pp-076 Tablets
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, Israel
Comments
Indication: Osteoporosis requiring anabolic bone-building therapy, particularly in patients at high risk of fractures or inadequate response to antiresorptive agents.
Clinical stage: Phase 2 clinical development.
Modality: Peptide therapeutic (oral PTH 1-34)
Mechanism / Target: Oral formulation of parathyroid hormone (PTH 1-34), designed to stimulate osteoblast activity, increase bone formation, and improve bone mineral density via intermittent PTH signaling.
Route / form: Oral tablets
Differentiation: First potential oral anabolic PTH therapy offering an alternative to daily injections; aims to improve adherence and expand accessibility of bone-building therapy in osteoporosis.
Manufacturer #38618
A clinical-stage biopharmaceutical company developing oral peptide and protein replacement therapies to transform standards of care in chronic metabolic and rare diseases. It leverages a proprietary oral delivery platform to advance first-in-class tablet programs with global strategic development goals. The organization progresses multiple clinical programs from Phase 2 toward Phase 3 readiness.