pp-214 Capsules
Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Unavailable markets
China
Comments
"Indication: Idiopathic pulmonary fibrosis (IPF)
Clinical stage: Phase 2 global — 80% enrollment complete as of April 2025; topline data expected 2026
Modality: Small molecule (first-in-class PRS/EPRS inhibitor — NCE)
Mechanism / Target: First-in-class inhibitor of prolyl-tRNA synthetase (PRS) / glutamyl-prolyl-tRNA synthetase (EPRS); blocks VEGF-IRES-mediated translation of VEGF-A, reducing pro-fibrotic and angiogenic signalling; entirely novel anti-fibrotic mechanism distinct from nintedanib (TKI) and pirfenidone (TGF-β inhibitor)
Route / form: Oral capsule (once daily)
Differentiation: First-in-class PRS/EPRS inhibitor; global Phase 2 IPF trial with 80% enrollment (April 2025); FDA Orphan Drug Designation + Fast Track Designation;
Manufacturer #7042
A pharmaceutical manufacturer engaged in the research, development, production and global supply of a broad range of pharmaceutical products, including prescription drugs, over-the-counter medicines and biologic therapies in finished dosage forms such as tablets, capsules, ointments, injections and liquids, as well as active pharmaceutical ingredients. The company combines integrated R&D with GMP-compliant manufacturing capabilities and commercial operations to support quality, safety and reliability in its pharmaceutical products for diverse therapeutic needs.
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