Propranolol - PharmaKB

Inderide-40/25, 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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Financial

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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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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 (generic drugs available since 1985-10-22)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

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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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

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Labels

FDA

EMA

Brand Name	Status	Last Update
hemangeol	New Drug Application	2023-01-02
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	2024-08-19
propranolol hyrochloride	ANDA	2014-05-15
propranolol scopolamine	unapproved drug other	2014-10-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	HP_0001635	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	HP_0001663	D014693	I49.01
supraventricular tachycardia	HP_0004755	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

379 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Liver cirrhosis	D008103	EFO_0001422	K74.0	1	4	12	10	17	40
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	4	13	5	7	3	29
Fibrosis	D005355	—	—	—	3	7	7	14	28
Esophageal and gastric varices	D004932	EFO_0009545	I85	1	—	7	8	9	25
Hemangioma	D006391	—	D18.0	1	9	6	4	7	24
Traumatic stress disorders	D040921	—	—	3	11	4	4	3	23
Portal hypertension	D006975	EFO_0000666	K76.6	1	2	7	2	12	22
Migraine disorders	D008881	EFO_0003821	G43	—	3	5	8	5	20
Hypertension	D006973	EFO_0000537	I10	1	3	7	2	7	17
Hemorrhage	D006470	MP_0001914	R58	1	2	4	5	6	17

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	11	3	1	—	5	19
Retinal diseases	D012164	HP_0000479	H35.9	2	6	1	—	1	8
Premature birth	D047928	EFO_0003917	O60	1	6	1	—	1	7
Retinopathy of prematurity	D012178	EFO_1001158	H35.1	1	6	1	—	1	7
Burns	D002056	—	T30.0	—	6	5	—	1	7
Melanoma	D008545	—	—	3	4	1	—	—	6
Thrombosis	D013927	—	—	—	—	2	—	3	5
Venous thrombosis	D020246	HP_0004936	I82.40	—	—	2	—	3	5
Cardiac arrhythmias	D001145	EFO_0004269	I49.9	—	—	1	—	3	4
Liver diseases	D008107	HP_0002910	K70-K77	1	1	2	—	1	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cocaine-related disorders	D019970	—	F14	2	4	—	—	1	7
Breast neoplasms	D001943	EFO_0003869	C50	1	3	—	—	1	5
Orthostatic intolerance	D054971	—	—	2	1	—	—	2	4
Neoplasms	D009369	—	C80	1	1	—	—	2	4
Autistic disorder	D001321	HP_0000717	F84.0	1	1	—	—	2	4
Sarcoma	D012509	—	—	—	4	—	—	—	4
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	1	1	—	—	1	3
Hypoglycemia	D007003	HP_0001943	E16.2	1	1	—	—	1	3
Adenocarcinoma	D000230	—	—	1	2	—	—	—	3
Hemangiosarcoma	D006394	—	—	1	3	—	—	—	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ovarian epithelial carcinoma	D000077216	—	—	3	—	—	—	1	4
Obesity	D009765	EFO_0001073	E66.9	2	—	—	—	1	3
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	2	—	—	—	1	3
Ovarian neoplasms	D010051	EFO_0003893	C56	2	—	—	—	1	3
Fallopian tube neoplasms	D005185	—	—	2	—	—	—	1	3
Memory	D008568	—	—	1	—	—	—	1	2
Hypoxia	D000860	HP_0012418	R09.02	2	—	—	—	—	2
Chronic renal insufficiency	D051436	—	N18	1	—	—	—	—	1
Kidney diseases	D007674	EFO_0003086	N08	1	—	—	—	—	1
Stem cell transplantation	D033581	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypersensitivity	D006967	HP_0012393	T78.40	—	—	—	—	2	2
Surgical portasystemic shunt	D011170	—	—	—	—	—	—	2	2
Tympanic membrane perforation	D018058	—	H72	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	1	1
Drug interactions	D004347	—	—	—	—	—	—	1	1
Insulin resistance	D007333	HP_0000855	E88.819	—	—	—	—	1	1
Vestibular diseases	D015837	EFO_0009691	H81	—	—	—	—	1	1
Orthodontic extrusion	D050793	—	—	—	—	—	—	1	1
Exercise test	D005080	EFO_0004328	—	—	—	—	—	1	1
Transjugular intrahepatic portasystemic shunt	D019168	—	—	—	—	—	—	1	1

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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 40,935 documents

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Safety

Black-box Warning

Black-box warning for: Metoclopramide

Adverse Events

Top Adverse Reactions

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19,940 adverse events reported

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