Drugs / Burosumab

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) CRYSVITA 2019-09-27 – 2026-04-23 fda.gov
Approved US (FDA) CRYSVITA 2018-04-17 fda.gov
Approved EU (EMA) Crysvita 2018-02-19 europa.eu

Trials 26 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03993821 Jul 2019 → Oct 2022 epidermal nevus syndrome, hypophosphatemic bone disease Laura Tosi Unknown No outcome recorded
Phase 12 trials
Phase 1 NCT02181764 Jul 2014 → Jun 2015 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT00830674 Dec 2008 → Dec 2011 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04188964 Feb 2020 → Oct 2023 X-linked hypophosphatemic rickets Kyowa Kirin Pharmaceutical Development Ltd Completed No outcome recorded
Phase 1/2 NCT01571596 Feb 2012 → Sep 2013 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1/2 NCT01340482 Apr 2011 → May 2013 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 26 trials
Phase 2 NCT05509595 Dec 2022 → Nov 2024 fibrous dysplasia National Institute of Dental and Craniofacial Research (NIDCR) Completed No outcome recorded
Phase 2 NCT02750618 May 2016 → Apr 2017 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 2 NCT02722798 Apr 2016 → Jul 2017 Oncogenic osteomalacia Kyowa Kirin, Inc. Completed No outcome recorded
Phase 2 NCT02304367 Mar 2015 → Jul 2017 Oncogenic osteomalacia, epidermal nevus syndrome Kyowa Kirin, Inc. Completed No outcome recorded
Phase 2 NCT02312687 Jan 2015 → Nov 2018 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 2 NCT02163577 Jul 2014 → Oct 2018 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 38 trials
Phase 3 NCT04695860 Jan 2021 → Mar 2023 X-linked hypophosphatemic rickets Wuerzburg University Hospital Completed No outcome recorded
Phase 3 NCT03920072 Mar 2019 → Apr 2022 X-linked hypophosphatemic rickets Kyowa Kirin Pharmaceutical Development Ltd Completed No outcome recorded
Phase 3 NCT03581591 Jan 2018 → Dec 2019 chronic pain syndrome, hypophosphatemia, hypophosphatemic rickets Redwood Dermatology Sciences Completed No outcome recorded
Phase 3 NCT04308096 Jan 2018 → Dec 2020 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 3 NCT03233126 Jul 2017 → Feb 2020 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 3 NCT02915705 Sep 2016 → Feb 2018 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 3 NCT02537431 Dec 2015 → Aug 2017 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 3 NCT02526160 Oct 2015 → Dec 2016 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 46 trials
Phase 4 NCT05357573 Sep 2022 → Nov 2023 Oncogenic osteomalacia Kyowa Kirin, Inc. Completed No outcome recorded
Phase 4 NCT04842032 Nov 2021 → Dec 2023 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 4 NCT04842019 Sep 2021 → Aug 2023 X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Completed No outcome recorded
Phase 4 NCT04320316 Jul 2020 → Jul 2021 epidermal nevus syndrome University of Alabama at Birmingham Completed No outcome recorded
Phase 4 NCT04146935 Nov 2019 → Aug 2022 X-linked hypophosphatemic rickets Yale University Completed No outcome recorded
Phase 4 NCT04419363 Mar 2018 → Mar 2019 Gaucher ichthyosis restrictive dermopathy, X-linked hypophosphatemic rickets Bicetre Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT03775187 Background Oncogenic osteomalacia, X-linked hypophosphatemic rickets Kyowa Kirin, Inc. Available No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Burosumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT02304367
14

NCT02750618

NCT02915705

NCT03920072

NCT04188964

NCT03775187

NCT04695860

NCT02537431

NCT03581591

NCT03993821

NCT04146935

NCT05509595

NCT04419363

NCT02526160

NCT02163577

Known as burosumab-twza ClinicalTrials.gov intervention name — accepted as the source's own label NCT04320316
Known as Crysvita Crysvita (burosumab-twza) Treatment” NCT04320316
Known as KRN23 “Burosumab (KRN23), is an IgG1 monoclonal antibody that binds to the FGF23 receptor and inhibits the activity of FGF23.” PMID 35899095 Jul 2022
12

“Anti- FGF23 Antibody Burosumab (KRN23) in Adult Patients” NCT04695860

NCT02722798

NCT00830674

NCT01340482

NCT04308096

NCT05357573

NCT02181764

NCT03233126

NCT04842032

NCT04842019

NCT02312687

NCT01571596

Action Inhibit “blocks its activity” PMID 26073451 Aug 2015
Modality Monoclonal antibody “KRN23 is a recombinant human IgG1 monoclonal antibodyPMID 26073451 Aug 2015
Route Intravenous “Single IV administration on day 1” NCT00830674
Target FGF23 “human anti-FGF23 antibody” PMID 24569459 Feb 2014