Romosozumab

Summary

Romosozumab (CHEMBL2107874) is an approved antibody (ATC M05BX06); indicated across 6 conditions including postmenopausal osteoporosis and osteoporosis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: M05BX06
• Indications: 6 conditions
• Clinical trials: 37

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2107874
Name	Romosozumab
Type	Antibody
Max phase	4
ATC	M05BX06

Also known as: AMG 785, AMG-785, CDP-7851, CDP7851, Evenity, Romosozumab, Romosozumab aqqg, Romosozumab-aqqg, ROMOSOZUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
postmenopausal osteoporosis	4	MONDO:0008159	EFO:0003854
osteoporosis	4	MONDO:0005298	EFO:0003882
bone disorder	4	MONDO:0005381	EFO:0004260
osteogenesis imperfecta	3	MONDO:0019019	MONDO:0019019
bone fracture	2	MONDO:0005315	EFO:0003931

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 37.

Phase distribution

Phase	Trials
PHASE4	12
PHASE1	9
PHASE3	8
PHASE2	7
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05010590	PHASE4	ACTIVE_NOT_RECRUITING	Anabolic Therapy in Postmenopausal Osteoporosis
NCT05058976	PHASE4	ACTIVE_NOT_RECRUITING	Romosozumab Use to Build Skeletal Integrity
NCT05101018	PHASE4	ACTIVE_NOT_RECRUITING	Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
NCT06059222	PHASE4	RECRUITING	The Optimised Use of Romozosumab Study
NCT06558188	PHASE4	RECRUITING	Combined Anabolic Therapy
NCT06720350	PHASE4	NOT_YET_RECRUITING	Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
NCT06938152	PHASE4	RECRUITING	Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
NCT07283887	PHASE4	RECRUITING	Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
NCT04091243	PHASE4	COMPLETED	Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
NCT04597931	PHASE4	UNKNOWN	Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
NCT06079476	PHASE4	COMPLETED	A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
NCT06472050	PHASE4	COMPLETED	Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months
NCT05972551	PHASE3	ACTIVE_NOT_RECRUITING	Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
NCT06533865	PHASE3	RECRUITING	Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
NCT01575834	PHASE3	COMPLETED	Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
NCT01631214	PHASE3	COMPLETED	Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
NCT02016716	PHASE3	COMPLETED	A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
NCT02186171	PHASE3	COMPLETED	A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
NCT02791516	PHASE3	COMPLETED	A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
NCT05067335	PHASE3	COMPLETED	A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
NCT04232657	PHASE2	ACTIVE_NOT_RECRUITING	Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
NCT06973109	PHASE2	NOT_YET_RECRUITING	Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
NCT00896532	PHASE2	COMPLETED	Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
NCT00907296	PHASE2	COMPLETED	Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
NCT01081678	PHASE2	COMPLETED	Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
NCT01992159	PHASE2	COMPLETED	Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
NCT04708886	PHASE2	COMPLETED	Romosozumab in Women With Chronic SCI
NCT05775094	PHASE1	ACTIVE_NOT_RECRUITING	A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis
NCT07384104	PHASE1	ENROLLING_BY_INVITATION	Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects
NCT00950950	PHASE1	COMPLETED	A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
NCT01059435	PHASE1	COMPLETED	A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
NCT01101061	PHASE1	COMPLETED	A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
NCT01588509	PHASE1	COMPLETED	Transition From Alendronate to Romosozumab (AMG 785)
NCT01825785	PHASE1	COMPLETED	A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
NCT01833754	PHASE1	COMPLETED	Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
NCT04545554	PHASE1	COMPLETED	Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
NCT06164795	Not specified	RECRUITING	Sequential Therapies After Osteoanabolic Treatment

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).