Denosumab's US approval (BLA 125320) is held by Amgen.

Is Denosumab approved?

Yes. Denosumab is approved in the US for Multiple Myeloma and an indication outside this site's tracked markets (FDA, January 2018). It remains investigational for Rheumatoid Arthritis, HR+/HER2- Metastatic Breast Cancer and Non-Small Cell Lung Cancer.

What is Denosumab's mechanism of action?

Denosumab is a monoclonal antibody. Its tracked mechanism of action is RANKL.

When is Denosumab's next trial readout?

The next registry-estimated readout is October 2026: a Phase 4 study (NCT06720350). The date is the ClinicalTrials.gov primary-completion estimate and can move as the trial progresses.

Asset profile

Denosumab

Monoclonal antibody

Approved / Phase 4RANKL

Approvedregulatory verdict

Evidence outlook

Approved: Multiple Myeloma

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Reliable signal

Also in development:Rheumatoid Arthritis · Phase 2 HR+/HER2- Metastatic Breast Cancer · Phase 3 Non-Small Cell Lung Cancer · Phase 2

Also approved:US: Stoboclo 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 P (product first approved 2025), outside this platform's coverage

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Featured trials

The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.

approvedFeatured evidence · 1

Drug	Stage	Modality	Mechanism
Denosumab: this drug	Approved	Monoclonal antibody	RANKL
Abatacept (Orencia)	Approved	Protein / enzyme therapeutic	CD80/CD86 (CTLA-4-Ig), Selective T Cell Costimulation Modulator, CD80/CD86 (B7-1/B7-2) on antigen-presenting cells
Abemaciclib (Verzenio)	Approved	Small molecule	CDK4 and CDK6
Adalimumab (Humira)	Approved	Monoclonal antibody	TNF-alpha
Adalimumab-Adbm (Cyltezo)	Approved	Monoclonal antibody	TNF-alpha
Adalimumab-Ryvk (Simlandi)	Approved	—	TNF-alpha
Afatinib (Gilotrif)	Approved	Small molecule	EGFR/HER1, HER2, HER4
Aldesleukin (Proleukin)	Approved	Recombinant Cytokine (il-2)	Interleukin-2 receptor (IL-2R)
Alectinib (Alecensa)	Approved	Small molecule	ALK
Alpelisib (BYL719)	Approved	Small molecule	PI3K-alpha
Alymsys (bevacizumab-Maly)	Approved	Monoclonal antibody	VEGF-A
Amivantamab	Approved	Multispecific antibody	EGFR x c-MET
Anakinra (r-metHuIL-1ra)	Approved	Protein / enzyme therapeutic	Interleukin-1 receptor (IL-1R), Interleukin-1 receptor type 1 (IL-1R1)
Anastrozole	Approved	Small molecule	Aromatase
Atezolizumab	Approved	Monoclonal antibody	PD-L1
Baricitinib (Olumiant)	Approved	Small molecule	JAK, JAK1/2

Trial	Phase	Endpoint	Key result	Signal	Source

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