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Last update 27 Jan 2026

Denosumab

Last update 27 Jan 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

anti-RANKL antibody, Denosumab (Genetical Recombination), Denosumab (genetical recombination) (JAN)

+ [15]

Target

RANKL

Action

inhibitors

Mechanism

RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [4]

Active Indication

Bone DiseasesGlucocorticoid-induced osteoporosisHumoral Hypercalcemia of Malignancy+ [11]

Inactive Indication

Advanced breast cancerAdvanced cancerAneurysmal Bone Cysts+ [49]

Originator Organization

Amgen, Inc.

Active Organization

Amgen Europe BVAmgen Australia Pty Ltd.

Amgen, Inc.

+ [5]

Inactive Organization

Celgene Corp.

GSK Plc

GlaxoSmithKline (China) Investment Co., Ltd.

+ [1]

License Organization

Dr. Reddy's Laboratories Ltd.

Amgen, Inc.

Mabwell (Shanghai) Bioscience Co., Ltd.

+ [10]

Drug Highest PhaseApproved

First Approval Date

European Union (26 May 2010),

Bone Diseases, MetabolicFractures, BoneOsteoporosis, Postmenopausal

RegulationOrphan Drug (United States), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Sequence Code 94568L

Source: *****

Sequence Code 143522H

Source: *****

370

Clinical Trials associated with Denosumab

KCT0011299

/ Not yet recruitingPhase 2IIT

Efficacy of Denosumab in Obese Subjects with Weight Loss and Bone Metabolism Risk Factors Following GLP-1 Receptor Agonist Class Therapy

Start Date12 Mar 2026

Sponsor / Collaborator

Ajou University

NCT07063797

/ Not yet recruitingNot ApplicableIIT

Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes

This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on bone density, bone turnover indicators, the risk of new fractures, and the risk of hypocalcemia. This will provide scientific evidence for clinical diagnosis and treatment, and offer important clinical research evidence for formulating national health policies.

Start Date01 Feb 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT07056478

/ Not yet recruitingPhase 3IIT

RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial

The objective of this study is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.

Start Date01 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Denosumab

100 Translational Medicine associated with Denosumab

100 Patents (Medical) associated with Denosumab

5,788

Literatures (Medical) associated with Denosumab

01 Apr 2026·TISSUE & CELL

Black tea extract exerts a protective effect on diethylnitrosamine-induced hepatic precancerous lesions through the Nrf2 signaling pathway

Article

Author: Luo, Jia-Jia ; Hu, Ying-Hao ; Wang, Xiu ; Wang, Yan

OBJECTIVE:

To investigate the protective effect and mechanism of black tea (BT) extract on diethylnitrosamine (DEN)-induced liver precancerous lesions in rats.

METHODS:

Fifty male Sprague-Dawley (SD) rats were randomly assigned to five groups: normal control, DEN model, and three black tea extract groups (low, medium, and high dose: DEN+BT-L, DEN+BT-M, DEN+BT-H). The model and treatment groups received DEN (50 mg/kg, i.p.) for 14 weeks, and black tea extract (25, 50, or 100 mg/kg) was administered via gavage. Liver histopathology was evaluated by hematoxylin-eosin (HE) and Masson staining. Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), alpha-fetoprotein (AFP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) were assessed. Hepatic oxidative stress markers-reactive oxygen species (ROS), superoxide dismutase (SOD), glutathione (GSH), and malondialdehyde (MDA)-were measured. Expression of nuclear factor erythroid 2-related factor 2 (Nrf2), heme oxygenase-1 (HO-1), NAD(P)H quinone dehydrogenase 1 (NQO1), signal transducer and activator of transcription 3 (STAT3), phosphorylated STAT3 (p-STAT3), nuclear factor-kappa B (p65), and phosphorylated p65 (p-p65) was evaluated by Western blot.

RESULTS:

Black tea extract alleviated DEN-induced hepatocyte damage, fibrosis, and inflammation. It reduced serum ALT, AST, ALP, AFP, IL-6, and TNF-α levels, decreased ROS and MDA, and increased SOD and GSH levels in a dose-dependent manner (P < 0.05). Nrf2 and HO-1 protein levels were upregulated, while STAT3, p-STAT3, p65, and p-p65 expressions were downregulated. NQO1 expression showed a decreasing trend.

CONCLUSIONS:

Black tea extract protects against DEN-induced liver precancerous changes by enhancing antioxidant capacity via the Nrf2/HO-1 pathway and inhibiting the NF-κB/STAT3 axis, suggesting its potential in preventing liver carcinogenesis.

01 Apr 2026·BONE

ITAM–Syk signaling mediates the rebound phenomenon after anti-RANKL antibody discontinuation

Article

Author: Iwasaki, Norimasa ; Shimizu, Tomohiro ; Yamamoto, Tomomaya ; Hasegawa, Tomoka ; Ishizu, Hotaka ; Amizuka, Norio ; Asano, Tsuyoshi

Rebound bone loss following discontinuation of antiresorptive therapy, especially denosumab, represents a major clinical issue due to rapid osteoclast activation and increased fracture risk. However, the molecular basis of this phenomenon remains poorly understood. In this study, we investigated the role of the DAP12/TREM2-Syk signaling pathway in rebound-associated bone resorption using a murine model treated with and withdrawn from a RANKL-neutralizing antibody. Wild-type (WT) mice exhibited marked rebound bone loss, with elevated expression of DAP12/TREM2-related genes (Tyrobp and Trem2), increased infiltration of CD206⁺ M2 macrophages, and enhanced osteoclast formation. In contrast, DAP12/DAP10 double-knockout (DKO) mice showed diminished osteoclast activity, reduced M2 macrophage presence, and preserved bone mass, indicating the essential role of this signaling axis. Furthermore, pharmacological inhibition of Syk in WT mice effectively prevented rebound bone loss without disturbing normal bone turnover. Histological and ultrastructural analyses revealed hyperactive osteoclasts with enlarged ruffled borders in WT but not in DKO mice. These results identify the DAP12/TREM2-Syk pathway as a key regulator of pathological osteoclast activation after anti-RANKL therapy withdrawal, suggesting that its inhibition may provide a novel therapeutic approach to prevent rebound bone loss while maintaining physiological bone remodeling.

01 Mar 2026·JOURNAL OF THEORETICAL BIOLOGY

Can physical activity augment drug efficacy in PMO treatments - Insights from in-silico simulations of PTH and denosumab treatments

Article

Author: Pivonka, Peter ; Ruiz-Lozano, Rocío ; Calvo-Gallego, José Luis ; Martínez-Reina, Javier

The aetiology of osteoporosis (OP) is diverse, with ageing and the oestrogen decline after menopause being the main causes of the most prevalent type, primary OP. The concurrence of other diseases (such as chronic kidney disease or hyperparathyroidism), the use of certain medications (glucocorticoids) or an inadequate diet or a sedentary lifestyle may also cause or accelerate the appearance of OP. To counteract the sedentary lifestyle, physical exercise is often recommended as a preventive therapy or even as a complement to pharmacological treatments. In this work, we use a mathematical model of bone remodelling based on cell populations that implements bone mechanical feedback as a function of the strain level and the number of cycles of daily activities. We coupled this bone remodelling model with PK-PD models of denosumab and teriparatide to study the joint effect of drug treatments and exercise on bone density of postmenopausal women. Our results show that low-intensity exercise alone could slow down bone loss and prevent OP, particularly if started at a young age, and it could improve the efficacy of drug treatments, increasing bone density and reducing fracture risk. The incremental benefit of physical activity is greater in denosumab treatments, where the anabolic effect of exercise complements the anticatabolic effect of denosumab. However, the bone density gain and the reduction in fracture risk is greater, in absolute terms, in teriparatide treatments. In any case, disuse and sedentary lifestyle are detrimental to bone density and compromises the efficacy of drug treatments.

302

News (Medical) associated with Denosumab

26 Jan 2026

·www.biospace.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

Drug ApprovalPhase 1

05 Jan 2026

·www.pharmaceutical-technology.com

Samsung Bioepis initiates Byooviz commercialisation in Europe

The CHMP issued a positive opinion for the pre-filled syringe. Credit: Me dia / Shutterstock.com. Samsung Bioepis has started direct commercialisation of Byooviz, a biosimilar to Genentech’s Lucentis (ranibizumab), in Europe. The company has assumed commercial rights for Byooviz from Biogen, and the product will now be available as a Samsung Bioepis brand across several European countries as part of its ongoing expansion. In August 2021, Byooviz received approval from the European Commission (EC) as a single-use vial for intravitreal administration (0.5mg/0.05ml). It is indicated for the treatment of visual impairment due to diabetic macular oedema, neovascular (wet) age-related macular degeneration, proliferative diabetic retinopathy, visual impairment due to choroidal neovascularisation, and visual impairment due to macular oedema secondary to retinal vein occlusion (branch or central). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the Byooviz pre-filled syringe (PFS) in November 2025. The syringe is anticipated to enter the European market in the second quarter of 2026. Samsung Bioepis vice-president Antonio Rito said: “This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialised products. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Leveraging the past three years of experience with Epysqli (eculizumab) and the newly launched Obodence (denosumab) and Xbryk (denosumab) in Europe, we will continue on our journey to become a fully integrated biopharmaceutical company with end-to-end capabilities from development to commercialisation. “We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.” In September 2023, Sandoz partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

