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Fintepla(fenfluramine)
Fintepla (fenfluramine) is a small molecule pharmaceutical. Fenfluramine was first approved as Fintepla on 2020-06-25. It is used to treat autistic disorder, bulimia, and obesity in the USA. It has been approved in Europe to treat myoclonic epilepsies. It is known to target tryptophan 5-hydroxylase 2 and tryptophan 5-hydroxylase 1.
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SARS-CoV-2 Interaction
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Fintepla
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fenfluramine hydrochloride
Tradename
Company
Number
Date
Products
FINTEPLAZogenixN-212102 RX2020-06-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
finteplaNew Drug Application2020-07-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
autistic disorderEFO_0003758D001321F84.0
bulimia—D002032F50.2
obesityEFO_0001073D009765E66.9
Agency Specific
FDA
EMA
Expiration
Code
FENFLURAMINE HYDROCHLORIDE, FINTEPLA, ZOGENIX INC
2029-09-25PED
2029-03-25ODE-393
2027-12-25PED
2027-06-25ODE-312
2025-09-25PED
2025-03-25I-887
2023-12-25PED
2023-06-25NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Fenfluramine Hydrochloride, Fintepla, Zogenix Inc
104528152038-06-29U-2859
106032902037-08-02U-2861, U-3347
110400182037-08-02U-2861, U-3347
114066062037-08-02U-3406, U-3407
109471832036-12-20DS, DP
95499092033-05-03U-2858
96038142033-05-03U-2858
96038152033-05-03U-2858
96102602033-05-03U-2858
104784412033-05-03U-2860
104784422033-05-03U-2860
ATC Codes
A: Alimentary tract and metabolism drugs
— A08: Antiobesity preparations, excl. diet products
— A08A: Antiobesity preparations, excl. diet products
— A08AA: Centrally acting antiobesity products
— A08AA02: Fenfluramine
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX26: Fenfluramine
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9—111—3
CognitionD003071EFO_0003925———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myoclonic epilepsiesD004831EFO_1001900G40.4116—29
Lennox gastaut syndromeD065768G40.81122——4
Reflex epilepsyD020195EFO_1001146——1——1
SeizuresD012640G40.4——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Infantile spasmsD013036EFO_1000643G40.82—1———1
ObesityD009765EFO_0001073E66.9—1———1
Vascular diseasesD014652EFO_0004264I77—1———1
Heart diseasesD006331EFO_0003777I51.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F141————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFENFLURAMINE
INNfenfluramine
Description
Fenfluramine is a secondary amino compound that is 1-phenyl-propan-2-amine in which one of the meta-hydrogens is substituted by trifluoromethyl, and one of the hydrogens attached to the nitrogen is substituted by an ethyl group. It binds to the serotonin reuptake pump, causing inhbition of serotonin uptake and release of serotonin. The resulting increased levels of serotonin lead to greater serotonin receptor activation which in turn lead to enhancement of serotoninergic transmission in the centres of feeding behavior located in the hypothalamus. This suppresses the appetite for carbohydrates. Fenfluramine was used as the hydrochloride for treatment of diabetes and obesity. It was withdrawn worldwide after reports of heart valve disease and pulmonary hypertension. It has a role as a serotonin uptake inhibitor, a serotonergic agonist and an appetite depressant. It is a secondary amino compound and a member of (trifluoromethyl)benzenes.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCNC(C)Cc1cccc(C(F)(F)F)c1
Identifiers
PDB—
CAS-ID458-24-2
RxCUI—
ChEMBL IDCHEMBL87493
ChEBI ID5000
PubChem CID3337
DrugBankDB00574
UNII ID2DS058H2CF (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
TPH2
TPH2
TPH1
TPH1
Organism
Homo sapiens
Gene name
TPH2
Gene synonyms
NTPH
NCBI Gene ID
121278
Protein name
tryptophan 5-hydroxylase 2
Protein synonyms
Neuronal tryptophan hydroxylase, Tryptophan 5-monooxygenase 2
Uniprot ID
Q8IWU9
Mouse ortholog
Tph2 (216343)
tryptophan 5-hydroxylase 2 (Q8CGV2)
Variants
Clinical Variant
No data
Financial
Fintepla - Zogenix
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,131 documents
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Safety
Black-box Warning
Black-box warning for: Fintepla
Adverse Events
Top Adverse Reactions
Mock data
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618 adverse events reported
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