CRYSVITA

(burosumab)

Phase 3Monoclonal antibody

Kyowa Kirin Co., Ltd.

CRYSVITA is one of 43 biologic programs targeting Hypophosphatemic Rickets. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Hypophosphatemic RicketsActive, not recruiting

Fibrous DysplasiaActive, not recruiting

X-Linked HypophosphatemiaActive, not recruiting

GrowthActive, not recruiting

Hypophosphatemic RicketsPhase 3

Active, not recruiting

Fibrous DysplasiaPhase 2

Active, not recruiting

X-Linked HypophosphatemiaPhase 2

Active, not recruiting

GrowthPreclinical

Active, not recruiting

Competition

Competitive Landscape

364 competitors in Growth

#DrugCompanyPhaseTrials

CRYSVITA

Kyowa Kirin Co., Ltd.

Phase 3

16 2

Genotropin

EMD Serono

Preclinical

35 3

Lovenox

Sanofi

Preclinical

2 4

Lenvima

Eisai

Preclinical

1 5

Aricept

Eisai

Preclinical

1 6

Zolymbus

AbbVie

Preclinical

1 7

Zyloprim

Alnylam Pharmaceuticals

Preclinical

1 8

Somavaratan

Herceptin

4 10

Glucophage

EMD Serono

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

X-linked hypophosphatemia6 trials

Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Completed·KKyowa Kirin, Inc.·Phase 3·NCT02526160·134 enrolled

Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Completed·KKyowa Kirin, Inc.·Phase 3·NCT02537431·14 enrolled

Burosumab in Children and Adolescents With X-linked Hypophosphatemia

Unknown status·—·Phase 4·NCT04419363·57 enrolled

Show 3 more trials

Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

Completed·KKyowa Kirin, Inc.·Phase 2·NCT02750618·13 enrolled

Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)

Completed·KKyowa Kirin, Inc.·Phase 2·NCT02163577·52 enrolled

An Observational, Prospective, European, Multicentre, Mixed Methods Study to Describe the Lived Experience of X-Linked Hypophosphatemia (XLH) for Adolescents at End of Skeletal Growth

Completed·KKyowa Kirin Pharmaceutical Development Ltd··NCT05181839·25 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH

Completed·KKyowa Kirin, Inc.·Phase 3·NCT02915705·61 enrolled

Adult1 trial

Anti-FGF23 (Burosumab) in Adult Patients With XLH

Completed·WWuerzburg University Hospital·Phase 3·NCT04695860·36 enrolled

Function1 trial

Examining the Effect of Burosumab on Muscle Function

Completed·YYale University·Phase 4·NCT04146935·10 enrolled

ESS1 trial

Expanded Access to Burosumab

Available· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.··NCT03775187

6 more indications

Hypophosphatemic Rickets1 trial

Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets

Completed·RRedwood Dermatology Sciences·Phase 3·NCT03581591·1 enrolled

Antibody1 trial

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

Completed·KKyowa Kirin Pharmaceutical Development Ltd·Phase 3·NCT03920072·35 enrolled

Efficacy1 trial

Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age

Completed·KKyowa Kirin Pharmaceutical Development Ltd·Phase 1/2·NCT04188964·16 enrolled

Tumor-Induced Osteomalacia1 trial

Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)

Completed·KKyowa Kirin, Inc.·Phase 2·NCT02304367·17 enrolled

Fibrous Dysplasia1 trial

Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT05509595·12 enrolled

Unspecified1 trial

Burosumab for CSHS

Unknown status·LLaura Tosi·Phase 1·NCT03993821·1 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 17, 2018

CRYSVITA

BLA BLA761068

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for burosumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — burosumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for burosumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761068). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Kyowa Kirin Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Kyowa Kirin Co., Ltd.

CRYSVITA

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

X-linked hypophosphatemia6 trials

Efficacy and Safety1 trial

Adult1 trial

Function1 trial

ESS1 trial

Hypophosphatemic Rickets1 trial

Antibody1 trial

Efficacy1 trial

Tumor-Induced Osteomalacia1 trial

Fibrous Dysplasia1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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