Last reviewed · How we verify
open-label denosumab
open-label denosumab is a RANKL inhibitor (monoclonal antibody) Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of osteoporosis in postmenopausal women, Giant cell tumor of bone.
Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption.
Denosumab is an open-label study intervention that targets tumor necrosis factor ligand superfamily member 11, an inhibitor of this protein. It is used to treat conditions such as osteoporosis, colorectal cancer, low bone mass, and low bone mineral density, and is administered subcutaneously.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | open-label denosumab |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Bone Metabolism |
| Phase | Phase 3 |
Mechanism of action
Denosumab binds to RANKL, a key mediator of osteoclast differentiation and activation. By preventing RANKL from engaging its receptor RANK on osteoclast precursors, the drug suppresses bone resorption and increases bone mineral density. This mechanism makes it effective for conditions characterized by excessive bone loss or osteolytic lesions.
Approved indications
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Treatment of osteoporosis in postmenopausal women
- Giant cell tumor of bone
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
- Back pain
Key clinical trials
- A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (PHASE4)
- Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China (PHASE4)
- Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone (PHASE4)
- Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (PHASE4)
- 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) (PHASE2)
- A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (PHASE2)
- A Clinical Trial to Evaluate Efficacy of Once or Twice ZOledronic Acid After Different Duration of denOsumMab Administration in Postmenopausal Women With Osteoporosis (ZOOM Study) (PHASE4)
- DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD) (PHASE4)
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:
- open-label denosumab CI brief — competitive landscape report
- open-label denosumab updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about open-label denosumab
What is open-label denosumab?
How does open-label denosumab work?
What is open-label denosumab used for?
Who makes open-label denosumab?
What drug class is open-label denosumab in?
What development phase is open-label denosumab in?
What are the side effects of open-label denosumab?
What does open-label denosumab target?
Related
- Drug class: All RANKL inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology, Bone Metabolism
- Indication: Drugs for Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Indication: Drugs for Treatment of osteoporosis in postmenopausal women
- Indication: Drugs for Giant cell tumor of bone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing