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  1. pharmadog
  2. ›drugs
  3. ›Mytesi
drug · small molecule
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crofelemer DR

Marketedupdated 3mo ago
by Napo Pharmaceuticals Inc🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for diarrhea and 2 investigational indications.

targets

Anoctamin-1Cystic fibrosis transmembrane conductance regulator

all catalysts(0)

nothing on the calendar yet

Trials studying crofelemer DR

  • phase3Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)active not recruitingn=6
  • EP1Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndromerecruitingn=6
  • phase4Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patientscompletedn=93
  • phase2Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinibcompletedn=11
  • phase2Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)recruitingn=18
  • phase3Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapycompletedn=287

Patent cliff

source: FDA Orange Book
first barrier falls
Oct 31, 2031
~5.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (2)

  • Oct 31, 2031method-of-use (U-1319)US 8962680
  • Oct 31, 2031method-of-use (U-1319)US 9585868

News(0)

no news has mentioned this drug yet

brand
Mytesi
trade names
Fulyzaq, Mytesi, Provir, Virend
generic
crofelemer
MOA
Anoctamin-1 blocker; Cystic fibrosis transmembrane conductance regulator inhibitor
indication
Chemotherapy-Induced Diarrhea (CID)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 57m ago
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