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Berahyaluronidase Alfa · Keytruda Qlex

Recombinant protein · Acts on hyaluronan · developed by Merck Sharp & Dohme Llc

Approved FDA, Sep 2025
MRK Developer
1 Registered trials

What is Berahyaluronidase Alfa?

Berahyaluronidase alfa is a recombinant variant of human hyaluronidase PH20 that reversibly depolymerizes hyaluronan in subcutaneous tissue, increasing tissue permeability. It is combined with pembrolizumab in Keytruda Qlex for treating melanoma and non-small cell lung cancer. The enzyme enhances absorption of co-administered agents.

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

At a glance

Also known as
Keytruda Qlex
Drug type
Recombinant protein
Targets
hyaluronan
Mechanism
Acts on hyaluronan
Pathways
extracellular matrix permeability
Therapy area
Oncology
Developer
Merck Sharp & Dohme Llc (MRK)
FDA status
Approved as Keytruda Qlex (September 19, 2025), BLA761467 · FDA label
UNII
9X4R4A4HQQ

✅ FDA-approved uses

From the indications section of the FDA label (version of Jul 31, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07513376 Phase 3 Non-small Cell Lung Cancer Recruiting MRK

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

Conditions studied

Non-small Cell Lung Cancer

More from Merck Sharp & Dohme Llc

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the MRK page.

Follow MRK, the company behind Berahyaluronidase Alfa

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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

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