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timolol 0.5% BID
timolol 0.5% BID is a Non-selective beta-adrenergic receptor blocker Small molecule drug developed by Inotek Pharmaceuticals Corporation. It is currently in Phase 3 development for Glaucoma, Ocular hypertension. Also known as: Timoptic.
Timolol is a non-selective beta-adrenergic receptor blocker that reduces intraocular pressure by decreasing aqueous humor production and increasing uveoscleral outflow.
Timolol 0.5% is a beta-1 adrenergic receptor antagonist used to treat conditions such as glaucoma and ocular hypertension. It is administered twice daily as a topical eyedrop.
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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 | timolol 0.5% BID |
|---|---|
| Also known as | Timoptic |
| Sponsor | Inotek Pharmaceuticals Corporation |
| Drug class | Non-selective beta-adrenergic receptor blocker |
| Target | Beta-adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Timolol works by blocking the action of epinephrine and norepinephrine on beta-adrenergic receptors in the eye, leading to a decrease in intraocular pressure. This is achieved through a reduction in aqueous humor production and an increase in uveoscleral outflow. The net effect is a decrease in intraocular pressure, which is beneficial for patients with glaucoma.
Approved indications
- Glaucoma
- Ocular hypertension
Common side effects
- Headache
- Dizziness
- Fatigue
- Nausea
- Allergic reactions
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)
- Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas (PHASE4)
- 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)
- Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension (PHASE2)
- Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone) (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:
- timolol 0.5% BID CI brief — competitive landscape report
- timolol 0.5% BID updates RSS · CI watch RSS
- Inotek Pharmaceuticals Corporation portfolio CI
Frequently asked questions about timolol 0.5% BID
What is timolol 0.5% BID?
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Is timolol 0.5% BID also known as anything else?
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Related
- Drug class: All Non-selective beta-adrenergic receptor blocker drugs
- Target: All drugs targeting Beta-adrenergic receptors
- Manufacturer: Inotek Pharmaceuticals Corporation — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma
- Indication: Drugs for Ocular hypertension
- Also known as: Timoptic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing