drug · small molecule
fenfluramine hydrochloride
Marketedupdated 3mo agoby UCB SA🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 2 investigational indications.
targets
5-hydroxytryptamine receptor 2CSigma non-opioid intracellular receptor 15-hydroxytryptamine receptor 1D
all catalysts(11)
approval · 11
Jun 25, 2020
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Mar 25, 2022
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Jun 15, 2022
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Jan 3, 2023
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
May 30, 2023
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Sep 14, 2023
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Sep 14, 2023
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Dec 11, 2023
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Apr 2, 2024
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Apr 8, 2025
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Oct 15, 2025
approval
FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approval
fenfluramine hydrochloride
→
Trials studying fenfluramine hydrochloride
- phase3A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
- phase3A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
- phase3An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
- phase3Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).
- phase3A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
- —ZX008 Expanded Access Protocol
- phase3A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 25, 2027
318 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (27)
- Dec 29, 2038patentUS 10452815*PED
- Feb 2, 2038patentUS 10603290*PED
- Feb 2, 2038patentUS 11040018*PED
- Feb 2, 2038patentUS 11406606*PED
- Feb 2, 2038patentUS 11759440*PED
- Feb 2, 2038patentUS 11786487*PED
- Aug 2, 2037method-of-use (U-3347)US 10603290
- Aug 2, 2037method-of-use (U-3347)US 11040018
- Aug 2, 2037method-of-use (U-3407)US 11406606
- Aug 2, 2037method-of-use (U-3694)US 11759440
- Aug 2, 2037method-of-use (U-3733)US 11786487
- Jun 20, 2037patentUS 10947183*PED
- Dec 20, 2036compositionUS 10947183
- Nov 3, 2033patentUS 10478441*PED
- Nov 3, 2033patentUS 10478442*PED
- Nov 3, 2033patentUS 12097206*PED
- Nov 3, 2033patentUS 9549909*PED
- Nov 3, 2033patentUS 9603814*PED
- Nov 3, 2033patentUS 9603815*PED
- Nov 3, 2033patentUS 9610260*PED
- May 3, 2033method-of-use (U-2860)US 10478441
- May 3, 2033method-of-use (U-2860)US 10478442
- May 3, 2033method-of-use (U-4013)US 12097206
- May 3, 2033method-of-use (U-2858)US 9549909
- May 3, 2033method-of-use (U-2858)US 9603814
- May 3, 2033method-of-use (U-2858)US 9603815
- May 3, 2033method-of-use (U-2858)US 9610260
FDA exclusivities (4)
- Sep 25, 2029PEDPediatric (6mo bonus)3.1y
- Mar 25, 2029ODE-393Orphan Drug (7y)2.6y
- Dec 25, 2027PEDPediatric (6mo bonus)1.4y
- Jun 25, 2027ODE-312Orphan Drug (7y)318d
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