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NCT06666491
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
Phase 3 trial testing Tafenoquine in Malaria, Vivax in 300 participants. Currently enrolling.
25 May 2026
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 13 November 2024 |
| Primary completion | 25 May 2026 |
| Estimated completion | 25 May 2026 |
| Sites | 4 locations across India |
Drugs / interventions tested
- Tafenoquine (TAFENOQUINE) — full drug profile →
- Primaquine — full drug profile →
- Chloroquine (CHLOROQUINE) — full drug profile →
Conditions studied
- Malaria, Vivax — all drugs for Malaria, Vivax →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 2 to 64, any sex, with Malaria, Vivax. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06666491
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tafenoquine
Trials testing the same drug.
- NCT06575647 — Vivax Elimination With Tafenoquine (VET) Study · Phase 4 · completed
- NCT04704999 — Southeast Asia Dose Optimization of Tafenoquine · Phase 4 · recruiting
- NCT06207370 — Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis · Phase 2 · recruiting
- NCT06148792 — A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria · Phase 3 · recruiting
- NCT04984759 — Tafenoquine and Primaquine in Colostrum and Breast Milk · Phase 4 · withdrawn
Other recruiting trials for Malaria, Vivax
Currently open trials in the same condition.
- NCT05788094 — ACT vs CQ With Tafenoquine for P. Vivax Mono-infection · Phase 4 · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06666491 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06666491.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing