Drug Profile

Siplizumab - ITBMed Biopharmaceuticals

Alternative Names: MEDI-507; TCD 601

Latest Information Update: 11 Sep 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; Skin disorder therapies; 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

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

24 Jul 2025 ITB-Med terminates a phase II trial in Type 1 diabetes mellitus (Newly diagnosed) in United Kingdom, Sweden, Spain, Italy, Belgium (IV), due to business reasons and the decision is not related to any safety, efficacy, or regulatory concerns (NCT06025110)
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)

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