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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: 14 Aug 2026

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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; Skin disorder therapies
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Amyotrophic lateral sclerosis
  • Phase 0 Hidradenitis suppurativa
  • Discontinued Lymphoproliferative disorders; Psoriasis; Psoriatic arthritis; Rheumatoid arthritis; T-cell lymphoma; Type 1 diabetes mellitus

Most Recent Events

  • 02 Jul 2026 ITBMed Biopharmaceuticals terminates a phase-I trial in Amyotrophic lateral sclerosis (Treatment-naive) in Sweden due to significant enrolment challenges (NCT06453668)
  • 17 Feb 2026 ITBMed Biopharmaceuticals terminates a phase II trial in Renal transplant rejection in South Korea, USA due to Sponsor's decision (IV) (NCT04803058)
  • 19 Nov 2025 Discontinued - Phase-I/II for Type 1 diabetes mellitus (In adolescents, In children, Treatment-naive, In adults) in USA (Parenteral) before April 2026 (NCT05574335)

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