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SG 001 - ADMA Biologics

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Drug Profile

SG 001 - ADMA Biologics

Alternative Names: Anti-pneumococcal immune globulin - ADMA Biologics; S pneumonia immune globulin - ADMA Biologics; S. pneumonia hyperimmune globulin - ADMA Biologics; SG-001 - ADMA Biologics; Streptococcus pneumonia immune globulin - ADMA Biologics

Latest Information Update: 21 Jan 2026

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At a glance

  • Originator ADMA Biologics
  • Class Antibacterials; Immunoglobulins
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical Pneumococcal infections

Most Recent Events

  • 12 Jan 2026 ADMA Biologics announces intention to submit a pre-IND application to FDA for Pneumococcal infections, in 2026
  • 12 Jan 2026 ADMA Biologics plans a registrational clinical trial for Pneumococcal infections (Parenteral)
  • 05 Nov 2025 ADMA Biologics submits Commissioner’s National Priority Voucher (CNPV) application to the US FDA for SG 001

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