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X-linked Hypophosphatemia

1
Pipeline Programs
4
Companies
12
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 4 programs with unclassified modality

Competitive Landscape

3 companies ranked by most advanced pipeline stage

UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
CalcitriolPhase 41 trial
Active Trials
NCT03820518Unknown100Est. Dec 2022
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
4 programs
KK8123PHASE_1_21 trial
KRN23PHASE_1_25 trials
BurosumabPHASE_3Monoclonal Antibody1 trial
burosumabPHASE_3Monoclonal Antibody1 trial
Active Trials
NCT06525636Recruiting24Est. May 2028
NCT02750618Completed13Est. Sep 2019
NCT02537431Completed14Est. Dec 2018
+5 more trials
IQVIA
IQVIADURHAM, NC
1 program
Registry for Patients With X-Linked HypophosphatemiaN/A1 trial
Active Trials
NCT03193476Recruiting1,343Est. Jul 2029

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
UNION therapeuticsCalcitriol
Kyowa Hakko KirinBurosumab
Kyowa Hakko Kirinburosumab
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKRN23
Kyowa Hakko KirinKK8123
Kyowa Hakko KirinKRN23
IQVIARegistry for Patients With X-Linked Hypophosphatemia

Clinical Trials (12)

Total enrollment: 1,837 patients across 12 trials

NCT03820518UNION therapeuticsCalcitriol

Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia

Start: Jan 2017Est. completion: Dec 2022100 patients
Phase 4Unknown
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
NCT02526160Kyowa Hakko KirinKRN23

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

Start: Oct 2015Est. completion: Dec 2018134 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
NCT03193476IQVIARegistry for Patients With X-Linked Hypophosphatemia

Registry for Patients With X-Linked Hypophosphatemia

Start: Sep 2017Est. completion: Jul 20291,343 patients
N/ARecruiting

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 actively recruiting trials targeting 1,837 patients
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.