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DE-117 Middle Dose ophthalmic solution
DE-117 Middle Dose ophthalmic solution is a Rho kinase (ROCK) inhibitor Small molecule drug developed by Santen Inc.. It is currently in Phase 2 development for Glaucoma or ocular hypertension (Phase 2). Also known as: DE-117.
DE-117 is a selective rho kinase (ROCK) inhibitor that reduces intraocular pressure by improving aqueous humor outflow through the trabecular meshwork and Schlemm's canal.
DE-117 Middle Dose ophthalmic solution is being studied in a clinical trial for the treatment of open-angle glaucoma and ocular hypertension. The study, NCT02179008, is a multi-center Phase II trial assessing the safety and efficacy of DE-117 Middle Dose ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.
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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).
| 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 | DE-117 Middle Dose ophthalmic solution |
|---|---|
| Also known as | DE-117 |
| Sponsor | Santen Inc. |
| Drug class | Rho kinase (ROCK) inhibitor |
| Target | ROCK1/ROCK2 |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 2 |
Mechanism of action
ROCK inhibitors modulate the cytoskeleton of trabecular meshwork cells and endothelial cells lining Schlemm's canal, increasing conventional aqueous humor drainage and thereby lowering intraocular pressure. This mechanism differs from prostaglandin analogs and beta-blockers, offering a potential new therapeutic option for glaucoma and ocular hypertension.
Approved indications
- Glaucoma or ocular hypertension (Phase 2)
Common side effects
- Conjunctival hyperemia
- Eye irritation
- Ocular discomfort
Key clinical trials
- Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension (PHASE2)
- Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension (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:
- DE-117 Middle Dose ophthalmic solution CI brief — competitive landscape report
- DE-117 Middle Dose ophthalmic solution updates RSS · CI watch RSS
- Santen Inc. portfolio CI
Frequently asked questions about DE-117 Middle Dose ophthalmic solution
What is DE-117 Middle Dose ophthalmic solution?
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Who makes DE-117 Middle Dose ophthalmic solution?
Is DE-117 Middle Dose ophthalmic solution also known as anything else?
What drug class is DE-117 Middle Dose ophthalmic solution in?
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What does DE-117 Middle Dose ophthalmic solution target?
Related
- Drug class: All Rho kinase (ROCK) inhibitor drugs
- Target: All drugs targeting ROCK1/ROCK2
- Manufacturer: Santen Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma or ocular hypertension (Phase 2)
- Also known as: DE-117
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing