EVENITY (romosozumab-aqqg)
EVENITY is indicated for the treatment of Osteoporosis.
How EVENITY Works
Evenity works by inhibiting sclerostin, a regulatory factor that controls bone metabolism. By blocking sclerostin, the drug increases bone formation and, to a lesser extent, decreases bone resorption. This mechanism stimulates osteoblastic activity on both trabecular and cortical bone surfaces, leading to increased bone mass. These actions result in measurable improvements in bone structure and strength.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-04-09
- Revenue
- $599M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EVENITY Approval History
What EVENITY Treats
1 indicationsEVENITY is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
EVENITY Boxed Warning
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVEN...
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. ( 5.1 )
EVENITY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EVENITY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06472050 | CIRB-2024-224-3 | Ph 4 | completed | Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months |
| NCT05972551 | 20200105 2023-503294-37 | Ph 3 | recruiting | Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta |
| NCT06533865 | 2024P000273 | Ph 3 | recruiting | Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea |
| NCT04232657 Chronic Romo | B3415-R BAU-19-66, 1600530 | Ph 2 | active not recruiting | Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI |
| NCT06558188 CAT | 2024P002279 1R21AR083567-01A1 | Ph 4 | recruiting | Combined Anabolic Therapy |
| NCT05010590 | 2021P002125 | Ph 4 | active not recruiting | Anabolic Therapy in Postmenopausal Osteoporosis |
| NCT06973109 | STUDY24090048 BECKW 12879, 2024YIRGA | Ph 2 | not yet recruiting | Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes |
| NCT05058976 RUBI | STUDY20060028 5R01AG066825-02 | Ph 4 | active not recruiting | Romosozumab Use to Build Skeletal Integrity |
| NCT07384104 | SAL023A102 | Ph 1 | enrolling by invitation | Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects |
| NCT05775094 | 23-038 | Ph 1 | active not recruiting | A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis |
| NCT07283887 | 202509047MINA | Ph 4 | recruiting | Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis |
| NCT06079476 | 20210025 | Ph 4 | completed | A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. |
| NCT04708886 results posted | STU00212405 20197268 | Ph 2 | completed | Romosozumab in Women With Chronic SCI |
| NCT05101018 | BAU-19-60 | Ph 4 | active not recruiting | Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI |
| NCT01631214 ARCH results posted | 20110142 2011-003142-41 | Ph 3 | completed | Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis |
| NCT05067335 results posted | OP0002 | Ph 3 | completed | A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis |
| NCT04091243 | NTWC/REC/19074 | Ph 4 | completed | Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users |
| NCT01575834 FRAME results posted | 20070337 2011-001456-11 | Ph 3 | completed | Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis |
| NCT04545554 results posted | 20160227 2017-004972-74 | Ph 1 | completed | Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta |
| NCT06059222 OPTIMIST | CT-2023-505940-20-00 | Ph 4 | recruiting | The Optimised Use of Romozosumab Study |
| NCT00896532 results posted | 20060326 2008-005991-28 | Ph 2 | completed | Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density |
| NCT00907296 STARTT results posted | 20062017 2008-008392-34 | Ph 2 | completed | Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing |
| NCT01081678 STARTT-Hip results posted | 20080394 | Ph 2 | completed | Study To Assess FRacTure Healing With SclerosTin Antibody - Hip |
| NCT01833754 results posted | 20110227 | Ph 1 | completed | Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis |
| NCT02791516 results posted | 20150242 | Ph 3 | completed | A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis |
| NCT01101061 results posted | 20090378 | Ph 1 | completed | A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women |
| NCT00950950 results posted | 20090153 | Ph 1 | completed | A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass |
| NCT02186171 BRIDGE results posted | 20110174 2013-005551-32 | Ph 3 | completed | A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis |
| NCT01588509 results posted | 20110253 | Ph 1 | completed | Transition From Alendronate to Romosozumab (AMG 785) |
| NCT01992159 results posted | 20101291 | Ph 2 | completed | Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EVENITY FDA Label Details
Indications & Usage
FDA Label (PDF)EVENITY is indicated for the treatment of Osteoporosis.
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or strok...
Pro Intelligence Preview
Deep insights for EVENITY
Revenue Insights
- • Q4-2025: $599M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 32 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment