pp-039 Injection, pre-filled syringe
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Advanced prostate cancer (hormone-sensitive prostate adenocarcinoma) requiring androgen-deprivation therapy.
Completed Phase II. Depot formulation of gonadotropin-releasing hormone [GnRH] agonist using patented depo technology for long-acting subcutaneous monthly injection.
Designed for self-administration. Shows ~50% higher bioavailability versus comparator product in Phase 2.
Offers improved convenience, improved pharmacokinetics vs standard depot formulations, potentially better patient compliance and lower injection burden.
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.