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brimonidine/timolol fixed combination
brimonidine/timolol fixed combination is a Small molecule drug developed by Allergan. It is currently in Phase 3 development.
Brimonidine/timolol fixed combination is used to treat conditions such as ocular hypertension and glaucoma, including open-angle glaucoma. It is a small molecule that works by combining brimonidine, an alpha-2 adrenergic agonist, with timolol, a beta-adrenergic receptor blocker.
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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 | brimonidine/timolol fixed combination |
|---|---|
| Sponsor | Allergan |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma (PHASE4)
- Prophylaxis for Anti-VEGF-induced IOP Elevation (NA)
- 24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol (PHASE4)
- Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide (PHASE2)
- Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma (PHASE4)
- Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan® (PHASE4)
- Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow (PHASE4)
- Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects (PHASE4)
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:
- brimonidine/timolol fixed combination CI brief — competitive landscape report
- brimonidine/timolol fixed combination updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about brimonidine/timolol fixed combination
What is brimonidine/timolol fixed combination?
Who makes brimonidine/timolol fixed combination?
What development phase is brimonidine/timolol fixed combination in?
Related
- Manufacturer: Allergan — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing