NS-229 / Nippon Shinyaku - LARVOL DELTA

FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis (PRNewswire)

Fast track • Eosinophilic Granulomatosis With Polyangiitis

FDA Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis (PRNewswire) - "NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA)."

Orphan drug • Eosinophilic Granulomatosis With Polyangiitis

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: NS Pharma, Inc. | Trial completion date: May 2025 ➔ Jul 2026 | Trial primary completion date: Apr 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: NS Pharma, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2023 ➔ Dec 2023

Enrollment open • Trial initiation date • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

The European Commission Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis (PRNewswire) - "NS Pharma, Inc...a subsidiary of Nippon Shinyaku Co., Ltd, announced today that the European Commission (EC) has granted orphan drug designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA)....The Orphan Drug Designation provides NS Pharma with a ten-year marketing exclusivity period, supporting the company's continued development and evaluation of this therapy."

European regulatory • Orphan drug • Eosinophilic Granulomatosis With Polyangiitis • Immunology

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: NS Pharma, Inc.

New P2 trial • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis