Denosumab

Phase 3Completed

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Interest: 40/100

Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

✓

Phase 2

Phase 3

Approved

Indication / Disease

Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer

Trial Timeline

Nov 22, 2011 → Aug 10, 2018

NCT ID

NCT01419717

About Denosumab

Denosumab is a phase 3 stage product being developed by Amgen for Bone Metastases in Men With Hormone-Refractory Prostate Cancer. The current trial status is completed. This product is registered under clinical trial identifier NCT01419717. Target conditions include Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer.

What happened to similar drugs?

10 of 20 similar drugs in Bone Metastases in Men With Hormone-Refractory Prostate Cancer were approved

Approved (10) Terminated (1) Active (9)

🔄Denosumab + Zoledronic AcidDaiichi SankyoPhase 3

🔄Arzoxifene + PlaceboEli LillyPhase 3

🔄TanezumabEli LillyPhase 3

🔄Anastrozole + TamoxifenAstraZenecaPhase 3

🔄zoledronic acid + placebo to zoledronic acid + Risedronate + Placebo to risedronate + Calcium and vitamin D supplementsNovartisPhase 3

🔄Zoledronic acidNovartisPhase 3

🔄Zoledronic acid + LetrozoleNovartisPhase 3

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (20)

NCT ID	Phase	Status	Start	Completion	Indication
NCT03925532	Phase 2	Completed	Dec 19, 2019	Nov 16, 2022	Allogeneic Hematopoietic Stem Cell Transplantation Recipient
NCT03839459	Phase 2	Completed	Apr 19, 2019	Jan 30, 2025	Smoldering Multiple Myeloma
NCT03605199	Phase 2	UNKNOWN	Jun 18, 2018	Jun 1, 2023	Aneurysmal Bone Cysts
NCT03164928	Phase 3	Completed	May 7, 2018	Dec 20, 2023	Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With
NCT03301857	Approved	Completed	Nov 13, 2017	Jul 27, 2023	Giant Cell Tumor of Bone
NCT03070002	Phase 2	Terminated	Oct 19, 2017	Apr 24, 2018	Breast Carcinoma Metastatic in the Bone
NCT02613416	Phase 2	Completed	Nov 1, 2015	Aug 20, 2021	Breast Cancer
NCT02352753	Phase 3	Terminated	Jun 24, 2015	Mar 26, 2022	Osteogenesis Imperfecta
NCT02435147	Pre-clinical	Completed	Apr 1, 2015	Jun 1, 2016	Osteoporosis
NCT01952054	Phase 2	Terminated	Feb 9, 2015	Oct 10, 2018	Breast Cancer
NCT02129699	Phase 3	Terminated	Jan 6, 2015	Feb 29, 2020	Lung Cancer Non-small Cell Stage IV
NCT02099461	Phase 1	Completed	Apr 1, 2014	Jul 1, 2014	Healthy Volunteer, Female, Breast
NCT01869686	Phase 1	Completed	Jun 1, 2013	Sep 1, 2013	Healthy Volunteer
NCT01545648	Phase 2	Terminated	Nov 1, 2012	Jun 9, 2016	Early Stage Breast Cancer
NCT01652690	Pre-clinical	Completed	Jun 26, 2012	May 15, 2015	Osteoporosis, Postmenopausal
NCT01558115	Approved	Terminated	Jan 1, 2012	Oct 1, 2014	Primary Hyperparathyroidism
NCT01358669	Phase 2	Completed	Dec 14, 2011	Dec 31, 2021	Revision Surgery of Total Hip Arthroplasty
NCT01419717	Phase 3	Completed	Nov 22, 2011	Aug 10, 2018	Bone Metastases in Men With Hormone-Refractory Prostate Cancer
NCT01464931	Phase 1	Completed	Nov 1, 2011	Mar 1, 2013	Renal Impairment
NCT01824342	Phase 3	Completed	Jan 1, 2011	Feb 1, 2014	Castrate-resistant Prostate Cancer

Competing Products

20 competing products in Bone Metastases in Men With Hormone-Refractory Prostate Cancer

See all competitors

Product	Company	Stage	Hype Score
Denosumab + Zoledronic Acid	Daiichi Sankyo	Phase 3	40
Enzalutamide	Astellas Pharma	Phase 2	35
Enzalutamide	Astellas Pharma	Phase 2	35
Tacrolimus	Astellas Pharma	Phase 2	35
Tacrolimus	Astellas Pharma	Phase 2	35
Merestinib	Eli Lilly	Phase 1	21
FORTEO + Placebo	Eli Lilly	Phase 1	29
Arzoxifene + Placebo	Eli Lilly	Phase 3	40
Tanezumab	Eli Lilly	Phase 3	40
Anastrozole + Tamoxifen	AstraZeneca	Phase 3	40
zoledronic acid + placebo to zoledronic acid + Risedronate + Placebo to risedronate + Calcium and vitamin D supplements	Novartis	Phase 3	40
Zoledronic acid	Novartis	Phase 3	40
Zoledronic acid + Letrozole	Novartis	Phase 3	40
Zoledronic acid	Novartis	Phase 3	40
Nilotinib	Novartis	Phase 1	29
Reclast (ZOL446, zoledronic acid)	Novartis	Approved	43
Zoledronic acid	Novartis	Phase 3	32
Zoledronic Acid + Risedronate + Placebo to Risedronate + Placebo to Zoledronic Acid	Novartis	Phase 3	40
zoledronic acid	Novartis	Phase 1	29
Ruxolitinib continuous therapy	Novartis	Phase 2	39