Drugs / Setrusumab
last change Oct 2025 re-read 2 minutes ago

Setrusumab

also known as BPS804 · MOR05813

Monoclonal antibody targets SOST via inhibition

Developed for
osteogenesis imperfecta · hypophosphatasia · osteogenesis imperfecta type 1 · osteogenesis imperfecta type 3 · osteogenesis imperfecta type 4 · osteoporosis
Investigated by
Ultragenyx Pharmaceutical Inc · Mereo BioPharma · Novartis

Trials 10 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 27 trials
Phase 2 NCT05312697 Apr → Jul 2022 osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Terminated No outcome recorded
Phase 2 NCT03216486 Oct 2017 → Nov 2018 osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Withdrawn No outcome recorded
Phase 2 NCT03118570 Sep 2017 → Oct 2019 osteogenesis imperfecta type 1, osteogenesis imperfecta type 3, osteogenesis imperfecta type 4 Ultragenyx Pharmaceutical Inc Completed No outcome recorded
Phase 2 NCT01806610 Aug 2013 → Apr 2014 end stage renal failure Ultragenyx Pharmaceutical Inc Withdrawn No outcome recorded
Phase 2 NCT01406548 Jul 2011 → Oct 2013 osteoporosis Ultragenyx Pharmaceutical Inc Completed No outcome recorded
Phase 2 NCT01406977 Jul 2011 → Sep 2012 hypophosphatasia Ultragenyx Pharmaceutical Inc Completed No outcome recorded
Phase 2 NCT01417091 Jun 2011 → Dec 2012 osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05125809 Feb 2022 → Oct 2025 overdue osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Active not recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT06636071 Oct 2024 → Jan 2027 expected osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Active not recruiting No outcome recorded
Phase 3 NCT05768854 Jun 2023 → Oct 2025 overdue osteogenesis imperfecta Ultragenyx Pharmaceutical Inc Active not recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Setrusumab “BPS804 IV Setrusumab given in escalating doses from 5mg/Kg to 20mg/Kg” NCT01406977
5

NCT03118570

NCT05125809

NCT06636071

NCT05768854

NCT05312697

Known as BPS804 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03216486
4

NCT01417091

NCT01406977

NCT01806610

NCT01406548

Known as MOR05813 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297918
Action Inhibit “Setrusumab, a neutralizing antibody to sclerostin” PMID 39012717 Sep 2024
1

“Sclerostin inhibitor” CHEMBL4297918

Modality Monoclonal antibody “BPS804, a fully human anti-sclerostin monoclonal antibodyPMID 28436937 Apr 2017
Route Intravenous “received 3 ascending intravenous doses of 5, 10, and 20 mg/kg BPS804” PMID 28436937 Apr 2017
Target SOST “Sclerostin inhibitor” CHEMBL4297918