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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.
 

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