Romosozumab

ApprovedMonoclonal antibody

Romosozumab is a monoclonal antibody that works as a Sclerostin Inhibitor.[2] It is being used across 10 indications, with its most advanced program in Approved.[1]

Romosozumab is one of 181 small molecule programs targeting Bone Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

180

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bone DiseaseUnknown

OsteopeniaActive, not recruiting

Bone DensityActive, not recruiting

Bone FractureUnknown

Postmenopausal OsteoporosisUnknown

Osteogenesis ImperfectaActive, not recruiting

AmenorrheaActive, not recruiting

Multiple MyelomaActive, not recruiting

OsteoporosisRecruiting

Spinal Cord InjuryActive, not recruiting

Bone DiseasePreclinical

Unknown

OsteopeniaPhase 1

Active, not recruiting

Bone DensityPhase 2

Active, not recruiting

Bone FracturePreclinical

Unknown

Postmenopausal OsteoporosisPreclinical

Unknown

Osteogenesis ImperfectaPhase 1

Active, not recruiting

AmenorrheaPhase 3

Active, not recruiting

Multiple MyelomaPhase 1

Active, not recruiting

OsteoporosisApproved

Recruiting

Spinal Cord InjuryApproved

Active, not recruiting

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Romosozumab

Amgen

Approved

1 2

Ninlaro

Takeda

Preclinical

18 3

Prolia

Amgen

Preclinical

5 4

Eliquis

Bristol-Myers Squibb

Preclinical

3 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

2 6

Adriamycin

GGynecologic Oncology Group

Preclinical

9 7

Nolvadex

AstraZeneca

Preclinical

1 8

Oncovin

EEastern Cooperative Oncology Group

Preclinical

8 9

Intron a

Systemic Therapy

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Postmenopausal Osteoporosis

NCT07283887

Q1 2027

Phase 1Active, not recruiting

Multiple Myeloma

NCT05775094

Phase 2Active, not recruiting

Chronic

NCT04232657

Post-ApprovalActive, not recruiting

ILD

NCT05058976

Q2 2027

Recruiting

Treatment

NCT06164795

Phase 2Not yet recruiting

Bone Density

NCT06973109

Clinical

Trials by Indication[1]

Osteoporosis11 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

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

Show 8 more trials

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

A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.

Completed· Amgen logo

Amgen·Phase 4·NCT06079476·100 enrolled

A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

Completed· UCB logo

UCB·Phase 3·NCT05067335·327 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

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT01575834·7,180 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 Osteoporosis3 trials

Anabolic Therapy in Postmenopausal Osteoporosis

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

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

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

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

Completed· Amgen logo

Amgen·Phase 2·NCT01992159·252 enrolled

Treatment2 trials

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

Sequential Therapies After Osteoanabolic Treatment

Recruiting·—··NCT06164795·150 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 Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Completed· Amgen logo

Amgen·Phase 1·NCT04545554·25 enrolled

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

14 more indications

Chronic2 trials

Romosozumab in Women With Chronic SCI

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

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Active, not recruiting·VVA Office of Research and Development·Phase 2·NCT04232657·36 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

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

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

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

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

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

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

ILD1 trial

Romosozumab Use to Build Skeletal Integrity

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

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

Combined Anabolic Therapy

Recruiting·MMassachusetts General Hospital·Phase 4·NCT06558188·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 37 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: Approved[1]
Company: Amgen

Romosozumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Osteoporosis11 trials

Postmenopausal Osteoporosis3 trials

Treatment2 trials

Postmenopausal Women2 trials

Osteogenesis Imperfecta2 trials

Chronic2 trials

Low Bone Mineral Density1 trial

Spinal Cord Injury1 trial

Women1 trial

Amenorrhea1 trial

Tics1 trial

Fracture1 trial

Immunogenicity1 trial

Renal Impairment1 trial

Bone Density1 trial

Multiple Myeloma1 trial

ILD1 trial

Fractures1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

Related News