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
Therapeutic Areas
Trade Name
FDA
EMA
Fintepla
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fintepla | New Drug Application | 2023-12-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| obesity | EFO_0001073 | D009765 | E66.9 |
| bulimia | — | D002032 | F50.2 |
| autistic disorder | HP_0000717 | D001321 | F84.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FENFLURAMINE HYDROCHLORIDE, FINTEPLA, UCB 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 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fenfluramine Hydrochloride, Fintepla, Ucb 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 | |
| 11759440 | 2037-08-02 | U-3694 | |
| 11786487 | 2037-08-02 | U-3733 | |
| 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
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Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | — | 9 | 1 | 2 | 13 |
| Myoclonic epilepsies | D004831 | HP_0002123 | G40.4 | 1 | — | 8 | 1 | 2 | 12 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | 3 | 1 | — | 5 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | 1 | 1 | — | 2 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | — | 1 |
| Malformations of cortical development | D054220 | — | — | — | — | — | 1 | — | 1 |
| Drug resistant epilepsy | D000069279 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lennox gastaut syndrome | D065768 | — | G40.81 | 1 | 1 | 3 | — | — | 5 |
| Seizures | D012640 | HP_0002069 | G40.4 | — | — | 3 | — | — | 3 |
| Reflex epilepsy | D020195 | EFO_1001146 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 1 | 1 | — | — | — | 2 |
| Spasm | D013035 | — | M62.83 | — | 1 | — | — | — | 1 |
| Infantile spasms | D013036 | HP_0011097 | 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 Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
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
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Variants
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Financial
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Fintepla – Zogenix
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Estimated US medical usage
Fenfluramine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 7,231 documents
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Safety
Black-box Warning
Black-box warning for: Fintepla
Adverse Events
Top Adverse Reactions
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2,431 adverse events reported
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