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GEM 21S

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Drug Profile

GEM 21S

Alternative Names: B-TCP Plus; GEM 21S; GEM21S; GEMESIS

Latest Information Update: 20 Aug 2026

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At a glance

  • Originator ZymoGenetics
  • Developer Luitpold Pharmaceuticals; LYNCH Biologics; Vanderbilt University Medical Center
  • Class Blood proteins; Growth factors; Recombinant proteins
  • Mechanism of Action Osteogenesis stimulants; Platelet-derived growth factor replacements
  • Orphan Drug Status

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

    Yes - Osteonecrosis
  • New Molecular Entity No

Highest Development Phases

  • Marketed Bone disorders
  • Phase II Wounds
  • No development reported Osteonecrosis

Most Recent Events

  • 18 Aug 2026 LYNCH Biologics, Vanderbilt University Medical Center complete enrolment in a phase II trial for Wounds (Adjunctive treatment) in USA (Intralesional) (NCT06634030)
  • 15 Jul 2026 LYNCH Biologics, Vanderbilt University Medical Center complete a phase II trial in Wounds (Adjunctive treatment) in USA (Intralesional) (NCT06634030)
  • 25 Mar 2026 Lynch Regenerative Medicine enters into a definitive distribution agreement with Lynch Biologics for GEM 21S® in the United States

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