Romosozumab

Phase 3Monoclonal antibody

Romosozumab is a monoclonal antibody that works as a Sclerostin Inhibitor.[2] It is being investigated across 12 indications, with its most advanced program in Phase 3.[1]

Romosozumab is one of 175 small molecule programs targeting Bone Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

174

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bone DiseaseUnknown

Bone DensityNot yet recruiting

Bone FractureUnknown

Postmenopausal OsteoporosisCompleted

Osteogenesis ImperfectaRecruiting

AmenorrheaRecruiting

Breast CancerRecruiting

Multiple MyelomaActive, not recruiting

OsteoporosisRecruiting

TreatmentActive, not recruiting

Bone DiseasePreclinical

Unknown

Bone DensityPhase 2

Not yet recruiting

Bone FracturePreclinical

Unknown

Postmenopausal OsteoporosisPhase 3

Completed

Osteogenesis ImperfectaPhase 3

Recruiting

AmenorrheaPhase 3

Recruiting

Breast CancerPhase 2

Recruiting

Multiple MyelomaPhase 1

Active, not recruiting

OsteoporosisPhase 3

Recruiting

TreatmentPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Romosozumab

Amgen

Phase 3

1 2

Lexiscan

Astellas

Preclinical

1 3

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 4

Duragesic

CCephalon

Preclinical

1 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Rilvegostomig

AstraZeneca

Preclinical

1 7

Ablavar

LLantheus Medical Imaging

Preclinical

2 8

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 9

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 10

Lapatinib Plus Capecitabine

GSK

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Study completion

NCT07811999

Phase 1Active, not recruiting

Multiple Myeloma

NCT05775094

Post-ApprovalActive, not recruiting

ILD

NCT05058976

Q2 2027

Phase 2Not yet recruiting

Bone Density

NCT06973109

Q3 2027

Phase 3Recruiting

Osteogenesis Imperfecta

NCT05972551

Q4 2027

Post-ApprovalActive, not recruiting

Treatment

NCT05101018

Clinical

Trials by Indication[1]

Osteoporosis10 trials

A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT02186171·245 enrolled

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT01631214·4,093 enrolled

Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users

Completed·TTuen Mun Hospital·Phase 4·NCT04091243·70 enrolled

Show 7 more trials

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT02016716·294 enrolled

A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT03432533·283 enrolled

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT01575834·7,180 enrolled

A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT02791516·67 enrolled

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

Completed· UCB logo

UCB·Phase 3·NCT05067335·327 enrolled

The Optimised Use of Romozosumab Study

Recruiting·UUniversity of Aarhus·Approved·NCT06059222·270 enrolled

Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial

Recruiting·NNational Taiwan University Hospital·Approved·NCT06938152·70 enrolled

Postmenopausal Osteoporosis5 trials

Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

Completed· Amgen logo

Amgen·Phase 2·NCT01992159·252 enrolled

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

Recruiting·NNational Taiwan University Hospital·Phase 4·NCT07283887·90 enrolled

Anabolic Therapy in Postmenopausal Osteoporosis

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT05010590·50 enrolled

Show 2 more trials

Romosozumab and Denosumab Combination Therapy for Osteoporosis: The ROAD Randomized Trial

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07909304·100 enrolled

An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a High Risk of Fracture.

Completed· Amgen logo

Amgen·Approved·NCT06079476·100 enrolled

Postmenopausal Women2 trials

A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women

Completed· Amgen logo

Amgen·Phase 1·NCT01059435·74 enrolled

A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass

Completed· Amgen logo

Amgen·Phase 1·NCT00950950·24 enrolled

Osteogenesis Imperfecta2 trials

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Recruiting· Amgen logo

Amgen·Phase 3·NCT05972551·106 enrolled

Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Completed· Amgen logo

Amgen·Phase 1·NCT04545554·25 enrolled

Osteoporosis, Postmenopausal2 trials

Combined Anabolic Therapy Study

Recruiting·MMassachusetts General Hospital·Approved·NCT06558188·50 enrolled

Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study

Recruiting·4424 General Military Hospital··NCT06164795·150 enrolled

19 more indications

Women1 trial

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

Completed· Amgen logo

Amgen·Phase 1·NCT01101061·31 enrolled

Spinal Cord Injury1 trial

Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

Unknown status·SSheba Medical Center·Phase 4·NCT04597931·30 enrolled

Treatment1 trial

Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

Active, not recruiting·JJames J. Peters Veterans Affairs Medical Center·Phase 4·NCT05101018·40 enrolled

