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Tividenofusp Alfa · Avlayah, DNL-310

Fusion protein · Protein replacement: transferrin receptor (TFRC) · developed by Denali Therapeutics

Approved FDA, Mar 2026
DNLI Developer
1 Registered trials

What is Tividenofusp Alfa?

Tividenofusp alfa is a fusion protein that supplies iduronate-2-sulfatase (IDS), a lysosomal enzyme, fused to an Fc component that binds the transferrin receptor to carry the enzyme across the blood-brain barrier and into peripheral tissues and the CNS. It is studied in mucopolysaccharidosis II (Hunter syndrome).

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Avlayah, DNL-310
Drug type
Fusion protein
Targets
transferrin receptor (TFRC), mannose-6-phosphate receptor (binding partner it blocks)
Mechanism
Protein replacement: transferrin receptor (TFRC)
Pathways
receptor-mediated transcytosis across the blood-brain barrier, lysosomal glycosaminoglycan degradation
Therapy area
Neurology
Developer
Denali Therapeutics Inc. (DNLI)
FDA status
Approved as Avlayah (March 24, 2026), BLA761485 · FDA label
UNII
QLD7UJN8CF

✅ FDA-approved uses

From the indications section of the FDA label (version of Mar 20, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05371613 Phase 2/3 Mucopolysaccharidosis II Active not recruiting DNLI

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Mucopolysaccharidosis II

More from Denali Therapeutics

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the DNLI page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.