Radotinib Phase 2 (France)

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

Il-Yang Pharm. Co., Ltd (South Korea), NCT04691661; sites in seven French cities (Lille, Limoges, Lyon, Nantes, Paris, Poitiers, Rouen).

What is being tested

Radotinib, a leukaemia drug that blocks c-Abl, like nilotinib (landmark 68) and risvodetinib (landmark 174), after c-Abl was linked to parkin (landmark 211). Doses 50, 100, 150 or 200 mg once daily for 6 months (8 on drug and 2 on placebo per dose group), double-blind. Actual start 9 September 2021; 43 enrolled; status "active, not recruiting"; primary completion 2 September 2026; completion estimated 30 April 2027; no results posted (checked 22 Oct 2026; the registry now marks the September 2026 primary completion as actual, so the primary follow-up is complete and April 2027 is the registry completion date and our expected date for results).

What would count as success

The registered main measure is safety: adverse events 12 months after dosing. Efficacy is secondary, so a positive result would be a signal only.

Sources

• ClinicalTrials.gov NCT04691661 (record updated 3 Sep 2026; re-read via API 22 Oct 2026)
• Not yet verified: the secondary measures; whether radotinib reaches the brain; the "Phase 2" is dose-escalation, not a powered efficacy study; discrepancy between 6-month dosing and 12-month safety endpoint.