Overview
An oligosaccharide antibiotic produced by various streptomyces. [PubChem]
Indication
For the treatment of acute and chronic intestinal amebiasis (it is not effective in extraintestinal amebiasis). Also for the management of hepatic coma as adjunctive therapy.
Associated Conditions
- Dientamoeba fragilis infection
- Hepatic coma
- Acute Intestinal amebiasis
- Chronic Intestinal amebiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/02 | Not Applicable | Recruiting | |||
2023/07/24 | Phase 2 | Active, not recruiting | Drugs for Neglected Diseases | ||
2019/02/04 | Phase 2 | Completed | Fundacion Nacional de Dermatologia | ||
2018/11/30 | N/A | UNKNOWN | University of Leipzig | ||
2018/01/17 | Phase 2 | UNKNOWN | Drugs for Neglected Diseases | ||
2017/04/26 | Phase 3 | Completed | Drugs for Neglected Diseases | ||
2017/03/30 | Phase 2 | Completed | Fundacion Nacional de Dermatologia | ||
2013/02/13 | Phase 3 | Completed | U.S. Army Medical Research and Development Command | ||
2013/01/31 | Not Applicable | UNKNOWN | |||
2012/07/17 | N/A | NO_LONGER_AVAILABLE | U.S. Army Medical Research and Development Command |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Department of State Health Services, Pharmacy Branch | 55695-022 | ORAL | 250 mg in 1 1 | 2/9/2016 | |
| Central Texas Community Health Centers | 76413-147 | ORAL | 250 mg in 1 1 | 11/7/2017 | |
| Waylis Therapeutics LLC | 80725-250 | ORAL | 250 mg in 1 1 | 3/26/2021 |
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 |
|---|---|---|---|---|---|
| HUMATIN 250 MG CAPSULAS DURAS | Pfizer S.L. | 36795 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.