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1 products found

pp-210

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Diabetic macular oedema (DME) — oral systemic therapy Clinical stage: Phase 2 — Phase 2a completed (positive); Phase 2b/3 strategy via FDA Type C meeting (planned 2025) Modality: Small molecule (vascular endothelial junction stabiliser via SIRT1 pathway) Mechanism / Target: Selectively stabilises endothelial cell-to-cell junctions in retinal vasculature via SIRT1 (sirtuin-1) pathway activation; reduces retinal vascular leakage in DME without anti-VEGF mechanism; addresses both inflammatory and metabolic drivers of DME Route / form: Oral tablet (once or twice daily) Differentiation: First potential oral treatment for DME; entirely novel mechanism vs. intravitreal anti-VEGF injections (aflibercept, ranibizumab); Phase 2a positive (67 patients, 3 months, US); major patient benefit — eliminates need for repeated eye injections; FDA regulatory strategy via Type C meeting; Thea Open Innovation = Phase 2 support for separate eye drop formulation;
Manufacturer #39347
South Korea-based clinical-stage company developing Rx synthetic small-molecule therapeutics for intractable vascular and metabolic diseases. Injectable and oral candidates target serious ophthalmic and renal complications. Advances multiple programs through domestic and global clinical trials.

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