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

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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: 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

Show 1 discontinued

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	2024-10-14
brimonidine tartrate/timolol maleate	ANDA	2024-05-16
brimonidine tartrate/timolol maleate ophthalmic solution	ANDA	2024-10-04
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	HP_0001635	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	HP_0000969	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

316 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Glaucoma	D005901	EFO_0000516	H40	14	32	72	90	38	239
Ocular hypertension	D009798	EFO_1001069	H40.0	8	25	72	54	28	181
Hypertension	D006973	EFO_0000537	I10	6	23	68	38	20	150
Open-angle glaucoma	D005902	EFO_0004190	H40.1	8	26	53	44	25	150
Hemangioma	D006391	—	D18.0	2	5	2	2	3	13
Port-wine stain	D019339	—	Q82.5	3	5	2	2	2	13
Capillary hemangioma	D018324	—	Q82.5	2	5	2	2	2	12
Low tension glaucoma	D057066	EFO_1001022	H40.12	—	2	—	3	1	6
Exfoliation syndrome	D017889	EFO_0004235	—	—	—	1	1	3	5
Healthy volunteers/patients	—	—	—	2	1	1	1	—	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Edema	D004487	HP_0000969	R60.9	—	2	2	—	1	4
Ulcer	D014456	MPATH_579	—	—	3	1	—	—	4
Wounds and injuries	D014947	—	T14.8	—	2	2	—	1	3
Wound healing	D014945	GO_0042060	—	—	3	2	—	—	3
Paronychia	D010304	EFO_0007421	L03.0	—	—	2	—	1	3
Macular degeneration	D008268	EFO_0001365	H35.30	—	2	1	—	—	2
Wet macular degeneration	D057135	EFO_0004683	—	—	2	1	—	—	2
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	2	—	—	2
Cataract	D002386	HP_0000518	H26.9	1	1	1	—	—	2
Surgical wound	D000072836	—	—	—	2	2	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hereditary hemorrhagic telangiectasia	D013683	—	I78.0	1	3	—	—	—	3
Telangiectasis	D013684	—	—	1	3	—	—	—	3
Epistaxis	D004844	EFO_0003895	R04.0	—	2	—	—	—	2
Migraine disorders	D008881	EFO_0003821	G43	—	1	—	—	1	2
Retinal vein occlusion	D012170	EFO_1001157	H34.81	—	1	—	—	—	1
Varicose ulcer	D014647	—	—	—	1	—	—	—	1
Leg ulcer	D007871	—	—	—	1	—	—	—	1
Burns	D002056	—	T30.0	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Syndrome	D013577	—	—	1	—	—	—	1	2
Acne vulgaris	D000152	EFO_0003894	L70	1	—	—	—	1	2
Rosacea	D012393	—	L71	1	—	—	—	—	1
Ophthalmic administration	D060433	—	—	1	—	—	—	—	1
Ischemia	D007511	EFO_0000556	—	1	—	—	—	—	1
Peripheral nervous system diseases	D010523	HP_0009830	G64	1	—	—	—	—	1
Ischemic optic neuropathy	D018917	EFO_1000809	H47.01	1	—	—	—	—	1
Optic nerve diseases	D009901	EFO_1001330	H47.14	1	—	—	—	—	1
Brain stem infarctions	D020526	EFO_1000847	G46.3	1	—	—	—	—	1
Sturge-weber syndrome	D013341	Orphanet_3205	Q85.89	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myopia	D009216	EFO_0003927	H52.1	—	—	—	—	3	3
Retinal detachment	D012163	EFO_0005773	H33.2	—	—	—	—	2	2
Covid-19	D000086382	—	—	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	1	1
Drug interactions	D004347	—	—	—	—	—	—	1	1
Diabetes complications	D048909	—	—	—	—	—	—	1	1
Diabetes mellitus	D003920	HP_0000819	E08-E13	—	—	—	—	1	1
Ocular physiological phenomena	D009799	—	—	—	—	—	—	1	1
Scleral buckling	D012591	—	—	—	—	—	—	1	1
Hypersensitivity	D006967	HP_0012393	T78.40	—	—	—	—	1	1

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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

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Trends

PubMed Central

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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18,555 adverse events reported

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