crofelemer
Trade name: mytesi
Approved
Dec 31, 2012
Crofelemer, previously known as the investigational drug SP-303, is a novel proanthocyanidin purified from the bark latex of the Amazonian Croton tree Croton lechleri. It is marketed under the brand name Fulyzaq and indicated for the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy. Fulyzaq treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacteria, virus or parasite). It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhoea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012. — NCATS
Clinical trial activity
16 trials · 12 clinical orgs · 2 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00002310)
Timeline
Indications
Studied for
- Acquired Immunodeficiency Syndrome · Phase 4
- Breast Neoplasms · Phase 2
- Colonic Diseases · Phase 2
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Gastrointestinal Diseases · Phase 2
- Healthy Volunteers · Phase 4
- HIV · Phase 4
- HIV Enteropathy · Phase 3
- HIV Infections · Phase 4
- Intestinal Diseases · Phase 2
- Irritable Bowel Syndrome · Phase 2
- Malabsorption Syndromes · Phase 2
- Microvilli · Phase 2
- Neoplasms · Phase 3
- Postoperative Complications · Phase 2
- Rare Diseases · Phase 2
- Short Bowel Syndrome · Phase 2
Mechanism of action
- Anoctamin-1BLOCKER
ANO1 blocker
CFTR inhibitor
Approval history
- approvedPriority reviewFast trackDec 31, 2012
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaCrofelemer ↗
- NCATSPY79D6C8RX ↗
- ChEMBLCHEMBL2108184 ↗
Also known as
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- crofelemer
- fulyzaq
- fulyzaq
- fulyzaq
- fulyzaq
- fulyzaq
- provir
- provir
- sp 303
- sp-303
- sp-303
- sp-303
- sp-303
- virend
- virend
- virend
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06904872 | Phase 2 | May 29, 2025 | Napo Pharmaceuticals |
| NCT06721871 | Phase 2 | Jan 31, 2025 | Harvard University, Napo Pharmaceuticals |
| NCT06326645 | Early Phase 1 (Phase 1) | Dec 1, 2024 | Napo Pharmaceuticals, The Cleveland Clinic |
| NCT04538625 | Phase 3 | Oct 7, 2020 | Napo Pharmaceuticals, University of Texas at Houston |
| NCT04486326 | Phase 4 | Aug 20, 2020 | Harvard University |
| NCT04192487 | Phase 4 | Oct 22, 2019 | Integrium, Napo Pharmaceuticals |
| NCT03898856 | Phase 4 | Apr 1, 2019 | Napo Pharmaceuticals, Prometheus Inc., University of Texas at Houston |
| NCT02910219 | Phase 2 | Jan 31, 2017 | Genentech, Georgetown University, Napo Pharmaceuticals |
| NCT03094052 | Phase 2 | Jan 4, 2017 | Napo Pharmaceuticals, Puma Biotechnology, Inc., University of California, San Francisco |
| NCT01374490 | Phase 3 | Jun 1, 2011 | Bausch Health Companies |
| NCT00547898 | Phase 3 | Oct 1, 2007 | Bausch Health Companies |
| NCT00461526 | Phase 2 | Oct 1, 2006 | Bausch Health Companies |
| NCT00101725 | Phase 2 | Dec 1, 2004 | Bausch Health Companies |
| NCT00002186 | N/A | Nov 2, 1999 | Shaman Pharmaceuticals |
| NCT00002408 | Phase 3 | Nov 2, 1999 | Shaman Pharmaceuticals |
| NCT00002310 | N/A | Nov 2, 1999 | Shaman Pharmaceuticals |
Organizations
Research & Development (12)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Napo Pharmaceuticals | For profit | 8 | 4 | 4 | 2017 |
| Bausch Health Companies | For profit | 4 | 4 | 2 | 2004 |
| Shaman Pharmaceuticals | For profit | 3 | 3 | 2 | 1999 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2020 |
| University of Texas at Houston | Academic/Hospital | 2 | 1 | 2 | 2019 |
| Genentech | For profit | 1 | 0 | 1 | 2017 |
| Georgetown University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Integrium | For profit | 1 | 0 | 1 | 2019 |
| Prometheus Inc. | For profit | 1 | 0 | 1 | 2019 |
| Puma Biotechnology, Inc. | For profit | 1 | 0 | 1 | 2017 |
| The Cleveland Clinic | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2017 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Napo Pharmaceuticals | For profit | NDA2 | Dec 31, 2012 |
| Salix | For profit | NDA | Dec 31, 2012 |