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 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMPHADASE is a hyaluronidase enzyme injection that modifies connective tissue permeability by hydrolyzing hyaluronic acid, a polysaccharide in the intercellular matrix. It temporarily decreases tissue viscosity and promotes dispersion of injected fluids, facilitating absorption of localized exudates and transudates. This enzyme is used as an adjunct to enhance the spread and absorption of other injected substances.
LOE Approaching
As LOE approaches, the AMPHADASE team is likely contracting; career trajectory on this brand faces headwinds from generic competition.
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)
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
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
Started Dec 2023
147 enrolled
Non-Small Cell Lung CancerRenal Cell CarcinomaMelanoma
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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.