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DE-117 Ophthalmic Solution QD
DE-117 Ophthalmic Solution QD is a Prostaglandin EP2 receptor agonist Small molecule drug developed by Santen Inc.. It is currently in Phase 2 development.
DE-117 is a selective EP2 receptor agonist that lowers intraocular pressure through increased uveoscleral outflow.
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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 Ophthalmic Solution QD |
|---|---|
| Sponsor | Santen Inc. |
| Drug class | Prostaglandin EP2 receptor agonist |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
DE-117 selectively activates the EP2 prostaglandin receptor subtype, which promotes aqueous humor drainage through the uveoscleral pathway. This mechanism differs from traditional prostaglandin analogs that primarily target the FP receptor, potentially offering an alternative treatment approach for glaucoma patients.
Approved indications
Common side effects
Key clinical trials
- Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6 (PHASE2)
- A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT (PHASE1, PHASE2)
- 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)
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 Ophthalmic Solution QD CI brief — competitive landscape report
- DE-117 Ophthalmic Solution QD updates RSS · CI watch RSS
- Santen Inc. portfolio CI
Frequently asked questions about DE-117 Ophthalmic Solution QD
What is DE-117 Ophthalmic Solution QD?
How does DE-117 Ophthalmic Solution QD work?
Who makes DE-117 Ophthalmic Solution QD?
What drug class is DE-117 Ophthalmic Solution QD in?
What development phase is DE-117 Ophthalmic Solution QD in?
Related
- Drug class: All Prostaglandin EP2 receptor agonist drugs
- Manufacturer: Santen Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing