Last reviewed 2026-05-22 · How we verify

Denosumab (reduced dosing)

Swiss Cancer Institute · Phase 3 active Small molecule Under review

Denosumab (reduced 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 giant cell tumor of bone. Also known as: XGEVA®.

Denosumab is a monoclonal antibody that inhibits RANKL, preventing osteoclast formation and bone resorption.

Denosumab is a tumor necrosis factor ligand superfamily member 11 inhibitor, classified as an antibody, which has been studied for the prevention of symptomatic skeletal events in conditions such as metastatic breast cancer, metastatic prostate cancer, and bone metastases. Clinical trials have compared the effectiveness of denosumab administered every 4 weeks versus every 12 weeks in these conditions.

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 (reduced 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
Phase	Phase 3

Mechanism of action

Denosumab binds to receptor activator of nuclear factor kappa-B ligand (RANKL), a key mediator of osteoclast differentiation and activation. By blocking RANKL signaling, it reduces bone turnover and increases bone mineral density. The reduced dosing regimen aims to maintain efficacy while minimizing systemic exposure and potential adverse effects.

Approved indications

Prevention of skeletal-related events in patients with bone metastases from solid tumors
Treatment of giant cell tumor of bone

Common side effects

Hypocalcemia
Osteonecrosis of the jaw
Atypical femoral fractures
Infections
Fatigue

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

Frequently asked questions about Denosumab (reduced dosing)

What is Denosumab (reduced dosing)?

Denosumab (reduced 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 giant cell tumor of bone.

How does Denosumab (reduced dosing) work?

Denosumab is a monoclonal antibody that inhibits RANKL, preventing osteoclast formation and bone resorption.

What is Denosumab (reduced dosing) used for?

Denosumab (reduced dosing) is indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone.

Who makes Denosumab (reduced dosing)?

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

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

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

What drug class is Denosumab (reduced dosing) in?

Denosumab (reduced 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 (reduced dosing) in?

Denosumab (reduced dosing) is in Phase 3.

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

Common side effects of Denosumab (reduced dosing) include Hypocalcemia, Osteonecrosis of the jaw, Atypical femoral fractures, Infections, Fatigue.

What does Denosumab (reduced dosing) target?

Denosumab (reduced 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
Indication: Drugs for Prevention of skeletal-related events in patients with bone metastases from solid tumors
Indication: Drugs for Treatment of giant cell tumor of bone
Also known as: XGEVA®

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