A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Latest Information Update: 21 Oct 2025
At a glance
- Drugs Rilzabrutinib (Primary)
 - Indications Idiopathic thrombocytopenic purpura
 - Focus Registrational; Therapeutic Use
 - Acronyms LUNA3
 - Sponsors Principia Biopharma
 
Most Recent Events
- 29 Aug 2025 According to a Sanofi media release, company announced that the US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
 - 10 Feb 2025 Planned End Date changed from 20 Nov 2026 to 26 Aug 2026.
 - 11 Dec 2024 Status changed from recruiting to active, no longer recruiting.