Fluphenazine - PharmaKB

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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Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
mental disorders	D001523

Trade Name

FDA

EMA

Fluphenazine (discontinued: Fluphenazine, Permitil, Prolixin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Fluphenazine hydrochloride

Tradename	Company	Number	Date	Products
PROLIXIN	Bristol Myers Squibb	N-012145 DISCN	1982-01-01	1 products, RLD
PROLIXIN	Bristol Myers Squibb	N-011751 DISCN	1982-01-01	5 products
PERMITIL	Merck & Co	N-016008 DISCN	1982-01-01	1 products
PERMITIL	Merck & Co	N-012419 DISCN	1982-01-01	1 products
PERMITIL	Merck & Co	N-012034 DISCN	1982-01-01	4 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
fluphenazine decanoate	ANDA	2025-11-07
fluphenazine hydrochloride	ANDA	2026-01-29
fluphenazine hydrochoride	ANDA	2025-10-08

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

ATC Codes

N: Nervous system drugs

— N05: Psycholeptics

— N05A: Antipsychotics

— N05AB: Phenothiazines with piperazine structure, antipsychotics

— N05AB02: Fluphenazine

HCPCS

Code	Description
J2680	Injection, fluphenazine decanoate, up to 25 mg

Clinical

Clinical Trials

18 clinical trials

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Indications Phases 4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vomiting	D014839	—	R11.1	—	—	1	—	—	1

Indications Phases 2

No data

Indications Phases 1

No data

Indications Without Phase

No data

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

Agency Approved

DRD2

Organism

Homo sapiens

Gene name

DRD2

Gene synonyms

NCBI Gene ID

1813

Protein name

D(2) dopamine receptor

Protein synonyms

Dopamine D2 receptor, seven transmembrane helix receptor

Uniprot ID

Q9UPA9

Mouse ortholog

Drd2 (13489)

D(2) dopamine receptor (Q0VGH9)

Alternate

DRD1

HTR2A

HTR7

DRD5

HTR6

HRH1

Organism

Homo sapiens

Gene name

DRD1

Gene synonyms

NCBI Gene ID

1812

Protein name

D(1A) dopamine receptor

Protein synonyms

Dopamine D1 receptor

Uniprot ID

Q4QRJ0

Mouse ortholog

Drd1 (13488)

D(1A) dopamine receptor (Q8C8P8)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Fluphenazine

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 4,673 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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1,512 adverse events reported

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