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DE-117 ophthalmic solution high
DE-117 ophthalmic solution high is a Anti-inflammatory agent Small molecule drug developed by Santen Pharmaceutical Co., Ltd.. It is currently in Phase 2 development for Treatment of non-infectious uveitis affecting the posterior segment of the eye.
DE-117 ophthalmic solution high is an anti-inflammatory agent.
DE-117 ophthalmic solution high is an anti-inflammatory agent. Used for Treatment of non-infectious uveitis affecting the posterior segment of the eye.
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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 high |
|---|---|
| Sponsor | Santen Pharmaceutical Co., Ltd. |
| Drug class | Anti-inflammatory agent |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 2 |
Mechanism of action
It works by inhibiting the production of inflammatory mediators in the eye, reducing inflammation and improving symptoms of ocular diseases.
Approved indications
- Treatment of non-infectious uveitis affecting the posterior segment of the eye
Common side effects
- Eye irritation
Key clinical trials
- 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)
- Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension (PHASE2)
- A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study- (PHASE2, 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:
- DE-117 ophthalmic solution high CI brief — competitive landscape report
- DE-117 ophthalmic solution high updates RSS · CI watch RSS
- Santen Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about DE-117 ophthalmic solution high
What is DE-117 ophthalmic solution high?
How does DE-117 ophthalmic solution high work?
What is DE-117 ophthalmic solution high used for?
Who makes DE-117 ophthalmic solution high?
What drug class is DE-117 ophthalmic solution high in?
What development phase is DE-117 ophthalmic solution high in?
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Related
- Drug class: All Anti-inflammatory agent drugs
- Manufacturer: Santen Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Treatment of non-infectious uveitis affecting the posterior segment of the eye
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing