FAB122

Ferrer is a pharmaceutical company based in Spain. It licensed this oral edaravone formulation (then called TW001) from the Dutch company Treeway in October 2021 and ran the ADORE trial with the European research network TRICALS.

Like Radicava, FAB122 contained edaravone, which neutralises unstable oxygen molecules (free radicals) thought to damage motor neurons. The idea was that a daily pill would be easier and might work better than on/off cycles of infusions.

ADORE enrolled 313 people across Europe and finished in October 2023. Ferrer announced in January 2024 that the trial had missed its main and key secondary goals, and the open-label extension study (ADOREXT) was ended.

Ferrer and TRICALS announced that FAB122 did not slow ALS progression compared with placebo. Because the trial was large and lasted nearly a year, it gives a clear negative answer for this daily oral formulation.

ADORE compared FAB122 100 mg a day with placebo for 48 weeks. Its main goal, slower loss of ALSFRS-R points at 48 weeks, was not met, and there was no benefit on the combined measure of function and survival (CAFS) at 48 or 72 weeks or on other key secondary goals. The drug was safe and well tolerated. Ferrer has not published the size of the difference. This result does not directly test Radicava, which uses a different formulation and dosing schedule.

This is the most favourable result reported. See all key studies for the full picture.

ADORE enrolled adults with ALS in 11 European countries. Two in three participants received FAB122 and one in three received placebo, taken by mouth every day for 48 weeks.

FAB122 is not available and no trials are recruiting. Ferrer stopped the extension study after the ADORE results. People interested in edaravone should ask their neurologist about approved forms where they live.