Fluphenazine decanoate
Fluphenazine (fluphenazine decanoate) is a small molecule pharmaceutical. Fluphenazine decanoate was first approved as Prolixin decanoate on 1982-01-01. It is used to treat psychotic disorders and schizophrenia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Fluphenazine decanoate (discontinued: Fluphenazine decanoate, Prolixin decanoate)
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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluphenazine decanoate | ANDA | 2025-03-20 |
| fluphenazine hydrochloride | ANDA | 2025-02-21 |
| fluphenazine hydrochoride | ANDA | 2024-12-13 |
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 | — | R11.1 | — | — | 1 | — | — | 1 |
| Nausea | D009325 | — | 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 | — | — | 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 | — | F30 | — | — | — | — | 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 decanoate |
| INN | — |
| 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) | CCCCCCCCCC(=O)OCCN1CCN(CCCN2c3ccccc3Sc3ccc(C(F)(F)F)cc32)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 69-23-8 |
| RxCUI | 4496 |
| ChEMBL ID | CHEMBL1200854 |
| ChEBI ID | — |
| PubChem CID | 3372 |
| DrugBank | DB00623 |
| UNII ID | — |
Target
No data
Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,447 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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1,466 adverse events reported
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