pp-040 Injection, pre-filled pen
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Pulmonary arterial hypertension (WHO Group 1). Phase 1 completed with positive topline results; planning further clinical development. Long-acting subcutaneous depot formulation of prostacyclin analogue using the company’s proprietary patented depo technology for weekly (or less frequent) injection, designed to replace continuous infusion. Subcutaneous injection depot (ready-to-use, small volume) for self-administration. Current PAH therapies with prostacyclin analogue require continuous infusion or frequent administrations; the simplified, less burdensome dosing may improve adherence and quality of life.
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.