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Nexagon® High Dose
Nexagon® High Dose is a Small molecule drug developed by OcuNexus Therapeutics, Inc.. It is currently in Phase 2 development.
Nexagon High Dose is a small molecule treatment that has been studied as a potential therapy for various conditions, including Diabetic Foot Ulcers, Corneal Persistent Epithelial Defect, Venous Leg Ulcers, and Persistent Corneal Epithelial Defect. The exact mechanism of Nexagon High Dose is not specified, but it is known to contain cotinine, a component that makes up 15% of the dose.
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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 | Nexagon® High Dose |
|---|---|
| Sponsor | OcuNexus Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED (PHASE2)
- NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries (PHASE2)
- A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (PHASE2)
- A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE) (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:
- Nexagon® High Dose CI brief — competitive landscape report
- Nexagon® High Dose updates RSS · CI watch RSS
- OcuNexus Therapeutics, Inc. portfolio CI
Frequently asked questions about Nexagon® High Dose
What is Nexagon® High Dose?
Who makes Nexagon® High Dose?
What development phase is Nexagon® High Dose in?
Related
- Manufacturer: OcuNexus Therapeutics, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing