Drugs / Setrusumab
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials | ||||||
| Phase 2 | NCT05312697 | Apr → Jul 2022 | osteogenesis imperfecta | Ultragenyx Pharmaceutical Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03216486 | Oct 2017 → Nov 2018 | osteogenesis imperfecta | Ultragenyx Pharmaceutical Inc | Withdrawn | No outcome recorded |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 | Mixed |
| Phase 2 | NCT01806610 | Aug 2013 → Apr 2014 | end stage renal failure | Ultragenyx Pharmaceutical Inc | Withdrawn | No outcome recorded |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 · 1 missed | ||||||
| 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 | Missed primary |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-12-29 | Mereo BioPharma | Results Mereo BioPharma Announces Phase 3 ORBIT and COSMIC Results for Setrusumab (UX143) in Osteogenesis Imperfecta mereobiopharma.com ↗
Neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively. |
| 2025-12-29 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx Announces Phase 3 Orbit and Cosmic Results for Setrusumab (UX143) in Osteogenesis Imperfecta ultragenyx.com ↗
Neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively. |
| 2025-07-09 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx and Mereo BioPharma Announce UX143 Phase 3 Orbit Study for Osteogenesis Imperfecta Progressing to Final Analysis ultragenyx.com ↗
The Data Monitoring Committee (DMC) met and informed the company that UX143 demonstrates an acceptable safety profile and the company should continue the study to the final analysis. |
| 2025-05-30 | Mereo BioPharma | Results Mereo BioPharma Group plc Announces Positive Early 6 Month Data from the Open Label Arm of the Phase 2b Clinical Study in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with the Anti-Sclerostin Antibody, BPS-804 (setrusumab) mereobiopharma.com ↗
today announced encouraging 6 month data from the open label arm of its phase 2b dose-ranging clinical study in adults with Type I, III or IV osteogenesis imperfecta (OI) treated with BPS-804 (setrusumab) |
| 2024-11-12 | Mereo BioPharma | Regulatory Mereo BioPharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update mereobiopharma.com ↗
The recent receipt of Breakthrough Therapy designation from the U.S. FDA follows on from the PRIME designation we obtained in Europe. |
| 2024-10-07 | Ultragenyx Pharmaceutical Inc | Regulatory Ultragenyx Receives Breakthrough Therapy Designation for Setrusumab (UX143) in Osteogenesis Imperfecta ultragenyx.com ↗
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for setrusumab (UX143) as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta (OI) Type I, III, or IV in patients 2 years of age and older. |
| 2024-08-13 | Mereo BioPharma | Results Mereo BioPharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update mereobiopharma.com ↗
New long-term Phase 2 data from the Phase 2/3 Orbit study demonstrated continued reduction in fracture rates |
| 2024-06-11 | Mereo BioPharma | Results Ultragenyx and Mereo BioPharma Announce New Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Sustained Reductions in Fracture Rates Following Treatment with Setrusumab (UX143) in Patients with Osteogenesis Imperfecta (OI) mereobiopharma.com ↗ |
| 2024-06-11 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx and Mereo BioPharma Announce New Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Sustained Reductions in Fracture Rates Following Treatment with Setrusumab (UX143) in Patients with Osteogenesis Imperfecta (OI) ultragenyx.com ↗
The large reduction in annualized radiologically confirmed fracture rate previously reported in patients treated for a minimum of 6 months was sustained in patients treated for at least 14 months with a high degree of significance. |
| 2023-10-16 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx Announces Program and Pipeline Updates at Analyst Day Including Interim Data from Ongoing Studies in Osteogenesis Imperfecta (OI), Angelman Syndrome (AS) and Wilson Disease ultragenyx.com ↗
Treatment with setrusumab (UX143) for at least 6 months resulted in 67% reduction in annualized fracture rate in patients with OI in Phase 2/3 Orbit study |
| 2023-10-14 | Mereo BioPharma | Results Ultragenyx and Mereo BioPharma Announce Interim Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Setrusumab (UX143) Significantly Reduced Fracture Rates in Patients with Osteogenesis Imperfecta (OI) mereobiopharma.com ↗
The median annualized fracture rate of 0.72 in the 2 years prior to treatment was reduced to 0.00 (n=24, p=0.042) during the mean treatment duration period of 9 months. |
| 2023-10-14 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx and Mereo BioPharma Announce Interim Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Setrusumab (UX143) Significantly Reduced Fracture Rates in Patients with Osteogenesis Imperfecta (OI) ultragenyx.com ↗
As of the cut-off date and following at least 6 months of treatment with setrusumab, the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%. |
| 2023-06-05 | Mereo BioPharma | Results Ultragenyx and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI) mereobiopharma.com ↗
Across all patients evaluated, as of the data cut off, setrusumab demonstrated statistically significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months. |
| 2023-06-05 | Ultragenyx Pharmaceutical Inc | Results Ultragenyx and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI) ultragenyx.com ↗
Across all patients evaluated setrusumab demonstrated statistically significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months. |
| 2021-10-01 | Mereo BioPharma | Results Mereo BioPharma and Ultragenyx Present Data from the Phase 2b ASTEROID Study of UX143 (setrusumab) in Osteogenesis Imperfecta (OI) at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting mereobiopharma.com ↗
today presented secondary endpoint data on UX143 (setrusumab) from the Phase 2b ASTEROID study for the Treatment of Osteogenesis Imperfecta (OI). |
| 2021-10-01 | Ultragenyx Pharmaceutical Inc | Results Mereo BioPharma and Ultragenyx Present Data from the Phase 2b ASTEROID Study of UX143 (setrusumab) in Osteogenesis Imperfecta (OI) at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting ultragenyx.com ↗
today presented secondary endpoint data on UX143 (setrusumab) from the Phase 2b ASTEROID study for the Treatment of Osteogenesis Imperfecta (OI). |
| 2020-09-24 | Mereo BioPharma | Regulatory Mereo BioPharma Receives FDA Rare Pediatric Disease Designation for Setrusumab for the Treatment of Osteogenesis Imperfecta mereobiopharma.com ↗
today announces that the U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease designation to setrusumab for the treatment of osteogenesis imperfecta (“OI”). |
| 2020-01-14 | Mereo BioPharma | Results Mereo BioPharma Announces Additional Positive Data from Phase 2b ASTEROID Study of Setrusumab in Adults with Osteogenesis Imperfecta and Provides Update on Regulatory Progress mereobiopharma.com ↗
Additional Data Demonstrate Dose-Dependent Increase in Bone Strength Stiffness and Failure Load at the Radius as Measured by Finite Element Analysis, a Second Prespecified Primary Endpoint, Reaching Statistical Significance in High Dose Cohort |
| 2019-11-11 | Mereo BioPharma | Results Mereo BioPharma’s Setrusumab Demonstrates Dose-Dependent Bone Building and Trend in Fracture Reduction in Phase 2b ASTEROID Study in Adults with Osteogenesis Imperfecta mereobiopharma.com ↗ |
All press releases naming this drug 35 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Setrusumab | “BPS804 IV Setrusumab given in escalating doses from 5mg/Kg to 20mg/Kg” NCT01406977 ↗ |
| Known as | BPS804 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03216486 ↗ |
| 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 20241“Sclerostin inhibitor” CHEMBL4297918 ↗ |
| Modality | Monoclonal antibody | “BPS804, a fully human anti-sclerostin monoclonal antibody” PMID 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 ↗ |