X-linked Hypophosphatemia

5
Pipeline Programs
2
Companies
9
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
2
0
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 2 programs with unclassified modality

On Market (1)

Approved therapies currently available

Kyowa Hakko Kirin
CRYSVITAApproved
burosumab
Kyowa Hakko Kirin
injection2018

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
4 programs
2
2
1
BurosumabPhase 3Monoclonal Antibody1 trial
burosumabPhase 3Monoclonal Antibody1 trial
KK8123Phase 1/21 trial
KRN23Phase 1/25 trials
Active Trials
NCT06525636Recruiting24Est. May 2028
NCT02750618Completed13Est. Sep 2019
NCT02537431Completed14Est. Dec 2018
+5 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Kyowa Hakko KirinBurosumab
Kyowa Hakko Kirinburosumab
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKK8123
Kyowa Hakko KirinKRN23

Clinical Trials (9)

Total enrollment: 260 patients across 9 trials

NCT04695860Kyowa Hakko KirinBurosumab

Anti-FGF23 (Burosumab) in Adult Patients With XLH

Start: Jan 2021Est. completion: Mar 202336 patients
Phase 3Completed
NCT02915705Kyowa Hakko Kirinburosumab

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

Start: Sep 2016Est. completion: Jul 201961 patients
Phase 3Completed
NCT02537431Kyowa Hakko KirinKRN23

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

Start: Dec 2015Est. completion: Dec 201814 patients
Phase 3Completed
NCT02750618Kyowa Hakko KirinKRN23

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

Start: May 2016Est. completion: Sep 201913 patients
Phase 2Completed
NCT02304367Kyowa Hakko KirinKRN23

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

Start: Mar 2015Est. completion: Jan 202117 patients
Phase 2Completed
NCT02312687Kyowa Hakko KirinKRN23

Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)

Start: Jan 2015Est. completion: Nov 201820 patients
Phase 2Completed
NCT02163577Kyowa Hakko KirinKRN23

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

Start: Jul 2014Est. completion: Oct 201852 patients
Phase 2Completed
NCT06525636Kyowa Hakko KirinKK8123

A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia

Start: Oct 2024Est. completion: May 202824 patients
Phase 1/2Recruiting
NCT01571596Kyowa Hakko KirinKRN23

An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

Start: Feb 2012Est. completion: Jun 201423 patients
Phase 1/2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 260 patients
2 companies competing in this space