Tafenoquine clinical trials
Tafenoquine is named as an intervention in 4 current clinical trials in our USA, India and Brazil registers. 4 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is 60 Degrees Pharmaceuticals LLC (2). The most-studied condition is Chronic Babesiosis.
Where Tafenoquine is approved
All regulators →Of the three regulators tracked here, the first to approve Tafenoquine was the US, on 20 Jul 2018.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tafenoquine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tafenoquine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 2 Dec 2035 (US 10342791).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Tafenoquine works
All drug targets →- COVID-19Phase 2
- Plasmodium falciparum malariaPhase 2
- BabesiosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL298470, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9722, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Tafenoquine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tafenoquine
- ChEMBL
- CHEMBL298470
- DrugBank
- DB06608
- PubChem CID
- 115358
- CAS number
- 106635-80-7
- FDA UNII
- 262P8GS9L9
- Wikidata
- Q2387553
- Wikipedia
- Tafenoquine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Tafenoquine
4 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
NCT06148792 · ClinicalTrials.gov ↗ · Vivax Malaria
|
Phase 3 | Recruiting | Menzies School of Health Research | Brazil |
|
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
NCT06666491 · Malaria, Vivax
|
Phase 3 | Recruiting | GlaxoSmithKline | India |
|
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
NCT06207370 · Babesiosis
|
Phase 2 | Recruiting | 60 Degrees Pharmaceuticals LLC | USA |
|
B-FREE Chronic Babesiosis Study
NCT06656351 · Chronic Babesiosis
|
Phase 2 | Recruiting | 60 Degrees Pharmaceuticals LLC | USA |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Tafenoquine
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| 60 Degrees Pharmaceuticals LLC | 2 |
| GlaxoSmithKline | 1 |
| Menzies School of Health Research | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 2 | 2 |
| Clinical trials in India | 1 | 1 |
| Clinical trials in Brazil | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Tafenoquine trials
How many clinical trials are testing Tafenoquine?
4 current trials in our USA, India and Brazil registers name Tafenoquine as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Tafenoquine trials recruiting patients?
Yes. 4 of the 4 trials are recruiting: 2 with sites in USA, 1 with sites in India and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tafenoquine clinical trials?
60 Degrees Pharmaceuticals LLC (2), GlaxoSmithKline (1) and Menzies School of Health Research (1). The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tafenoquine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tafenoquine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tafenoquine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.