ADMA BIOLOGICS, INC. (ADMA)
ADMA Biologics, Inc. functions as a biopharmaceutical company specializing in the development, manufacturing, and commercialization of advanced biologic therapies derived from blood plasma. These specialized products are engineered to address immune system disorders and infectious diseases, catering to markets across the United States and internationally. Their current product portfolio includes BIVIGAM and ASCENIV, both intravenous immune globulin (IVIG) treatments prescribed for primary humoral immunodeficiency (PI). Additionally, the company offers Nabi-HB, utilized for immediate treatment following acute exposure to the Hepatitis B virus and other specified exposures. Beyond its existing offerings, ADMA is actively developing a pipeline of new plasma-derived therapeutics. This includes immunoglobulin products specifically targeting the prevention and treatment of S. pneumonia infections. The company also oversees its own facilities for source plasma collection. Product distribution is managed through a comprehensive network involving independent distributors, sales agents, specialty pharmacies, and other alternative healthcare providers. ADMA Biologics, Inc. was founded in 2004 and maintains its corporate headquarters in Ramsey, New Jersey.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
ADMA Biologics, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
Bivigam
Humoral Immune Response
NCT03164967Enrollment16StartDec 2016Primary CompletionAug 2022CompletionDec 2022 - Phase 4Unknown status
An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
Asceniv™
Primary Immune Deficiency
NCT05070455Enrollment12StartSep 2022Primary CompletionMar 2023est.CompletionJun 2023est. - Phase 3Completed
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Primary Immune Deficiency Disorders (PIDD)
NCT00538915Enrollment63StartSep 2007Primary CompletionJul 2009CompletionJul 2009 - Phase 3Completed
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
RI-002
Primary Immune Deficiency Disorder
NCT01814800Enrollment59StartFeb 2014Primary CompletionDec 2014CompletionJan 2015 - Phase 2Terminated
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
Hepatitis C Immune Globulin Intravenous (Human) 5%
Sequelae of Viral Hepatitis, Transplantation Infection +1
NCT00473824Enrollment7StartMay 2007Primary CompletionFeb 2009CompletionFeb 2009 - Phase 2Completed
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
RI-001, RI-001
Upper Respiratory Tract Infection, Lower Respiratory Tract Infection
NCT00632463Enrollment21StartFeb 2008Primary CompletionMay 2010CompletionMay 2010 - ObservationalUnknown status
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
Bivigam, Other
Primary Immune Deficiency Disorder
NCT03037359Enrollment200StartDec 2016Primary CompletionDec 2022CompletionJun 2023est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | Bivigam | NCT03164967 |
| Phase 4 | Unknown status | Asceniv™ | NCT05070455 |
| Phase 3 | Completed | Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%] | NCT00538915 |
| Phase 3 | Completed | RI-002 | NCT01814800 |
| Phase 2 | Terminated | Hepatitis C Immune Globulin Intravenous (Human) 5% | NCT00473824 |
| Phase 2 | Completed | RI-001, RI-001 | NCT00632463 |
| Observational | Unknown status | Bivigam, Other | NCT03037359 |