Timolol - PharmaKB

Timoptic, Duotrav(timolol)

/ Timolol, Azarga, Betimol, Combigan, Cosopt, DuoTrav, Ganfort, Istalol, Timolide, Timolol, Timoptic (timolol) is a small molecule pharmaceutical. Timolol was first approved as Timolide 10-25 on 1982-01-01. It is used to treat angina pectoris, heart failure, hypertension, myocardial infarction, and open-angle glaucoma in the USA. It has been approved in Europe to treat ocular hypertension and open-angle glaucoma. The pharmaceutical is active against beta-2 adrenergic 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
eye diseases	D005128
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Betimol, Istalol, Timolol, Timoptic, Timoptic in ocudose, Timoptic-xe (discontinued: Blocadren, Timolol)

Combinations

Brimonidine timolol, Combigan, Cosopt, Dorzolamide timolol (discontinued: Brimonidine timolol, Dorzolamide timolol, Timolide)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Timolol maleate

Tradename	Company	Number	Date	Products
ISTALOL	Bausch Health Companies	N-021516 RX	2004-06-04	1 products, RLD, RS
TIMOPTIC	Bausch Health Companies	N-018086 RX	1982-01-01	2 products, RLD
TIMOPTIC IN OCUDOSE	Bausch Health Companies	N-019463 RX	1986-11-05	2 products, RLD, RS
TIMOPTIC-XE	Bausch Health Companies	N-020330 RX	1993-11-04	2 products, RLD
TIMOLOL MALEATE	Sandoz	N-020963 RX	1998-10-21	2 products, RLD, RS

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Hydrochlorothiazide

Timolol maleate

Tradename	Company	Number	Date	Products
TIMOLIDE 10-25	Merck & Co	N-018061 DISCN	1982-01-01	1 products

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Timolol

Tradename	Company	Number	Date	Products
BETIMOL	Thea Pharma	N-020439 RX	1995-03-31	2 products, RLD, RS

Dorzolamide hydrochloride

Timolol maleate

Tradename	Company	Number	Date	Products
COSOPT	Thea Pharma	N-020869 RX	1998-04-07	1 products, RLD, RS
COSOPT PF	Thea Pharma	N-202667 RX	2012-02-01	1 products, RLD, RS

Brimonidine tartrate

Timolol maleate

Tradename	Company	Number	Date	Products
COMBIGAN	AbbVie	N-021398 RX	2007-10-30	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
betimol	New Drug Application	2024-04-17
brimonidine tartrate and timolol maleate	ANDA	2025-02-19
brimonidine tartrate/timolol maleate	ANDA	2024-05-16
brimonidine tartrate/timolol maleate ophthalmic solution	ANDA	2025-03-10
combigan	New Drug Application	2024-07-26
cosopt	New Drug Application	2024-04-17
cosopt pf	New Drug Application	2024-01-08
dorzolamide and timolol	ANDA	2024-05-25
dorzolamide hcl /timolol maleate	ANDA	2013-01-29
dorzolamide hcl and timolol maleate	ANDA	2018-02-13

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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
angina pectoris	EFO_0003913	D000787	I20
open-angle glaucoma	EFO_0004190	D005902	H40.1
nephrotic syndrome	EFO_0004255	D009404	N04
edema	—	D004487	R60.9

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

— C07AA: Beta blocking agents, non-selective

— C07AA06: Timolol

— C07B: Beta blocking agents and thiazides

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

— C07BA06: Timolol and thiazides

— C07D: Beta blocking agents, thiazides and other diuretics

— C07DA: Beta blocking agents, non-selective, thiazides and other diuretics

— C07DA06: Timolol, thiazides and other diuretics

S: Sensory organ drugs

— S01: Ophthalmologicals

— S01E: Antiglaucoma preparations and miotics

— S01ED: Beta blocking agents, antiglaucoma preparations and miotics

— S01ED01: Timolol

— S01ED51: Timolol, combinations

HCPCS

No data

Clinical

Clinical Trials

312 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ocular hypertension	D009798	EFO_1001069	H40.0	1	1	14	10	6	32
Hypertension	D006973	EFO_0000537	I10	1	1	14	9	4	29
Glaucoma	D005901	EFO_0000516	H40	1	—	10	14	4	29
Open-angle glaucoma	D005902	EFO_0004190	H40.1	1	—	4	6	5	16
Low tension glaucoma	D057066	EFO_1001022	H40.12	—	—	—	1	—	1
Angle-closure glaucoma	D015812	—	—	—	—	—	1	—	1

Indications Phases 3

No data

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	Timolol
INN	timolol
Description	(S)-timolol (anhydrous) is the (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine. It has a role as an antiglaucoma drug, an antihypertensive agent, an anti-arrhythmia drug and a beta-adrenergic antagonist. It is a conjugate base of a (S)-timolol(1+). It is an enantiomer of a (R)-timolol.
Classification	Small molecule
Drug class	beta-blockers (propranolol type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)(C)NC[C@H](O)COc1nsnc1N1CCOCC1

Identifiers

PDB	—
CAS-ID	26839-75-8
RxCUI	—
ChEMBL ID	CHEMBL499
ChEBI ID	9599
PubChem CID	33624
DrugBank	DB00373
UNII ID	5JKY92S7BR (ChemIDplus, GSRS)

Target

Agency Approved

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)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€

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Betimol – Akorn

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Estimated US medical usage

Timolol

Brimonidine

Total medical expenditures per year (USD, in millions)

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Timolol

Dorzolamide

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Timolol

Hydrochlorothiazide

Total medical expenditures per year (USD, in millions)

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Timolol

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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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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16,976 adverse events reported

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