DMAB Discontinuation and Switching — Competitive Intelligence Brief

DMAB Discontinuation and Switching (DMAB Discontinuation and Switching) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: RANKL inhibitor (monoclonal antibody). Area: Bone Metabolism / Osteoporosis.

marketed RANKL inhibitor (monoclonal antibody) RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) Bone Metabolism / Osteoporosis Small molecule

Target snapshot

DMAB Discontinuation and Switching (DMAB Discontinuation and Switching) — University of Alabama at Birmingham. This is a clinical study protocol examining the safety and efficacy of discontinuing or switching from denosumab (DMAB), a RANKL inhibitor used for bone loss prevention.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
DMAB Discontinuation and Switching TARGET	DMAB Discontinuation and Switching	University of Alabama at Birmingham	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Denosumab Prefilled Syringe [Prolia]	Denosumab Prefilled Syringe [Prolia]	Seoul National University Bundang Hospital	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Denosumab (Prolia)	Denosumab (Prolia)	Prince of Wales Hospital, Shatin, Hong Kong	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (receptor activator of nuclear factor kappa-B ligand)
Placebo to Denosumab	Placebo to Denosumab	Amgen	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Xgeva®	Xgeva®	Jiangsu Hansoh Pharmaceutical Co., Ltd.	marketed	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
Denosumab-Ref	Denosumab-Ref	Lambda Therapeutic Research Ltd.	phase 3	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
AMG 162 / Denosumab	AMG 162 / Denosumab	Amgen	phase 3	RANKL inhibitor (monoclonal antibody)	RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (RANKL inhibitor (monoclonal antibody) class)

1. Amgen · 5 drugs in this class
2. Swiss Cancer Institute · 2 drugs in this class
3. Jiangsu Hansoh Pharmaceutical Co., Ltd. · 1 drug in this class
4. Lambda Therapeutic Research Ltd. · 1 drug in this class
5. Luye Pharma Group Ltd. · 1 drug in this class
6. Prince of Wales Hospital, Shatin, Hong Kong · 1 drug in this class
7. Seoul National University Bundang Hospital · 1 drug in this class
8. University of Alabama at Birmingham · 1 drug in this class
9. mAbxience Research S.L. · 1 drug in this class
10. GlaxoSmithKline · 1 drug in this class