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denosumab (RTPR045 / RTPR 045 / DenosteRel)

✓ Approved

Reliance Life Sciences Private Limited · TNFSF11 · Monoclonal Antibodies

What is denosumab?

denosumab is a monoclonal antibodies developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesRTPR045, RTPR 045, DenosteRel
CompanyReliance Life Sciences Private Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetTNFSF11
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Reliance Life Sciences Private Limited

Mechanism of Action

Molecular Targets

denosumab acts on 1 molecular target:

TNFSF11TNF superfamily member 11 (ODF, CD254)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

denosumab is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Bone cancer✓ Approved
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

Related Research Articles

PubMedClinical rheumatology2026-10-14

Osteoporosis and fracture severity as independent risk factors for osteonecrosis of the jaw in rheumatoid arthritis: a TriNetX cohort study.

Nagafuchi Hiroko H, Ando Takayasu T, Kawahata Kimito K

To investigate the independent impact of osteoporosis and its severity, characterised by bone fractures, on osteonecrosis of the jaw (ONJ) risk in patients with rheumatoid arthritis (RA) using a global real-world database. We hypothesised that osteoporosis independently increases ONJ risk in patients with RA, irrespective of medication exposure. This retrospective cohort study utilised the TriNetX database. Primary analysis estimated the association between osteoporosis and incident ONJ (primary outcome) after propensity score matching (PSM). Secondary analysis evaluated the impact of bone fractures using multivariable Cox proportional hazards models. Sensitivity analyses assessed robustness. In the primary PSM analysis (160,789 pairs), osteoporosis was the strongest independent risk factor for ONJ (adjusted hazard ratio [aHR] 3.135, 95% confidence interval [CI] 2.740-3.584, P < 0.001). Among patients with osteoporosis (22,821 pairs), ONJ incidence was higher in those with bone fractures (P = 0.047). Multivariable analysis identified bone fractures (aHR 1.522, 95% CI 1.202-1.931, P < 0.001) and denosumab use (aHR 1.970, 95% CI 1.397-2.777, P < 0.001) as independent risk factors. Sensitivity analyses confirmed that the association between osteoporosis and ONJ remained robust in antiresorptive-naïve and glucocorticoid-naïve patients after excluding bone metastasis and high-dose antiresorptive therapy (aHR 3.125, 95% CI 2.564-3.817, P < 0.0001). Osteoporosis and fracture history are independent risk factors for ONJ in patients with RA. These findings support a disease-driven paradigm where underlying bone fragility drives ONJ development beyond antiresorptive or glucocorticoid effects, highlighting the need for comprehensive bone health management in this population. Future prospective studies are needed to evaluate targeted screening interventions. Key points • Osteoporosis is a stronger independent risk factor for ONJ than antiresorptive medication. • Prior bone fractures significantly increase ONJ risk among patients with rheumatoid arthritis and osteoporosis. • Managing underlying bone fragility is crucial for ONJ prevention, beyond monitoring osteoporosis medication use.

PMID 42870199
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PubMedOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2026-10-13

Building bone in the jaw with denosumab in adult Langerhans cell histiocytosis.

Makras Polyzois P, Kouveletsou Marina M, Siska Ioanna I, Kalkanis Dimitrios D et al.

A patient with multisystem Langerhans cell histiocytosis and extensive jaw osteolysis experienced remarkable mandibular bone regeneration following short-term denosumab therapy. This unique observation challenges current concepts of denosumab action in the jaw and provides novel in vivo evidence of structural repair through RANKL inhibition. Denosumab is an established inhibitor of receptor activator of nuclear factor-κB ligand (RANKL) that effectively suppresses osteoclastic bone resorption but has also been associated with medication-related osteonecrosis of the jaw (MRONJ). We report a 41-year-old man with multisystem Langerhans cell histiocytosis (LCH) presenting with extensive osteolytic destruction of the maxilla and mandible following multiple dental extractions, clinically resembling MRONJ. Molecular analysis identified a MAP2K1 mutation, and staging confirmed multisystem disease involving the jaw, clavicle, and lungs. The patient received denosumab (120 mg every 2 months for 6 months), resulting in rapid pain relief, marked suppression of serum C-terminal telopeptide of type I collagen and procollagen type I N-terminal propeptide, and substantial reduction in metabolic activity on FDG-PET/CT. Most remarkably, serial imaging demonstrated extensive new bone formation with restoration of mandibular cortical integrity and alveolar architecture despite profound suppression of bone turnover. This striking regenerative response contrasts with the established association between denosumab and MRONJ and suggests that inhibition of disease-driven RANKL signaling in LCH may permit reversal of severe jaw destruction. These observations provide novel in vivo evidence that denosumab may promote structural repair of LCH-associated jaw lesions and raise important mechanistic questions regarding the role of RANKL in pathological jaw bone remodeling.

