CDEK
← All drugs Report issue

burosumab-twza

Trade name: crysvita

mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Apr 17, 2018

Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia. — Wikipedia

Clinical trial activity

27 trials · 11 clinical orgs · 2 marketing orgs

Phase 1
6
Phase 2
17
Phase 3
8
Phase 4
6

Earliest trial started Dec 1, 2008 (NCT00830674)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  2. Dec 14, 2009

    Orphan Drug Designation

2010s

  1. Jan 1, 2014

    Ultragenyx Inc. — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    Ultragenyx Inc. — Earliest Phase 3 Sponsor(trial)

  3. Apr 17, 2018

    Ultragenyx Inc. — Earliest FDA Approval

  4. Apr 17, 2018

    Ultragenyx Inc. — Marketing Organization

  5. Apr 17, 2018

    Kyowa Kirin — Marketing Organization

  6. Apr 17, 2018

    Ultragenyx Inc. — NDA Organization

  7. Apr 17, 2018

    Kyowa Kirin — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughApr 17, 2018

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • burosumab
  • burosumab
  • burosumab
  • burosumab-twza
  • krn23
  • krn-23

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05509595Phase 2Dec 7, 2022National Institute of Dental and Craniofacial Research (NIDCR)
NCT05357573Phase 4Aug 11, 2022Kyowa Hakko Kirin
NCT04695860Phase 3Dec 31, 2021Julius-Maximilians University, Kyowa Kirin
NCT04842032Phase 4Oct 5, 2021Kyowa Hakko Kirin
NCT04842019Phase 4Aug 30, 2021Kyowa Hakko Kirin
NCT04320316Phase 4Apr 15, 2020Ultragenyx Inc., University of Alabama, Birmingham
NCT04188964Phase 1/Phase 2 (Phase 2)Feb 29, 2020Kyowa Hakko Kirin
NCT04146935Phase 4Nov 30, 2019Yale University
NCT03993821Early Phase 1 (Phase 1)Aug 31, 2019Children's National Medical Center, Ultragenyx Inc.
NCT03920072Phase 3Mar 7, 2019Assistance Publique - Hôpitaux de Paris, Kyowa Hakko Kirin
NCT04419363Phase 4Mar 18, 2018Assistance Publique - Hôpitaux de Paris
NCT03581591Phase 3Jan 31, 2018Redwood Dermatology Center, Ultragenyx Inc.
NCT04308096Phase 3Jan 9, 2018Kyowa Hakko Kirin
NCT03233126Phase 3Jul 6, 2017Kyowa Hakko Kirin
NCT02915705Phase 3Sep 1, 2016Kyowa Hakko Kirin, Ultragenyx Inc.
NCT02750618Phase 2May 1, 2016Indiana University, Ultragenyx Inc.
NCT02722798Phase 2Apr 1, 2016Kyowa Hakko Kirin
NCT02537431Phase 3Dec 1, 2015Kyowa Hakko Kirin, Ultragenyx Inc.
NCT02526160Phase 3Oct 1, 2015Kyowa Hakko Kirin, Ultragenyx Inc.
NCT02304367Phase 2Apr 23, 2015Ultragenyx Inc.
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Kyowa Hakko KirinFor profit181252008
Ultragenyx Inc.For profit11852014
Yale UniversityAcademic/Hospital3132008
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2122018
Children's National Medical CenterAcademic/Hospital1112019
Indiana UniversityAcademic/Hospital1012016
Julius-Maximilians UniversityAcademic/Hospital1112021
Kyowa KirinFor profit1012021
National Institute of Dental and Craniofacial Research (NIDCR)Government1112022
Redwood Dermatology CenterAcademic/Hospital1112018
University of Alabama, BirminghamAcademic/Hospital1112020
11 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Kyowa KirinFor profitMKTGApr 17, 2018
Kyowa KirinFor profitNDA2Apr 17, 2018
Ultragenyx Inc.For profitMKTGApr 17, 2018
Ultragenyx Inc.For profitNDAApr 17, 2018