Overview
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.
Indication
For the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy.
Associated Conditions
- Noninfectious diarrhea
Research Report
A Comprehensive Monograph on Crofelemer (DB04941): From Ethnobotany to a First-in-Class Antisecretory Agent
Executive Summary
Crofelemer is a first-in-class, orally administered antisecretory agent approved for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.[1] A novel botanical drug, Crofelemer is a purified oligomeric proanthocyanidin extracted from the red bark latex of the South American tree,
Croton lechleri.[1] Its development represents a significant milestone, bridging traditional ethnobotanical knowledge with modern, evidence-based pharmaceutical science. The drug's therapeutic effect is mediated by a unique, localized mechanism of action within the gastrointestinal lumen. It dually inhibits two distinct, structurally unrelated chloride ion channels on the apical membrane of intestinal enterocytes: the cystic fibrosis transmembrane conductance regulator (CFTR) and the calcium-activated chloride channel (CaCC).[1] By modulating these channels, Crofelemer normalizes the intestinal secretion of chloride ions and, consequently, the passive outflow of sodium and water, thereby improving stool consistency and reducing the frequency of watery stools without affecting gastrointestinal motility.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/01 | Phase 2 | Recruiting | Napo Therapeutics, S.p.A. | ||
2024/12/06 | Phase 2 | Recruiting | |||
2024/03/22 | Early Phase 1 | Recruiting | Lindsey Russell, MD | ||
2020/09/04 | Phase 3 | Completed | |||
2020/07/24 | Phase 4 | Terminated | |||
2019/12/10 | Phase 4 | Completed | |||
2019/04/02 | Phase 4 | Completed | |||
2017/03/29 | Phase 2 | Completed | |||
2016/09/21 | Phase 2 | Completed | Sandra Swain | ||
2011/06/16 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Napo Pharmaceuticals, Inc. | 70564-802 | ORAL | 125 mg in 1 1 | 8/17/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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