Drugs / Fenfluramine
Fenfluramine
also known as
Fenfluramine Hydrochloride · ZX008 · FFA · fenfluramine HCl · Acino · AHR-3002 · Brabafen · Dl-fenfluramine hydrochloride · +17 more
Small molecule targets HTR1D, HTR2C, SIGMAR1 via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed CDKL5 disorder 1 milestone | |||||
| Filed | US (FDA) | FINTEPLA | CDKL5 disorder | — | “In March 2026, FINTEPLA ® (fenfluramine) was filed for regulatory approval in CDKL5 Deficiency Disorder (CDD) with the U.S. Food and Drug Administration (FDA)” ucb.com ↗ |
| Filed Dravet syndrome 1 milestone | |||||
| Filed | Japan (PMDA) | FINTEPLA | Dravet syndrome | 2021-12-21 | “Zogenix Submits New Drug Application for FINTEPLA ® (Fenfluramine) in Japan for the Treatment of Epileptic Seizures Associated with Dravet Syndrome.” ucb.com ↗ |
| Filed Lennox-Gastaut syndrome 2 milestones | |||||
| Filed | US (FDA) | FINTEPLA | Lennox-Gastaut syndrome | 2021-12-01 | “Zogenix Announces U.S. FDA Acceptance for Priority Review of Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with...” ucb.com ↗ |
| Filed | Japan (PMDA) | — | Lennox-Gastaut syndrome | — | “In June, fenfluramine was filed with the Japanese regulatory authority for the treatment of patients with Lennox-Gastaut syndrome (LGS)” ucb.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | FINTEPLA | — | 2022-03-25 | fda.gov ↗ |
| Approved | EU (EMA) | Fintepla | — | 2020-12-18 | europa.eu ↗ |
| Approved | US (FDA) | FINTEPLA | — | 2020-06-25 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03467113 | Jan 2018 → Jun 2020 | Dravet syndrome, Lennox-Gastaut syndrome | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00000313 | — | substance-related disorder | National Institute on Drug Abuse (NIDA) | Terminated | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04289467 | Jun 2023 → Dec 2026 expected | infantile spasms | Children's Hospital of Orange County | Recruiting | No outcome recorded |
| Phase 2 | NCT03861871 | Oct 2019 → Aug 2022 | — | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT02655198 | Jan 2016 → Sep 2018 | Lennox-Gastaut syndrome | KU Leuven | Unknown | No outcome recorded |
| Phase 2 | NCT00000506 | May 1983 → Apr 1988 | heart disorder, obesity disorder, vascular disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 310 trials · 5 met primary | ||||||
| Phase 3 | NCT07503444 | Jul 2026 → Feb 2029 expected | Rett syndrome | UCB BIOSCIENCES, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06118255 | May 2024 → Sep 2026 | Dravet syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05560282 | Jan 2023 → May 2025 | Dravet syndrome | University Health Network, Toronto | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05064878 | Mar 2022 → Nov 2027 expected | CDKL5 disorder, epilepsy with generalized tonic-clonic seizures | Zogenix, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03790137 | May 2019 → Nov 2021 | photosensitive epilepsy | Elizabeth Anne Thiele | Completed | Met primary |
| Phase 3 | NCT03936777 | Apr 2019 → May 2025 | Dravet syndrome, Lennox-Gastaut syndrome | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03355209 | Nov 2017 → May 2024 | Lennox-Gastaut syndrome | Zogenix, Inc. | Completed | Met primary |
| Phase 3 | NCT02926898 | Jan 2017 → Jun 2018 | Dravet syndrome | Zogenix, Inc. | Completed | Met primary |
| Phase 3 | NCT02823145 | Jun 2016 → Jan 2023 | Dravet syndrome | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02682927 | Jan 2016 → Jul 2020 | Dravet syndrome | Zogenix, Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07112365 | Apr 2026 → Sep 2027 expected | Dravet syndrome | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 4 | NCT06598449 | Oct 2024 → Dec 2026 expected | Dravet syndrome | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT05232630 | Oct 2022 → Dec 2024 | developmental and epileptic encephalopathy, 15, developmental and/or epileptic encephalopathy with spike-wave activation in sleep, focal or multifocal malformations in neuronal migration | Hospital Ruber Internacional | Completed | No outcome recorded |
| Phase 4 | NCT05026398 | Apr 2021 → Jun 2022 | cognitive disorder | University of Oxford | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07651293 | Jul 2026 → Jul 2028 expected | major depressive disorder | Imperial College Healthcare NHS Trust | Not yet recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT03780127 | — | Dravet syndrome | Zogenix, Inc. | Approved for marketing | No outcome recorded |
| — | NCT04437004 | — | Dravet syndrome | University of California, Los Angeles | Approved for marketing | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06679413 Background | Dec 2024 → Jun 2025 | — | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03299842 Background | Jul 2017 → Jul 2018 | Dravet syndrome | Zogenix, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-09-01 | UCB Pharma | Results UCB presents data at EEC 2026 highlighting continued leadership in epilepsy and developmental and epileptic encephalopathies ucb.com ↗
