ARAKODA (tafenoquine succinate)
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. It is administered to prevent infection in individuals traveling to or residing in areas where malaria is endemic.
How ARAKODA Works
Tafenoquine is an 8-aminoquinoline derivative. It functions as a causal prophylactic by targeting the pre-erythrocytic (liver) and erythrocytic (blood) stages of the *Plasmodium* life cycle. It is also active against the dormant liver stages (hypnozoites) of *P. vivax*.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-08-08
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
ARAKODA Approval History
What ARAKODA Treats
1 indicationsARAKODA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malaria
ARAKODA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARAKODA
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03320174 results posted | 60PH04 | Ph 2 | completed | Long-Term Safety Study of Tafenoquine |
| NCT06575647 VET | MAL24004 | Ph 4 | completed | Vivax Elimination With Tafenoquine (VET) Study |
| NCT06207370 | TQ-BA-2024-1 | Ph 2 | recruiting | Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis |
| NCT06666491 | 208550 | Ph 3 | recruiting | An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older |
| NCT06148792 TADORE | TADORE | Ph 3 | recruiting | A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria |
| NCT04704999 SEADOT | MAL20005 21-0023 | Ph 4 | recruiting | Southeast Asia Dose Optimization of Tafenoquine |
| NCT04411836 EFFORT | EFFORT | Ph 3 | completed | Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine |
| NCT04984759 TBM | MAL21004 | Ph 4 | withdrawn | Tafenoquine and Primaquine in Colostrum and Breast Milk |
| NCT05081089 NECTAR3 | 26257 | Ph 2 | completed | Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali |
| NCT02563496 results posted | 113577 | Ph 2 | completed | A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria |
| NCT02802501 results posted | 200894 | Ph 3 | completed | Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria |
| NCT02216123 results posted | 116564 | Ph 3 | completed | Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria |
| NCT02184637 | 200951 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine Tetraphosphate |
| NCT01205178 | 110027 | Ph 1 | completed | G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARAKODA FDA Label Details
Indications & Usage
FDA Label (PDF)ARAKODA is indicated for the treatment of Malaria.
Pro Intelligence Preview
Deep insights for ARAKODA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 3 active patents
Trial Analysis
- • 14 total trials
- • Stage: Stable
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment