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An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

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Trial Profile

An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2026

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Bacterial infections; Immunodeficiency disorders; Primary immunodeficiency diseases
  • Focus Registrational; Therapeutic Use
  • Sponsors ADMA Biologics

Most Recent Events

  • 04 May 2026 According to an ADMA Biologics media release, company announced the U.S. Food and Drug Administration has approved the Company's supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act for ASCENIV.
  • 01 Apr 2019 According to an ADMA Biologics media release, the U.S. Food and Drug Administration has approved ASCENIV, an Intravenous Immune Globulin, for the treatment of Primary Humoral Immunodeficiency Disease in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.
  • 17 Oct 2018 According to an ADMA Biologics media release, the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of ADMAs September 28, 2018 BLA resubmission for RI-002 with an action due date of April 2, 2019, under the Prescription Drug User Fee Act (PDUFA).

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