Timolide 10-25, Duotrav(timolol)

Azarga, Betimol, Combigan, Cosopt, DuoTrav, Ganfort, Istalol, Timolide, 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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Novartis Pharmaceuticals

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
eye diseases	D005128
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Betimol, Istalol, Timoptic, Timoptic in ocudose, Timoptic-xe (generic drugs available since 1990-06-08, discontinued: Blocadren)

Combinations

Combigan, Cosopt (generic drugs available since 1990-06-08, discontinued: Timolide)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Brimonidine tartrate

Timolol maleate

Tradename	Company	Number	Date	Products
COMBIGAN	AbbVie	N-021398 RX	2007-10-30	1 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

Hydrochlorothiazide

Timolol maleate

Tradename	Company	Number	Date	Products
TIMOLIDE 10-25	Merck KGaA	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

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

Labels

FDA

EMA

Brand Name	Status	Last Update
betimol	New Drug Application	2022-11-14
combigan	New Drug Application	2015-10-01
cosopt pf	New Drug Application	2022-11-08
dorzolamide hydrochloride and timolol maleate	ANDA	2022-06-30
istalol	New Drug Application	2019-10-31
timoptic	New Drug Application	2022-04-30
timoptic-xe	New Drug Application	2021-02-22

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
angina pectoris	EFO_0003913	D000787	I20
heart failure	EFO_0003144	D006333	I50
hypertension	EFO_0000537	D006973	I10
myocardial infarction	EFO_0000612	D009203	I21
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

— 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

270 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	6	21	64	42	17	145
Open-angle glaucoma	D005902	EFO_0004190	H40.1	6	21	45	39	15	120
Glaucoma	D005901	EFO_0000516	H40	3	5	23	45	11	87
Healthy volunteers/patients	—			2	1	1	1	—	5
Low tension glaucoma	D057066	EFO_1001022	H40.12	—	1	—	3	1	5
Macular edema	D008269			—	2	1	1	—	3
Exfoliation syndrome	D017889	EFO_0004235		—	—	1	1	1	3
Eye diseases	D005128	EFO_0003966	H44	—	—	—	2	—	2
Anterior uveitis	D014606	EFO_1000811		—	—	—	1	—	1
Angle-closure glaucoma	D015812			—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemangioma	D006391		D18.0	1	2	1	—	1	5
Macular degeneration	D008268	EFO_0001365	H35.30	—	2	1	—	—	2
Wet macular degeneration	D057135	EFO_0004683		—	2	1	—	—	2
Surgical wound	D000072836			—	2	2	—	—	2
Visual acuity	D014792			—	—	1	—	—	1
Corneal edema	D015715	EFO_1000879	H18.20	—	—	1	—	—	1
Diabetic foot	D017719	EFO_1001459		—	—	1	—	—	1
Melanoma	D008545			—	—	1	—	—	1
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	—	1	—	—	1
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	1	—	—	1

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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	—	2	—	—	1	3
Migraine disorders	D008881	EFO_0003821	G43	—	1	—	—	1	2
Retinal vein occlusion	D012170	EFO_1001157	H34.81	—	1	—	—	—	1
Ulcer	D014456	MPATH_579		—	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
Acne vulgaris	D000152	EFO_0003894	L70	1	—	—	—	1	2
Rosacea	D012393		L71	1	—	—	—	—	1
Ischemic optic neuropathy	D018917	EFO_1000809	H47.01	1	—	—	—	—	1
Sturge-weber syndrome	D013341	Orphanet_3205	Q85.89	1	—	—	—	—	1
Port-wine stain	D019339		Q82.5	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes complications	D048909			—	—	—	—	1	1
Ocular physiological phenomena	D009799			—	—	—	—	1	1
Scleral buckling	D012591			—	—	—	—	1	1
Retinal detachment	D012163	EFO_0005773	H33.2	—	—	—	—	1	1
Retinal perforations	D012167	EFO_1001028		—	—	—	—	1	1
Intraocular pressure	D007429			—	—	—	—	1	1
Paronychia	D010304	EFO_0007421	L03.0	—	—	—	—	1	1

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	1546004
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

Clinical Variant

No data

Financial

Betimol - Akorn

€

₣

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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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717 adverse events reported

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