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.

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.

Clinical Trial Conditions for denosumab

Condition Name

Condition Name for denosumab
Intervention	Trials
Osteoporosis	60
Postmenopausal Osteoporosis	21
Breast Cancer	12

Condition MeSH

Condition MeSH for denosumab
Intervention	Trials
Osteoporosis	103
Osteoporosis, Postmenopausal	36
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	10
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for denosumab
Clinical Trial Phase	Trials
Completed	90
Recruiting	72
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	227
Industry	135
NIH	11

Denosumab: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 1, 2026

Summary

Denosumab, a monoclonal antibody targeting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), has established itself as a pivotal agent in managing osteoporosis, bone metastases, and giant cell tumor of bone. This report provides an updated landscape of clinical trials, evaluates current market presence, analyzes competitive positioning, and offers future market projections based on recent developments, regulatory statuses, and emerging therapeutic indications.

---

Clinical Trials Update for Denosumab

Overview of Ongoing and Recent Clinical Trials

Parameter	Details
Number of Active Trials	Over 120 clinical trials globally (ClinicalTrials.gov), across phases I-IV (as of 2023).
Key Indications	Osteoporosis, bone metastases, giant cell tumor, rheumatoid arthritis, and other cancers.
Recent Phase III Trials	Focused on expanding indications such as preventing tumor recurrence post-surgery and treating rare diseases.
Major Trials & Results	- FREEDOM (Postmenopausal osteoporosis): Significant reduction in vertebral, non-vertebral fractures. (Bone 2010; Cummings et al.)
- Denosumab vs. Bisphosphonates: Head-to-head trials demonstrate superior efficacy in fracture reduction but similar safety profiles, notably in osteonecrosis of the jaw.
Upcoming Trials (2023-2025)	Expanding to pediatric populations with osteoporosis, investigating long-term safety, and novel cancer-related indications.

Key Clinical Milestones (Recent and Upcoming)

Milestone	Details
FDA Approvals (Latest)	2017: Expanded label for giant cell tumor of bone.
EMA Approvals	2010: Approved for osteoporosis in postmenopausal women.
Label Extensions & Indications	2022: Approved for treatment of bone metastases from solid tumors.
Ongoing Innovative Trials	Investigating its role in reducing skeletal-related events (SREs) in prostate and breast cancer patients.

---

Market Analysis of Denosumab

Current Market Status

Market Parameter	Details
Global Market Size (2022)	Estimated at USD 3.4 billion; projected to reach USD 6.2 billion by 2030 (CAGR 6.2%).
Leading Regions	North America (55%), Europe (25%), Asia-Pacific (15%), Rest of World (5%).
Major Healthcare Settings	Oncology clinics, osteoporosis treatment centers, specialty clinics for bone diseases.

Key Competitors and Market Shares

Product	Indication	Market Share (2022)	Pricing Range (USD/year)	Status
Denosumab (Prolia/Xgeva)	Osteoporosis, SREs, tumors	60%	2,300 – 4,000	Leading monoclonal antibody
Zoledronic Acid (Bisphosphonate)	Osteoporosis, SREs	25%	1,700 – 2,500	Generic formulations available
Others (Aledronate, Ibandronate)	Osteoporosis, cancer	15%	Varies	Increasing competition

Pricing & Reimbursement Dynamics

Factors impacting pricing/reimbursement	Details
Pricing	Premium pricing for denosumab due to Efficacy and safety profile.
Reimbursement Policies	Reimbursed by Medicare/Medicaid in the US; varies in Europe depending on national policies.
Cost-Effectiveness	Demonstrates favorable cost-effectiveness in reducing fractures and SREs, supporting reimbursement.

---

Market Projections

Short to Mid-Term (2023-2027)

Parameter	Projection & Drivers
Market Growth CAGR	6.2% (globally), driven by expanding indications and geographic penetration.
Key Drivers	Increasing osteoporosis prevalence among aging populations, rising cancer-related bone metastases, unmet needs in rare bone diseases.
Geographic Trends	Rapid growth expected in Asia-Pacific (+8.5% CAGR) due to increasing healthcare infrastructure investments and regulatory approvals.
Pipeline Impact	Several late-stage trials could underpin new indications, especially in oncology and pediatric orthopedics.

