Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Crofelemer Powder for Oral Solution
Crofelemer for · 2 trials · 8 indications
Frequency of Treatment-Emergent-Adverse Events
Change in weekly volume of parenteral support (PS: parenteral nutrition (PN) with or without intravenous (IV) fluid volume) from baseline, by recording PS volume in the patient daily diary
Changes from baseline in physical exam and signs of dehydration, such as decreased urine output, sunken eyes, lethargy and abnormal skin turgor.
Incidence in changes from baseline of individual lab values within a chemistry, hematology and metabolic panel analysis.
| Arm | Type | Description |
|---|---|---|
| Crofelemer 3 mg/kg/dose three times daily (TID) | EXPERIMENTAL | Participants randomized to the Crofelemer 3 mg/kg/dose arm will receive Crofelemer 3 mg/kg/dose by oral route three times per day (TID) morning, midday, and evening for 24 weeks. |
| Crofelemer 10 mg/kg/dose three times daily (TID) | EXPERIMENTAL | Participants randomized to the Crofelemer 10 mg/kg/dose arm will receive Crofelemer 10 mg/kg/dose by oral route three times per day (TID) morning, midday, and evening for 24 weeks. |
| Matched Placebo three times per day (TID) | PLACEBO_COMPARATOR | Participants randomized to the matched placebo arm will receive matched placebo by oral route three times per day (TID) morning, midday, and evening for 24 weeks. |
| Dose Level 1/Treatment Period 1: 1mg/kg/dose 3x/day | EXPERIMENTAL | Participants may be randomized to crofelemer powder for oral solution during Treatment Period 1 (1 month duration) |
| Dose Level 1/Treatment Period 1: Placebo 3x/day | PLACEBO_COMPARATOR | Participants may be randomized to the placebo comparator during Treatment Period 1 (1 month duration) |
| Dose Level 1/Treatment Period 2: 1mg/kg/dose 3x/day | EXPERIMENTAL | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Dose Level 2/Treatment Period 1: 3mg/kg/dose 3x/day | EXPERIMENTAL | Participants will crossover to either crofelemer powder for oral solution or placebo comparator or continue on crofelemer powder for oral solution or the placebo comparator that they were previously on during Dose Level 1 (1 month duration) |
| Dose Level 2/Treatment Period 1: Placebo 3x/day | PLACEBO_COMPARATOR | Participants will crossover to either crofelemer powder for oral solution or placebo comparator or continue on crofelemer powder for oral solution or the placebo comparator that they were previously on during Dose Level 1 (1 month duration) |
| Dose Level 2/Treatment Period 2: 3mg/kg/dose 3x/day | EXPERIMENTAL | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Dose Level 2/Treatment Period 2: Placebo 3x/day | PLACEBO_COMPARATOR | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Dose Level 3/Treatment Period 1: 10mg/kg/dose 3x/day | EXPERIMENTAL | Participants will crossover to either crofelemer powder for oral solution or placebo comparator or continue on crofelemer powder for oral solution or the placebo comparator that they were previously on during Dose Level 2 (1 month duration) |
| Dose Level 3/Treatment Period 1: Placebo 3x/day | PLACEBO_COMPARATOR | Participants will crossover to either crofelemer powder for oral solution or placebo comparator or continue on crofelemer powder for oral solutionor the placebo comparator that they were previously on during Dose Level 2 (1 month duration) |
| Dose Level 3/Treatment Period 2: 10mg/kg/dose 3x/day | EXPERIMENTAL | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Dose Level 3/Treatment Period 2: Placebo 3x/day | PLACEBO_COMPARATOR | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Dose Level 1/Treatment Period 2: Placebo 3x/day | PLACEBO_COMPARATOR | Participants will crossover to either crofelemer powder for oral solution or placebo comparator |
| Name | Type | Description |
|---|---|---|
| Crofelemer Powder for Oral Solution | DRUG | Crofelemer Powder for Oral Solution |
| Matched Placebo Powder for Oral Solution | DRUG | Matched Placebo Powder for Oral Solution |
| Placebo Powder for Oral Solution | DRUG | Matching Placebo Powder for Oral Solution |
Inclusion Criteria Patients will be enrolled in the study if they meet all the following criteria: 1. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures and be willing to complete the required assessment...
Crofelemer is an investigational small molecule being studied for cancer therapy-related diarrhea, breast cancer, short bowel syndrome, and microvillus inclusion disease. It is being developed by Jaguar Health, Inc. (JAGX) and is currently in Phase 2 clinical development for these indications.
Crofelemer is a small molecule that targets the gastrointestinal tract to reduce diarrhea. It is being studied for its ability to prevent and treat diarrhea associated with cancer therapies, as well as diarrhea related to short bowel syndrome and microvillus inclusion disease.
Crofelemer is developed by Jaguar Health, Inc., a biopharmaceutical company traded under the ticker JAGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple gastrointestinal and oncology-related conditions.
Crofelemer is in Phase 2 clinical development. It is not FDA approved and remains investigational. The drug is being studied in multiple trials, including a Phase 2 trial for breast cancer and a Phase 2 trial for microvillus inclusion disease, with additional trials in short bowel syndrome.
Crofelemer has been studied in several clinical trials, including NCT02910219 for HER2 positive breast cancer patients, NCT04538625 for cancer therapy-related diarrhea, NCT06721871 for pediatric microvillus inclusion disease, and NCT06904872 for short bowel syndrome. These trials are at various stages of completion.
Yes, Crofelemer is also known as Crofelemer Powder for Oral Solution. This formulation is being studied in clinical trials, including a Phase 2 trial for pediatric microvillus inclusion disease, to evaluate its safety and efficacy in treating diarrhea-related conditions.