Fenfluramine hydrochloride is under clinical development by UCB and currently in Phase II for Myoclonic Seizure. According to GlobalData, Phase II drugs for Myoclonic Seizure have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Fenfluramine hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Fenfluramine hydrochloride overview

Fenfluramine hydrochloride (Fintepla) is an amphetamine derivative a sympathomimetic stimulant. It is formulated as solution for oral route of administration. Fintepla is indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Fenfluramine hydrochloride (ZX-008) is under development for the treatment of Dravet syndrome (Severe Myoclonic Epilepsy of Infancy), infantile spasm, Doose syndrome, Lennox Gastaut syndrome as an adjuvant therapy and to treat convulsive seizures in patients with CDKL5 deficiency disorder (a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene). It is also under development for the treatment of LGS, convulsive seizures (generalized tonic clonic seizures, tonic seizures, atonic seizures, tonic/atonic seizures, focal seizures with clear observable motor signs.

UCB overview

UCB is a biopharmaceutical company that is engaged in the discovery and development of novel medicines and solutions for the treatment of various severe diseases. It strives to develop products for the treatment of neurology and immunology related conditions. The company’s marketed products include Cimzia for ankylosing spondylitis, axial spondyloarthritis, Crohn’s disease, psoriatic arthritis, non-radiographic axial spondyloarthritis and rheumatoid arthritis; Neupro for Parkinson’s disease and restless legs syndrome; Evenity for osteoporosis, and Vimpat, Keppra and Briviact for epilepsy. The company operates through subsidiaries in the US, Japan, Germany, Italy, Spain, France, China, the UK, Ireland, Belgium, Brazil, Russia, India, Mexico, Turkey and other countries. UCB is headquartered in Brussels, Brussels-Capital Region, Belgium.

For a complete picture of Fenfluramine hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 18 March 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.