Crofelemer has been studied in over 3000 patients to date, including patients with HIV/AIDS-related diarrhea, diarrhea-predominant irritable bowel syndrome and acute adult infectious diarrhea resulting from Vibrio cholera and E. coli infections as well as non-specific Travelers’ diarrhea.

Follow-On Indications Being Planned and/or Developed:

Chemotherapy-Induced Diarrhea (CID) is a development priority for crofelemer. Based on completed market research with oncologists and oncology nurses, there is an unmet need and opportunity for new treatments for CID given the incidence of diarrhea with chemotherapy drugs/regimens, particularly some of the newer agents.

Diarrhea-Predominant Irritable Bowel Syndrome (Phase 2)

Acute Adult Infectious Diarrhea Including Cholera (Phase 2)

Travelers’ Diarrhea (Phase 2)

Pediatric Acute Diarrhea (Phase 1)

C. difficile-related Diarrhea (Planning stage)

Summary Of Crofelemer Clinical Studies In Humans
Clinical PhaseIndication# of PatientsCitation
3HIV-associated diarrheaCrofelemer (136)
Placebo (138)
MacArthur RD et al. HIV Clinical Trials. 2013.
3HIV-associated diarrheaCrofelemer (251)Unpublished Data on File, Napo Pharmaceuticals.
3HIV-associated diarrheaCrofelemer (302)
Placebo (98)
Hoop RS  et al. Poster, DIA 2005.
2HIV-associated diarrheaCrofelemer (43)
Placebo (42)
Holodniy M  et al. Am J Gastroenterol. 1999.
Investigational Uses of Crofelemer In Humans
2Severe CholeraCrofelemer (80)
Placebo (20)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2Acute Watery DiarrheaCrofelemer (51)
Placebo (47)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2Traveler’s DiarrheaCrofelemer (140)
Placebo (44)
DiCesare D et al. Am J Gastroenterol. 2002.
2IBS-DCrofelemer (183)
Placebo (61)
Lembo AJ et al. Oral session, DDW 2007.
1Pediatric Safety30 patients from 3-24 monthsConnor JD Unpublished data. Napo Pharmaceuticals. 1995.

Important Safety Information:

Mytesi® (crofelemer 125 mg delayed-release tablets) is approved for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Rule out infectious etiologies of diarrhea before starting Mytesi® in order to avoid the risk of potential worsening of disease due to delay of appropriate therapy. The most common adverse events (incidence ≥ 3%) reported in Mytesi® clinical trials were upper respiratory tract infection, bronchitis, cough, flatulence, and increased billirubin.