Drug Profile

Setrusumab - Mereo BioPharma/Ultragenyx Pharmaceutical

Alternative Names: Anti-sclerostin-monoclonal-antibody-Mereo; BPS-804; UX-143

Latest Information Update: 18 Aug 2026

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At a glance

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Osteogenesis imperfecta
New Molecular Entity Yes
Available For Licensing Yes

11 Aug 2026 Mereo and Ultragenyx Pharmaceutical hold discussions with the regulators in the US and UK for setrusumab in Osteogenesis imperfecta (In children), prior to August 2026
11 Aug 2026 Mereo and Ultragenyx Pharmaceutical engages with regulatory agencies to determine a potential path forward for setrusumab in paediatric patients with Osteogenesis imperfecta, prior to August 2026
29 Dec 2025 Efficacy and adverse events data from the phase III COSMIC trial in Osteogenesis imperfecta released by Ultragenyx Pharmaceutical

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