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Glanatec
Glanatec is a Small molecule drug developed by Michael D. Straiko, MD. It is currently in Phase 2 development for Glaucoma, Ocular hypertension. Also known as: Ripasudil.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Glanatec |
|---|---|
| Also known as | Ripasudil |
| Sponsor | Michael D. Straiko, MD |
| Target | Serine/threonine-protein kinase TAO3, 5'-AMP-activated protein kinase subunit gamma-1, Aurora kinase B |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Approved indications
- Glaucoma
- Ocular hypertension
Common side effects
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD) (PHASE3)
- A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD) (PHASE3)
- Descemet Endothelial Thickness Comparison Trial II (PHASE3)
- Descemet Endothelial Thickness Comparison Trial I (PHASE3)
- Study to Assess Safety and Tolerability of Multiple Doses of EO2002 (PHASE1)
- The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery (PHASE3)
- A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery (PHASE3)
- Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy (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 |
|---|---|
| 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:
- Glanatec CI brief — competitive landscape report
- Glanatec updates RSS · CI watch RSS
- Michael D. Straiko, MD portfolio CI
Frequently asked questions about Glanatec
What is Glanatec?
What is Glanatec used for?
Who makes Glanatec?
Is Glanatec also known as anything else?
What development phase is Glanatec in?
What does Glanatec target?
Related
- Target: All drugs targeting Serine/threonine-protein kinase TAO3, 5'-AMP-activated protein kinase subunit gamma-1, Aurora kinase B
- Manufacturer: Michael D. Straiko, MD — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Glaucoma
- Indication: Drugs for Ocular hypertension
- Also known as: Ripasudil