Drug Approval

23 Dec 2025

·www.biospace.com

Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

Approvals expand Amneal’s biosimilars portfolio Company expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia ® , and Oziltus™ (denosumab-mobz), a biosimilar referencing XGEVA ® . Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related conditions. Under Amneal’s partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights. “Biosimilars are the next wave of affordable medicines in the U.S., expanding access to life-changing biologics for millions of patients. With the addition of two denosumab biosimilars, Amneal now has five commercial biosimilars, strengthening our position in this rapidly growing category. We view biosimilars as a major long-term growth vector within our Affordable Medicines segment,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and for our collaboration with Amneal. It reflects the strength of our scientific capabilities, our commitment to the highest quality standards, and our shared ambition to expand access to affordable, high-quality biologic medicines in the United States. This achievement reinforces our globalization strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Both drugs should be administered by a healthcare provider. Patients should be advised to maintain serum calcium levels and to seek medical attention for an allergic reaction. Prolia ® : Prolia has a Boxed Warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out prior to administration. In postmenopausal women, reported adverse drug events included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain, and nasopharyngitis were frequently reported by men. XGEVA ® : The most serious reported adverse drug reaction was dyspnea, with other reactions including fatigue, nausea, and hypophosphatemia. For patients been treated for bone metastases, common side effects were fatigue and nausea, while those with multiple myeloma frequently experienced gastrointestinal issues and anemia. Cases of giant cell tumor and hypercalcemia of malignancy showed frequent pain, nausea, and headache. Discontinuation occurred in some patients due to osteonecrosis or hypocalcemia. The drug can cause fetal harm and females of reproductive potential should use effective contraception. According to IQVIA ® , U.S. annual sales for Prolia ® and XGEVA ® for the 12 months ended October 2025 were approximately $5.3 billion. Note: Prolia ® and XGEVA ® are registered trademarks of Amgen Inc. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit and follow us on LinkedIn . About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, mAbxience’s mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With three approved products and a robust pipeline in development, mAbxience has established a B2B presence in over 100 markets. Alongside this, the company has formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Its three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( ) or connect with us on LinkedIn . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Amneal Contact Anthony DiMeo VP, Investor Relations anthony.dimeo@amneal.com mAbxience Contact Miguel Martínez-Cava Corporate Affairs & Marketing Associate Director miguel.martinezcava@mabxience.com

