Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Crofelemer Powder for Oral Solution, Crofelemer for
Crofelemer · 2 trials · 7 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.
| 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. |
| 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 |
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 an investigational small molecule being studied for Short Bowel Syndrome, Cancer Therapy-Related Diarrhea, Microvillus Inclusion Disease, and Breast Cancer. It is in Phase 2 clinical development for these indications. Crofelemer is not FDA approved and remains under investigation.
Crofelemer targets and blocks two ion channels, ANO1 and CFTR. By blocking these channels, it is being studied for its potential to reduce fluid secretion in the gut, which may help manage diarrhea associated with various conditions.
Crofelemer is being developed by Jaguar Health, Inc., a company traded on NASDAQ under the ticker JAGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple patient populations.
Crofelemer is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Active trials are evaluating it for Short Bowel Syndrome and Microvillus Inclusion Disease, while completed trials have studied it in breast cancer and cancer therapy-related diarrhea.
Crofelemer has been studied in several trials. NCT02910219 was a completed Phase 2 trial in HER2 positive breast cancer patients. NCT04538625 was a completed Phase 3 trial for cancer therapy-related diarrhea. NCT06721871 is an active Phase 2 trial in pediatric Microvillus Inclusion Disease, and NCT06904872 is a recruiting Phase 2 trial in Short Bowel Syndrome.
Yes, Crofelemer is also known as Crofelemer Powder for Oral Solution. This formulation is being tested in clinical trials, including a study of ascending doses in pediatric patients with Microvillus Inclusion Disease.