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Romosozumab · Evenity, AMG-785

Monoclonal antibody · Antagonist of sclerostin (SOST) · developed by Amgen

Approved FDA, Apr 2019
AMGN Developer
1 Registered trials

What is Romosozumab?

Romosozumab is a humanized IgG2 monoclonal antibody that inhibits sclerostin, a negative regulator of bone formation. It stimulates osteoblastic activity, increasing bone formation and decreasing bone resorption to improve bone mass and structure.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Evenity, AMG-785, CDP-7851
Drug type
Monoclonal antibody
Targets
sclerostin (SOST)
Mechanism
Antagonist of sclerostin (SOST)
Pathways
Wnt signaling, osteoblast development and function
Therapy area
Endocrine
Developer
Amgen Inc (AMGN)
FDA status
Approved as Evenity (April 9, 2019), BLA761062 · FDA label
UNII
3VHF2ZD92J

✅ FDA-approved uses

From the indications section of the FDA label (version of Jul 16, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07811999 Phase 1 Healthy Participants Not yet recruiting AMGN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Healthy Participants

More from Amgen

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the AMGN page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

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