FDA grants Orphan Designation for the treatment of CRPS with AKI-007

Published 

November 21, 2024

Dramatic, durable and safe pain relief in chronic CRPS patients has lead to this milestone. A phase III trial is the next step.

The FDA has granted AKIGAI the Orphan designation (ODD) for our 1st drug candidate AKI-007, for the treatment of Complex Regional Pain Syndrome (CRPS).

This comes shortly after having been granted the ODD from the EMA. There has never been a drug approved for these patients, suffering day in and day out from the most excruciating pain.

We aim at changing that as our first step to enter the neuropathic pain market and will start a phase III trial for these patients next year.

A big Thank You to our CRPS patients, who for several years have shared their experiences about anti-EGFR treatment with us. They are a continuing source of motivation for us.