Last reviewed · How we verify
Matched-Placebo for Tafenoquine
Matched-Placebo for Tafenoquine is a 8-aminoquinoline Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Treatment of malaria caused by Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae, Prevention of malaria caused by Plasmodium falciparum.
Tafenoquine is an antimalarial drug that works by targeting the parasite's heme detoxification pathway.
Tafenoquine is a small molecule with an unknown mechanism of action, used in a clinical trial to evaluate its safety and efficacy in treating mild to moderate COVID-19 disease. The trial compared tafenoquine to a placebo in patients with low risk of disease progression.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Matched-Placebo for Tafenoquine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | 8-aminoquinoline |
| Target | Plasmodium heme detoxification pathway |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Tafenoquine is a blood schizonticide that inhibits the parasite's ability to detoxify heme, ultimately leading to the parasite's death. This mechanism of action is thought to be responsible for the drug's efficacy against Plasmodium species.
Approved indications
- Treatment of malaria caused by Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae
- Prevention of malaria caused by Plasmodium falciparum
Common side effects
- Hemolysis
- Neuropsychiatric events
- Gastrointestinal disturbances
Key clinical trials
- A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression (PHASE2)
- Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria (PHASE3)
- Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Matched-Placebo for Tafenoquine CI brief — competitive landscape report
- Matched-Placebo for Tafenoquine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Matched-Placebo for Tafenoquine
What is Matched-Placebo for Tafenoquine?
How does Matched-Placebo for Tafenoquine work?
What is Matched-Placebo for Tafenoquine used for?
Who makes Matched-Placebo for Tafenoquine?
What drug class is Matched-Placebo for Tafenoquine in?
What development phase is Matched-Placebo for Tafenoquine in?
What are the side effects of Matched-Placebo for Tafenoquine?
What does Matched-Placebo for Tafenoquine target?
Related
- Drug class: All 8-aminoquinoline drugs
- Target: All drugs targeting Plasmodium heme detoxification pathway
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Treatment of malaria caused by Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae
- Indication: Drugs for Prevention of malaria caused by Plasmodium falciparum
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing