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Osteogenesis Imperfecta

10
Pipeline Programs
9
Companies
20
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Monoclonal Antibody
675%
Peptide
225%
+ 17 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
4 programs
1
1
TeriparatidePhase 4Peptide
FresolimumabPhase 1Monoclonal Antibody
BBD Longitudinal Study of Osteogenesis ImperfectaN/A
Dental Malocclusion and Craniofacial Development in OIN/A
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
AlendronatePhase 41 trial
Active Trials
NCT02303873Completed99Est. Aug 2014
Prevail Therapeutics
1 program
1
TeriparatidePhase 4Peptide1 trial
Active Trials
NCT00131469Completed79Est. Jan 2011
Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
2
HumatropePhase 31 trial
PamidronatePhase 31 trial
Evaluation and Intervention for the Effects of Osteogenesis ImperfectaN/A1 trial
Active Trials
NCT00001594Completed88
NCT00001305Completed42Est. May 2017
NCT00005901Completed34Est. Mar 2015
Sandoz
SandozAustria - Kundl
3 programs
2
1
Zoledronic AcidPhase 31 trial
Zoledronic AcidPhase 21 trial
Zoledronic AcidPhase 21 trial
Active Trials
NCT00063479Completed158Est. May 2007
NCT00131118Completed127Est. May 2007
NCT00982124Completed14Est. Apr 2016
Angitia Biopharmaceuticals
Angitia BiopharmaceuticalsCA - Woodland Hills
1 program
1
AGA2115Phase 23 trials
Active Trials
NCT07557446Not Yet Recruiting48Est. Jul 2029
NCT07062588Recruiting80Est. Feb 2029
NCT06086613Completed72Est. Oct 2024
Ultragenyx Pharmaceutical
6 programs
BPS804PHASE_2
BPS804PHASE_21 trial
SetrusumabPHASE_2Monoclonal Antibody
SetrusumabPHASE_2_3Monoclonal Antibody
BisphosphonatePHASE_31 trial
+1 more programs
Active Trials
NCT01417091Completed10Est. Dec 2012
NCT05768854Active Not Recruiting69Est. Apr 2027
NCT06636071Active Not Recruiting6Est. Jan 2028
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
3 programs
BBD Longitudinal Study of Osteogenesis ImperfectaN/A1 trial
Dental Malocclusion and Craniofacial Development in OIN/A1 trial
InvisalignN/A1 trial
Active Trials
NCT02432625Recruiting1,000Est. Dec 2031
NCT02934451Active Not Recruiting75Est. Dec 2027
NCT04815564Active Not Recruiting57Est. Dec 2027
Mereo BioPharma
Mereo BioPharmaUK - London
3 programs
BPS804PHASE_21 trial
SetrusumabPHASE_2Monoclonal Antibody1 trial
SetrusumabPHASE_2_3Monoclonal 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
2029
2030
2031
UNION therapeuticsAlendronate
Prevail TherapeuticsTeriparatide
Ultragenyx Pharmaceuticalsetrusumab
Ultragenyx PharmaceuticalBisphosphonate
SandozZoledronic Acid
Human BioSciencesPamidronate
Human BioSciencesHumatrope
Mereo BioPharmaSetrusumab
Angitia BiopharmaceuticalsAGA2115
Angitia BiopharmaceuticalsAGA2115
Mereo BioPharmaSetrusumab
Mereo BioPharmaBPS804
Ultragenyx PharmaceuticalBPS804
SandozZoledronic Acid
SandozZoledronic Acid

Showing 15 of 20 trials with date data

Clinical Trials (20)

Total enrollment: 2,243 patients across 20 trials

NCT02303873UNION therapeuticsAlendronate

Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta

Start: Mar 2007Est. completion: Aug 201499 patients
Phase 4Completed
NCT00131469Prevail TherapeuticsTeriparatide

Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta

Start: Jun 2005Est. completion: Jan 201179 patients
Phase 4Completed
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
NCT00982124SandozZoledronic Acid

An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta

Start: Oct 2007Est. completion: Apr 201614 patients
Phase 3Completed
NCT00005901Human BioSciencesPamidronate

Pamidronate to Treat Osteogenesis Imperfecta in Children

Start: Jun 2000Est. completion: Mar 201534 patients
Phase 3Completed
NCT00001305Human BioSciencesHumatrope

Growth Hormone Therapy in Osteogenesis Imperfecta

Start: Nov 1991Est. completion: May 201742 patients
Phase 3Completed
NCT05125809Mereo BioPharmaSetrusumab

Setrusumab vs Placebo for Osteogenesis Imperfecta

Start: Feb 2022Est. completion: Apr 2027183 patients
Phase 2/3Active Not Recruiting
NCT07557446Angitia BiopharmaceuticalsAGA2115

A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)

Start: May 2026Est. completion: Jul 202948 patients
Phase 2Not Yet Recruiting
NCT07062588Angitia BiopharmaceuticalsAGA2115

Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)

Start: Dec 2025Est. completion: Feb 202980 patients
Phase 2Recruiting
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
NCT00131118SandozZoledronic Acid

Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Start: Jul 2004Est. completion: May 2007127 patients
Phase 2Completed
NCT00063479SandozZoledronic Acid

Bisphosphonate Treatment of Osteogenesis Imperfecta

Start: Jun 2003Est. completion: May 2007158 patients
Phase 2Completed
NCT06086613Angitia BiopharmaceuticalsAGA2115

A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers

Start: Oct 2023Est. completion: Oct 202472 patients
Phase 1Completed
NCT04815564Angeles TherapeuticsInvisalign

Clear Aligners for the Treatment of Dental Malocclusion in OI

Start: Aug 2022Est. completion: Dec 202757 patients
N/AActive Not Recruiting
NCT02934451Angeles TherapeuticsDental Malocclusion and Craniofacial Development in OI

Dental Malocclusion and Craniofacial Development in OI

Start: Aug 2016Est. completion: Dec 202775 patients
N/AActive Not Recruiting
NCT02432625Angeles TherapeuticsBBD Longitudinal Study of Osteogenesis Imperfecta

BBD Longitudinal Study of Osteogenesis Imperfecta

Start: Jun 2015Est. completion: Dec 20311,000 patients
N/ARecruiting
NCT00001594Human BioSciencesEvaluation and Intervention for the Effects of Osteogenesis Imperfecta

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

Start: Jan 199788 patients
N/ACompleted

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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

3 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 2,243 patients
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.