NS-229
/ Nippon Shinyaku
- LARVOL DELTA
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September 09, 2025
FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis
(PRNewswire)
Fast track • Eosinophilic Granulomatosis With Polyangiitis
April 21, 2025
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
July 22, 2024
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
February 19, 2024
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
January 22, 2024
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
September 21, 2023
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
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