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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Commercial
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 |
---|---|---|---|---|
FINTEPLA | Zogenix | N-212102 RX | 2020-06-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
fintepla | New Drug Application | 2020-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
autistic disorder | EFO_0003758 | D001321 | F84.0 |
bulimia | — | D002032 | F50.2 |
obesity | EFO_0001073 | D009765 | E66.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
FENFLURAMINE HYDROCHLORIDE, FINTEPLA, ZOGENIX INC | |||
2029-09-25 | PED | ||
2029-03-25 | ODE-393 | ||
2027-12-25 | PED | ||
2027-06-25 | ODE-312 | ||
2025-09-25 | PED | ||
2025-03-25 | I-887 | ||
2023-12-25 | PED | ||
2023-06-25 | NP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Fenfluramine Hydrochloride, Fintepla, Zogenix Inc | |||
10452815 | 2038-06-29 | U-2859 | |
10603290 | 2037-08-02 | U-2861, U-3347 | |
11040018 | 2037-08-02 | U-2861, U-3347 | |
11406606 | 2037-08-02 | U-3406, U-3407 | |
10947183 | 2036-12-20 | DS, DP | |
9549909 | 2033-05-03 | U-2858 | |
9603814 | 2033-05-03 | U-2858 | |
9603815 | 2033-05-03 | U-2858 | |
9610260 | 2033-05-03 | U-2858 | |
10478441 | 2033-05-03 | U-2860 | |
10478442 | 2033-05-03 | U-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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | 1 | 1 | — | 3 |
Cognition | D003071 | EFO_0003925 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myoclonic epilepsies | D004831 | EFO_1001900 | G40.4 | 1 | 1 | 6 | — | 2 | 9 |
Lennox gastaut syndrome | D065768 | G40.81 | 1 | 2 | 2 | — | — | 4 | |
Reflex epilepsy | D020195 | EFO_1001146 | — | — | 1 | — | — | 1 | |
Seizures | D012640 | G40.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infantile spasms | D013036 | EFO_1000643 | G40.82 | — | 1 | — | — | — | 1 |
Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | — | 1 |
Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | FENFLURAMINE |
INN | fenfluramine |
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-ID | 458-24-2 |
RxCUI | — |
ChEMBL ID | CHEMBL87493 |
ChEBI ID | 5000 |
PubChem CID | 3337 |
DrugBank | DB00574 |
UNII ID | 2DS058H2CF (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Variants
Clinical Variant
No data
Financial
Fintepla - Zogenix
$
€
£
₣
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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
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618 adverse events reported
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