Overview
Felzartamab is under investigation in clinical trial NCT04145440 (Trial to Assess Safety and Efficacy of MOR202 in Anti-pla2r + Membranous Nephropathy (Amn)).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Felzartamab (MOR-202): A Comprehensive Monograph on a Novel Anti-CD38 Antibody for Immune-Mediated Diseases
Executive Summary
Felzartamab is an investigational, fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody poised to address significant unmet medical needs in a portfolio of rare, immune-mediated diseases. Originally developed for multiple myeloma, the therapeutic has been strategically repositioned to leverage its unique pharmacological profile in the field of nephrology. It specifically targets CD38, a glycoprotein highly expressed on mature plasma cells and natural killer (NK) cells, which are central to the pathophysiology of numerous antibody-driven disorders.
The primary mechanism of action for felzartamab involves the selective depletion of CD38-positive (CD38+) cells through potent antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). A key differentiating feature is its minimal induction of complement-dependent cytotoxicity (CDC), a mechanism associated with higher rates of infusion-related reactions in other anti-CD38 agents. This characteristic likely contributes to its favorable safety and tolerability profile observed across multiple clinical trials, positioning it as a promising candidate for the long-term management of chronic autoimmune conditions.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/08 | Phase 3 | Recruiting | |||
2025/04/20 | Phase 3 | Recruiting | |||
2024/11/12 | Phase 3 | Recruiting | |||
2023/10/03 | Phase 1 | Recruiting | |||
2021/10/04 | Phase 2 | Completed | |||
2021/08/25 | Phase 2 | Completed | Farsad Eskandary | ||
2021/05/19 | Phase 2 | Completed | Mario Negri Institute for Pharmacological Research | ||
2021/02/01 | Phase 2 | Completed | |||
2019/10/30 | Phase 1 | Completed | |||
2011/08/22 | Phase 1 | Completed |
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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