Drug Profile

DNL 952

Alternative Names: DNL-952; ETV GAA

Latest Information Update: 24 Mar 2026

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At a glance

Originator Denali Therapeutics Inc
Class Alpha-glucosidases; Recombinant fusion proteins
Mechanism of Action Alpha-glucosidase replacements

Orphan Drug Status

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

No
New Molecular Entity Yes
Available For Licensing Yes

Highest Development Phases

Preclinical Glycogen storage disease type II

Most Recent Events

09 Mar 2026 Denali Therapeutics submitted a CTA application for DNl 952 in United Kingdom and Europe
21 Jan 2026 Denali Therapeutics plans to initiate a phase I trial for Glycogen storage disease type II (IV) in March 2026 (NCT07354724)
06 Jan 2026 Denali announced that the US FDA has lifted the clinical hold on the Investigational New Drug (IND) application for DNL952

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