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bimatoprost/timolol fixed combination
bimatoprost/timolol fixed combination is a Small molecule drug developed by Allergan. It is currently in Phase 3 development.
Bimatoprost, a prostaglandin F2-alpha receptor agonist, is used to treat conditions such as glaucoma and ocular hypertension. It is often combined with timolol, a beta-blocker, in a fixed combination to help lower intraocular pressure.
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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 | bimatoprost/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)
- Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting
- 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)
- A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
- Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated (PHASE4)
- A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension (PHASE1, PHASE2)
- Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension (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:
- bimatoprost/timolol fixed combination CI brief — competitive landscape report
- bimatoprost/timolol fixed combination updates RSS · CI watch RSS
- Allergan portfolio CI
Frequently asked questions about bimatoprost/timolol fixed combination
What is bimatoprost/timolol fixed combination?
Who makes bimatoprost/timolol fixed combination?
What development phase is bimatoprost/timolol fixed combination in?
Related
- Manufacturer: Allergan — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing