MedPath

Siplizumab

Generic Name
Siplizumab
Drug Type
Biotech
CAS Number
288392-69-8
Unique Ingredient Identifier
KUW1QG1ZM3

Overview

No overview information available.

Indication

Investigated for use/treatment in psoriasis and psoriatic disorders, transplant (rejection), graft versus host disease, lymphoma (unspecified), and leukemia (unspecified).

Associated Conditions

No associated conditions information available.

Research Report

Published: Sep 10, 2025

Comprehensive Therapeutic and Developmental Report: Siplizumab (DB06371)

Molecular Profile and Physicochemical Properties of Siplizumab (MEDI-507)

Identification and Classification

Siplizumab is an investigational, protein-based, biotech therapeutic agent that functions as a potent and selective immunomodulator.[1] As a biological drug, it is classified as a monoclonal antibody (mAb), a modality that leverages the high specificity of the adaptive immune system to target disease-related molecules.[1]

The compound is formally identified by several key international identifiers:

  • Generic Name: Siplizumab [1]
  • DrugBank Accession Number: DB06371 [1]
  • CAS (Chemical Abstracts Service) Number: 288392-69-8 [1]
  • UNII (Unique Ingredient Identifier): KUW1QG1ZM3 [2]

Throughout its extensive development history, Siplizumab has been known by various synonyms and external codes, which reflect its journey through different corporate and academic research programs. The most prominent of these are MEDI-507, associated with its development at MedImmune, and TCD 601, linked to its current development by ITB-Med Biopharmaceuticals.[1] Other historical identifiers include Humanized LO-CD2a and ALLOMUNE.[5] This multiplicity of names points toward a protracted and non-linear development pathway, characteristic of a therapeutic asset that has undergone strategic repositioning. The transition from a large pharmaceutical entity (MedImmune, as MEDI-507) to a more specialized biotechnology company (ITB-Med, as TCD 601) suggests a strategic shift from pursuing broad indications to focusing on niche therapeutic areas where the drug's unique mechanism offers a distinct advantage, a common and often successful strategy in modern drug development.

Structural Characteristics

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.