treatment for chemotherapy-induced diarrhea in dogs, and has already shown safety in canine studies. The company is ready to discuss partnership opportunities at the Pet Connect conference, scheduled for December 3-5, 2024, in Hollywood, California. In this proposed arrangement, the partnering organization would receive the commercial rights to NP300 in the U.S., allowing Jaguar to address an important gap in veterinary care.
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NP-300 - FDA Regulatory Timeline and Events
NP-300 is a drug developed by Jaguar Animal Health for the following indication: Symptomatic Relief of Diarrhea from Cholera.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NP-300
- Announced Date:
- February 18, 2025
- Indication:
- Symptomatic Relief of Diarrhea from Cholera
Announcement
Jaguar Health, announced that, on January 29, 2025, they extended their collaboration with Streeterville related to Napo's plans to develop its NP-300 drug product candidate for the symptomatic relief of diarrhea and dehydration in cholera patients and pursue a possible Tropical Disease Priority Review Voucher ("TDPRV") from the U.S. Food and Drug Administration ("FDA") for this indication.
AI Summary
On January 29, 2025, Jaguar Health announced an extension of its collaboration with Streeterville. This expanded partnership supports Napo’s plans to develop NP-300, a drug product candidate aimed at providing symptomatic relief for diarrhea and dehydration in cholera patients. The collaboration will also focus on pursuing a Tropical Disease Priority Review Voucher (TDPRV) from the U.S. Food and Drug Administration (FDA) for this important indication. Achieving a TDPRV could help speed up the review process, potentially bringing NP-300 to market faster and offering a critical treatment option for patients affected by cholera. This move underscores Jaguar Health’s commitment to addressing unmet medical needs in tropical diseases and reflects a promising step forward in the company’s efforts to improve patient care with innovative therapeutic solutions.
Read Announcement
