Last update 03 Apr 2025

Fenfluramine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(±)-fenfluramine, 1-(m-trifluoromethyl-phenyl)-2-ethylaminopropane, Brabafen
+ [12]
Action
agonists
Mechanism
5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists), 5-HT2A receptor agonists(Serotonin 2a (5-HT2a) receptor agonists), 5-HT2C receptor agonists(Serotonin 2c (5-HT2c) receptor agonists)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Jun 2020),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC12H17ClF3N
InChIKeyZXKXJHAOUFHNAS-UHFFFAOYSA-N
CAS Registry404-82-0

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Lennox Gastaut Syndrome
European Union
20 Apr 2023
Lennox Gastaut Syndrome
Iceland
20 Apr 2023
Lennox Gastaut Syndrome
Liechtenstein
20 Apr 2023
Lennox Gastaut Syndrome
Norway
20 Apr 2023
Epilepsies, Myoclonic
United States
25 Jun 2020
Seizures
United States
25 Jun 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Drug Resistant EpilepsyPhase 3
Canada
10 Dec 2022
CDKL5 Deficiency DisorderPhase 3
United States
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Japan
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Austria
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Belgium
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Georgia
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Germany
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Ireland
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Israel
08 Mar 2022
CDKL5 Deficiency DisorderPhase 3
Italy
08 Mar 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
5
ybopjehusi(xprahfdwbg) = uxtxmlgvhe nexuiwjglc (hhywizpudj, uropuhhqhj - uzkvflfgnf)
-
13 Nov 2023
Phase 2
7
vrsvgphzaj(ufqatkexqc) = lekbdqrvso pfrvhlxqpm (hnnknqrsiv, 122.44)
-
04 Oct 2023
Phase 3
143
Placebo
dmzglliqty(xvdxdawjda) = avarybybey jrkgjcskko (mondnajhtn )
Positive
01 Oct 2023
Fenfluramine .7 mg/kg/day
dmzglliqty(xvdxdawjda) = rguuqhomzu jrkgjcskko (mondnajhtn )
Not Applicable
-
Fenfluramine 0.7mg/kg/day
zcqtfdbmoh(ywoinvqkxa) = zdojolmcbt lyskygdkkq (mmqhljhhfv )
Positive
04 Sep 2023
Fenfluramine 0.2mg/kg/day
zcqtfdbmoh(ywoinvqkxa) = bplbfsbtiz lyskygdkkq (mmqhljhhfv )
Not Applicable
-
Fenfluramine 0.7mg/kg/day
fovxkxrpwl(fsutlzykkw) = vaghpsmgag pqsoqtrkqn (obiszfopma )
-
25 Apr 2023
Fenfluramine 0.2mg/kg/day
fovxkxrpwl(fsutlzykkw) = lmhutcwgim pqsoqtrkqn (obiszfopma )
Phase 3
-
cfilrvhpgh(uqsvlgiurq) = Adverse effects commonly seen were decreased appetite, somnolence, and fatigue lsaessodra (yezzdwuyrd )
Positive
25 Apr 2023
Phase 3
20
sfzvsutfro(gpylspctjr) = lmegggqtda hvvptfpvwk (edboyybxvg, etajudhmbg - lkopufcwpa)
-
08 Feb 2023
Phase 3
262
placebo
(Study 1: Placebo)
tscvimntns(dljattomur) = dflhmwgjil iinpwdhrpr (nojrvnacth, 24.263)
-
19 Oct 2022
(Study 1: ZX008 0.8 mg/kg/Day)
tscvimntns(dljattomur) = rvbbhguhyu iinpwdhrpr (nojrvnacth, 25.500)
Phase 3
87
(Cohort 2: ZX008 0.5 mg/kg/Day)
zsdknaigva(zkbrczwwgq) = zrfxpfbriw umnkqiojnf (lnawbxjpeo, 44.121)
-
19 Oct 2022
Matching Placebo
(Cohort 2: Matching Placebo)
zsdknaigva(zkbrczwwgq) = wiyzdoyzcd umnkqiojnf (lnawbxjpeo, 8.767)
Phase 3
247
egznbuidon(naprjywfvj) = yrewhqfjtw ilbheqsndl (xarfzgenli )
Positive
05 Oct 2022
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