CDEK
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romosozumab

Trade name: Evenity

mAbapproved

Approved

Apr 9, 2019

Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis. It has been found to decrease the risk of fractures of the spine. — Wikipedia

Clinical trial activity

42 trials · 20 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
19
Phase 3
11
Phase 4
14

Earliest trial started Dec 1, 2006 (NCT01059435)

Timeline

2000s

  1. Jan 1, 2006

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    Amgen — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Amgen — Earliest Phase 3 Sponsor(trial)

  2. Apr 9, 2019

    Amgen — Earliest FDA Approval

  3. Apr 9, 2019

    Amgen — Marketing Organization

  4. Apr 9, 2019

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • SclerostinINHIBITOR

    SOST inhibitor

    Inhibits the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown.

Approval history

  • approvedApr 9, 2019

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • amg785
  • amg 785
  • amg 785
  • amg-785
  • amg-785
  • cdp7851
  • cdp 7851
  • cdp-7851
  • cdp-7851
  • romosozumab
  • romosozumab
  • romosozumab
  • romosozumab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06973109Phase 2Dec 31, 2025Amgen, University of Pittsburgh
NCT07283887Phase 4Dec 3, 2025National Taiwan University
NCT06975644N/ASep 1, 2025Zhejiang University
NCT07010393Phase 4Jul 1, 2025Fujian Medical University
NCT06938152Phase 4Apr 8, 2025National Taiwan University
NCT06558188Phase 4Apr 1, 2025Harvard University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NCT06720350Phase 4Jan 15, 2025Marmara University
NCT06533865Phase 3Oct 1, 2024Harvard University
NCT06472050Phase 4Sep 30, 2024Tuen Mun Hospital, Hong Kong
NCT05972551Phase 3Jan 5, 2024Amgen
NCT06079476Phase 4Oct 30, 2023Amgen
NCT06059222Phase 4Oct 2, 2023Aarhus University
NCT05775094Phase 1Mar 7, 2023Memorial Sloan-Kettering Cancer Center
NCT05010590Phase 4Jan 1, 2022Harvard University
NCT05101018Phase 4Nov 1, 2021Department of Veteran Affairs, Kessler Institute for Rehabilitation
NCT05067335Phase 3Oct 21, 2021UCB
NCT04779216Phase 3Sep 20, 2021Amgen, Harvard University
NCT05058976Phase 4Sep 15, 2021National Institute on Aging (NIA), National Institutes of Health (NIH), University of Pittsburgh
NCT04800367Phase 2Mar 12, 2021Amgen, Columbia University
NCT05180032Phase 4Mar 1, 2021Department of Veteran Affairs, Kessler Institute for Rehabilitation
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit242042006
Harvard UniversityAcademic/Hospital4422021
Department of Veteran AffairsGovernment3322020
Kessler Institute for RehabilitationAcademic/Hospital3022020
National Taiwan UniversityAcademic/Hospital2212025
Tuen Mun Hospital, Hong KongAcademic/Hospital2212020
University of PittsburghAcademic/Hospital2222021
Aarhus UniversityAcademic/Hospital1112023
Columbia UniversityAcademic/Hospital1112021
Fujian Medical UniversityAcademic/Hospital1112025
Hoosier Cancer Research NetworkAcademic/Hospital1012009
Marmara UniversityAcademic/Hospital1112025
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112023
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government1012025
National Institute on Aging (NIA)Government1012021
National Institutes of Health (NIH)Government1012021
Northwestern UniversityAcademic/Hospital1112021
Tel Aviv UniversityAcademic/Hospital1112020
UCBFor profit1112021
Zhejiang UniversityAcademic/Hospital1112025
20 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGApr 9, 2019
AmgenFor profitNDAApr 9, 2019