MYTESI
Peakcrofelemer
NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Mechanism of Action
(cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl¯) channel, and the calcium-activated Cl¯ channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl¯ channel and CaCC regulate Cl¯ and fluid secretion by intestinal epithelial cells. Crofelemer…
Pharmacologic Class:
Antidiarrheal
Clinical Trials (4)
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
Started Jan 2017
53 enrolled
Breast Cancer
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Started Jun 2011
250 enrolled
HIV EnteropathyDiarrhea With HIV
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
Started Oct 2007
374 enrolled
HIV Associated Diarrhea
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
Started Dec 2004
245 enrolled
Irritable Bowel SyndromeColonic DiseasesDiarrhea+1 more
Loss of Exclusivity
LOE Date
Oct 31, 2031
68 months away
Patent Expiry
Oct 31, 2031