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TIMOLOL MALEATE
Timolol Maleate is a marketed drug primarily indicated for the reduction of elevated intraocular pressure. Its key strength lies in its well-established mechanism and market presence, with a key composition patent expiring in 2028. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | TIMOLOL MALEATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1978 |
Approved indications
- Reduction of Elevated Intraocular Pressure
Common side effects
- Allergic conjunctivitis
- Conjunctival hyperemia
- Eye pruritus
- Ocular burning
- Stinging
- Conjunctival folliculosis
- Asthenia
- Blepharitis
- Corneal erosion
- Depression
- Epiphora
- Eye discharge
Serious adverse events
- Cardiac failure
- Severe respiratory reactions
- Severe cardiac reactions
- Hypersensitivity reactions
- Potentiation of vascular insufficiency
- Increased reactivity to allergens
- Potentiation of muscle weakness
- Masking of hypoglycemic symptoms
- Vitreous detachment
- Visual field defect
Key clinical trials
- Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant (PHASE3)
- Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris (EARLY_PHASE1)
- Effect of IOP Lowering on Progressive HM (NA)
- Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas (PHASE4)
- 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 (PHASE2)
- Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance (PHASE4)
- Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant (PHASE2, PHASE3)
- Study of an Investigational Product, QLS-111, Provided as an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TIMOLOL MALEATE CI brief — competitive landscape report
- TIMOLOL MALEATE updates RSS · CI watch RSS