- UCB Reports Positive Phase 3 Results for Epilepsy Drug Fenfluramine in Rare CDD Disorder
BRUSSELS – Global biopharmaceutical company UCB announced Thursday that its drug fenfluramine (FINTEPLA®) showed positive results in a Phase 3 trial for treating CDKL5 deficiency disorder (CDD), a rare and severe developmental and epileptic encephalopathy.
Dimitrios Bourikas, Global Medical Head for DEE and Epilepsy at UCB, stated that sharing the new data reflects the company’s dedication to addressing the needs of people living with epilepsy. He commented, “By highlighting clinical outcomes and the experiences of patients and caregivers, we hope to inform better care and support.”
The findings will be presented at the American Epilepsy Society (AES) Annual Meeting.
UCB will share 21 scientific abstracts at the conference, which runs from December 5-9, 2025.
The centerpiece is the new data on fenfluramine, which demonstrated a significantly greater reduction in motor seizure frequency for patients with CDD compared to a placebo. The drug’s safety profile was consistent with previous studies. CDD is the third severe epilepsy for which fenfluramine has yielded positive late-stage trial results, following Dravet syndrome and Lennox-Gastaut syndrome, for which it is already approved.
UCB To Present New Research At The 15th European Epilepsy Congress
The company will also present data from a long-term study showing the sustained safety and clinical benefit of fenfluramine in patients with Dravet and Lennox-Gastaut syndromes. Other research highlights the significant burden that disruptive seizures place on the daily lives of both patients and caregivers, emphasizing the need for improved support and rapid, user-friendly treatment options for prolonged seizures.
The research was announced on December 4, 2025, from UCB’s headquarters in Brussels, ahead of the formal presentations at the AES meeting. While the Phase 3 results for CDD are positive, fenfluramine is not yet approved by regulatory authorities for this specific indication.