Betaxolol - PharmaKB

Betaxolol

Betaxolol, Betoptic, Kerledex (betaxolol) is a small molecule pharmaceutical. Betaxolol was first approved as Betoptic on 1985-08-30. It is used to treat hypertension and open-angle glaucoma in the USA. The pharmaceutical is active against beta-1 adrenergic receptor. In addition, it is known to target beta-2 adrenergic 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
eye diseases	D005128
cardiovascular diseases	D002318

Trade Name

FDA

EMA

Betoptic (generic drugs available since 1999-10-22, discontinued: Kerlone)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Betaxolol hydrochloride

Tradename	Company	Number	Date	Products
BETOPTIC S	Novartis	N-019845 RX	1989-12-29	1 products, RLD, RS
BETOPTIC	Sandoz	N-019270 RX	1985-08-30	1 products, RLD, RS

Show 1 discontinued

Betaxolol hydrochloride

Chlorthalidone

Tradename	Company	Number	Date	Products
KERLEDEX	Sanofi	N-019807 DISCN	1992-10-30	2 products

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Betaxolol hydrochloride

Pilocarpine hydrochloride

Tradename	Company	Number	Date	Products
BETOPTIC PILO	Alcon Research	N-020619 DISCN	1997-04-17	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
betaxolol	ANDA	2022-05-23
betaxolol hydrochloride	ANDA	2024-02-14
betoptic		2006-10-30
betoptic pilo		2006-06-19
betoptic s	New Drug Application	2023-08-02

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypertension	EFO_0000537	D006973	I10
open-angle glaucoma	EFO_0004190	D005902	H40.1

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

C: Cardiovascular system drugs

— C07: Beta-adrenergic blocking agents

— C07A: Beta blocking agents

— C07AB: Beta blocking agents, selective

— C07AB05: Betaxolol

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01E: Antiglaucoma preparations and miotics

— S01ED: Beta blocking agents, antiglaucoma preparations and miotics

— S01ED02: Betaxolol

— S01ED52: Betaxolol, combinations

HCPCS

No data

Clinical

Clinical Trials

12 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Heart diseases	D006331	EFO_0003777	I51.9	—	—	—	4	—	4
Heart failure	D006333	HP_0001635	I50	—	—	—	3	—	3
Diastolic heart failure	D054144	EFO_1000899	I50.30	—	—	—	2	—	2

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ocular hypertension	D009798	EFO_1001069	H40.0	—	—	2	—	—	2
Open-angle glaucoma	D005902	EFO_0004190	H40.1	—	—	2	—	—	2
Glaucoma	D005901	EFO_0000516	H40	—	—	1	—	—	1

Indications Phases 2

No data

Indications Phases 1

No data

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	2	2
Covid-19	D000086382	—	U07.1	—	—	—	—	1	1
Hypersensitivity	D006967	HP_0012393	T78.40	—	—	—	—	1	1
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	—	—	—	1	1
Cardiac arrhythmias	D001145	EFO_0004269	I49.9	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Betaxolol
INN	betaxolol
Description	Betaxolol is a propanolamine that is 3-aminopropane-1,2-diol in which the hydrogen of the primary hydoxy is substituted by a 4-[2-(cyclopropylmethoxy)ethyl]phenyl group and one of the hydrogens attached to the amino group is substituted by isopropyl. It is a selective beta1-receptor blocker and is used in the treatment of glaucoma as well as hypertension, arrhythmias, and coronary heart disease. It is also used to reduce non-fatal cardiac events in patients with heart failure. It has a role as a beta-adrenergic antagonist, an antihypertensive agent and a sympatholytic agent.
Classification	Small molecule
Drug class	beta-blockers (propranolol type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)NCC(O)COc1ccc(CCOCC2CC2)cc1

Identifiers

PDB	—
CAS-ID	63659-18-7
RxCUI	—
ChEMBL ID	CHEMBL423
ChEBI ID	3082
PubChem CID	2369
DrugBank	DB00195
UNII ID	O0ZR1R6RZ2 (ChemIDplus, GSRS)

Target

Agency Approved

ADRB1

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

ADRB2

Organism

Homo sapiens

Gene name

ADRB2

Gene synonyms

ADRB2R, B2AR

NCBI Gene ID

154

Protein name

beta-2 adrenergic receptor

Protein synonyms

adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor

Uniprot ID

Q9UMZ5

Mouse ortholog

Adrb2 (11555)

beta-2 adrenergic receptor (Q8BH38)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Betaxolol

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 1,584 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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784 adverse events reported

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