Drug ApprovalLicense out/in

100 Deals associated with Denosumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03684	Denosumab	M05BX04	DB06643

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bone Diseases	United Kingdom	Amgen Ltd.	01 Jan 2021
Glucocorticoid-induced osteoporosis	United States	Amgen, Inc.	18 May 2018
Humoral Hypercalcemia of Malignancy	United States	Amgen, Inc.	04 Jan 2018
Rheumatoid Arthritis	Japan	Daiichi Sankyo Co., Ltd.	03 Jul 2017
Multiple Myeloma	Japan	Amgen, Inc.	18 Jan 2012
Bone Cancer	European Union	Amgen Europe BV	13 Jul 2011
Bone Cancer	Iceland	Amgen Europe BV	13 Jul 2011
Bone Cancer	Liechtenstein	Amgen Europe BV	13 Jul 2011
Bone Cancer	Norway	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	European Union	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Iceland	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Liechtenstein	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Norway	Amgen Europe BV	13 Jul 2011
Bone metastases	United States	Amgen, Inc.	18 Nov 2010
Osteoporosis	Australia	Amgen Australia Pty Ltd.	07 Jun 2010
Bone Diseases, Metabolic	European Union	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Iceland	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Liechtenstein	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Norway	Amgen Europe BV	26 May 2010
Fractures, Bone	European Union	Amgen Europe BV	26 May 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Atypical anorexia nervosa	Phase 3	United States	Amgen, Inc.	25 Oct 2017
Feeding and Eating Disorders	Phase 3	United States	Amgen, Inc.	25 Oct 2017
Osteogenesis Imperfecta	Phase 3	United States	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Australia	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Belgium	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Bulgaria	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Canada	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Czechia	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	France	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Germany	Amgen, Inc.	24 Jun 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SABCS2025	Not Applicable	Bone metastases	165	Initial Denosumab	ifouwxymtd(bgvgovrcac) = gujstqmxqm qnsrautuwd (yqgbzwuwzg, 0 - 12.3)	Positive	10 Dec 2025
				Sequential Bisphosphonate-to-Denosumab	ifouwxymtd(bgvgovrcac) = owcxqcnkgd qnsrautuwd (yqgbzwuwzg, 8.1 - 22.7)
SABCS2025	Phase 3	Breast Cancer	66	Denosumab	ntwcvmwkke(vxastyrrzk) = fcfjacatrd ujteajgimf (qwsoaokeao ) View more	Positive	10 Dec 2025
				Control (hormone alone)	ntwcvmwkke(vxastyrrzk) = lekdlkkolo ujteajgimf (qwsoaokeao ) View more
SABCS2025	Not Applicable	Metastatic breast cancer \| Bone metastases	1,250	Zoledronic acid	wopqrkmjwj(raatlrocst): HR = 1.524 (95.0% CI, 1.407 - 1.65), P-Value = < 0.001 View more	Positive	10 Dec 2025
				Pamidronate
NCT04087096 (CTgov)	Phase 4	Bone Diseases, Metabolic	36	Zoledronic Acid+Denosumab (Denosumab)	nrxprvauru(xifbsrxwrf) = oeukfiyioh ximcvmwvda (hlysmjgdvs, ihjmptdawe - htwhjaqwby) View more	-	29 Oct 2025
				Placebo+Zoledronic Acid (Placebo)	nrxprvauru(xifbsrxwrf) = xpqyfajtmm ximcvmwvda (hlysmjgdvs, hytnringed - afivlyhqwy) View more
ChiCTR2100047759 (ESMO2025)	Phase 2	KRAS mutant Non-small Cell Lung Cancer Maintenance KRAS mutations \| RANKL \| CCER2	29	ICI + Denosumab maintenance treatment	vejjnbdeyx(rxuvrwksil) = rkncrjisrf uwujnibhrr (umtgmgqhbu ) View more	Positive	17 Oct 2025
				Immunochemotherapy	vejjnbdeyx(rxuvrwksil) = oijeumuxii uwujnibhrr (umtgmgqhbu ) View more
NCT00330759 \| NCT00321464 \| NCT00321620 (FDA_CDER) Manual	Phase 3	Bone metastases	-	Denosumab (Study 20050136 Metastatic Breast Cancer)	mivbetmuxl(wbzjxwfxjh) = gijolwgdce esdvsaftur (fhdpiawjri ) View more	-	29 Aug 2025
				Zoledronic Acid (Study 20050136 Metastatic Breast Cancer)	mivbetmuxl(wbzjxwfxjh) = mktbldgwyx esdvsaftur (fhdpiawjri ) View more
ASCO2025	Not Applicable	Bone metastases	340	Denosumab monotherapy	ydogiboovj(wllnmnqtgs): P-Value = 0.027	Positive	30 May 2025
				Bisphosphonate switching to Denosumab
ASCO2025	Not Applicable	Giant Cell Tumor of Bone Neoadjuvant \| Adjuvant	31	Denosumab	trpfwusuph(ktowakccrn) = ggodymhoyl uiavttmjec (nbzirqdqsi, 1 - 150) View more	-	30 May 2025
ESMO_BC2025	Not Applicable	Premenopausal breast cancer Adjuvant	69	Denosumab	geetueapun(subgopqacl) = One ONJ case occurred (1.4 %) with no fractures reported ulvzgvwnkc (birjpodprc )	Positive	14 May 2025
ESMO_BC2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer Second line BRCA1/2	1,399	Denosumab	haxeaovhnn(inerjbtgyf) = bojzmdrgex jsaqcupcek (ggfemdbuov, 24 - NR)	Positive	14 May 2025
				denosumab (BRCA1/2-mutated HR+/HER2- bone metastatic breast cancer patients)	haxeaovhnn(inerjbtgyf) = eqmslonkkz jsaqcupcek (ggfemdbuov, 9 - 27)

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