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ADMA Biologics (ADMA) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Asceniv™ | Phase IV | Primary Immune Deficiency | 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 | ― |
| Bivigam | Phase IV | Humoral Immune Response | Completed | Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16 | Jan 30, 2017 | ― |
| Ri-002 | Phase III | Primary Immune Deficiency Disorder | Completed | Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD) | Mar 06, 2013 | ― |
| Nabi-Igiv 10% [Immune Globulin Intravenous (Human). 10%] | Phase III | Primary Immune Deficiency Disorders (Pidd) | 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 | ― |
| Hepatitis C Immune Globulin Intravenous (Human) 5% | Phase II | Sequelae Of Viral Hepatitis, Transplantation Infection, Evidence Of Liver Transplantation | Terminated | Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation | May 14, 2007 | ― |
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
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 Inc (ADMA) have in its pipeline
ADMA Biologics ADMA is currently developing the following drugs: Asceniv™, Bivigam, Ri-002, Nabi-Igiv 10% [Immune Globulin Intravenous (Human). 10%], Hepatitis C Immune Globulin Intravenous (Human) 5%. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
