Pentazocine - PharmaKB

Pentazocine

Naloxone / Pentazocine, Talacen, Talwin (pentazocine) is a small molecule pharmaceutical. Pentazocine was first approved as Talwin compound on 1982-01-01. It is used to treat pain in the USA. The pharmaceutical is active against sigma non-opioid intracellular receptor 1. In addition, it is known to target delta-type opioid receptor, mu-type opioid receptor, and kappa-type opioid receptor.

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Commercial

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
signs and symptoms pathological conditions	D013568
psychological phenomena	D011579
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Combinations

Naloxone pentazocine (discontinued: Acetaminophen pentazocine, Talacen, Talwin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Acetaminophen

Pentazocine hydrochloride

Tradename	Company	Number	Date	Products
TALACEN	Sanofi	N-018458 DISCN	1982-09-23	1 products

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Aspirin

Pentazocine hydrochloride

Tradename	Company	Number	Date	Products
TALWIN COMPOUND	Sanofi	N-016891 DISCN	1982-01-01	1 products, RLD

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Naloxone hydrochloride

Pentazocine hydrochloride

Tradename	Company	Number	Date	Products
TALWIN NX	Sanofi	N-018733 DISCN	1982-12-16	1 products

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Pentazocine hydrochloride

Tradename	Company	Number	Date	Products
TALWIN 50	Sanofi	N-016732 DISCN	1982-01-01	1 products

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Pentazocine lactate

Tradename	Company	Number	Date	Products
TALWIN	Hospira	N-016194 DISCN	1982-01-01	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
pentazocine and naloxone	ANDA	2024-04-30
pentazocine hcl and acetaminophen	ANDA	2010-11-10
pentazocine hcl and naloxone hcl	ANDA	2010-06-21
pentazocine hydrochloride and acetaminophen	ANDA	2011-07-12
pentazocine hydrochloride and naloxone hydrochloride	ANDA	2025-08-28

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
septic shock	—	D012772	A48.3
pain	EFO_0003843	D010146	R52
opioid-related disorders	EFO_0005611	D009293	F11
respiration disorders	—	D012120	J00-J99
fever	—	D005334	R50.9
rheumatoid arthritis	EFO_0000685	D001172	M06.9
inflammation	MP_0001845	D007249	—
osteoarthritis	EFO_0002506	D010003	M15-M19
rheumatic fever	EFO_1001160	D012213	I00-I02
gout	EFO_0004274	D006073	M10

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

N: Nervous system drugs

— N02: Analgesics

— N02A: Opioid analgesics

— N02AD: Benzomorphan derivative analgesics

— N02AD01: Pentazocine

HCPCS

Code	Description
J3070	Injection, pentazocine, 30 mg

Clinical

Clinical Trials

15 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pain	D010146	EFO_0003843	R52	—	—	—	3	—	3
Postoperative pain	D010149	—	G89.18	—	—	—	1	—	1
Anesthesia	D000758	—	—	—	—	—	1	—	1
Induced abortion	D000028	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ebola hemorrhagic fever	D019142	EFO_0007243	A98.4	—	1	1	—	—	1
Virus diseases	D014777	—	B34	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bipolar disorder	D001714	EFO_0000289	F30.9	—	2	—	—	—	2
Mania	D000087122	—	F30	—	1	—	—	—	1
Psychotic disorders	D011618	—	F20.81	—	1	—	—	—	1
Substance withdrawal syndrome	D013375	EFO_0005800	—	1	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hot flashes	D019584	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Labor pain	D048949	—	—	—	—	—	—	1	1
Postoperative period	D011184	—	—	—	—	—	—	1	1
Analgesia	D000698	—	—	—	—	—	—	1	1
Agnosia	D000377	EFO_0007136	F88	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Pentazocine
INN	pentazocine
Description	Pentazocine is a benzazocine.
Classification	Small molecule
Drug class	narcotic antagonists/agonists (6,7-benzomorphan derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)=CCN1CCC2(C)c3cc(O)ccc3CC1C2C

Identifiers

PDB	—
CAS-ID	359-83-1
RxCUI	—
ChEMBL ID	CHEMBL100116
ChEBI ID	—
PubChem CID	441278
DrugBank	DB00652
UNII ID	768DQ5A5AI (ChemIDplus, GSRS)

Target

Agency Approved

SIGMAR1

Organism

Homo sapiens

Gene name

SIGMAR1

Gene synonyms

OPRS1, SRBP

NCBI Gene ID

10280

Protein name

sigma non-opioid intracellular receptor 1

Protein synonyms

Aging-associated gene 8 protein, hSigmaR1, SIG-1R, Sigma 1-type opioid receptor, Sigma1-receptor, Sigma1R, SR-BP, SR31747 binding protein 1, SR31747-binding protein

Uniprot ID

Q99720

Mouse ortholog

Sigmar1 (18391)

sigma non-opioid intracellular receptor 1 (O55242)

Alternate

OPRM1

Organism

Homo sapiens

Gene name

OPRM1

Gene synonyms

MOR1

NCBI Gene ID

4988

Protein name

mu-type opioid receptor

Protein synonyms

hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a

Uniprot ID

Q9UN57

Mouse ortholog

Oprm1 (18390)

mu-type opioid receptor (P42866)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Pentazocine

Acetaminophen

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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Price per prescription (USD)

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Pentazocine

Naloxone

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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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 4,545 documents

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Safety

Black-box Warning

Black-box warning for: Pentazocine and naloxone, Pentazocine hydrochloride and naloxone hydrochloride

Adverse Events

Top Adverse Reactions

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1,430 adverse events reported

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