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Krintafel (TAFENOQUINE)
Tafenoquine works by targeting the parasite's heme detoxification pathway, preventing the parasite from producing heme and ultimately leading to its death.
Tafenoquine (Krintafel), marketed by 60 Degrees Pharms, is a prophylactic treatment for malaria, positioned in a competitive landscape dominated by off-patent generics such as chloroquine, hydroxychloroquine, and primaquine. Its key strength lies in its unique mechanism of action, which targets the parasite's heme detoxification pathway, offering a distinct therapeutic approach compared to traditional antimalarials. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TAFENOQUINE |
|---|---|
| Sponsor | 60 Degrees Pharms |
| Drug class | tafenoquine |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology (12.4)].
Approved indications
- Malaria Prophylaxis
Common side effects
- Dizziness
- Nausea
- Vomiting
- Headache
- Decreased Hemoglobin
- Anxiety
- Somnolence
- Increased blood creatinine
- Increased blood methemoglobin
- Increased alanine aminotransferase
- Hypersensitivity reactions
- Vortex keratopathy
Drug interactions
- drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters
Key clinical trials
- Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
- Pharmacokinetic (PK) Study of Tafenoquine in Healthy Adults (EARLY_PHASE1)
- Tafenoquine and ACTs (TADORE- Plus) (PHASE4)
- Postpartum 8-aminoquinoline Breast Milk Study (PHASE2,PHASE3)
- Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children (PHASE4)
- This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria (PHASE2)
- Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria (PHASE4)
- Vivax Elimination With Tafenoquine (VET) Study (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Krintafel CI brief — competitive landscape report
- Krintafel updates RSS · CI watch RSS
- 60 Degrees Pharms portfolio CI