Last reviewed 2026-04-22 · How we verify

Denosumab (standard dosing)

Swiss Cancer Institute · Phase 3 active Small molecule

Denosumab (standard dosing) is a RANKL inhibitor (monoclonal antibody) Small molecule drug developed by Swiss Cancer Institute. It is currently in Phase 3 development for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of hypercalcemia of malignancy, Osteoporosis in postmenopausal women and men at high risk of fracture. Also known as: XGEVA®.

Denosumab is a monoclonal antibody that binds to RANKL, preventing bone resorption by inhibiting osteoclast formation and activation.

Denosumab is a monoclonal antibody that binds to RANKL, preventing bone resorption by inhibiting osteoclast formation and activation. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of hypercalcemia of malignancy, Osteoporosis in postmenopausal women and men at high risk of fracture.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Denosumab (standard dosing)
Also known as	XGEVA®
Sponsor	Swiss Cancer Institute
Drug class	RANKL inhibitor (monoclonal antibody)
Target	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Modality	Small molecule
Therapeutic area	Oncology, Bone Health
Phase	Phase 3

Mechanism of action

Denosumab targets receptor activator of nuclear factor kappa-B ligand (RANKL), a key mediator of osteoclast differentiation and survival. By blocking RANKL signaling, it reduces bone turnover and increases bone mineral density. This mechanism is used to prevent skeletal-related events in patients with bone metastases and to treat osteoporosis and hypercalcemia of malignancy.

Approved indications

Prevention of skeletal-related events in patients with bone metastases from solid tumors
Treatment of hypercalcemia of malignancy
Osteoporosis in postmenopausal women and men at high risk of fracture

Common side effects

Hypocalcemia
Fatigue
Nausea
Dyspnea
Osteonecrosis of the jaw
Atypical femoral fractures

Key clinical trials

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (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:

Denosumab (standard dosing) CI brief — competitive landscape report
Denosumab (standard dosing) updates RSS · CI watch RSS
Swiss Cancer Institute portfolio CI

Frequently asked questions about Denosumab (standard dosing)

What is Denosumab (standard dosing)?

Denosumab (standard dosing) is a RANKL inhibitor (monoclonal antibody) drug developed by Swiss Cancer Institute, indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of hypercalcemia of malignancy, Osteoporosis in postmenopausal women and men at high risk of fracture.

How does Denosumab (standard dosing) work?

Denosumab is a monoclonal antibody that binds to RANKL, preventing bone resorption by inhibiting osteoclast formation and activation.

What is Denosumab (standard dosing) used for?

Denosumab (standard dosing) is indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of hypercalcemia of malignancy, Osteoporosis in postmenopausal women and men at high risk of fracture.

Who makes Denosumab (standard dosing)?

Denosumab (standard dosing) is developed by Swiss Cancer Institute (see full Swiss Cancer Institute pipeline at /company/swiss-cancer-institute).

Is Denosumab (standard dosing) also known as anything else?

Denosumab (standard dosing) is also known as XGEVA®.

What drug class is Denosumab (standard dosing) in?

Denosumab (standard dosing) belongs to the RANKL inhibitor (monoclonal antibody) class. See all RANKL inhibitor (monoclonal antibody) drugs at /class/rankl-inhibitor-monoclonal-antibody.

What development phase is Denosumab (standard dosing) in?

Denosumab (standard dosing) is in Phase 3.

What are the side effects of Denosumab (standard dosing)?

Common side effects of Denosumab (standard dosing) include Hypocalcemia, Fatigue, Nausea, Dyspnea, Osteonecrosis of the jaw, Atypical femoral fractures.

What does Denosumab (standard dosing) target?

Denosumab (standard dosing) targets RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) and is a RANKL inhibitor (monoclonal antibody).

Drug class: All RANKL inhibitor (monoclonal antibody) drugs
Target: All drugs targeting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Manufacturer: Swiss Cancer Institute — full pipeline
Therapeutic area: All drugs in Oncology, Bone Health
Indication: Drugs for Prevention of skeletal-related events in patients with bone metastases from solid tumors
Indication: Drugs for Treatment of hypercalcemia of malignancy
Indication: Drugs for Osteoporosis in postmenopausal women and men at high risk of fracture
Also known as: XGEVA®

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing