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KI1001
KI1001 is a regenerative medicine therapy designed to restore corneal endothelial cell function and transparency in corneal diseases.
KI1001 is a regenerative medicine therapy designed to restore corneal endothelial cell function and transparency in corneal diseases. Used for Fuchs endothelial corneal dystrophy, Corneal endothelial dysfunction.
At a glance
| Generic name | KI1001 |
|---|---|
| Also known as | Prolonged release melatonin 2mg |
| Sponsor | Kuhnil Pharmaceutical Co., Ltd. |
| Drug class | Cell therapy / Regenerative medicine |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
KI1001 appears to be a cell-based or tissue engineering approach targeting corneal endothelial dysfunction, which is responsible for corneal edema and vision loss in conditions like Fuchs endothelial corneal dystrophy. By restoring endothelial cell integrity and pump function, the therapy aims to restore corneal clarity and improve visual acuity.
Approved indications
- Fuchs endothelial corneal dystrophy
- Corneal endothelial dysfunction
Common side effects
Key clinical trials
- Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients (PHASE3)
- Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients (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:
- KI1001 CI brief — competitive landscape report
- KI1001 updates RSS · CI watch RSS
- Kuhnil Pharmaceutical Co., Ltd. portfolio CI