Low Bone Mineral Density1 trial

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00896532·419 enrolled

Amenorrhea1 trial

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Recruiting·MMassachusetts General Hospital·Phase 3·NCT06533865·114 enrolled

Tics1 trial

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

Completed· Amgen logo

Amgen·Phase 1·NCT01825785·48 enrolled

Fracture1 trial

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

Completed· Amgen logo

Amgen·Phase 2·NCT01081678·332 enrolled

Fractures1 trial

Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

Completed· Amgen logo

Amgen·Phase 2·NCT00907296·402 enrolled

Immunogenicity1 trial

Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects

Enrolling by invitation·SShenzhen Salubris Pharmaceuticals Co., Ltd.·Phase 1·NCT07384104·118 enrolled

ILD1 trial

Romosozumab Use to Build Skeletal Integrity

Active, not recruiting·SSusan L. Greenspan·Phase 4·NCT05058976·184 enrolled

Renal Impairment1 trial

Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

Completed· Amgen logo

Amgen·Phase 1·NCT01833754·24 enrolled

Chronic1 trial

Romosozumab in Women With Chronic SCI

Completed·NNorthwestern University·Phase 2·NCT04708886·12 enrolled

Bone Density1 trial

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes

Not yet recruiting·NNitin Agarwal·Phase 2·NCT06973109·36 enrolled

Multiple Myeloma1 trial

A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05775094·10 enrolled

Spinal Cord Injury (=3 Years)1 trial

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Completed·VVA Office of Research and Development·Phase 2·NCT04232657·36 enrolled

Breast Cancer1 trial

A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07776613·25 enrolled

Osteoporosis in Post-menopausal Women1 trial

Short-course Romosozumab Followed by Denosumab Versus Zoledronic Acid: A Multicentre Randomized Active-controlled Trial in Postmenopausal Women at High Fracture Risk

Not yet recruiting·SSahlgrenska University Hospital·Approved·NCT07772609·216 enrolled

Osteopenia1 trial

Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Randomized Controlled Trial At 6 Years

Not yet recruiting·TTuen Mun Hospital·Approved·NCT07757373·54 enrolled

Unspecified3 trials

Transition From Alendronate to Romosozumab (AMG 785)

Completed· Amgen logo

Amgen·Phase 1·NCT01588509·60 enrolled

Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study

Recruiting·TTuen Mun Hospital·Phase 4·NCT06472050·63 enrolled

A Phase 1, Open-label, Randomized, Parallel Group Study to Evaluate the Relative Bioavailability of Romosozumab (AMG 785) 210 mg Administered as a Single SC Injection or 2 SC Injections in Healthy Participants

Recruiting· Amgen logo

Amgen·Phase 1·NCT07811999·308 enrolled

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Romosozumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Romosozumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Romosozumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sclerostin Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Amgen

Romosozumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Osteoporosis10 trials

Postmenopausal Osteoporosis5 trials

Postmenopausal Women2 trials

Osteogenesis Imperfecta2 trials

Osteoporosis, Postmenopausal2 trials

Women1 trial

Spinal Cord Injury1 trial

Treatment1 trial

Low Bone Mineral Density1 trial

Amenorrhea1 trial

Tics1 trial

Fracture1 trial

Fractures1 trial

Immunogenicity1 trial

ILD1 trial

Renal Impairment1 trial

Chronic1 trial

Bone Density1 trial

Multiple Myeloma1 trial

Spinal Cord Injury (=3 Years)1 trial

Breast Cancer1 trial

Osteoporosis in Post-menopausal Women1 trial

Osteopenia1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

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