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pp-188

Solution for injection

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Post-bariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass surgery Clinical stage: Phase 2a Modality: Biological (first-in-class GLP-1 receptor antagonist peptide) Mechanism / Target: Competitive antagonist at GLP-1 receptor (GLP-1R); prevents postprandial hypersecretion of insulin triggered by exaggerated GLP-1 response after RYGB; novel mechanism of blocking rather than activating GLP-1R Route / form: Subcutaneous injection Differentiation: First-in-class GLP-1 receptor antagonist peptide; uniquely opposite mechanism to GLP-1 agonists (semaglutide class); addresses post-bariatric hypoglycemia — a debilitating complication with no approved pharmacological treatment;
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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