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ADMA Biologics

ADMA Biologics logo
🇺🇸United States
Ownership
Public
Established
2004-01-01
Employees
624
Market Cap
$4B
Website
http://www.admabiologics.com

Clinical Trials

7

Active:1
Completed:4

Trial Phases

3 Phases

Phase 2:2
Phase 3:2
Phase 4:2

Drug Approvals

3

FDA:3

Drug Approvals

BIVIGAM

Approval Date
Mar 15, 2024
FDA

ASCENIV

Approval Date
Mar 11, 2024
FDA

Nabi-HB

Approval Date
Nov 22, 2022
FDA

Clinical Trials

Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials

Phase 2
2 (33.3%)
Phase 3
2 (33.3%)
Phase 4
2 (33.3%)

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)

Phase 4
Recruiting
Conditions
Primary Immune Deficiency
First Posted Date
2021-10-07
Last Posted Date
2022-09-16
Lead Sponsor
ADMA Biologics, Inc.
Target Recruit Count
12
Registration Number
NCT05070455
Locations
🇺🇸

Immunoe Research Centers, Centennial, Colorado, United States

🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

🇺🇸

University of Utah, Salt Lake City, Utah, United States

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16

Phase 4
Completed
Conditions
Humoral Immune Response
First Posted Date
2017-05-24
Last Posted Date
2023-02-01
Lead Sponsor
ADMA Biologics, Inc.
Target Recruit Count
16
Registration Number
NCT03164967
Locations
🇺🇸

IMMUNOe Research Centers, Centennial, Colorado, United States

🇺🇸

Duke University Medical Center, Durham, Florida, United States

🇺🇸

Allergy Associates of the Palm Beaches, North Palm Beach, Florida, United States

and more 5 locations

A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

Active, not recruiting
Conditions
Primary Immune Deficiency Disorder
First Posted Date
2017-01-31
Last Posted Date
2023-02-01
Lead Sponsor
ADMA Biologics, Inc.
Target Recruit Count
200
Registration Number
NCT03037359
Locations
🇺🇸

Santa Barbara Specialty Pharmacy, Carpinteria, California, United States

🇺🇸

Allergy and Asthma of the Bay Area, Walnut Creek, California, United States

🇺🇸

Immunoe Research Centers, Centennial, Colorado, United States

and more 14 locations

Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Phase 3
Completed
Conditions
Primary Immune Deficiency Disorder
First Posted Date
2013-03-20
Last Posted Date
2016-10-05
Lead Sponsor
ADMA Biologics, Inc.
Target Recruit Count
59
Registration Number
NCT01814800
Locations
🇺🇸

IMMUNOe Health Centers, Cenntennial, Colorado, United States

🇺🇸

Allergy Associates of the Palm Beaches, P.A., North Palm Beach, Florida, United States

🇺🇸

Family Allergy Center, PC, Atlanta, Georgia, United States

and more 6 locations

RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

Phase 2
Completed
Conditions
Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
First Posted Date
2008-03-10
Last Posted Date
2013-04-24
Lead Sponsor
ADMA Biologics, Inc.
Target Recruit Count
21
Registration Number
NCT00632463
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

University of Colorado Health Sciences Center, Aurora, Colorado, United States

🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

and more 16 locations
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News

ADMA Biologics Secures FDA Clearance for Yield Enhancement Process, Poised for Margin Expansion in 2026

ADMA Biologics has received FDA clearance for a yield enhancement process that is expected to significantly improve production margins for its immunoglobulin products starting in 2026.

FDA Approves ADMA Biologics' Innovative Yield Enhancement Process for Immune Globulin Production

ADMA Biologics has received FDA approval for a groundbreaking production process that increases immune globulin yields by approximately 20% from the same plasma volume, becoming the first U.S. company to achieve this regulatory milestone.

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