Birtamimab

drug
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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

FieldValue
ChEMBL IDCHEMBL3833345
NameBirtamimab
TypeAntibody
Max phase3

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).

IndicationTrial phaseMONDOEFO
hereditary amyloidosis3MONDO:0018634MONDO:0019438
amyloidosis2MONDO:0019065EFO:1001875

Clinical trials

Total trials: 7.

Phase distribution

PhaseTrials
PHASE24
PHASE32
PHASE1/PHASE21

Top trials by phase / activity

NCTPhaseStatusTitle
NCT02312206PHASE3TERMINATEDThe VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
NCT04973137PHASE3TERMINATEDA Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
NCT01707264PHASE1/PHASE2COMPLETEDPhase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
NCT02613182PHASE2TERMINATEDOpen-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
NCT02632786PHASE2COMPLETEDThe PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
NCT03154047PHASE2TERMINATEDStudy in Subjects With Light Chain (AL) Amyloidosis
NCT03168906PHASE2TERMINATEDRenal 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.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).