Fluphenazine
Fluphenazine (fluphenazine) is a small molecule pharmaceutical. Fluphenazine was first approved as Prolixin decanoate on 1982-01-01. It is used to treat psychotic disorders and schizophrenia in the USA. The pharmaceutical is active against D(2) dopamine receptor. In addition, it is known to target D(1A) dopamine receptor, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 7, D(1B) dopamine receptor, 5-hydroxytryptamine receptor 6, and histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluphenazine decanoate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROLIXIN DECANOATE | Bristol Myers Squibb | N-016727 DISCN | 1982-01-01 | 1 products, RLD |
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Fluphenazine enanthate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROLIXIN ENANTHATE | Bristol Myers Squibb | N-016110 DISCN | 1982-01-01 | 1 products |
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Fluphenazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROLIXIN | Bristol Myers Squibb | N-011751 DISCN | 1982-01-01 | 5 products |
| PROLIXIN | Bristol Myers Squibb | N-012145 DISCN | 1982-01-01 | 1 products, RLD |
| PERMITIL | Merck & Co | N-012034 DISCN | 1982-01-01 | 4 products |
| PERMITIL | Merck & Co | N-012419 DISCN | 1982-01-01 | 1 products |
| PERMITIL | Merck & Co | N-016008 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluphenazine decanoate | ANDA | 2023-11-15 |
| fluphenazine hydrochloride | ANDA | 2024-10-01 |
| fluphenazine hydrochoride | ANDA | 2024-06-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| schizophrenia | EFO_0000692 | D012559 | F20 |
| psychotic disorders | — | D011618 | F20.81 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2680 | Injection, fluphenazine decanoate, up to 25 mg |
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | 2 | 4 | 3 | 10 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | — | 1 | 2 | 3 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | 1 | — | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | 1 | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 1 | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 1 | — | — | — | 2 |
| Gambling | D005715 | EFO_1001926 | F63.0 | — | 1 | — | — | — | 1 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Body weight | D001835 | EFO_0004338 | — | 1 | — | — | — | — | 1 |
| Weight gain | D015430 | HP_0004324 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Mania | D000087122 | — | — | — | — | — | — | 1 | 1 |
| Breast feeding | D001942 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluphenazine |
| INN | fluphenazine |
| Description | Fluphenazine is a member of the class of phenothiazines that is 10H-phenothiazine having a trifluoromethyl subsitituent at the 2-position and a 3-[4-(2-hydroxyethyl)piperazin-1-yl]propyl group at the N-10 position. It has a role as a phenothiazine antipsychotic drug, a dopaminergic antagonist and an anticoronaviral agent. It is an organofluorine compound, a member of phenothiazines and a N-alkylpiperazine. It derives from a hydride of a 10H-phenothiazine. |
| Classification | Small molecule |
| Drug class | Typical antipsychotic |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | OCCN1CCN(CCCN2c3ccccc3Sc3ccc(C(F)(F)F)cc32)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 69-23-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL726 |
| ChEBI ID | 5123 |
| PubChem CID | 3372 |
| DrugBank | DB00623 |
| UNII ID | S79426A41Z (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Fluphenazine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 4,267 documents
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Safety
Black-box Warning
Black-box warning for: Fluphenazine decanoate, Fluphenazine hydrochloride, Fluphenazine hydrochoride
Adverse Events
Top Adverse Reactions
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1,388 adverse events reported
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