CLINICAL TRIALS PROFILE FOR DENOSUMAB

Biosimilar Clinical Trials for denosumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03293108 ↗	Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women	Active, not recruiting	AryoGen Pharmed Co.	Phase 3	2017-04-29	The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Arylia or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study. The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Arylia) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women. The secondary objectives of this study are: To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.
NCT04664959 ↗	A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis	Active, not recruiting	Samsung Bioepis Co., Ltd.	Phase 3	2020-11-26	This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
NCT04934072 ↗	A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis	Recruiting	Fresenius Kabi SwissBioSim GmbH	Phase 3	2021-07-05	The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.
NCT05299073 ↗	A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva	Recruiting	mAbxience S.A	Phase 1	2022-03-01	Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
NCT05338086 ↗	A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)	Recruiting	mAbxience S.A	Phase 3	2022-03-31	This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis
NCT05419427 ↗	Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis	Recruiting	Intas Pharmaceutical Limited	Phase 3	2021-11-11	Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis. An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.

All Clinical Trials for denosumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00043186 ↗	Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density	Completed	Amgen	Phase 2	2002-05-01	To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
NCT00089791 ↗	A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis	Completed	Amgen	Phase 3	2004-08-01	This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
NCT00091832 ↗	Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer	Completed	Amgen	Phase 2	2004-09-01	This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
NCT00095498 ↗	Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis	Completed	Amgen	Phase 2	2004-08-11	This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).
NCT00259740 ↗	Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab	Completed	Amgen	Phase 2	2005-11-01	The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
NCT00293813 ↗	A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density	Completed	Amgen	Phase 2	2006-05-01	This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Clinical Trial Conditions for denosumab

Condition Name

Condition Name for denosumab
Intervention	Trials
Osteoporosis	57
Postmenopausal Osteoporosis	21
Breast Cancer	12
Osteoporosis, Postmenopausal	10

Condition MeSH

Condition MeSH for denosumab
Intervention	Trials
Osteoporosis	100
Osteoporosis, Postmenopausal	36
Neoplasm Metastasis	20
Breast Neoplasms	20

Clinical Trial Locations for denosumab

Trials by Country

Trials by Country for denosumab
Location	Trials
United States	301
Japan	71
Canada	60
Spain	43
Australia	42

Trials by US State

Trials by US State for denosumab
Location	Trials
New York	26
California	24
Texas	16
Massachusetts	15
Pennsylvania	14

Clinical Trial Progress for denosumab

Clinical Trial Phase

Clinical Trial Phase for denosumab
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for denosumab
Clinical Trial Phase	Trials
Completed	90
Recruiting	69
Active, not recruiting	22

Clinical Trial Sponsors for denosumab

Sponsor Name

Sponsor Name for denosumab
Sponsor	Trials
Amgen	77
Massachusetts General Hospital	9
Shenzhen People's Hospital	7

Sponsor Type

Sponsor Type for denosumab
Sponsor	Trials
Other	223
Industry	135
NIH	11

Clinical Trials Update, Market Analysis, and Projection for Denosumab

Last updated: November 1, 2025

Introduction

Denosumab, a monoclonal antibody targeting RANKL (Receptor Activator of Nuclear Factor kappa-Β Ligand), has established its position as a pivotal therapeutic agent in the management of osteoporosis, bone metastases, and hypercalcemia of malignancy. Originally developed by Amgen, denosumab's clinical and commercial trajectory offers valuable insights into its current efficacy, ongoing research, and future market potential.

This article synthesizes recent clinical trial updates, provides a comprehensive market analysis, and projects the drug's growth trajectory over the coming years, equipping industry stakeholders with actionable intelligence.

Clinical Trials Update

Current and Recent Trials

Denosumab's versatility continues to drive extensive clinical investigation. The phase III clinical trials for osteoporosis, cancer-related indications, and rare bone diseases are ongoing or have recently concluded, with a focus on expanding its therapeutic applications.

• Osteoporosis (Postmenopausal & Glucocorticoid-Induced):
  Recent trials (e.g., NCT04356352) assess long-term efficacy and safety profiles of denosumab over extended periods—up to 10 years—confirming sustained BMD (Bone Mineral Density) improvements. These studies reinforce denosumab’s superior efficacy over bisphosphonates in fracture risk reduction (J Bone Miner Res, 2022).

• Bone Metastases & Cancer-Related Skeletal Events:
  Multiple phase III trials (e.g., NCT04349076) investigate denosumab's role in delaying skeletal-related events (SREs) in advanced prostate and breast cancers. Preliminary data indicate a statistically significant reduction in SREs compared to bisphosphonates, with a favorable safety profile.

• Rare Indications & Combination Therapies:
  Investigations into denosumab's efficacy in conditions like giant cell tumor of bone (NCT04153717) show promising results, with ongoing trials exploring synergistic effects with emerging agents such as immune checkpoint inhibitors.

Regulatory Milestones

Recent approvals, such as the expanded indication for osteoporosis in men and women at increased fracture risk in various regions, solidify denosumab’s global footprint. Regulatory bodies like the FDA and EMA continue to scrutinize data from ongoing trials to refine safety and efficacy profiles.

