OSENVELT (denosumab-bmwo)
Osenvelt (denosumab-bmwo) is a RANK ligand inhibitor indicated for the prevention of skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors. It is also approved for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgery would result in severe morbidity. Additionally, the drug is used to treat hypercalcemia of malignancy in patients whose condition is refractory to bisphosphonate therapy. This therapeutic agent serves to manage bone pathology and calcium release associated with specific oncological conditions.
How OSENVELT Works
Osenvelt binds to RANKL, a protein essential for the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By preventing RANKL from activating its receptor (RANK) on the surface of osteoclasts and their precursors, the drug inhibits bone breakdown and the resulting release of calcium. In giant cell tumors of bone, this process interferes with the signaling that contributes to osteolysis and tumor growth. This mechanism modulates bone pathology in instances where increased osteoclast activity is stimulated by solid tumors or osseous metastases.
Details
- Status
- Prescription
- First Approved
- 2025-02-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OSENVELT Approval History
What OSENVELT Treats
4 indicationsOSENVELT is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Bone Metastasis
- Giant Cell Tumor of Bone
- Hypercalcemia of Malignancy
Pharmacists can substitute OSENVELT for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
OSENVELT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
What's emerging in OSENVELT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OSENVELT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OSENVELT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
111 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 |
| NCT03921060 | STU 052018-007 | Ph 4 | recruiting | Markers of Osteoporosis in Cystic Fibrosis |
| NCT06374459 | 202406065 BC200714 | Ph 1, Ph 2 | recruiting | Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis |
| 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 |
| NCT07537972 | BONE-HCC-010 | Ph 2 | not yet recruiting | Denosumab Strategy for Liver Cancer With Bone Metastases |
| NCT05010590 | 2021P002125 | Ph 4 | active not recruiting | Anabolic Therapy in Postmenopausal Osteoporosis |
| NCT03401060 DenosuMast | P150918J 2016-000596-25 | Ph 3 | completed | Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis |
| NCT04067726 TRIDENT | 201907039 | Ph 2 | active not recruiting | RANKL Inhibition and Mammographic Breast Density |
| NCT03620019 results posted | LCCC1620 | Ph 2 | completed | Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma |
| NCT03839459 results posted | UMMY18121 | Ph 2 | completed | Denosumab for Smoldering Multiple Myeloma |
| NCT05419050 | 10000780 000780-D | Ph 2 | completed | Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia |
| NCT05666310 MITO | STUDY22080139 P30AG024827 | Ph 4 | active not recruiting | Muscle Impact of Treating Osteoporosis |
| NCT06300229 NAPO | 2023-508325-27-00 | Ph 1, Ph 2 | completed | NAPO - Novel Approach for Oligospermia |
| NCT07283887 | 202509047MINA | Ph 4 | recruiting | Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis |
| NCT07271771 DENMUSIN | CTIS: 2024-510637-18-00 CTIS: 2024-510637-18-00 | Ph 4 | recruiting | The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity |
| NCT05884372 ESCORT | ELD-IIS00X | Ph 4 | completed | Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT) |
| NCT04087096 results posted | 20187525 20187525 | Ph 4 | completed | Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery |
| NCT05101018 | BAU-19-60 | Ph 4 | active not recruiting | Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI |
| NCT06524960 | 23797 JDRF Award:3-SRA-2023-1421-M-B | Ph 1, Ph 2 | recruiting | Denosumab for Type 1 Diabetes |
| NCT05493761 OsteoNAFLD | 88235 | Ph 4 | active not recruiting | Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease |
| NCT05395091 ALVOBOND results posted | AVT03-GL-C01 | Ph 3 | completed | Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND |
| NCT05876949 results posted | AVT03-GL-P03 | Ph 1 | completed | AVT03 With Xgeva in Healthy Male Subjects |
| NCT04907539 results posted | RXC004/0002 | Ph 2 | completed | A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) |
| NCT04711109 BRCA-P | A211801 NCI-2020-11358, UG1CA189823 | Ph 3 | active not recruiting | Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation |
| NCT04907851 KEYNOTE-E86 results posted | RXC004/0003 MK-3475-E86, KEYNOTE-E86 | Ph 2 | completed | A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) |
| NCT06749886 | 2024LY0208 | Ph 2 | recruiting | An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting |
| NCT05212337 | 19642021 | Ph 2 | active not recruiting | FITMI - First In Treating Male Infertility |
| NCT06643780 | 2022.555 | Ph 4 | recruiting | RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis |
| NCT02771860 results posted | AGO/2015/008 2015-003223-53 | Ph 2 | completed | RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints |
| NCT02129699 SPLENDOUR results posted | ETOP 5-12 / EORTC 08111 2013-003156-21, 20080166 | Ph 3 | terminated | Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy |
| NCT02753283 PROUD results posted | STUDY19050268 1R01AG052123-01 | Ph 4 | completed | Preventing Osteoporosis Using Denosumab |
| NCT01575834 FRAME results posted | 20070337 2011-001456-11 | Ph 3 | completed | Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis |
| NCT02613416 Dmab results posted | 706513 | Ph 2 | completed | Denosumab and MRI Breast Imaging |
| NCT03164928 results posted | 20140444 2016-003083-39 | Ph 3 | completed | Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis |
| NCT03301857 results posted | 20140114 2017-001758-32 | Ph 4 | completed | Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 |
| NCT03868033 DST | 201811067MIPC | Ph 4 | completed | Denosumab Sequential Therapy |
| NCT06314698 | IIT-2024-0011 | Ph 3 | not yet recruiting | Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease |
| NCT03925532 results posted | I 78618 NCI-2019-01921, I 78618 | Ph 2 | completed | Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant |
| NCT02470091 results posted | AOST1321 NCI-2015-00543, s15-01360 | Ph 2 | completed | Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma |
| NCT02792413 HDENO | RECHMPL15_0496 UF 9676 | Ph 4 | terminated | Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease |
| NCT04026256 results posted | 2018P002537 5R01AR073191-04 | Ph 4 | completed | Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration |
| NCT03030196 | 01112016 2016-003546-84 | Ph 2 | completed | Denosumab and Male Infertility: a RCT |
| NCT03623633 | 2018P001612 | Ph 4 | active not recruiting | Comparative Antiresorptive Efficacy Discontinuation of Denosumab |
| NCT05813665 | JMT103-011 | Ph 3 | not yet recruiting | A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone |
| NCT02352753 OI results posted | 20130173 2014-000184-40 | Ph 3 | terminated | Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI |
| NCT03638128 results posted | 20170534 2018-000550-21 | Ph 3 | terminated | Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta |
| NCT02049866 results posted | AAAN0161 1R01FD005114-01A2 | Ph 2 | completed | Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP |
| NCT04621318 | SB16-1001 | Ph 1 | completed | Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects |
| NCT01345019 results posted | 20090482 2010-020454-34 | Ph 3 | completed | Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma |
| NCT01558115 results posted | AAAF2568 R01DK032333, 20090741 | Ph 4 | terminated | Denosumab in Primary Hyperparathyroidism |
Showing 50 of 111 trials
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.
OSENVELT FDA Label Details
Indications & Usage
FDA Label (PDF)OSENVELT is indicated for the treatment of Multiple Myeloma; Bone Metastasis; Giant Cell Tumor of Bone; Hypercalcemia of Malignancy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.