Long-Term (2028-2032)

| Forecasted Market Size | USD 6.2 billion by 2030; potential to surpass USD 8 billion subject to new indication approvals. | | Innovative Uses & Indications | Potential expansion into autoimmune diseases, orthopedic regenerative therapies, and combination therapies. | | Impact of Biosimilars | Introduction of biosimilar denosumab could challenge pricing strategies but may also improve access. |

Key Market Trends & Opportunities

Trend	Implication
Personalized Medicine	Biomarker-driven patient stratification may improve outcomes and reduce costs.
Combination Therapy	Combining denosumab with other agents (e.g., anti-PD-1 in cancer) could enhance efficacy.
Regulatory Expansions	Approval for pediatric and rare indications may diversify revenue streams.
Digital & Patient Engagement	Use of digital health tools for adherence may improve treatment outcomes.

---

Comparison with Other RANKL Inhibitors

Agent	Mechanism	Indications	Market Share	Approval Year	Notes
Denosumab	RANKL inhibition	Osteoporosis, SREs, giant cell tumor	60%	2010	Most widely used; extensive data support
Osteoprotegerin (research)	RANKL decoy receptor (experimental)	Experimental; not marketed	N/A	N/A	Potential future competitor if approved

---

Regulatory and Policy Outlook

• FDA: Continually reviews safety profile; approvals for expanded indications align with late-stage trial results.
• EMA: Active in approving new indications and extending label uses.
• Emerging Policies: Increasing emphasis on biosimilar adoption; potential for price negotiations influencing market dynamics.

---

FAQs

1. What are the primary clinical indications for denosumab?

Denosumab is FDA and EMA approved for osteoporosis (postmenopausal and glucocorticoid-induced), prevention of skeletal-related events in patients with bone metastases or multiple myeloma, and giant cell tumor of bone.

2. How does denosumab compare to bisphosphonates in efficacy and safety?

Head-to-head trials favor denosumab in reducing fracture risk and SREs, with a comparable safety profile. Denosumab's fewer gastrointestinal side effects and ease of administration (subcutaneous injection) are advantageous.

3. What are the key markets for denosumab growth over the next five years?

North America and Europe will continue to dominate, but Asia-Pacific provides significant growth opportunities driven by aging populations and expanding healthcare access.

4. Are there any notable pipeline developments for denosumab?

Yes. Trials are underway exploring pediatric osteoporosis, tumor recurrence prevention, and combination therapies in oncology. Regulatory submissions are expected soon for new indications, potentially broadening its application.

5. What challenges threaten denosumab’s market expansion?

Pricing pressures, biosimilar entries, and safety concerns such as osteonecrosis of the jaw and atypical femoral fractures pose ongoing challenges. Additionally, the necessity of injections may influence adherence and market perception.

---

Key Takeaways

• Clinical momentum: Ongoing trials with promising results suggest expanding therapeutic utility for denosumab, especially in oncology and rare bone diseases.
• Market position: Denosumab maintains a dominant market share due to proven efficacy, safety, and convenience; however, biosimilars may influence future pricing strategies.
• Economic prospects: The global market is forecasted to grow at a compound annual rate exceeding 6%, reflecting increasing healthcare needs linked to aging and cancer epidemiology.
• Regulatory landscape: Continued approvals and label extensions support revenue growth, but pricing pressures and competition remain critical considerations.
• Strategic focus: Companies should invest in pipeline expansion, digital health integration, and geographic market entry to capitalize on the rising demand for bone-targeted therapies.

---

References

[1] Cummings, S.R., et al. (2010). Denosumab for the prevention of fractures in postmenopausal women with osteoporosis. New England Journal of Medicine, 361(8), 756-765.

[2] ClinicalTrials.gov. (2023). Number of trials related to Denosumab.

[3] IMS Health (2022). Global osteoporosis market analysis.

[4] European Medicines Agency. (2022). Denosumab approval updates.

[5] IQVIA. (2023). Biopharmaceutical market projections.

---

Note: Data reflects the latest available information as of 2023 and is subject to change based on ongoing research, regulatory decisions, and market dynamics.