Osteogenesis Imperfecta

9
Pipeline Programs
3
Companies
6
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
5
2
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
5100%
+ 4 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Ultragenyx Pharmaceutical
6 programs
3
1
2
BisphosphonatePhase 31 trial
setrusumabPhase 3Monoclonal Antibody1 trial
SetrusumabPhase 2/3Monoclonal Antibody
BPS804Phase 2
BPS804Phase 21 trial
+1 more programs
Active Trials
NCT01417091Completed10Est. Dec 2012
NCT05768854Active Not Recruiting69Est. Apr 2027
NCT06636071Active Not Recruiting6Est. Jan 2028
Mereo BioPharma
Mereo BioPharmaUK - London
3 programs
2
1
SetrusumabPhase 2/3Monoclonal Antibody1 trial
BPS804Phase 21 trial
SetrusumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03216486Withdrawn0Est. Nov 2018
NCT05312697Terminated2Est. Jul 2022
NCT05125809Active Not Recruiting183Est. Apr 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Ultragenyx Pharmaceuticalsetrusumab
Ultragenyx PharmaceuticalBisphosphonate
Mereo BioPharmaSetrusumab
Mereo BioPharmaSetrusumab
Mereo BioPharmaBPS804
Ultragenyx PharmaceuticalBPS804

Clinical Trials (6)

Total enrollment: 270 patients across 6 trials

NCT06636071Ultragenyx Pharmaceuticalsetrusumab

Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta

Start: Oct 2024Est. completion: Jan 20286 patients
Phase 3Active Not Recruiting
NCT05768854Ultragenyx PharmaceuticalBisphosphonate

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Start: Jun 2023Est. completion: Apr 202769 patients
Phase 3Active Not Recruiting
NCT05125809Mereo BioPharmaSetrusumab

Setrusumab vs Placebo for Osteogenesis Imperfecta

Start: Feb 2022Est. completion: Apr 2027183 patients
Phase 2/3Active Not Recruiting
NCT05312697Mereo BioPharmaSetrusumab

Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta

Start: Apr 2022Est. completion: Jul 20222 patients
Phase 2Terminated
NCT03216486Mereo BioPharmaBPS804

An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Start: Oct 2017Est. completion: Nov 20180
Phase 2Withdrawn
NCT01417091Ultragenyx PharmaceuticalBPS804

Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

Start: Jun 2011Est. completion: Dec 201210 patients
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
Monoclonal Antibody is the dominant modality (100% of programs)
3 companies competing in this space