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.

Brought to you by Scientific Education Support

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.

View all

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

View on

Important announcement

13 Mar 2025

On March 11, 2025, the EMA Pediatric Committee provided a positive opinion and cleared the pediatric investigation plan to assess MaaT013 in patients from 6 years old to <18 years old with aGvHD. The study is planned to start in 2026. Read more: https://businesswire.com/news/home/20250311353696/en/MaaT-Pharma-Receives-Positive-Opinion-from-EMA-Pediatric-Committee-on-the-Pediatric-Investigation-Plan-for-MaaT013

View all drug updates

More drug updates

VIEW ALL

Important announcement

@EMA_News has granted orphan drug designation to RLS-0071 (pegtarazimod) for the treatment of #GvHD, based on preliminary data from an ongoing phase II study including patients with SR-aGvHD. Read more: https://loom.ly/Ozl53ck

Aug 22, 2025

MaaT013 marketing authorization application

On June 2, 2025, a marketing authorization application was submitted to the @EMA_News for MaaT013, a pooled fecal microbiota product, for the treatment of gastrointestinal acute #GvHD. This follows positive data from the Pivotal ARES study. Read more: https://businesswire.com/news/home/20250602568637/en/MaaT-Pharma-Advances-Toward-Commercialization-And-Submits-Marketing-Authorization-Application-to-the-European-Medicines-Agency-EMA-for-Xervyteg-MaaT013-in-Acute-Graft-versus-Host-Disease

Jun 4, 2025

Important announcement

@US_FDA approves remestemcel-L, an allogeneic bone marrow-derived MSC therapy, for the treatment of pediatric patients (aged ≥2 months) with SR-aGvHD, based on data from the MSB-GVHD001 study. Read more: https://loom.ly/0g3c-cc

Dec 20, 2024

Important announcement

RLS-0071, an investigational dual-targeting anti-inflammatory peptide, has received @US_FDA Orphan Drug Designation and Fast Track Designation for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD): https://loom.ly/pVARecA A phase II open-label trial in hospitalized patients with SR-aGvHD is currently recruiting.

Aug 20, 2024