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Asceniv™
Primary Immune Deficiency
Phase IV
Unknown
An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
Sep 23, 2021
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Bivigam
Humoral Immune Response
Phase IV
Completed
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
Jan 30, 2017
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Ri-002
Primary Immune Deficiency Disorder
Phase III
Completed
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Mar 06, 2013
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Nabi-Igiv 10% [Immune Globulin Intravenous (Human). 10%]
Primary Immune Deficiency Disorders (Pidd)
Phase III
Completed
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Oct 01, 2007
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Hepatitis C Immune Globulin Intravenous (Human) 5%
Sequelae Of Viral Hepatitis, Transplantation Infection, Evidence Of Liver Transplantation
Phase II
Terminated
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
May 14, 2007
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does ADMA Biologics (ADMA) have in its pipeline
ADMA is currently developing the following drugs: Asceniv™, Bivigam, Ri-002. These drug candidates are in various stages of clinical development as the company works toward FDA approval.