Propranolol - PharmaKB

Inderal, Hemangiol(propranolol)

Hemangeol, Hemangiol, Inderal, Inderide, Inderide-, Innopran, Propranolol (propranolol) is a small molecule pharmaceutical. Propranolol was first approved as Inderide-40/25 on 1982-01-01. It is used to treat angina pectoris, esophageal and gastric varices, essential tremor, heart failure, and hypertension amongst others in the USA. It has been approved in Europe to treat hemangioma. The pharmaceutical is active against beta-1 adrenergic receptor, beta-2 adrenergic receptor, and beta-3 adrenergic receptor. In addition, it is known to target 5-hydroxytryptamine receptor 5A, hepatic sodium/bile acid cotransporter, and 5-hydroxytryptamine receptor 1A.

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Variants

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Trends

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
nervous system diseases	D009422
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568
mental disorders	D001523

Trade Name

FDA

EMA

Hemangeol, Inderal, Innopran, Propranolol (discontinued: Inderal, Propranolol)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Propranolol hydrochloride

Tradename	Company	Number	Date	Products
INDERAL LA	ANI Pharmaceuticals	N-018553 RX	1983-04-19	4 products, RLD
INNOPRAN XL	ANI Pharmaceuticals	N-021438 RX	2003-03-12	2 products, RLD, RS
HEMANGEOL	Laboratoires Pierre Fabre	N-205410 RX	2014-03-14	1 products, RLD, RS

Show 3 discontinued

Hydrochlorothiazide

Propranolol hydrochloride

Tradename	Company	Number	Date	Products
INDERIDE LA 80/50	Wyeth	N-019059 DISCN	1985-07-03	1 products
INDERIDE LA 120/50	Wyeth	N-019059 DISCN	1985-07-03	1 products
INDERIDE LA 160/50	Wyeth	N-019059 DISCN	1985-07-03	1 products
INDERIDE-40/25	Wyeth	N-018031 DISCN	1982-01-01	1 products, RLD
INDERIDE-80/25	Wyeth	N-018031 DISCN	1982-01-01	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
hemangeol	New Drug Application	2024-11-06
inderal	New Drug Application	2024-08-01
inderal xl	New Drug Application	2024-03-20
innopran xl	New Drug Application	2024-03-20
metoclopramide	ANDA	2012-08-29
propranolol	ANDA	2024-07-15
propranolol hcl er propranolol hydrochloride er	ANDA, NDA authorized generic	2019-04-19
propranolol hydrochloride	ANDA	2025-04-03
propranolol hyrochloride	ANDA	2014-05-15
propranolol scopolamine	unapproved drug other	2014-10-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	EFO_0003144	D006333	I50
hypertension	EFO_0000537	D006973	I10
myocardial infarction	EFO_0000612	D009203	I21
pheochromocytoma	—	D010673	—
angina pectoris	EFO_0003913	D000787	I20
ventricular tachycardia	—	D017180	I47.2
essential tremor	EFO_0003108	D020329	G25.0
esophageal and gastric varices	EFO_0009545	D004932	I85
ventricular fibrillation	EFO_0004287	D014693	I49.01
supraventricular tachycardia	—	D013617	I47.1

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Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	FDA Information
Propranolol Hydrochloride, Hemangeol, Pierre Fabre Derma
8338489	2028-10-16	U-1496
8987262	2028-10-16	U-1988

ATC Codes

C: Cardiovascular system drugs

— C07: Beta-adrenergic blocking agents

— C07A: Beta blocking agents

— C07AA: Beta blocking agents, non-selective

— C07AA05: Propranolol

— C07B: Beta blocking agents and thiazides

— C07BA: Beta blocking agents, non-selective, and thiazides

— C07BA05: Propranolol and thiazides

— C07F: Beta blocking agents, other combinations

— C07FX: Beta blocking agents, other combinations

— C07FX01: Propranolol and other combinations

HCPCS

Code	Description
J1800	Injection, propranolol hcl, up to 1 mg

Clinical

Clinical Trials

394 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
Hemangioma	D006391	—	D18.0	—	2	1	—	—	2
Port-wine stain	D019339	—	Q82.5	—	2	1	—	—	2
Capillary hemangioma	D018324	—	Q82.5	—	2	1	—	—	2

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	Propranolol
INN	propranolol
Description	Propranolol is a propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3. It has a role as a beta-adrenergic antagonist, an anxiolytic drug, an anti-arrhythmia drug, a vasodilator agent, an antihypertensive agent, a xenobiotic, an environmental contaminant and a human blood serum metabolite. It is a secondary amine, a propanolamine and a member of naphthalenes. It is functionally related to a 1-naphthol.
Classification	Small molecule
Drug class	beta-blockers (propranolol type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)NCC(O)COc1cccc2ccccc12

Identifiers

PDB	—
CAS-ID	525-66-6
RxCUI	—
ChEMBL ID	CHEMBL27
ChEBI ID	8499
PubChem CID	4946
DrugBank	DB00571
UNII ID	9Y8NXQ24VQ (ChemIDplus, GSRS)

Target

Agency Approved

ADRB1

ADRB2

ADRB3

Organism

Homo sapiens

Gene name

ADRB1

Gene synonyms

ADRB1R, B1AR

NCBI Gene ID

153

Protein name

beta-1 adrenergic receptor

Protein synonyms

adrenergic, beta-1-, receptor, Beta-1 adrenoceptor, Beta-1 adrenoreceptor

Uniprot ID

Q9UKG8

Mouse ortholog

Adrb1 (11554)

beta-1 adrenergic receptor (P34971)

Alternate

HTR5A

SLC10A1

HTR1A

Organism

Homo sapiens

Gene name

HTR5A

Gene synonyms

NCBI Gene ID

3361

Protein name

5-hydroxytryptamine receptor 5A

Protein synonyms

5-HT-5, 5-HT-5A, 5-hydroxytryptamine (serotonin) receptor 5A, G protein-coupled, Serotonin receptor 5A

Uniprot ID

Q2M2D2

Mouse ortholog

Htr5a (15563)

5-hydroxytryptamine receptor 5A (Q3URB0)

Variants

No data

Financial

Revenue by drug

€

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No data

Estimated US medical usage

Propranolol

Hydrochlorothiazide

Total medical expenditures per year (USD, in millions)

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Propranolol

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 42,927 documents

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Safety

Black-box Warning

Black-box warning for: Metoclopramide

Adverse Events

Top Adverse Reactions

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25,153 adverse events reported

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