Drug Database
DE

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

PubMedFrontiers in endocrinology2026-09-19

Case Report: Reopening the anabolic window - romosozumab added to ongoing denosumab for severe osteoporosis in two kidney transplant recipients.

Barbuto Simona S, Mastromauro Paolo P, Zavatta Guido G, Vetrano Daniele D et al.

Kidney transplant recipients develop disorders of mineral and bone metabolism that further impair bone strength, leading to osteoporosis and a high fracture risk. However, evidence in this setting is limited. Romosozumab, a sclerostin inhibitor with both anabolic and antiresorptive effects, is an attractive option, but its use in transplant recipients, as well as its combination with denosumab, has rarely been reported. We describe two female kidney transplant recipients with severe osteoporosis and persistently high fracture risk despite long-term denosumab, in whom romosozumab (210 mg monthly) was added to ongoing denosumab for 12 months. In both patients the bone-formation markers P1NP and BAP rose early, and bone mineral density improved preferentially at the lumbar spine (Case 1 + 5.9%, Case 2 + 11.2%), with only modest changes at the femoral neck and total hip. Serum calcium, parathyroid hormone, 25-hydroxyvitamin D and allograft function remained stable throughout, with no clinically significant hypocalcemia, and neither patient sustained a new vertebral fracture. Adding romosozumab to ongoing denosumab thus reopened the anabolic window and improved lumbar-spine bone mineral density without compromising mineral metabolism or graft function. This combination may represent a reasonable option for carefully selected transplant recipients who continue to lose bone or to fracture despite antiresorptive therapy, pending confirmation in controlled studies.

PMID 42761068
Read full article →
PubMedMediterranean journal of rheumatology2026-09-18

Cardiovascular Safety Signals of Osteoporosis Therapies: A FAERS Pharmacovigilance Study.

Sondhi Manush M, Singh Namrata N, Carkin Julie J, Hughes Grant G

To evaluate the associations between commonly used osteoporosis medications and major adverse cardiovascular events (MACE) using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We conducted a retrospective pharmacovigilance analysis of FAERS reports between January 2019 and December 2024, identifying all reports involving alendronate, risedronate, zoledronic acid, denosumab, teriparatide, abaloparatide, or romosozumab. MACE outcomes included myocardial infarction (MI), stroke, atrial fibrillation (A-fib), and cardiac failure (CF), defined using Medical Dictionary for Regulatory Activities Preferred Terms. Disproportionality was assessed using reporting odds ratios (RORs), with signals defined by a lower 95% confidence interval >1. All analyses were descriptive and hypothesis-generating. FAERS contained more than 30 million adverse event reports during the study period. Romosozumab demonstrated the highest ROR for MI (2.38) and stroke (3.72), and also showed elevated signals for A-fib and CF (ROR 3.76). Zoledronic acid showed notable associations with stroke (ROR 2.42) and A-fib (ROR 3.22). Denosumab and abaloparatide were associated with the lowest RORs across all cardiovascular outcomes. Alendronate and risedronate demonstrated intermediate disproportionality signals, particularly for A-fib and CF. Romosozumab and zoledronic acid demonstrated prominent cardiovascular disproportionality signals in FAERS, whereas denosumab, abaloparatide, and teriparatide showed more favorable reporting profiles. These findings should not discourage osteoporosis treatment but underscore the importance of individualised cardiovascular risk assessment and the need for further prospective evaluation to inform safe therapy selection.

PMID 42756536
Read full article →
PubMedCalcified tissue international2026-09-18

Anti-osteoporotic Pharmacotherapy and Muscle Outcomes in Osteosarcopenia: a Source-Verified Translational Evidence Map.

Lim Dong-Ju DJ, Kang Min Kue MK

Anti-osteoporotic drugs are increasingly discussed as candidate dual bone-muscle therapies in osteosarcopenia, yet clinical claims often conflate biological plausibility, observational signals, and randomized efficacy. We conducted a source-verified scoping evidence map and translational review, updated through 25 July 2026 using PubMed/MEDLINE, Europe PMC, and citation tracking. Evidence was classified as primary randomized evidence, secondary randomized analysis, observational human evidence, mechanistic/preclinical rationale, or review-level context; quantitative pooling was avoided because no drug-outcome pair had a sufficiently homogeneous randomized evidence base. Denosumab has the most coherent translational rationale through RANKL/RANK/NF-kB signaling, but randomized long-term-care data were neutral for muscle mass, strength, and performance despite bone mineral density improvement. Long-term-care context may reduce anabolic reserve, but a drug-by-exercise interaction remains unproven. Early pamidronate data in severe pediatric burns support prevention of resorption-linked muscle catabolism rather than reversal of established age-related sarcopenia. Bisphosphonates and teriparatide have preclinical or secondary signals; romosozumab and abaloparatide lack direct clinical muscle-efficacy evidence. Nandrolone is retained only as a historical positive control. Future trials should distinguish prevention from reversal and use factorial or rigorously standardized exercise designs with prespecified strength, muscle-mass, physical-performance, and pathway endpoints.

PMID 42758353
Read full article →
PubMedJCEM case reports2026-09-17

Medication-related osteonecrosis of the external auditory canal and treatment with teriparatide.

Xia Daheng D, Ting Matthew J M MJM, Atlas Marcus D MD, Boeddinghaus Rudolf R et al.

Medication-related osteonecrosis of the external auditory canal (MROEAC) is a rare complication of antiresorptive therapy, and guidance for diagnosis and management remains limited. We describe 2 patients with prolonged antiresorptive exposure who developed MROEAC and were treated with teriparatide. An 81-year-old woman developed bilateral external auditory canal erosions after 10 years of denosumab therapy. An 8-week course of teriparatide was associated with clinical improvement and a transient rise in bone formation markers, but computed tomography findings remained unchanged. Denosumab withdrawal led to delayed rebound bone resorption, prompting denosumab reintroduction. A 67-year-old woman developed left-sided MROEAC after 15 years of alendronate followed by a short course of denosumab. Four months of teriparatide was associated with symptomatic and biochemical improvement, but radiologic abnormalities persisted, and definitive surgery was required. These cases highlight the difficulty of differentiating MROEAC from more common otologic disorders, the discordance between clinical, biochemical, and radiologic response, the importance of multidisciplinary management, and therapeutic challenges created by denosumab discontinuation. Teriparatide was well tolerated and was associated with increased bone turnover markers, but radiologic resolution was incomplete. Surgical management may still be necessary.

PMID 42751062
Read full article →
PubMedKidney research and clinical practice2026-09-15

Denosumab for kidney transplant recipients: clinical value and unresolved questions.

Park Hye-Sun HS

PMID 42736595
Read full article →
PubMedPediatric blood & cancer2026-09-15

Successful Denosumab Treatment of a Pediatric Spinal Aneurysmal Bone Cyst With COL1A1-USP6 Rearrangement Histologically Mimicking Giant Cell Tumor of Bone.

Aydin Sultan S, Alparslan Ahmet Sukru AS

PMID 42742538
Read full article →

+5564 more articles available with a free account

Sign up free to view all articles →

Ask about denosumab