Overview
Rifamycin is the prime member of the rifamycin family which are represented by drugs that are a product of fermentation from the gram-positive bacterium Amycolatopsis mediterranei, also known as Streptomyces mediterranei. The parent compound of rifamycin was rifamycin B which was originally obtained as a main product in the presence of diethylbarburitic acid. Some small modifications where performed in this inactive compound and with the creation of rifamycin SV there was the first antibiotic used intravenously for the treatment of tuberculosis. Rifamycin has had several direct derivative products such as rifamycin SV, rifaximin, rifampin and rifamycin CV. All of the derivatives have slight different physicochemical properties when compared to the parent structure. Rifamycin was further developed by Cosmo Technologies Ltd and approved in November 16, 2018 by the FDA as a prescription drug after being granted the designation of Qualified Infectious Disease Product which allowed it to have a status a priority review. This drug was also sent for review to the EMA in 2015 by Dr. Falk Pharma Gmbh and it was granted a waiver for the tested conditions.
Indication
Rifamycin is indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of E. coli. The status of the disease should not be complicated by fever or blood in the stool. To prevent drug-resistant bacteria, it is important to mention that the use of rifamycin for this indication should be only done in cases where the infection is proven or strongly suspected to be caused by bacteria. Travallers' diarrhea is very common problem affecting 20-60% of the travellers and it is defined as an increase in frequency of bowel movements to three or more loose stools per day during a trip abroad. This condition is rarely life threatening but in severe cases it can produce dehydration and sepsis. The most common cause of travellers' diarrhea is a pathogen and from the pathogens identified, bacteria is the most common cause followed by norovirus, rotavirus and similar viruses.
Associated Conditions
- Not complicated by fever, not complicated by bloody stool Traveler's Diarrhea caused by noninvasive strains of Escherichia coli
- Susceptible Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/10/12 | Phase 3 | Recruiting | Stellah Mpagama | ||
2020/08/06 | Phase 2 | UNKNOWN | Bradley Connor | ||
2020/04/16 | Phase 4 | Active, not recruiting | Yuzuncu Yıl University | ||
2019/09/09 | Phase 2 | Completed | Hunter Holmes Mcguire Veteran Affairs Medical Center | ||
2019/07/22 | Phase 2 | Not yet recruiting | |||
2019/07/19 | Phase 2 | Not yet recruiting | |||
2017/04/04 | Phase 2 | Completed | |||
2016/11/21 | Phase 1 | Completed | |||
2013/05/07 | Phase 2 | Completed | |||
2010/09/24 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| RedHill Biopharma Ltd | 57841-1201 | ORAL | 194 mg in 1 1 | 2/5/2021 | |
| RedHill Biopharma Ltd | 57841-1200 | ORAL | 194 mg in 1 1 | 2/5/2021 |
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 |
|---|---|---|---|---|---|
| Rifamycin Sodium Injection | 国药准字H32025722 | 化学药品 | 注射剂 | 11/21/2022 | |
| Rifamycin Sodium Injection | 国药准字H20053169 | 化学药品 | 注射剂 | 6/19/2020 | |
| Rifamycin Sodium Injection | 国药准字H20046664 | 化学药品 | 注射剂 | 6/15/2020 | |
| Rifamycin Sodium Injection | 国药准字H51024010 | 化学药品 | 注射剂(注射液) | 4/21/2021 | |
| Rifamycin Sodium Injection | 国药准字H20045088 | 化学药品 | 注射剂 | 7/18/2022 | |
| Rifamycin Sodium Injection | 国药准字H20063560 | 化学药品 | 注射剂 | 5/18/2020 | |
| Rifamycin Sodium Injection | 国药准字H20068150 | 化学药品 | 注射剂 | 4/20/2021 | |
| Rifamycin Sodium Injection | 国药准字H20063561 | 化学药品 | 注射剂 | 5/18/2020 | |
| Rifamycin Sodium Injection | 国药准字H20045893 | 化学药品 | 注射剂 | 3/1/2023 | |
| Rifamycin Sodium Injection | 国药准字H20045894 | 化学药品 | 注射剂 | 3/1/2023 |
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.