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
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.
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.
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.
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.

All Clinical Trials for denosumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
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.
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.

Clinical Trial Conditions for denosumab

Condition Name

Condition Name for denosumab
Intervention	Trials
Osteoporosis	53
Postmenopausal Osteoporosis	20
Breast Cancer	12
Osteoporosis, Postmenopausal	10

Condition MeSH

Condition MeSH for denosumab
Intervention	Trials
Osteoporosis	95
Osteoporosis, Postmenopausal	34
Neoplasm Metastasis	20
Bone Neoplasms	20

Clinical Trial Locations for denosumab

Trials by Country

+

−

Trials by Country for denosumab
Location	Trials
United States	295
Japan	71
Canada	60
Spain	43
Australia	42

Trials by US State

+

−

Trials by US State for denosumab
Location	Trials
New York	26
California	23
Texas	16
Massachusetts	15
Pennsylvania	14

Clinical Trial Progress for denosumab

Clinical Trial Phase

Clinical Trial Phase for denosumab
Clinical Trial Phase	Trials
Phase 4	55
Phase 3	56
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for denosumab
Clinical Trial Phase	Trials
Completed	90
Recruiting	58
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	206
Industry	132
NIH	11

Denosumab: Clinical Trials, Market Analysis, and Projections

Introduction to Denosumab

Denosumab is a monoclonal antibody used to treat osteoporosis, bone metastases, and giant cell tumors of bone. It works by targeting the RANK ligand, thereby inhibiting bone resorption and increasing bone density.

Clinical Trials Update

Denosumab Sequential Therapy Trial

A recent randomized clinical trial, the Denosumab Sequential Therapy (DST) trial, investigated the use of zoledronate after denosumab discontinuation to prevent bone loss. The trial, conducted in Taiwan, involved postmenopausal women and men aged 50 or older who had received denosumab for at least two years. Participants were randomized into two groups: one receiving continuous denosumab and the other receiving a single dose of zoledronate in the first year.

• The results showed that at the end of the first year, there was no significant difference in C-terminal telopeptide (CTX) serum levels between the continuous denosumab group and the zoledronate group. However, for participants who had received denosumab for three or more years, CTX serum levels were significantly different in the zoledronate group compared to the continuous denosumab group[1].

• Additionally, N-terminal propeptide of type 1 collagen (P1NP) serum levels increased significantly in the zoledronate group, indicating an anabolic effect on bone formation[1].

Biosimilar Trials

The denosumab market is also seeing the emergence of biosimilars. Recent applications for denosumab biosimilars have been accepted by regulatory bodies. For example, Teva's TVB-009P and Shanghai Henlius Biotech's HLX14 have undergone phase 3 trials comparing their efficacy, safety, and pharmacokinetics to the reference product, Prolia. These biosimilars are expected to launch in 2025 or later, potentially expanding access to denosumab treatments[4].

Market Analysis

Current Market Size and Growth

The global denosumab market has experienced significant growth in recent years. As of 2024, the market size is estimated to be $3.27 billion, up from $2.89 billion in 2023, reflecting a compound annual growth rate (CAGR) of 13.2%[2][3].

Market Segmentation

The denosumab market is segmented by drug classification, type, and end-users.

• Drug Classification: The market is dominated by Prolia and Xgeva, with other classifications also present. Prolia is particularly prominent due to its widespread use in treating osteoporosis[2][5].
• Type: Denosumab is available in 60 mg and 120 mg formulations, with the 60 mg dose being more commonly used for osteoporosis treatment[2][5].
• End-Users: The primary end-users include hospitals, homecare, specialty clinics, and ambulatory surgical centers. Hospitals and specialty clinics are significant segments due to the need for supervised administration of the drug[2][5].

Regional Analysis

The global denosumab market is analyzed across various regions, with North America currently dominating due to its strong healthcare infrastructure and high prevalence of bone disorders. The Asia-Pacific region is expected to witness significant growth driven by government initiatives, rising health awareness, and a large population pool[5].

Market Projections

Forecasted Growth

The denosumab market is projected to continue its rapid growth. By 2028, the market is expected to reach $5.06 billion, with a CAGR of 11.5% from 2024 to 2028. By 2030, the market is forecasted to grow to $7.109 billion, reflecting a CAGR of 11.9% during the forecast period[2][3][5].

Drivers of Growth

Several factors are driving the growth of the denosumab market:

• Increasing Prevalence of Osteoporosis: As the global population ages, the incidence of osteoporosis is rising, leading to increased demand for denosumab[2][3][5].
• Advancements in Clinical Trials and Research: Continuous research and FDA approvals for new indications are expanding the market[2][3].
• Growing Awareness and Diagnosis: Increased awareness about osteoporosis and its impact on health is leading more individuals to seek diagnosis and treatment[5].
• Efficacy and Safety Profile: Denosumab's proven efficacy in reducing fracture risk and its generally well-tolerated safety profile contribute to its popularity[5].

Restraints and Challenges

Despite the growth, the market faces some challenges:

• Competition from Existing Therapies: The presence of other antiosteoporosis medications and upcoming biosimilars could pose competition to branded denosumab products[5].
• Regulatory Framework: Changes in regulatory scenarios and the approval process for biosimilars can impact market dynamics[5].

Opportunities and Future Outlook

Research and Development

Ongoing research and development in bone health offer opportunities for optimizing denosumab's efficacy and safety. Exploring combination treatments and novel therapies that complement denosumab's mechanism of action could further expand its market[5].

Biosimilars and Generic Competition

The approval and launch of biosimilars, such as Sandoz’s Jubbonti and others, are expected to increase market competition and potentially reduce costs, making denosumab more accessible to a broader patient population[4].

Increasing Aging Population

The global aging population presents a significant opportunity for the denosumab market, as age is a major risk factor for osteoporosis and other bone-related conditions[5].

Key Takeaways

• Denosumab is a critical treatment for osteoporosis and bone metastases, with ongoing clinical trials exploring its use in sequential therapy.
• The global denosumab market is growing rapidly, driven by increasing osteoporosis prevalence, advancements in clinical trials, and growing awareness.
• Market segmentation includes drug classification, type, and end-users, with Prolia dominating the market.
• North America currently leads the market, but the Asia-Pacific region is expected to see significant growth.
• The market is projected to reach $5.06 billion by 2028 and $7.109 billion by 2030.
• Drivers include the increasing prevalence of osteoporosis, advancements in research, and growing awareness.
• Restraints include competition from existing therapies and regulatory challenges.

FAQs

What is denosumab used for?

Denosumab is used to treat osteoporosis, prevent skeletal-related events in patients with bone metastases from solid tumors, and treat giant cell tumors of bone.

What is the current market size of denosumab?

As of 2024, the global denosumab market size is estimated to be $3.27 billion.

What is the projected growth rate of the denosumab market?

The market is expected to grow at a CAGR of 11.5% from 2024 to 2028 and reach $5.06 billion by 2028.

What are the main drivers of the denosumab market growth?

The main drivers include the increasing prevalence of osteoporosis, advancements in clinical trials and research, growing awareness and diagnosis, and the efficacy and safety profile of denosumab.

Are there any biosimilars available for denosumab?

Yes, several biosimilar applications have been accepted, and the first biosimilar, Sandoz’s Jubbonti, is set to launch by May 31, 2025.

Which regions are expected to dominate the denosumab market?

North America currently dominates the market, but the Asia-Pacific region is expected to witness significant growth in the forecast period.

Sources

1. JAMA Network Open: "Zoledronate Sequential Therapy After Denosumab Discontinuation to Prevent Loss of Bone Mineral Density: A Randomized Clinical Trial"[1].
2. The Business Research Company: "Global Denosumab Market Report 2024"[2].
3. The Business Research Company: "Global Denosumab Market Insights 2024, Forecast To 2033"[3].
4. Biosimilars Review & Report: "New Denosumab Applications Filed, New Ustekinumab Biosimilar Approved"[4].
5. Data Bridge Market Research: "Global Denosumab Market – Industry Trends and Forecast to 2030"[5].