Last reviewed · How we verify
Active Comparator: Timolol 0.5%
Active Comparator: Timolol 0.5% is a Non-selective beta-adrenergic antagonist Small molecule drug developed by Allergan. It is currently in Phase 3 development for Glaucoma, Ocular hypertension.
Timolol is a non-selective beta-adrenergic receptor antagonist that reduces intraocular pressure by decreasing aqueous humor production in the eye.
Timolol is a non-selective beta-adrenergic receptor antagonist that reduces intraocular pressure by decreasing aqueous humor production in the eye. Used for Glaucoma, Ocular hypertension.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Active Comparator: Timolol 0.5% |
|---|---|
| Sponsor | Allergan |
| Drug class | Non-selective beta-adrenergic antagonist |
| Target | Beta-1 and beta-2 adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Timolol blocks beta-1 and beta-2 adrenergic receptors in the ciliary body of the eye, which reduces the rate of aqueous humor secretion. This leads to a decrease in intraocular pressure, making it effective for treating glaucoma and ocular hypertension. The 0.5% formulation is a topical ophthalmic solution applied directly to the eye.
Approved indications
- Glaucoma
- Ocular hypertension
Common side effects
- Ocular irritation or discomfort
- Blurred vision
- Bradycardia (systemic absorption)
- Bronchospasm (in susceptible patients)
- Conjunctival hyperemia
Key clinical trials
- Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5% (PHASE3)
- Clinical Study Comparing Two Models of a Travoprost Intraocular Implant (PHASE3)
- Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension (PHASE3)
- Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension (PHASE3)
- Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002) (PHASE3)
- Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED) (PHASE3)
- MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED) (PHASE3)
- Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED) (PHASE3)
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 |
|---|---|
| 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:
- Active Comparator: Timolol 0.5% CI brief — competitive landscape report
- Active Comparator: Timolol 0.5% updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about Active Comparator: Timolol 0.5%
What is Active Comparator: Timolol 0.5%?
How does Active Comparator: Timolol 0.5% work?
What is Active Comparator: Timolol 0.5% used for?
Who makes Active Comparator: Timolol 0.5%?
What drug class is Active Comparator: Timolol 0.5% in?
What development phase is Active Comparator: Timolol 0.5% in?
What are the side effects of Active Comparator: Timolol 0.5%?
What does Active Comparator: Timolol 0.5% target?
Related
- Drug class: All Non-selective beta-adrenergic antagonist drugs
- Target: All drugs targeting Beta-1 and beta-2 adrenergic receptors
- Manufacturer: Allergan — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma
- Indication: Drugs for Ocular hypertension
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing