19 completed, 1 available. 8 Phase 2, 6 Phase 3, 5 Phase 1, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 8 |
| Phase 3 | 6 | Completed 6 |
| Phase 1 | 5 | Completed 5 |
| Phase 4 | 3 | Completed 3 |
Follow KRN23: new trials by email Literature Review of KRN23 trials Research Report on KRN23
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO KRN23 - Tumor-Induced Osteomalacia (TIO) | Phase 4 | Completed | Kyowa Kirin Co., Ltd. | 9 | 2022-09-07 | 2024-07-09 |
| Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH KRN23 - X-linked Hypophosphatemia (XLH) | Phase 4 | Completed | Kyowa Kirin Co., Ltd. | 28 | 2021-11-01 | 2024-07-09 |
| Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH KRN23 - X-linked Hypophosphatemia (XLH) | Phase 4 | Completed | Kyowa Kirin Co., Ltd. | 18 | 2021-09-28 | 2024-07-09 |
| Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age Burosumab - X-linked Hypophosphatemia (XLH) | Phase 1 / Phase 2 | Completed | Kyowa Kirin Pharmaceutical Development Ltd | 16 | 2020-02-26 | 2024-11-07 |
| Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH Burosumab - X-linked Hypophosphatemia | Phase 3 | Completed | Kyowa Kirin Pharmaceutical Development Ltd | 35 | 2019-03-07 | 2022-05-20 |
| A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia KRN23 - XLH | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 27 | 2018-01-09 | 2022-09-06 |
| A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia KRN23 - X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 16 | 2017-07-06 | 2022-09-06 |
| Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH burosumab, Oral Phosphate Supplement, active vitamin D - X-Linked Hypophosphatemia | Phase 3 | Completed | Kyowa Kirin, Inc. | 61 | 2016-09-08 | 2024-08-29 |
| Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH) Burosumab - X-Linked Hypophosphatemia | Phase 2 | Completed | Kyowa Kirin, Inc. | 13 | 2016-05-05 | 2024-05-06 |
| A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome KRN23 - Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 14 | 2016-04-01 | 2022-09-06 |
| Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH) burosumab - X-linked Hypophosphatemia | Phase 3 | Completed | Kyowa Kirin, Inc. | 14 | 2015-12-23 | 2024-06-18 |
| Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) burosumab, Placebo - X-linked Hypophosphatemia | Phase 3 | Completed | Kyowa Kirin, Inc. | 134 | 2015-10-22 | 2024-06-18 |
| Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS) Burosumab - Tumor Induced Osteomalacia (TIO), Epidermal Nevus Syndrome (ENS) | Phase 2 | Completed | Kyowa Kirin, Inc. | 17 | 2015-03-24 | 2024-05-06 |
| Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH) KRN23 - X-Linked Hypophosphatemia | Phase 2 | Completed | Kyowa Kirin, Inc. | 20 | 2015-01-30 | 2024-05-06 |
| Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) burosumab - X-linked Hypophosphatemia | Phase 2 | Completed | Kyowa Kirin, Inc. | 52 | 2014-07-02 | 2024-05-06 |
| A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia KRN23 - X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 15 | 2014-07-01 | 2017-03-03 |
| An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia KRN23 - X-linked Hypophosphatemia | Phase 1 / Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 23 | 2012-02-01 | 2024-06-18 |
| A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia KRN23 - X-linked Hypophosphatemia | Phase 1 / Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 29 | 2011-04-01 | 2024-06-18 |
| A Study of KRN23 in X-linked Hypophosphatemia Placebo, KRN23 - X-linked Hypophosphatemia | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 42 | 2008-12-01 | 2024-06-17 |
| Expanded Access to Burosumab Burosumab - X-linked Hypophosphatemia, Tumor-Induced Osteomalacia | Available | Kyowa Kirin Co., Ltd. | 2025-03-05 |
Familial Hypophosphatemic Rickets (16) · Oncogenic osteomalacia (4) · Nevus, Sebaceous of Jadassohn (2) · Osteomalacia (2)
Kyowa Kirin Co., Ltd. (11) · Kyowa Kirin, Inc. (7) · Kyowa Kirin Pharmaceutical Development Ltd (2)
United States (10) · Japan (7) · South Korea (6) · France (5) · United Kingdom (5) · Canada (4) · China (3) · Italy (3) · Ireland (2) · Sweden (2) · Australia (1) · Austria (1) · Denmark (1) · Netherlands (1) · Spain (1)
Amy Zhang, PhD (2) · Peter Kamenicky (1) · Thomas O. Carpenter, M.D. (1)
PMID 39151033, PMID 32721016, PMID 25919461, PMID 36719566, PMID 36854566, PMID 24569459, PMID 26073451, PMID 29791829, PMID 29947083, PMID 30638856, PMID 31104833, PMID 31165191, PMID 33484279, PMID 34548383, PMID 34636899, PMID 34660853, PMID 35533340, PMID 35775373, PMID 35927518, PMID 36072994, PMID 37084401, PMID 42044650
2014 (1)