Drug intelligence / Profile preview

NNC0385-0434 B (Novo Nordisk)

Development stage
Discontinued
Lead developer
Novo Nordisk
Modality
Peptides
Administration
Oral
01

Overview

NNC0385-0434 B is a specific oral tablet formulation of NNC0385-0434, an investigational peptide-based PCSK9 inhibitor developed by Novo Nordisk for the treatment of hypercholesterolemia. The drug is a peptide mimic of the EGF-A domain of the human LDL receptor, designed to competitively bind free PCSK9 and prevent its interaction with the LDL receptor, thereby increasing receptor availability and lowering LDL cholesterol levels. To enable oral delivery, the peptide is co-formulated with the absorption enhancer sodium N-[8-(2-hydroxybenzoyl)amino] caprylate (SNAC). Formulation 'B' was one of several versions (including G and F) tested in Phase 1 pharmacokinetic studies to optimize bioavailability. Although Phase 2 trials demonstrated significant LDL cholesterol reduction comparable to injectable inhibitors like evolocumab, Novo Nordisk discontinued development in 2023 due to strategic portfolio decisions.

Other names
NNC0385-0434 formulation BNNC-0385-0434 formulation BNNC 0385-0434 formulation B
02

Targets

PCSK9 (Proprotein convertase subtilisin/kexin type 9)

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