Overview
Tafenoquine is an 8-aminoquinoline analogue of primaquine which varies only on the presence of a 5-phenoxy group. It was discovered by the scientists at the Walter Reed Army Institute of Research in 1978 as a substitute for primaquine that would be more effective against relapsing vivax malaria. Tafenoquine was further developed collaboratively between GlaxoSmithKline and Medicines for Malaria Venture. It was FDA approved on July 20, 2018.
Indication
用于16岁及以上疟疾患者，根治(预防复发)由间日疟原虫(P.vivax)导致的疟疾。
Associated Conditions
- Malaria caused by plasmodium vivax
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | |||
2024/10/30 | Phase 3 | Recruiting | |||
2024/10/24 | Phase 2 | Not yet recruiting | 60 Degrees Pharmaceuticals LLC | ||
2024/08/28 | Phase 4 | Active, not recruiting | |||
2024/06/27 | N/A | AVAILABLE | 60 Degrees Pharmaceuticals LLC | ||
2024/01/17 | Phase 2 | Recruiting | 60 Degrees Pharmaceuticals LLC | ||
2023/11/28 | Phase 3 | Recruiting | |||
2023/07/17 | Phase 2 | Not yet recruiting | |||
2023/03/03 | N/A | Completed | Dr. Prayuth Sudathip | ||
2022/05/04 | N/A | Recruiting | Medicines for Malaria Venture |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| 60 Degrees Pharmaceuticals, LLC | 71475-257 | ORAL | 100 mg in 1 1 | 9/8/2021 | |
| GlaxoSmithKline LLC | 0173-0889 | ORAL | 150 mg in 1 1 | 8/2/2023 |
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 |
|---|---|---|---|---|---|
| KOZENIS tafenoquine 50 mg film-coated dispersible tablet blister pack | 350774 | Medicine | A | 3/9/2022 | |
| KODATEF tafenoquine (as succinate) 100 mg tablet blister pack | 293438 | Medicine | A | 9/19/2018 | |
| KOZENIS tafenoquine 150 mg film-coated tablet blister pack | 297214 | Medicine | A | 9/13/2018 |
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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