Last reviewed · How we verify
Romosozumab Prefilled Syringe
Romosozumab Prefilled Syringe is a monoclonal antibody that targets sclerostin to increase bone formation and decrease bone resorption.
Romosozumab Prefilled Syringe is a monoclonal antibody that targets sclerostin to increase bone formation and decrease bone resorption. Used for Treatment of osteoporosis in postmenopausal women at high risk of fracture.
At a glance
| Generic name | Romosozumab Prefilled Syringe |
|---|---|
| Sponsor | Karen Klahr Miller, MD |
| Drug class | Monoclonal antibody |
| Target | Sclerostin |
| Modality | Small molecule |
| Therapeutic area | Bone disorders |
| Phase | Phase 3 |
Mechanism of action
By binding to sclerostin, romosozumab increases the production of osteoblasts, which are cells responsible for bone formation. This leads to an increase in bone mass and a decrease in bone resorption, making it a potential treatment for osteoporosis and other bone-related disorders.
Approved indications
- Treatment of osteoporosis in postmenopausal women at high risk of fracture
Common side effects
- Back pain
- Headache
- Musculoskeletal pain
Key clinical trials
- Romosozumab/Denosumab Study for Premenopausal IOP (PHASE2)
- A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis (PHASE1)
- Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (PHASE3)
- A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. (PHASE4)
- Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures (PHASE4)
- Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis (PHASE1)
- A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (PHASE3)
- A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Romosozumab Prefilled Syringe CI brief — competitive landscape report
- Romosozumab Prefilled Syringe updates RSS · CI watch RSS
- Karen Klahr Miller, MD portfolio CI