All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional.
The gvhd Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the gvhd Hub cannot guarantee the accuracy of translated content. The gvhd and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The GvHD Hub is an independent medical education platform, sponsored by Medac and supported through grants from Sanofi and Therakos. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View GvHD content recommended for you
RLS-0071 (pegtarazimod) granted orphan drug designation by the EMA
On August 21, 2025, the European Medicines Agency granted orphan drug designation to RLS-0071 (pegtarazimod), an investigational dual-targeting anti-inflammatory peptide, for the treatment of graft-versus-host disease.1 RLS-0071 modulates both neutrophil and complement-mediated inflammatory pathways by selectively inhibiting complement activation at C1, while also suppressing myeloperoxidase activity and the formation of neutrophil extracellular traps.1 The designation was supported by preliminary data from an ongoing phase II study (NCT06343792) assessing the safety and efficacy of pegtarazimod in a cohort of patients with steroid-refractory acute graft-versus-host-disease.1 Data from additional cohorts enrolled in this trial are expected in 2026.
Pegtarazimob was previously granted orphan drug designation and fast track designation by the U.S. Food and Drug Administration for the treatment of patients with steroid-refractory acute graft-versus-host-disease.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
When would you be most likely to consider prescribing belumosudil third-line and beyond?
