pp-187 Solution for injection
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Chronic hypoparathyroidism (HypoPT) in adults
Clinical stage: Phase 2 completed (positive data); Phase 3 planned Q3 2026
Modality: Biological (novel long-acting PTH receptor agonist peptide)
Mechanism / Target: Modified PTH analogue engineered for prolonged receptor engagement; activates PTH1R with sustained calcium normalisation; designed for once-weekly or less frequent dosing
Route / form: Subcutaneous injection
Differentiation: Novel long-acting PTH analogue enabling potential once-weekly dosing vs. daily NATPARA (PTH 1-84); Phase 2 demonstrated superior sustained calcium normalisation;
Manufacturer #39328
US-based clinical-stage biopharmaceutical company developing Rx injectable peptide therapeutics engineered for improved pharmacokinetics over native peptide drugs. Pipeline targets serious endocrine and metabolic disorders.
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