Post hoc analyses showed that fenfluramine had an impact on seizure control in CDKL5 deficiency disorder (CDD) including increasing seizure-free days; |
| 2026-04-15 | UCB Pharma | Results UCB presents new data demonstrating quality-of-life impacts for epilepsy patients and caregivers at AAN 2026 meeting ucb.com ↗
Claims analysis data evaluating treatment persistence with FINTEPLA ® ▼ 4,5 (fenfluramine) for people in the U.S. living with Lennox-Gastaut syndrome (LGS) show reductions in healthcare resource utilization and antiseizure medication claims for patients with treatment persistence at 6 and 12 months. |
| 2025-12-08 | UCB Pharma | Results UCB presents positive results from GEMZ phase 3 study at AES showing fenfluramine significantly reduces countable motor seizure frequency in CDKL5 Deficiency Disorder ucb.com ↗
The trial met its primary endpoint and key secondary endpoints, demonstrating a statistically significant reduction in countable motor seizure frequency (CMSF) and a clinically meaningful improvement on the Clinical Global Impression-Improvement (CGI-I) scale, compared with placebo. |
| 2025-12-04 | UCB Pharma | Results UCB shares leading scientific research and advances at American Epilepsy Society Annual Meeting ucb.com ↗
Sustained long-term safety and clinical benefit - as assessed by investigator and caregiver reported Clinical Global Impression-Improvement (CGI) ratings - in patients living with DS and LGS. |
| 2025-10-14 | UCB Pharma | Results Final analysis of open-label extension (OLE) study of Fintepla[®]▼ (fenfluramine) in Lennox-Gastaut syndrome published in Epilepsy and Behavior ucb.com ↗
No new or unexpected treatment-emergent adverse events (TEAEs) were reported. |
| 2025-07-31 | UCB Pharma | Results From Differentiated Innovation to Outstanding Delivery - A Strong First Half Performance ucb.com ↗
positive results from the GEMZ phase 3 study of fenfluramine in CDKL5 Deficiency Disorder (CDD); |
| 2025-06-27 | UCB Pharma | Results UCB announces positive results from GEMZ phase 3 study of fenfluramine in CDKL5 Deficiency Disorder ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the phase 3 study investigating the safety and efficacy of adjunctive fenfluramine in CDKL5 Deficiency Disorder (CDD) met its primary and key secondary endpoints. |
| 2024-05-08 | UCB Pharma | Results UCB presents final open-label extension FINTEPLA®▼(fenfluramine)[1] data at International Child Neurology Congress (ICNC) Annual Meeting ucb.com ↗
In the modified intent-to-treat (mITT) population (n=324), the median percent MCSF change from baseline over the entire OLE was -66.8%, P<0.001. |
| 2024-04-17 | UCB Pharma | Regulatory FINTEPLA[®]▼ (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) ucb.com ↗
The approval by the MHLW was based on safety and efficacy data from a global, double-blind, placebo-controlled, parallel-group randomized Phase 3 clinical trial (1601 Study Cohort A & B), in 296 patients with LGS (aged 2-35 years), including 33 in Japan. |
| 2023-02-08 | UCB Pharma | Regulatory FINTEPLA[®]▼ (fenfluramine) oral solution approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) ucb.com ↗ |
| 2022-12-19 | UCB Pharma | Regulatory FINTEPLA[®]▼ (fenfluramine) oral solution recommended for approval in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) ucb.com ↗ |
| 2022-12-01 | UCB Pharma | Results UCB to present data at the American Epilepsy Society 76th Annual Meeting 2022 supporting a decades-long commitment to transforming epilepsy care ucb.com ↗
Fenfluramine Treatment Is Associated With Improvement in Everyday Executive Function in Adults With Lennox-Gastaut Syndrome: Post-Hoc Analysis of Dose Effects From a Phase 3 Trial |
| 2022-09-27 | UCB Pharma | Regulatory FINTEPLA[®▼] (fenfluramine) Approved in Japan for the Treatment of Seizures Associated with Dravet Syndrome ucb.com ↗ |
| 2022-05-02 | UCB Pharma | Results JAMA Neurology Publishes Phase 3 Study Results on the Efficacy and Safety of FINTEPLA[®]▼(fenfluramine) Oral Solution for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) ucb.com ↗
Primary endpoint was met demonstrating that fenfluramine, as adjunctive treatment, is effective in significantly reducing the frequency of drop seizures in LGS patients compared to placebo |
| 2022-03-28 | UCB Pharma | Regulatory U.S. FDA Approves FINTEPLA[®] ▼(fenfluramine) Oral Solution for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS) ucb.com ↗
FINTEPLA ® (fenfluramine) oral solution CIV has been approved in the United States, by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. |
