Ozmosi | Denosumab Drug Profile

Product Description

Denosumab (pronounced den-oh-sue-mab) is a type of targeted therapy called a monoclonal antibody. It is made in the laboratory to recognise and find specific proteins on the outside of some cells. Denosumab is also known by its brand names, Xgeva and Prolia. It helps to prevent fractures and other cancer related bone problems in adults with cancer that has spread to the bones. (Sourced from: https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/denosumab)

Mechanisms of Action: TNFSF11 Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Subcutaneous

FDA Designation: *

Approval Status: Approved

Approved Indications: None

Company: Amgen
Company Location: Western America
Company Founding Year: 1980
Additional Commercial Interests: BeOne Medicines

Clinical Description

Map of Global Clinical Trials for Denosumab

Countries in Clinic: Australia, Bulgaria, China, Czech Republic, Denmark, Estonia, Hungary, Latvia, Lithuania, Poland, Serbia, Slovakia, South Africa, Spain, United Kingdom

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer|Oncology Solid Tumor Unspecified|Osteoporosis|Osteoporosis, Postmenopausal

Phase 1: Healthy Volunteers|Hip Fracture|Oncology Unspecified

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
2023-503790-37-00	BP16-301	P3	Recruiting	Osteoporosis	2025-11-30		2025-05-02	Treatments
NCT05405725	ALK22/ENZ215-DEN2	P3	Completed	Osteoporosis, Postmenopausal	2024-07-18	18%	2026-02-12	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Trial Status
2024-514903-33-00	2024-514903-33-00	P2	Active, not recruiting	Total Knee Arthroplasty\|Osteoarthritis, Knee	2027-06-01		2025-05-02	Treatments
2018-002096-17	2018-002096-17	P2	Completed	Giant Cell Tumor of Bone	2025-04-21		2022-03-13	Treatments
2016-005244-42	2016-005244-42	P2	Completed	Granuloma, Giant Cell\|Bone Cysts, Aneurysmal	2024-06-04		2025-05-06	Treatments\|Trial Status
2024-512996-11-00	2024-512996-11-00	P2	Not yet recruiting	Infertility, Male	2026-02-28		2025-05-02	Treatments
2017-002505-35	BRCA-P	P3	Active, not recruiting	Breast Cancer	2032-05-08		2022-03-13	Treatments
CTR20212746	CTR20212746	P2	Recruiting	Osteoporosis, Postmenopausal	None		2025-04-29
2021-005071-40	ALVOBOND	P3	Completed	Osteoporosis	2024-10-28		2025-07-08	Treatments
2021-006545-36	DEVOTE	P3	Completed	Osteoporosis, Postmenopausal	2024-06-12		2025-05-06	Primary Completion Date\|Study Completion Date\|Treatments\|Trial Status
2021-002187-49	2021-002187-49	P3	Active, not recruiting	Osteoporosis	2024-04-12		2022-03-13	Treatments
2021-003609-24	SIMBA	P3	Active, not recruiting	Osteoporosis, Postmenopausal	2024-02-29		2022-03-13	Treatments
CTR20233478	CTR20233478	P1	Completed	Osteoporosis, Postmenopausal	2024-06-05		2025-04-29	Patient Enrollment\|Primary Completion Date\|Start Date\|Study Completion Date\|Treatments\|Trial Status
CTR20223114	CTR20223114	P3	Active, not recruiting	Oncology Solid Tumor Unspecified	None		2025-04-29	Patient Enrollment\|Treatments\|Trial Status
ACTRN12623000520639	ACTRN12623000520639	P1	Completed	Osteoporosis	2024-05-25		2025-04-21	Patient Enrollment\|Primary Completion Date\|Treatments\|Trial Status
NCT05876949	AVT03-GL-P03	P1	Completed	Healthy Volunteers	2024-04-15		2025-02-07	Primary Endpoints
CTR20201905	CTR20201905	P1	Completed	Osteoporosis, Postmenopausal	2024-01-19		2025-04-29	Patient Enrollment\|Primary Completion Date\|Study Completion Date\|Treatments\|Trial Status
ACTRN12620000013965	ACTRN12620000013965	P1	Not yet recruiting	Osteoporosis	2020-06-01		2026-02-15	Treatments
CTR20251941	CTR20251941	P1	Active, not recruiting	Osteoporosis, Postmenopausal\|Hip Fracture	None		2025-07-06	Start Date\|Treatments\|Trial Status
CTR20192487	CTR20192487	P1	Active, not recruiting	Oncology Unspecified\|Healthy Volunteers	None		2025-04-29	Patient Enrollment\|Treatments

Recent News Events

Date	Type	Title
04/23/2026	News Article	Samsung Epis Holdings Reports First Quarter 2026 Financial Results
04/21/2026	News Article	Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
04/21/2026	News Article	Biocon Receives Health Canada Approval of Bosaya™ (Denosumab) and Vevzuo™ (Denosumab), Biosimilars to Prolia® and Xgeva®
04/21/2026	News Article	Celltrion to present seven abstracts in inflammatory bowel disease (IBD) at 2026 Digestive Disease Week® (DDW)

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Denosumab

Alternative Names: denosumab, prolia, xgeva, amg-162, amg 162, amg162, hlx-14, tk-006, tk006, tk 006 Clinical Status: Inactive Latest Update: 2026-05-27 Latest Update Note: Clinical Trial Update