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Drug

Romosozumab

Approved · EMA
Late-stage development

Also known as Evenity.

RxNorm2123126UNII3VHF2ZD92J
11
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis: A Three-Arm Randomized Pilot Trial

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

The Optimised Use of Romozosumab Study

Clinical trial2026-07-02Results expected Q3 2030 · ClinicalTrials.gov

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

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Clinical trial2026-05-27Results expected Q2 2027 · ClinicalTrials.gov

Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial

Clinical trial2026-04-30Completed · ClinicalTrials.gov

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea

Clinical trial2026-04-23Results expected Q4 2028 · ClinicalTrials.gov

Combined Anabolic Therapy Study

Clinical trial2026-04-17Results expected Q4 2027 · ClinicalTrials.gov

Anabolic Therapy in Postmenopausal Osteoporosis

Clinical trial2026-04-15Results expected Q4 2027 · ClinicalTrials.gov

Innovative Approach to Geriatric Osteoporosis

Clinical trial2026-02-17Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Open-Label, Single-Dose, Parallel-Controlled Biosimilarity Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Adult Chinese Subjects

Clinical trial2026-02-05Primary completion · ClinicalTrials.gov

Approval: Evenity (EMA)

Regulatory2019-12-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Romosozumab
Aliases & brands
Evenity
RxNorm CUI
2123126
UNII
3VHF2ZD92J
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-12-09
Latest approval
2019-12-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2019-12-09Approval
Approval: Evenity (EMA)

Indication: Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

33 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
33
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
5
Recruiting
17
Late-stage (III+)
20
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 33
Phase 19Phase 27Phase 37Phase 410

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Optimised Use of Romozosumab Study

RecruitingPH IVUniversity of Aarhusn=2702032

Combined Anabolic Therapy Study

RecruitingPH IVMassachusetts General Hospitaln=502028

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

Active, not recruitingPH IVJames J. Peters Veterans Affairs Medical Centern=402027

Anabolic Therapy in Postmenopausal Osteoporosis

Active, not recruitingPH IVMassachusetts General Hospitaln=502027

Innovative Approach to Geriatric Osteoporosis

Active, not recruitingPH IVSusan L. Greenspann=1842027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial

CompletedPH IVTuen Mun Hospitaln=542026

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.

CompletedPH IVAmgenn=1002025

Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis

CompletedPH IINorthwestern Universityn=122024

Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

CompletedPH IVTuen Mun Hospitaln=702023

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

CompletedPH IIIUCB Biopharma SRLn=3272023

An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

CompletedPH IAmgenn=252023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.