Overview
Nitazoxanide belongs to the class of drugs known as thiazolides. Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. This drug is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. It is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths . Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses .
Indication
用于治疗隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻。
Associated Conditions
- Diarrhea caused by Cryptosporidium parvum
- Diarrhea caused by Giardia lamblia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/29 | Phase 2 | Recruiting | |||
2025/02/14 | Phase 4 | Completed | |||
2024/09/19 | Phase 3 | Not yet recruiting | |||
2023/09/22 | Phase 3 | Recruiting | |||
2023/08/25 | Phase 2 | Recruiting | |||
2023/06/09 | Phase 2 | Not yet recruiting | |||
2023/01/11 | Not Applicable | Completed | |||
2022/07/29 | Phase 3 | Completed | |||
2022/07/12 | Phase 1 | Recruiting | Sadat City University | ||
2022/05/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Romark Laboratories, L.C. | 67546-212 | ORAL | 100 mg in 5 mL | 12/5/2023 | |
| Rising Pharma Holdings, Inc. | 64980-526 | ORAL | 500 mg in 1 1 | 11/18/2021 | |
| Rising Pharmaceuticals, Inc. | 64980-526 | ORAL | 500 mg in 1 1 | 11/18/2021 | |
| Romark Laboratories, L.C. | 67546-111 | ORAL | 500 mg in 1 1 | 12/5/2023 | |
| LUPIN PHARMACEUTICALS, INC. | 27437-106 | ORAL | 100 mg in 5 mL | 3/20/2024 | |
| Lupin Pharmaceuticals, Inc. | 43386-405 | ORAL | 500 mg in 1 1 | 12/5/2023 |
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. | |||||
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