Birtamimab
drugOn this page
Also known as Hu2A4NEOD001
Summary
Birtamimab (CHEMBL3833345) is a phase-3 clinical-stage antibody; indicated across 2 conditions including hereditary amyloidosis and amyloidosis.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Indications: 2 conditions
- Clinical trials: 7
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3833345 |
| Name | Birtamimab |
| Type | Antibody |
| Max phase | 3 |
Also known as: Birtamimab, Hu2A4, NEOD001, BIRTAMIMAB
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
2 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hereditary amyloidosis | 3 | MONDO:0018634 | MONDO:0019438 |
| amyloidosis | 2 | MONDO:0019065 | EFO:1001875 |
Clinical trials
Total trials: 7.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 4 |
| PHASE3 | 2 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT02312206 | PHASE3 | TERMINATED | The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis |
| NCT04973137 | PHASE3 | TERMINATED | A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis |
| NCT01707264 | PHASE1/PHASE2 | COMPLETED | Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis |
| NCT02613182 | PHASE2 | TERMINATED | Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis |
| NCT02632786 | PHASE2 | COMPLETED | The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis |
| NCT03154047 | PHASE2 | TERMINATED | Study in Subjects With Light Chain (AL) Amyloidosis |
| NCT03168906 | PHASE2 | TERMINATED | Renal AL Amyloid Involvement and NEOD001 |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: hereditary amyloidosis