Data updated: May 26, 2026
BETIMOL (timolol)
Trial Activity: Declining 1 active trials
Ophthalmology
Approved 1995-03-31
Development Insights
Bausch & Lomb Incorporated conducting 2 trials (13%)
18 indications explored (Broad Platform)
→ ocular hypertension (5 trials)
→ glaucoma (4 trials)
→ open-angle glaucoma (3 trials)
1
Indication
--
Phase 3 Trials
31
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1995-03-31
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
BETIMOL Approval History
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 1995 to 2004
Feb 2002 SUPPL
Mfg · Manufacturing (CMC)
Jul 2001 SUPPL
Mfg · Manufacturing (CMC)
Nov 1999 SUPPL
Mfg
Apr 1999 SUPPL
Label
Mar 1999 SUPPL
Mfg
Sep 1998 SUPPL
Mfg
Nov 1997 SUPPL
Label
Jan 1997 SUPPL
Mfg
Mar 1995 ORIGINAL
New Ingredient
What BETIMOL Treats
1 FDA approvalsOriginally approved for its first indication in 1995 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 1995)
📋
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06120140 COCOON | 61186372NSC2007 61186372NSC2007, 2023-505863-35-00 | Ph 2 | active not recruiting | Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib |
| NCT05479123 results posted | HSC-MS-22-0246 | Ph 4 | terminated | Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas |
| NCT02422017 EETUV | PI2014_843_0022 2014-005046-22 | Ph 2 | completed | Topical Timolol Benefit in Venous Ulcers |
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT03282981 BAART-DFU results posted | SURG-004-16F 17-08-00792 | Ph 3 | completed | Beta Adrenergic Antagonist for the Healing of Chronic DFU |
| NCT02774590 | IRB00074049 | Ph 1 | completed | Timolol for the Treatment of Acne and Rosacea |
| NCT00716859 results posted | A6111137 | Ph 3 | completed | A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma. |
| NCT03836664 results posted | STUDY00140465 | Ph 2 | completed | A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine |
| NCT01533376 | AVL-SWS-TT4PWM | Ph 1 | terminated | Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol |
| NCT02742649 results posted | FSV5-FC-001 | Ph 1, Ph 2 | completed | A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension |
| NCT01749930 LUNAR results posted | 770 | Ph 3 | completed | Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension |
| NCT02731287 | IIBSP-TIM-2013-156 | Ph 2 | completed | Topical Timolol for Infantile Hemangioma in Early Proliferative Phase |
| NCT01749904 APOLLO results posted | 769 | Ph 3 | completed | Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension |
| NCT01927406 | 26654 | Ph 4 | withdrawn | The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients. |
| NCT01917383 | IPC-01-2013 | Ph 2 | completed | A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma |
| NCT02312544 | OTX-13-004 | Ph 2 | completed | Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BETIMOL FDA Label Details
Track BETIMOL with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment