Burosumab

Summary

Burosumab (CHEMBL3707326) is an approved antibody (ATC M05BX05); indicated across 7 conditions including bone disorder and osteomalacia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: M05BX05
• Indications: 7 conditions
• Clinical trials: 26

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3707326
Name	Burosumab
Type	Antibody
Max phase	4
ATC	M05BX05

Also known as: Burosumab, Burosumab twza, Burosumab-twza, Crysvita, KRN-23, KRN23, BUROSUMAB

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

7 indications (5 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
bone disorder	4	MONDO:0005381	EFO:0004260
osteomalacia	4	MONDO:0001068	EFO:1002027
X-linked hypophosphatemic rickets	4	MONDO:0020720	Orphanet:89936
hypophosphatemia	4	MONDO:0000313	HP:0002148
hypophosphatemic rickets	3	MONDO:0024300	MONDO:0024300
fibrous dysplasia	2	MONDO:0000845	MONDO:0000845

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 26.

Phase distribution

Phase	Trials
PHASE3	8
PHASE2	6
PHASE4	4
PHASE1/PHASE2	3
PHASE1	2
Not specified	2
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04419363	PHASE4	UNKNOWN	Burosumab in Children and Adolescents With X-linked Hypophosphatemia
NCT04842019	PHASE4	COMPLETED	Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH
NCT04842032	PHASE4	COMPLETED	Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
NCT05357573	PHASE4	COMPLETED	Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO
NCT02526160	PHASE3	COMPLETED	Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
NCT02537431	PHASE3	COMPLETED	Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
NCT02915705	PHASE3	COMPLETED	Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
NCT03233126	PHASE3	COMPLETED	A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
NCT03581591	PHASE3	COMPLETED	Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets
NCT03920072	PHASE3	COMPLETED	Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
NCT04308096	PHASE3	COMPLETED	A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
NCT04695860	PHASE3	COMPLETED	Anti-FGF23 (Burosumab) in Adult Patients With XLH
NCT01340482	PHASE1/PHASE2	COMPLETED	A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
NCT01571596	PHASE1/PHASE2	COMPLETED	An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
NCT02163577	PHASE2	COMPLETED	Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
NCT02304367	PHASE2	COMPLETED	Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)
NCT02312687	PHASE2	COMPLETED	Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
NCT02722798	PHASE2	COMPLETED	A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
NCT02750618	PHASE2	COMPLETED	Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
NCT04188964	PHASE1/PHASE2	COMPLETED	Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
NCT05509595	PHASE2	COMPLETED	Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
NCT00830674	PHASE1	COMPLETED	A Study of KRN23 in X-linked Hypophosphatemia
NCT02181764	PHASE1	COMPLETED	A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
NCT03993821	EARLY_PHASE1	UNKNOWN	Burosumab for CSHS
NCT03775187	Not specified	AVAILABLE	Expanded Access to Burosumab
NCT05181839	Not specified	COMPLETED	A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth

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).