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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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