Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Crofelemer · 4 trials · 7 indications
| Arm | Type | Description |
|---|---|---|
| Crofelemer | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Crofelemer 125 mg | EXPERIMENTAL | - |
| Crofelemer 250 mg | EXPERIMENTAL | - |
| Crofelemer 500 mg | EXPERIMENTAL | - |
| 125 mg crofelemer | EXPERIMENTAL | - |
| 250 mg crofelemer | EXPERIMENTAL | - |
| 500 mg crofelemer | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Crofelemer | DRUG | Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer. |
| Crofelemer 125 mg | DRUG | Crofelemer 125 mg |
| Crofelemer 250 mg | DRUG | Crofelemer 250 mg |
| Crofelemer 500 mg | DRUG | Crofelemer 500 mg |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Male or female ≥ 18 years old * History of HIV-1 infection * On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening *...
Crofelemer is an investigational small molecule being studied for HIV associated diarrhea, HIV enteropathy, and irritable bowel syndrome. It is in Phase 3 clinical development for these indications. The drug is not approved and remains under investigation.
Crofelemer is being developed by Bausch Health Companies Inc., traded on the New York Stock Exchange under the ticker BHC. The company is conducting clinical trials to evaluate the drug for gastrointestinal conditions including HIV associated diarrhea and irritable bowel syndrome.
Crofelemer is in Phase 3 clinical development. It has completed multiple trials, including Phase 2 studies in irritable bowel syndrome and Phase 3 studies in HIV associated diarrhea and HIV enteropathy. The drug is investigational and not yet approved.
Crofelemer has completed several clinical trials. NCT00101725 and NCT00461526 studied the drug in irritable bowel syndrome. NCT00547898 evaluated three doses in HIV associated diarrhea, and NCT01374490 assessed safety and tolerability in HIV enteropathy and diarrhea with HIV.
Crofelemer is also known by the brand name Mytesi. It is a small molecule being developed by Bausch Health for diarrheal conditions. The drug is in Phase 3 trials for HIV associated diarrhea and other gastrointestinal indications.