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.
Background
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 |
|---|---|---|---|---|---|
2025/04/23 | 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 | |||
2021/12/21 | Not Applicable | Completed |
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 |
|---|---|---|---|---|---|
| Timolol Maleate Tablets | 国药准字H20033026 | 化学药品 | 片剂 | 4/17/2020 | |
| Timolol Maleate Tablets | 国药准字H20033027 | 化学药品 | 片剂 | 4/17/2020 | |
| Timolol Maleate Eye Drops | 国药准字H20058929 | 化学药品 | 眼用制剂 | 9/20/2020 | |
| Timolol Maleate Eye Drops | 国药准字H32021200 | 化学药品 | 眼用制剂 | 8/13/2020 | |
| Timolol Maleate Eye Drops | 国药准字H31021731 | 化学药品 | 滴眼剂 | 9/14/2020 | |
| Timolol Maleate Eye Drops | 国药准字H12020054 | 化学药品 | 眼用制剂 | 8/6/2020 | |
| Timolol Maleate Eye Drops | 国药准字H20253876 | 化学药品 | 眼用制剂 | 4/15/2025 | |
| Timolol Maleate Eye Drops | 国药准字H12020053 | 化学药品 | 眼用制剂 | 8/6/2020 | |
| Timolol Maleate Eye Drops | 国药准字H31022200 | 化学药品 | 滴眼剂 | 12/19/2019 | |
| Timolol Maleate Eye Drops | 国药准字H20067218 | 化学药品 | 眼用制剂 | 8/31/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||