Overview
Timolol is a nonselective beta-adrenergic antagonist given in an eye drop solution to reduce intraocular pressure, or pressure in the eyes. It is also used in tablet form as a drug to treat hypertension. Timolol was first approved by the FDA in 1978. This drug is marketed by several manufacturers and is an effective agent for the management of conditions such as open-angle glaucoma and hypertension.
Indication
Ophthalmic timolol is indicated for the treatment of increased intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The oral form of this drug is used to treat high blood pressure. In certain cases, timolol is used in the prevention of migraine headaches.
Associated Conditions
- Increased Intra Ocular Pressure (IOP)
- Migraine
- Ocular Hypertension
- Open Angle Glaucoma (OAG)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/20 | Not Applicable | Recruiting | |||
2025/04/23 | Phase 1 | Recruiting | |||
2025/02/13 | Phase 1 | Completed | Auson Pharmaceuticals Inc. | ||
2024/11/07 | Phase 2 | Completed | Auson Pharmaceuticals Inc. | ||
2024/10/16 | Phase 3 | Recruiting | Queen Mary Hospital, Hong Kong | ||
2023/12/01 | Phase 2 | Recruiting | |||
2023/11/18 | Phase 3 | Recruiting | Queen Mary Hospital, Hong Kong | ||
2023/11/07 | Phase 1 | Active, not recruiting | SpyGlass Pharma, Inc. | ||
2023/06/22 | Phase 2 | Active, not recruiting | |||
2022/07/29 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 0781-7186 | OPHTHALMIC | 5 mg in 1 mL | 8/31/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-0055 | ORAL | 5 mg in 1 1 | 8/17/2006 | |
| Pacific Pharma, Inc. | 60758-802 | OPHTHALMIC | 2.5 mg in 1 mL | 3/18/2024 | |
| Lifestar Pharma LLC | 70756-655 | OPHTHALMIC | 2.5 mg in 1 mL | 7/3/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-546 | OPHTHALMIC | 5 mg in 1 mL | 2/14/2020 | |
| Leading Pharma, LLC | 69315-305 | OPHTHALMIC | 5 mg in 1 mL | 2/28/2022 | |
| Bausch Health US LLC | 0187-1496 | OPHTHALMIC | 6.8 mg in 1 mL | 1/6/2020 | |
| Sandoz Inc | 61314-030 | OPHTHALMIC | 5 mg in 1 mL | 9/28/2017 | |
| Rising Pharma Holdings, Inc. | 64980-513 | OPHTHALMIC | 2.5 mg in 1 mL | 10/25/2023 | |
| Bausch & Lomb Incorporated | 24208-819 | OPHTHALMIC | 5 mg in 1 mL | 2/22/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/23/2006 | ||
Authorised | 11/25/2008 | ||
Authorised | 5/19/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Ganfort Eye Drops | SIN13589P | SOLUTION, STERILE | 5mg/ml | 12/29/2008 | |
| LATOCHEK-T STERILE EYE DROPS | SIN14955P | SOLUTION, STERILE | 5mg/ml | 2/19/2016 | |
| Timolol Maleate Eye Drops, Solution 0.5% | SIN14204P | SOLUTION, STERILE | 5.0 mg/ml | 7/30/2012 | |
| ZOLICHEK-T EYE DROPS SOLUTION | SIN14984P | SOLUTION, STERILE | 5mg/ml | 4/8/2016 | |
| TIMOPTOL OPHTHALMIC SOLUTION 0.5% | SIN04135P | SOLUTION | 5.00 mg/mL | 4/20/1990 | |
| Azarga 10mg/mL + 5mg/mL eye drops, suspension | SIN13802P | SUSPENSION, STERILE | 5mg/mL | 5/19/2010 | |
| TIMO-COMOD 0.5% EYE DROPS | SIN13744P | SOLUTION | 5.00mg/ml | 12/11/2009 | |
| GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml) | SIN14966P | SOLUTION, STERILE | 5 mg/ml | 3/11/2016 | |
| DORZOLAMIDE AND TIMOLOL STADA EYE DROPS 20MG/5MG | SIN14556P | SOLUTION, STERILE | 5mg/ml | 6/3/2014 | |
| DuoTrav Eye Drops, Solution (5mg/40mcg) per mL | SIN13722P | SOLUTION, STERILE | 5mg/mL | 11/3/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TIMOLOL | aa pharma inc | 00755842 | Tablet - Oral | 5 MG | 12/31/1988 |
| NU-TIMOLOL TAB 20MG | nu-pharm inc | 02044625 | Tablet - Oral | 20 MG | 12/31/1993 |
| NU-TIMOLOL TAB 5MG | nu-pharm inc | 02044609 | Tablet - Oral | 5 MG | 12/31/1993 |
| TIMOLOL | aa pharma inc | 00755869 | Tablet - Oral | 20 MG | 12/31/1988 |
| TIMOLOL-10 TAB 10MG | PRO DOC LIMITEE | 00812447 | Tablet - Oral | 10 MG | 12/31/1989 |
| TIMOLOL SOLUTION - 0.5% | bdh inc. | 02147483 | Solution - Ophthalmic | 0.5 % | 10/13/1998 |
| TEVA-TIMOLOL | teva canada limited | 01947818 | Tablet - Oral | 10 MG | 12/31/1992 |
| TIMOLOL-5 TAB 5MG | PRO DOC LIMITEE | 00812455 | Tablet - Oral | 5 MG | 12/31/1989 |
| BLOCADREN TAB 20MG | merck frosst canada & cie, merck frosst canada & co. | 00495611 | Tablet - Oral | 20 MG / TAB | 12/31/1980 |
| BLOCADREN TAB 5MG | merck frosst canada & cie, merck frosst canada & co. | 00353914 | Tablet - Oral | 5 MG | 12/31/1978 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FIXAPROST 50 MICROGRAMOS/ML + 5 MG/ML COLIRIO EN SOLUCION EN ENVASES UNIDOSIS | 83560 | COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| TAPTIQOM 15 MICROGRAMOS/ML+ 5 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS | 80037 | COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| DUOTRAV 40 microgramos/ml + 5mg/ml COLIRIO EN SOLUCION | 106338004 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| CUSIMOLOL 5 MG/ML COLIRIO EN SOLUCIÓN | 55808 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| DORZOLAMIDA/TIMOLOL VIR 20 MG/ML + 5 MG/ML COLIRIO EN SOLUCION | Industria Quimica Y Farmaceutica Vir S.A. | 77386 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TIMOGEL 1mg/g GEL OFTALMICO | Laboratorios Thea S.A. | 63347 | GEL OFTÁLMICO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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