Last reviewed 2026-06-03 · How we verify

Denosumab (CP4)

Amgen · Phase 3 active Small molecule Under review

Denosumab (CP4) is a RANKL inhibitor (monoclonal antibody) Small molecule drug developed by Amgen. 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, Osteoporosis in postmenopausal women and men at high risk of fracture.

Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption.

Denosumab (CP4) is a monoclonal antibody that inhibits tumor necrosis factor ligand superfamily member 11, classified as an inhibitor. It is being studied for the treatment of postmenopausal osteoporosis in a double-blind study.

Likelihood of approval

64.3% 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.
Big-pharma sponsor +3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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 (CP4)
Sponsor	Amgen
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 precursor cells, the drug suppresses bone resorption and increases bone mineral density. This mechanism makes it effective for conditions characterized by excessive bone loss or osteoclast-mediated bone destruction.

Approved indications

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

Common side effects

Hypocalcemia
Osteonecrosis of the jaw
Atypical femoral fractures
Infections
Fatigue

Key clinical trials

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 (CP4) CI brief — competitive landscape report
Denosumab (CP4) updates RSS · CI watch RSS
Amgen portfolio CI

Frequently asked questions about Denosumab (CP4)

What is Denosumab (CP4)?

Denosumab (CP4) is a RANKL inhibitor (monoclonal antibody) drug developed by Amgen, indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Osteoporosis in postmenopausal women and men at high risk of fracture.

How does Denosumab (CP4) work?

Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption.

What is Denosumab (CP4) used for?

Denosumab (CP4) is indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Osteoporosis in postmenopausal women and men at high risk of fracture.

Who makes Denosumab (CP4)?

Denosumab (CP4) is developed by Amgen (see full Amgen pipeline at /company/amgen).

What drug class is Denosumab (CP4) in?

Denosumab (CP4) 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 (CP4) in?

Denosumab (CP4) is in Phase 3.

What are the side effects of Denosumab (CP4)?

Common side effects of Denosumab (CP4) include Hypocalcemia, Osteonecrosis of the jaw, Atypical femoral fractures, Infections, Fatigue.

What does Denosumab (CP4) target?

Denosumab (CP4) 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: Amgen — 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 giant cell tumor of bone
Indication: Drugs for Osteoporosis in postmenopausal women and men at high risk of fracture

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