Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Next Previous
Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Roxadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms MATTERHORN
  • Sponsors FibroGen

Most Recent Events

  • 15 Dec 2025 According to a FibroGen media release, the company announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS).
  • 06 Aug 2025 According to a FibroGen media release, the company plans to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year.
  • 12 May 2025 According to a FibroGen media release, company filed Type-C meeting request with FDA for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) and expect feedback on potential path forward in 3Q 2025

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top