Approval Probability
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Adjusted LOA
ML Risk
Label indication MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. ( 1 ) FDA label
Also known as Crofelemer Powder for Oral Solution, Crofelemer Oral Product, Crofelemer Product
Crofelemer · 5 trials · 15 indications
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.
Percentage of participants with any grade (based on CTCAE 4.0) diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy.
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.
Change in ostomy output from baseline over the entire 12-week treatment period as average weekly ostomy output at week 12.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food. |
| Crofelemer | EXPERIMENTAL | Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food. |
| Control | NO_INTERVENTION | Patients on the control arm will be on the study for cycles 1-3 of THP or TCHP. Patients on the control arm will not receive crofelemer at any time on this study. |
| 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 |
| Crofelemer Group | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Crofelemer 125 MG [Mytesi] | DRUG | Randomized, Double-blind, Placebo-controlled, two arm trial |
| Placebo | DRUG | Matching placebo tablets |
| Crofelemer | DRUG | Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP |
| 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 |
| Crofelemer Oral Product | DRUG | Crofelemer powder for solution (50g and 100g) or Crofelemer Powder for Oral Solution (100 mg/mL or 30 mg/mL vials for reconstitution and oral dosing) |
Inclusion Criteria: * 1\. Patients to receive targeted cancer therapy drugs that have a reported an all grade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors, cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors. 2\. Patients able to provide written informed conse...
Crofelemer is being studied for several conditions, including cancer therapy-related diarrhea, short bowel syndrome, microvillus inclusion disease, and breast cancer. It is an investigational small molecule developed by Jaguar Health, Inc. (JAGX).
Crofelemer targets ANO1 and CFTR. It acts as a blocker of these targets, which are involved in chloride secretion and fluid regulation in the gastrointestinal tract.
Crofelemer is being developed by Jaguar Health, Inc., which trades under the ticker symbol JAGX.
Crofelemer is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the indications currently being studied.
Crofelemer is being evaluated in several clinical trials, including NCT06904872 for short bowel syndrome, NCT06721871 for pediatric microvillus inclusion disease, NCT06326645 for short bowel syndrome, and NCT04538625 for cancer therapy-related diarrhea.
Yes, Crofelemer is also known as Crofelemer Powder for Oral Solution, Crofelemer for, Crofelemer 125 MG [Mytesi], Crofelemer Oral Product, and Crofelemer Product. These names refer to the same active ingredient.