PMID 42867634
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PubMedGlobal spine journal2026-10-13

Fracture and Vertebral Augmentation Utilization Following Androgen Deprivation Therapy in Men With Prostate Cancer: A Propensity Score-matched Cohort Study.

Taka Taha T, Cummings Carson C, Meng Sarah S, Miner Andrew A et al.

Study DesignRetrospective cohort study.ObjectiveTo investigate the association between androgen deprivation therapy (ADT), vertebral compression fracture (VCF) incidence, and subsequent vertebral augmentation (vertebroplasty/kyphoplasty) utilization in adult men with prostate cancer.MethodsAdult men with prostate cancer were stratified by ADT exposure and matched 1:1 to non-ADT controls on demographics, comorbidities, and bone health. Primary outcomes were VCF incidence at 3 months, 1 year, 3 years, and 5 years and vertebral augmentation utilization. Secondary outcomes included posterior spinal instrumentation, dependency, fracture burden, and bisphosphonate/denosumab use. Risks were compared using Kaplan-Meier and Cox proportional hazards models, with chi-square tests for categorical outcomes.ResultsAfter matching, 122,511 patients were included per cohort. ADT was associated with higher 5-year VCF incidence (1.95% vs 1.29%; HR, 1.49; p < 0.001), representing a 54% relative increase (NNH = 143), with consistent findings at earlier time points (all p < 0.05). Among 2,926 matched pairs with VCFs, vertebral augmentation utilization was higher with ADT (7.4% vs 5.1%; p < 0.001), representing a 45% relative increase. Posterior instrumentation (2.1% vs 2.0%) and dependency (7.5% vs 7.7%) were similar, while fracture burden did not differ (p = 0.07).ConclusionsADT is associated with increased VCF incidence and vertebral augmentation utilization without differences in posterior instrumentation. This pattern is consistent with osteoporotic insufficiency fractures and supports bone health screening and preventive therapy at ADT initiation.

PMID 42868235
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PubMedEndocrine connections2026-10-13

"Single-Centre Audit of Bone-Modifying Agents in Neuroendocrine Neoplasm Bone Metastases".

Osman Wessam W, Aravind Preetha P, Prabhudev Hemanth H, Todd Jeannie J et al.

Bone metastases in neuroendocrine neoplasms are uncommon but cause significant morbidity. A recent Italian survey of 320 patients with neuroendocrine neoplasms and bone metastases reported skeletal-related events in 23% and bone-targeted agent use in 31%, highlighting limited evidence for bone-modifying agents. We identified adults with confirmed or clinically suspected neuroendocrine bone involvement who received a bone-modifying agent at a UK tertiary centre (January 2019-September 2024), using institutional prescribing records. Demographic, tumour, treatment, and toxicity data were extracted from records. Twenty-two patients received treatment (denosumab 17 [77%], zoledronic acid 5 [23%]). Most (91%) had grade 1-2 tumours; 64% had gastro-entero-pancreatic primaries. Bone metastases were synchronous in 46% and widespread (more than three lesions) in 73%. At diagnosis, 22% were symptomatic; during follow-up, 78% developed pain, high blood calcium, or a skeletal-related event. Skeletal-related events, a composite of pathological fracture, spinal cord compression, radiotherapy to bone, or orthopaedic surgery, occurred in 41% (radiotherapy alone in 36%); pain-relieving medication was used universally. Treatment was mainly given every 12 weeks (median six doses). Low blood calcium occurred in 9% and osteonecrosis of the jaw in 5%; dental assessment before therapy was recorded in only 9%. These figures are broadly consistent with the Italian survey cited above. Treatment use was heterogeneous, reflecting a lack of disease-specific guidelines, and toxicity was comparable to other solid tumours and generally manageable. Our findings highlight the need for prospective studies and structured registries to clarify treatment use, dosing, and impact on quality of life and prognosis.

PMID 42868215
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PubMedEuropean journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2026-10-11

161Tb radiopharmaceutical therapy as a treatment for RANKL-positive multiple myeloma.

Yan Haoyi H, Li Jun J, Xu Chuanmian C, Huang Zixuan Z et al.

Denosumab, an anti-RANKL monoclonal antibody, is clinically approved for bone protection in multiple myeloma (MM) but lacks direct cytotoxic effects on tumor cells. Herein, we repurpose this well-tolerated antibody as a targeted delivery vehicle by conjugating it with the emerging radionuclide 161Tb, which emits low-energy conversion and Auger electrons with ultra-short tissue range, offering high relative biological effectiveness against single tumor cells and micrometastases. However, 161Tb-based radiopharmaceutical therapy has not been explored in MM. Our purpose is to evaluate the therapeutic potential of [161Tb]Tb-DOTA-Denosumab compared to [177Lu]Lu-DOTA-Denosumab for RANKL-positive MM. DOTA-conjugated Denosumab was labeled with 161Tb and 177Lu. Radiochemical purity, in vitro stability and biodistribution were assessed. Therapeutic efficacy was evaluated in U266 and H929 subcutaneous xenograft models. Tumor volume, survival, body weight, hematologic, and biochemical parameters were monitored. Administered-activity-escalation toxicity studies were performed in tumor-free mice. Both radiolabeled conjugates showed high radiochemical purity (>95%), excellent in vitro stability and comparable tumor uptake. [161Tb]Tb-DOTA-Denosumab demonstrated significantly enhanced antitumor efficacy compared to [177Lu]Lu-DOTA-Denosumab at equivalent (1.85 MBq) or lower activities. In the U266 model, median survival was prolonged from 33 days (saline) to 45 days with 161Tb (1.85 MBq) versus 39 days with 177Lu (1.85 MBq). In the H929 model, median survival extended to 47 days with 161Tb (1.85 MBq) versus 31 days (saline) and 41 days with 177Lu (1.85 MBq). Toxicity studies confirmed reversible hematologic changes only at administered activities ≥3.70 MBq, with no severe organ damage. This is the first demonstration of 161Tb-based radiopharmaceutical therapy targeting RANKL in MM. [161Tb]Tb-DOTA-Denosumab exhibits superior antitumor efficacy and prolonged survival compared to its 177Lu-labeled counterpart. The unique Auger/conversion electron emission of 161Tb enables potent cytotoxicity against MM cells with favorable organ tolerability. These findings support 161Tb as a next-generation theranostic radionuclide for RANKL-positive malignancies and provide a strong rationale for clinical translation, highlighting the value of repurposing a clinically established antibody for radiopharmaceutical therapy.

PMID 42858891
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PubMedZhonghua nei ke za zhi2026-10-10

[Mosaic Turner syndrome with a 45, X/46, XX/47, XXX karyotype presenting with recurrent fractures: a case report and literature review].

Li R R, Zhu Z F ZF, Wang S Q SQ, Wang O O et al.

A case of a patient with Turner syndrome (TS) with a karyotype of 45, X/46, XX/47, XXX who was admitted to the Department of Endocrinology at Peking Union Medical College Hospital in March 2025 were reported. The patient presented with primary amenorrhea and recurrent fractures. Dual-energy X-ray absorptiometry revealed osteoporosis, and spinal X-rays showed multiple vertebral wedge-shaped deformities. Screening for other secondary causes of osteoporosis revealed no significant abnormalities. Based on these results, together with the patient's sex hormone levels indicating hypergonadotropic hypogonadism and a peripheral blood karyotype of 45, X/46, XX/47, XXX, the patient was diagnosed with mosaic TS complicated by osteoporosis. The patient was treated with denosumab 60 mg subcutaneously once every 6 months, in combination with calcium carbonate/vitamin D3 600 mg orally once daily and vitamin D3 2 000 U orally once daily. No new fractures occurred through 9 months of follow-up. A literature review revealed that 26 cases of 45, X/46, XX/47, XXX mosaic TS with complete clinical data have been reported worldwide to date. The median age at diagnosis was 20.50 (range, 7.38-32.75) years. Patients diagnosed under 18 years of age predominantly presented with short stature; patients of reproductive age may present with infertility, with some achieved a successful pregnancy through assisted reproductive technology; and patients over 40 years of age often presented with other systemic diseases, such as hearing impairment, psychiatric disorders, epilepsy, ovarian stromal cell tumors, multiple myeloma, and sideroblastic anemia.

PMID 42855758
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