Fenfluramine hydrochloride is under clinical development by Zogenix and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Fenfluramine hydrochloride’s likelihood of approval (LoA) and phase transition for Myoclonic Seizure took place on 08 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 08 Aug 2022 increased Fenfluramine hydrochloride’s LoA and PTSR for Tonic-Clonic (Grand Mal) Seizure.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Fenfluramine hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Fenfluramine hydrochloride LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Fenfluramine hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
Key Developers
Highest Development Stage
  • Marketed

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.