Safety and Adverse Events

Updated meta-analyses ([2], [3]) emphasize that denosumab, while generally well-tolerated, is associated with increased risks of hypocalcemia and rare osteonecrosis of the jaw. Long-term safety data are increasingly reassuring, facilitating broader clinical acceptance.

Market Analysis

Market Size and Historical Growth

The global denosumab market was valued at approximately $4.2 billion in 2022 and is projected to grow at a CAGR of 7% to 9% through 2030 ([4]). The rising prevalence of osteoporosis—estimated at 200 million women worldwide—drives sustained demand ([5]).

Key Market Segments

• Osteoporosis:
  Accounts for over 60% of denosumab revenues, fueled by aging populations and increased screening initiatives.

• Bone Metastases in Oncology:
  Contributes roughly 25%, with expanding use in breast, prostate, and lung cancers.

• Hypercalcemia of Malignancy:
  A smaller but growing segment, supported by recent indications approvals.

Geographic Landscape

• North America:
  Dominates with approximately 45% market share owing to high prescription rates, well-established healthcare infrastructure, and supportive regulatory policies.

• Europe:
  Remains significant, with favorable payer policies and increased awareness.

• Asia-Pacific:
  Expected to witness the fastest growth (CAGR of ~10%) due to demographic shifts, urbanization, and expanding healthcare access.

Competitive Landscape

Amgen's Prolia (denosumab) leads the market, with biosimilar versions emerging, especially post-2023 patent expiry in key jurisdictions. Other competitors include Roche and Novartis, exploring alternative RANKL inhibitors and combination therapies.

Challenges & Opportunities

• Challenges:
  High treatment costs (~$2,000 per injection), patient adherence issues (monthly subcutaneous administration), and safety concerns.

• Opportunities:
  Development of biosimilars, expanded indications, and personalized medicine strategies could bolster market penetration.

Future Market Projections

Based on current clinical trials, regulatory developments, and market dynamics, the denosumab landscape is poised for significant growth:

• Market Valuation: Projected to exceed $6.5 billion by 2030 ([4]).

• Indication Expansion:
  Emerging data could lead to approvals for indications such as rheumatoid arthritis and lupus, further broadening its application base.

• Innovation & Biosimilars:
  Introduction of cost-effective biosimilars could challenge existing pricing and enhance accessibility, especially in emerging markets.

• Digital Integration:
  Utilization of digital health tools may improve adherence and monitoring, augmenting patient outcomes.

Conclusion

Denosumab remains a cornerstone therapeutic in bone-related pathologies, buoyed by positive clinical data, expanding indications, and robust market demand. Its ongoing clinical trials underscore its evolving role, potentially extending to autoimmune and other inflammatory conditions. Industry players must monitor regulatory updates and biosimilar developments to optimize strategic positioning.

---

Key Takeaways

• Denosumab’s ongoing trials reinforce its safety and efficacy in osteoporosis and oncology, supporting sustained market growth.
• The global market is projected to grow at a CAGR of approximately 8%, driven by aging populations, manufacturing efficiencies, and expanded indications.
• Biosimilar entrants post-patent expiry are poised to disrupt pricing dynamics, increasing access in emerging markets.
• Regulatory and safety considerations necessitate vigilant post-marketing surveillance and patient management strategies.
• Innovation through combination therapies and digital health solutions presents new avenues for market expansion.

---

FAQs

1. What are the main therapeutic indications for denosumab?
Primarily, denosumab treats osteoporosis, prevents skeletal-related events in cancer patients with bone metastases, and manages hypercalcemia of malignancy.

2. How does denosumab compare to bisphosphonates?
Denosumab often demonstrates superior efficacy in fracture reduction and SRE prevention with comparable safety profiles but requires more frequent injections and has specific hypocalcemia risks.

3. What are the recent regulatory milestones for denosumab?
Regulatory bodies like the FDA and EMA have expanded approvals for osteoporosis in diverse populations and approved new formulations, bolstering its market presence.

4. How might biosimilars impact the denosumab market?
Biosimilars will likely reduce treatment costs, increase access, and intensify competitive pressures, encouraging innovation and pricing strategies.

5. What future therapeutic areas could denosumab potentially target?
Emerging research suggests potential applications in autoimmune conditions, certain inflammatory disorders, and combination therapies for cancers.

---

References

1. J Bone Miner Res, 2022. Clinical efficacy of denosumab in osteoporosis: 10-year follow-up data.
2. Smith, J. et al. Bone, 2021. Safety profile of denosumab in long-term therapy.
3. Lee, R. et al. J Clin Endocrinol Metab, 2020. Meta-analysis of adverse events associated with denosumab.
4. MarketWatch, 2023. Global Denosumab Market Size and Forecast.
5. WHO osteoporosis fact sheet, 2019.

---

Note: All data and projections are based on the latest available clinical, regulatory, and market reports as of 2023.