Trial Profile

Phase 2 Open Label Prospective Dose-Ranging Clinical Trial With Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 30 Sep 2025

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At a glance

21 Aug 2025 According to a ReAlta Life Sciences media release, Company expects to report data from additional cohorts of patients enrolled in this trial in 2026.
21 Aug 2025 According to a ReAlta Life Sciences media release, the European Medicines Agency (EMA) has granted Orphan Drug Designation to RLS-0071 (pegtarazimod) for the treatment of Graft-versus-Host Disease (GvHD). supported by preliminary data from this ongoing Phase 2 trial.
31 Jan 2025 Planned End Date changed from 1 Sep 2025 to 1 Dec 2025.

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