Fenfluramine hydrochloride is a Small Molecule owned by Zogenix, and is involved in 27 clinical trials, of which 14 were completed, 10 are ongoing, and 3 are planned.

Fenfluramine hydrochloride elicits anti-epileptic properties by elevating the levels of serotonin. Serotonin is a brain chemical which play a important role for well-being and associated behaviors. The drug candidates by selectively inhibiting the serotonin reuptake stimulate the release of serotonin thereby reduce the seizures associated with the disease.

The revenue for Fenfluramine hydrochloride is expected to reach a total of $1.7bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Fenfluramine hydrochloride NPV Report.

Fenfluramine hydrochloride is currently owned by Zogenix. Nippon Shinyaku and UCB are the other companies associated in development or marketing of Fenfluramine hydrochloride.

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.

Nippon Shinyaku Overview

Nippon Shinyaku develops, manufactures, and sells ethical pharmaceuticals and functional foods. The company offers a wide range of products including drugs for pain, inflammation, and allergies; urological diseases; hematologic malignancies; gastrointestinal disorders; cardiovascular and metabolic diseases among others. Nippon Shinyaku also provides functional food ingredients including health food ingredients, preservatives, spices and condiments, and protein preparations. Its functional food products find application in meat processing, fish processing, dairy product, prepared food, confectionery and bakery, and beverage, among others. The company operates business through a network of offices and research laboratories located in Japan, China, the UK and the US. Nippon Shinyaku is headquartered in Minami-ku, Kyoto, Japan.

The company reported revenues of (Yen) JPY137,484 million for the fiscal year ended March 2022 (FY2022), an increase of 12.8% over FY2021. In FY2022, the company’s operating margin was 20.6%, compared to an operating margin of 21.4% in FY2021. In FY2022, the company recorded a net margin of 16.8%, compared to a net margin of 17% in FY2021. The company reported revenues of JPY35,517 million for the second quarter ended September 2022, a decrease of 0.3% over the previous quarter.

Quick View – Fenfluramine hydrochloride

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

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.