All press releases naming this drug 16 releases
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fenfluramine | “This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered...” NCT03467113 ↗24“ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride.” NCT03355209 ↗ “Fenfluramine” NCT07112365 ↗ |
| Known as | Acino | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | AHR-3002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Brabafen | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Dl-fenfluramine hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Fenfluramin | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Fenfluramina | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | fenfluramine HCl | “A pilot, open-label study of the effectiveness and tolerability of low-dose ZX008 (fenfluramine HCl) in Lennox-Gastaut syndrome.” PMID 30146701 ↗ Aug 20181“Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study” NCT06679413 ↗ |
| Known as | Fenfluramine Hydrochloride | “Participants will receive fenfluramine hydrochloride for 14 weeks in a double-blind period (including titration and maintenance), followed by a 2-week double-blind transition period.” NCT07503444 ↗10“The active ingredient, fenfluramine hydrochloride, is designated chemically as N-ethyl-α- methyl-3-(trifluoromethyl) phenethylamine hydrochloride.” NCT05560282 ↗ “ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride.” NCT03355209 ↗ “ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride.” NCT03467113 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02926898 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT03936777 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT03299842 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02682927 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02823145 ↗ “Drug: Fenfluramine Hydrochloride” NCT03861871 ↗ |
| Known as | Fenfluramine Hydrochloride (ZX008) | “Fenfluramine Hydrochloride (ZX008)” NCT05026398 ↗ |
| Known as | Fenfluramine Hydrochloride HCl | “ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution” NCT02823145 ↗ |
| Known as | FFA | “To assess the impact of fenfluramine (FFA) on the expected mortality incidence, including sudden unexpected death in epilepsy (SUDEP), in persons with Dravet syndrome (DS).” PMID 34768178 ↗ Nov 20212“Fenfluramine (FFA), an antiseizure medication (ASM) indicated for treating convulsive seizures in Dravet syndrome, was assessed in six patients” PMID 33979451 ↗ May 2021 “fenfluramine (FFA)” PMID 40072476 ↗ Mar 2025 |
| Known as | Fintepla | “Fenfluramine treatment (Fintepla)” NCT07112365 ↗ |
| Known as | Ganal | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | HHR-965 | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | J5.760F | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Obedrex | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Pesos | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Phenfluramine | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Ponderax | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Ponderax pa | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Ponderax pacaps | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Rotondin | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | S-768 | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | Z-008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL87493 ↗ |
| Known as | ZX008 | “This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered...” NCT03467113 ↗8“A pilot, open-label study of the effectiveness and tolerability of low-dose ZX008 (fenfluramine HCl) in Lennox-Gastaut syndrome.” PMID 30146701 ↗ Aug 2018 “Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study” NCT06679413 ↗ “ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride.” NCT03355209 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02823145 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02926898 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT03936777 ↗ “ZX008 (Fenfluramine Hydrochloride)” NCT02682927 ↗ “Fenfluramine Hydrochloride (ZX008)” NCT03790137 ↗ |
| Action | Activate | “Fenfluramine is both a serotonin releasing agent and sigma-1 receptor agonist.” NCT05026398 ↗2“Serotonin 1d (5-HT1d) receptor agonist” CHEMBL87493 ↗ “Serotonin 2c (5-HT2c) receptor agonist” CHEMBL87493 ↗ |
| Action | Inhibit | “Sigma opioid receptor antagonist” CHEMBL87493 ↗ |
| Modality | Small molecule | — CHEMBL87493 ↗ |
| Route | Oral | “fenfluramine HCl oral solution” PMID 30146701 ↗ Aug 2018 |
| Target | HTR1D | “Serotonin 1d (5-HT1d) receptor agonist” CHEMBL87493 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor agonist” CHEMBL87493 ↗ |
| Target | SIGMAR1 | “Sigma opioid receptor antagonist” CHEMBL87493 ↗ |