Saturday, July 11, 2026

Drug profile · INN

crofelemer

crofelemer (MYTESI) is a cystic fibrosis transmembrane conductance regulator inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — crofelemer
US status
approved
Class
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

crofelemer (MYTESI) is a cystic fibrosis transmembrane conductance regulator inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN crofelemer
Brand MYTESI
Mechanism Cystic fibrosis transmembrane conductance regulator inhibitor
Target Anoctamin-1
Route ORAL
Formulation TABLET, DELAYED RELEASE

Mechanism of action

Cystic fibrosis transmembrane conductance regulator inhibitor

Primary target: Anoctamin-1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Crofelemer Placebo Powder for Oral Solution Phase 2 · Anaxis Pharma · Microvillous Inclusion Disease (MVID)

Frequently asked questions

What is crofelemer?

crofelemer (MYTESI) is a cystic fibrosis transmembrane conductance regulator inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for crofelemer?

MYTESI is a marketed brand name for crofelemer. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of crofelemer?

crofelemer has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.