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fenfluramine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
anorexics	1150	458-24-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fenfluramine DL-Fenfluramine fenfluramine hydrochloride fenfluramine HCl pondimin fintepla	A centrally active drug that apparently both blocks serotonin uptake and provokes transport-mediated serotonin release. The mechanisms by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome are unknown. Fenfluramine and the metabolite, norfenfluramine, increase extracellular levels of serotonin through interaction with serotonin transporter proteins, and exhibit agonist activity at serotonin 5HT-2 receptors. Molecular weight: 231.26 Formula: C12H16F3N CLOGP: 3.30 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 12.03 ALOGS: -4.03 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fenfluramine
DL-Fenfluramine
fenfluramine hydrochloride
fenfluramine HCl
pondimin
fintepla

A centrally active drug that apparently both blocks serotonin uptake and provokes transport-mediated serotonin release. The mechanisms by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome are unknown. Fenfluramine and the metabolite, norfenfluramine, increase extracellular levels of serotonin through interaction with serotonin transporter proteins, and exhibit agonist activity at serotonin 5HT-2 receptors.

Molecular weight: 231.26
Formula: C12H16F3N
CLOGP: 3.30
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 12.03
ALOGS: -4.03
ROTB: 5

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.12	g	O
8	mg	O

ADMET properties:

None

Approvals:

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Date	Agency	Company
Dec. 18, 2020	EMA	UCB PHARMA S.A.
June 25, 2020	FDA	UCB INC
Sept. 26, 2022	PMDA	UCB JAPAN CO., LTD.

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	133.20	76.18	42	294	132592	63356094

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	131.76	71.38	43	229	104814	34851845
Echocardiogram abnormal	83.00	71.38	13	259	1050	34955609

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	214.24	66.63	69	454	188765	79555100
Echocardiogram abnormal	117.60	66.63	19	504	2209	79741656

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A08AA02	ALIMENTARY TRACT AND METABOLISM ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Centrally acting antiobesity products
ATC	N03AX26	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics
CHEBI has role	CHEBI:35941	serotonin agonists
CHEBI has role	CHEBI:50949	SSRI
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D014179	Neurotransmitter Uptake Inhibitors
MeSH PA	D017367	Selective Serotonin Reuptake Inhibitors
MeSH PA	D018490	Serotonin Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Seizures associated with Dravet syndrome	indication	230437002
Dravet syndrome	indication	230437002
Obesity	indication	414916001	DOID:9970
Alcoholism	contraindication	7200002
Glaucoma	contraindication	23986001	DOID:1686
Hypertensive disorder	contraindication	38341003	DOID:10763
Diabetes mellitus type 2	contraindication	44054006	DOID:9352
Diabetes mellitus type 1	contraindication	46635009	DOID:9744
Pulmonary hypertension	contraindication	70995007	DOID:6432

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.22	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	10478441	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	10478442	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	9549909	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	9603814	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	9603815	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	9610260	May 3, 2033	USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	10603290	Aug. 2, 2037	USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	10603290	Aug. 2, 2037	USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	11040018	Aug. 2, 2037	USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	11040018	Aug. 2, 2037	USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	June 25, 2023	NEW PRODUCT
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	Dec. 25, 2023	PEDIATRIC EXCLUSIVITY
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	March 25, 2025	INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	Sept. 25, 2025	PEDIATRIC EXCLUSIVITY
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	June 25, 2027	INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	Dec. 25, 2027	PEDIATRIC EXCLUSIVITY
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	March 25, 2029	TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER
EQ 2.2MG BASE/ML	FINTEPLA	UCB INC	N212102	June 25, 2020	RX	SOLUTION	ORAL	Sept. 25, 2029	PEDIATRIC EXCLUSIVITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN	Ki	5.17	PDSP
Beta-1 adrenergic receptor	GPCR	P08588	ADRB1_HUMAN	Ki	6.00	PDSP
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	Ki	5.11	PDSP
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	Ki	6.43	PDSP
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN	Ki	6.18	PDSP
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN	Ki	6.17	PDSP
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	Ki	5.85	PDSP
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN	Ki	6.40	PDSP
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	Ki	5.79	PDSP
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN	Ki	5.04	PDSP

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External reference:

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ID	Source
001873	NDDF
004776	NDDF
1596	INN_ID
1756	MMSL
202366	RXNORM
2DS058H2CF	UNII
3337	PUBCHEM_CID
335891	MMSL
38581	MMSL
387262004	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FINTEPLA	HUMAN PRESCRIPTION DRUG LABEL	1	43376-322	SOLUTION	2.20 mg	ORAL	NDA	36 sections
FINTEPLA	HUMAN PRESCRIPTION DRUG LABEL	1	43376-322	SOLUTION	2.20 mg	ORAL	NDA	36 sections
FINTEPLA	HUMAN PRESCRIPTION DRUG LABEL	1	43376-322	SOLUTION	2.20 mg	ORAL	NDA	36 sections
FINTEPLA	HUMAN PRESCRIPTION DRUG LABEL	1	43376-322	SOLUTION	2.20 mg	ORAL	NDA	36 sections

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