Drug Profile

ABBV CLS 628

Alternative Names: ABBV-CLS-628

Latest Information Update: 11 Nov 2025

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At a glance

Originator AbbVie
Developer AbbVie; Calico
Class Monoclonal antibodies
Mechanism of Action Pregnancy-associated plasma protein-A inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Autosomal dominant polycystic kidney disease
New Molecular Entity Yes

Highest Development Phases

Phase II Autosomal dominant polycystic kidney disease

Most Recent Events

05 Nov 2025 ABBV CLS 628 receives Orphan Drug status for Autosomal dominant polycystic kidney disease in USA
02 Oct 2025 ABBV CLS 628 receives Fast Track designation for Autosomal dominant polycystic kidney disease [IV,Infusion] in USA
02 Oct 2025 Adverse events data from a phase I trial in Autosomal dominant polycystic kidney disease released by Calico

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