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 Phase Indication # of Patients Citation
3 HIV-associated diarrhea Crofelemer (136)
Placebo (138)
MacArthur RD et al. HIV Clinical Trials. 2013.
3 HIV-associated diarrhea Crofelemer (251) Unpublished Data on File, Napo Pharmaceuticals.
3 HIV-associated diarrhea Crofelemer (302)
Placebo (98)
Hoop RS  et al. Poster, DIA 2005.
2 HIV-associated diarrhea Crofelemer (43)
Placebo (42)
Holodniy M  et al. Am J Gastroenterol. 1999.
Investigational Uses of Crofelemer In Humans
2 Severe Cholera Crofelemer (80)
Placebo (20)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2 Acute Watery Diarrhea Crofelemer (51)
Placebo (47)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2 Traveler’s Diarrhea Crofelemer (140)
Placebo (44)
DiCesare D et al. Am J Gastroenterol. 2002.
2 IBS-D Crofelemer (183)
Placebo (61)
Lembo AJ et al. Oral session, DDW 2007.
1 Pediatric Safety 30 patients from 3-24 months Connor JD Unpublished data.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.