Relieves non-infectious diarrhea. Sold as Mytesi. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Crofelemer (sold as Mytesi), first approved Dec 31, 2012, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Mytesi | Part D | $8.1M | +0% | 403 |
| Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)Short Bowel Syndrome, Malabsorption Syndromes · Napo Therapeutics, S.p.A. | Phase 2 | Recruiting | Apr 1, 2025 |
| Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID)Microvillus Inclusion Disease, Congenital Disorders · Napo Pharmaceuticals, Inc. | Phase 2 / Phase 3 | Active, not recruiting | Dec 6, 2024 |
| Open-Label Pilot Study With Crofelemer in Patients With Short Bowel SyndromeShort Bowel Syndrome · Jessica Sosio | Early phase 1 | Active, not recruiting | Mar 22, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 31, 2012 | MytesiNDA 202292 · New molecular entity | Napo Pharms Inc | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
