BLAINJECTIONINJECTABLEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
HYLENEX RECOMBINANT (hyaluronidase) by Halozyme Therapeutics is agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. First approved in 2005.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HYLENEX RECOMBINANT is a recombinant human hyaluronidase enzyme that modifies connective tissue permeability by hydrolyzing hyaluronic acid, a structural polysaccharide in extracellular matrix. It is administered by injection to facilitate dispersion and absorption of co-injected fluids, localized transudates, or exudates. This endoglycosidase is used clinically as an adjunctive agent to enhance the bioavailability and spread of other therapeutic injections.
LOE Approaching
As LOE approaches, commercial teams are likely consolidating; expect reduced headcount and focus shift toward lifecycle management and cost containment strategies.
Mechanism of Action
agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also…
Pharmacologic Class:
Endoglycosidase
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Started Jun 2026
40 enrolled
Healthy Volunteers
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Started May 2026
876 enrolled
Non-small Cell Lung Cancer
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Started Nov 2024
67 enrolled
Lung CancerNon-Small Cell Lung Cancer
A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)
Started Oct 2024
66 enrolled
Classical Hodgkin Lymphoma RecurrentClassical Hodgkin Lymphoma RefractoryPrimary Mediastinal Large B-cell Lymphoma Recurrent+1 more
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Started Sep 2024
8 enrolled
Hematologic MalignancyBone Marrow Transplant RejectionAcute Myeloid Leukemia (AML)+9 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.