BLAINJECTIONINJECTABLEPriority Review
Approved
Oct 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
AMPHADASE (hyaluronidase) by R-Pharm US 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 2004.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMPHADASE (hyaluronidase) is an endoglycosidase enzyme that modifies connective tissue permeability by hydrolyzing hyaluronic acid, a polysaccharide in the intercellular ground substance. It temporarily decreases viscosity of cellular cement and promotes dispersion of injected fluids or localized transudates/exudates to facilitate absorption. The drug is administered by injection and serves as an adjunct in clinical settings requiring enhanced tissue penetration.
LOE Approaching
As LOE approaches, brand team focus shifts toward lifecycle extension, cost management, and preparation for generic entry; team size likely contracting or consolidating.
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.