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Siplizumab - ITBMed Biopharmaceuticals

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Drug Profile

Siplizumab - ITBMed Biopharmaceuticals

Alternative Names: MEDI-507; TCD 601

Latest Information Update: 21 May 2025

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At a glance

  • Originator Catholic University of Louvain; Ossium Health
  • Developer BioTransplant (CEASED); ITBMed Biopharmaceuticals; MedImmune
  • Class Antihyperglycaemics; Antineoplastics; Antipsoriatics; Antirheumatics; Immunotherapies; Monoclonal antibodies; Urologics
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Regulatory T-lymphocyte stimulants; T cell activation inhibitors
  • Orphan Drug Status

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

    Yes - Transplant rejection
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Amyotrophic lateral sclerosis; Liver transplant rejection; Renal transplant rejection; Type 1 diabetes mellitus
  • Phase I/II Graft-versus-host disease; Transplant rejection
  • Preclinical Hidradenitis suppurativa
  • Discontinued Psoriasis; Psoriatic arthritis; Rheumatoid arthritis; T-cell lymphoma

Most Recent Events

  • 14 May 2025 ITB-Med LLC plans a phase 0 trial for Renal failure(Combination therapy) in USA(IV) in May 2025 (NCT06972069)
  • 28 Jan 2025 Phase-II clinical trials in Amyotrophic lateral sclerosis (Parenteral) prior to January 2025 (ITB-Med Biopharmaceuticals Pipeline, January 2025)
  • 11 Dec 2024 ITBMed Biopharmaceuticals completes a phase II clinical trials in Renal transplant rejection (In adults, In the elderly) in Austria, Sweden, Spain (Parenteral) (NCT06365437)

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