pp-038 Injection, pre-filled pen
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Raynaud’s phenomenon secondary to Systemic Sclerosis (SSc). Phase IIa. Subcutaneous long-acting formulation via proprietary patented depo technology - aimed at improving digital vascular perfusion in Raynaud’s by vasodilation and improved microcirculation. There are limited approved treatments for SSc-related Raynaud’s phenomenon; this long-acting depot formulation offers potential improved compliance and vascular benefit. Subcutaneous injection (long-acting depot) for weekly self-administration.
Manufacturer #38501
This Swedish biopharmaceutical organization develops and commercializes long-acting treatments for severe and chronic diseases. It specializes in advanced drug-delivery systems designed to improve therapeutic outcomes and patient adherence. Its portfolio includes marketed products and a research pipeline targeting areas such as opioid dependence, endocrine disorders, and oncology.