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
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/06/12 | Phase 1 | Recruiting | Elizabeth C. Verna | ||
2024/04/15 | Phase 2 | Completed | |||
2024/03/22 | Early Phase 1 | Recruiting | |||
2023/10/12 | Phase 1 | Recruiting | |||
2023/09/06 | Phase 2 | Terminated | |||
2023/08/31 | Phase 2 | Active, not recruiting | |||
2023/06/12 | Phase 1 | Active, not recruiting | |||
2022/12/30 | Phase 2 | Active, not recruiting | |||
2022/10/10 | Phase 1 | Active, not recruiting | |||
2021/03/17 | Phase 2 | Active, not recruiting |
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. |
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