2 approved for marketing, 2 completed, 2 recruiting, 1 active not recruiting. 3 Phase 3, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Active not recruiting 1, Completed 1, Recruiting 1 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
| Not applicable | 1 | Not yet recruiting 1 |
Follow fenfluramine hydrochloride: new trials by email Literature Review of fenfluramine hydrochloride trials Research Report on fenfluramine hydrochloride
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome fenfluramine hydrochloride, Placebo - Rett Syndrome | Phase 3 | Recruiting | UCB BIOSCIENCES, Inc. | 200 | 2026-07-14 | 2026-10-15 |
| Using Fenfluramine to Test the Serotonin Deficiency Theory of Depression Fenfluramine Hydrochloride, [11C]Cimbi-36, Placebo - Depression - Major Depressive Disorder | Not applicable | Not yet recruiting | Imperial College Healthcare NHS Trust | 46 | 2026-07-01 | 2026-06-16 |
| Treatment of Refractory Infantile Spasms With Fenfluramine Fenfluramine - Infantile Spasm | Phase 2 | Recruiting | Children's Hospital of Orange County | 10 | 2023-06-16 | 2026-04-15 |
| A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. Fenfluramine, Placebo - CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure | Phase 3 | Active not recruiting | Zogenix, Inc. | 87 | 2022-03-08 | 2026-04-29 |
| Fenfluramine in CDKL5 Deficiency Disorder (CDD) Fenfluramine Hydrochloride - CDD | Phase 2 | Completed | NYU Langone Health | 7 | 2019-10-29 | 2023-10-04 |
| Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25). Fenfluramine Hydrochloride - Photosensitive Epilepsy | Phase 3 | Completed | Elizabeth Anne Thiele | 20 | 2019-05-31 | 2024-11-06 |
| Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) Fenfluramine - Dravet Syndrome | Approved for marketing | University of California, Los Angeles | 2026-04-20 | |||
| ZX008 Expanded Access Protocol Fenfluramine Hydrochloride - Dravet Syndrome | Approved for marketing | Zogenix, Inc. | 2023-10-24 |
Epilepsies, Myoclonic (2) · Spasms, Infantile (2) · CDKL5 deficiency disorder (1) · Depressive Disorder, Major (1) · Epilepsy (1) · Epilepsy, Reflex (1) · Epilepsy, Tonic-Clonic (1) · Rett Syndrome (1) · Seizures (1)
Zogenix, Inc. (2) · Children's Hospital of Orange County (1) · Elizabeth Anne Thiele (1) · Imperial College Healthcare NHS Trust (1) · NYU Langone Health (1) · UCB BIOSCIENCES, Inc. (1) · University of California, Los Angeles (1)
United States (6) · Belgium (2) · Georgia (2) · Germany (2) · Italy (2) · Japan (2) · Spain (2) · United Kingdom (2) · Austria (1) · France (1) · Hungary (1) · Ireland (1) · Israel (1) · Netherlands (1) · Poland (1)
Daniel Shrey, MD (1) · David Nutt, Professor (1) · Elizabeth Thiele, M.D., Ph.D. (1) · Orrin Devinsky, MD (1) · Phillip Cowen, Professor (1)
PMID 33979451, PMID 34768178, PMID 36562419
2023 (1), 2025 (1)