MYTESI
Peakcrofelemer
NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Dec 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
MYTESI (crofelemer) is (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. First approved in 2012.
Drug data last refreshed 8m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYTESI (crofelemer) is an oral antidiarrheal small molecule approved in 2012 that acts as a chloride channel blocker, reducing fluid secretion in the gastrointestinal tract. It normalizes electrolyte and water balance by inhibiting cAMP-stimulated CFTR and calcium-activated chloride channels at the intestinal epithelium. The drug is indicated for non-infectious diarrhea in patients with HIV/AIDS on antiretroviral therapy.
$0.007BPart D
LOE Approaching5.3 years to LOEProduct is approaching loss of exclusivity with modest Part D utilization (~2,412 claims in 2023), suggesting a niche market with limited commercial team expansion.
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
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.