Denosumab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Denosumab appears in the FDA drug-label database. Marketed as CONEXXENCE.
- Drug class
- RANK Ligand Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- RANK Ligand Blocking Activity (as stated on the FDA label)
- Boxed warning
- The FDA label for Denosumab carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Conexxence is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Conexxence is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )]. 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Conexxence is indicated for treatme…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. — Amgen, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-09-17 |
| CGMP Deviations; potential temperature excursions due to transit delays — Mckesson Medical-Surgical Inc. Corporate Office | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-04-21 |
Phase breakdown
Conditions being studied
Recruiting trials involving Denosumab
- 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
- Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis
- Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis
- Denosumab for Type 1 Diabetes
- Markers of Osteoporosis in Cystic Fibrosis
- RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
- Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
- Sequential Therapies After Osteoanabolic Treatment
- Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
- The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
- Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Common questions
Is Denosumab FDA-approved?
Yes, marketed as CONEXXENCE. Its FDA label carries a boxed warning.
How many recruiting trials involve Denosumab?
11 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.