Active Ingredient History
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
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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HIV Enteropathy (approved 2012)
Acquired Immunodeficiency Syndrome (Phase 4)
Breast Neoplasms (Phase 2)
Colonic Diseases (Phase 2)
Diarrhea ()
Gastrointestinal Diseases (Phase 2)
Healthy Volunteers (Phase 4)
HIV (Phase 4)
HIV Enteropathy (Phase 3)
HIV Infections (Phase 4)
Irritable Bowel Syndrome (Phase 2)
Neoplasms (Phase 3)
Trial | Phase | Start Date | Organizations | Indications |
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