Mytesi® (crofelemer), a product of Jaguar’s wholly-owned subsidiary Napo Pharmaceuticals, is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. More information and complete Prescribing Information are available at Mytesi.com.
Jaguar controls global unencumbered rights to key indications for Mytesi®, and is pursuing a follow-on indication for Mytesi® in cancer therapy-related diarrhea (CTD), an important supportive care indication for patients undergoing primary or adjuvant chemotherapy for cancer treatment. Mytesi® is also in development for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome (SBS); for irritable bowel syndrome (IBS) (Mytesi® has demonstrated a reduction in pain in IBS-D patients in Phase 2 studies); for supportive care for inflammatory bowel disease (IBD); and as a second-generation anti-secretory agent for use in cholera patients. Mytesi® has received orphan-drug designation for SBS.
Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.