Fenfluramine hydrochloride is under clinical development by Zogenix and currently in Phase III for Tonic-Clonic (Grand Mal) Seizure. According to GlobalData, Phase III drugs for Tonic-Clonic (Grand Mal) Seizure have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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.

Zogenix overview

Zogenix is a specialty pharmaceutical company that develops and markets therapies for the treatment of patients with rare diseases. The company’s marketed products include Fintepla (fenfluramine) approved in the US, the UK and EU for the treatment of seizures associated with the Dravet syndrome. Its pipeline product candidates include MT1621, intended for the treatment of thymidine kinase 2 deficiency (TK2d); Fintepla for Lennox-Gastaut syndrome (LGS) and other rare epilepsies; and gene therapies for Dravet syndrome and other types of epilepsy. The company operates through its subsidiaries in the US, the UK, Germany, Ireland, Japan, France and Italy. Zogenix is headquartered in Emeryville, California, the US.

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


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.