pp-053 Injection
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
For smoking cessation; intended to reduce craving and support sustained abstinence in adult smokers.
Completed Phase 2a and Phase 2b clinical development.
Plant-derived, nicotine-free, standardized aqueous extract of tobacco leaves (denicotinized botanical immunotherapy).
Mechanism / Target: Immunomodulatory approach influencing neuro-immune pathways involved in nicotine dependence; shown in clinical studies to reduce cigarette satisfaction and craving without delivering nicotine.
Route / form: Subcutaneous injection; two-dose regimen .
Differentiation: Nicotine-free mechanism avoids reinforcing dependence; low-frequency dosing improves adherence
Manufacturer #38603
A biotechnology company developing botanical-based medicines to treat addiction (smoking, excess alcohol) and related disorders. It leverages natural extracts and botanical drug know-how to deliver safer addiction therapies with global partnership potential.