Monotherapy ezetimibe — Competitive Intelligence Brief

Monotherapy ezetimibe (Monotherapy ezetimibe) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Cholesterol absorption inhibitor. Area: Cardiovascular.

phase 3 Cholesterol absorption inhibitor NPC1L1 (Niemann-Pick C1-Like 1) Cardiovascular Small molecule

Target snapshot

Monotherapy ezetimibe (Monotherapy ezetimibe) — NewAmsterdam Pharma. Ezetimibe inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Monotherapy ezetimibe TARGET	Monotherapy ezetimibe	NewAmsterdam Pharma	phase 3	Cholesterol absorption inhibitor	NPC1L1 (Niemann-Pick C1-Like 1)
Ezetimibe/Rosuvastatin	Ezetimibe/Rosuvastatin	Addpharma Inc.	marketed	Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor (statin combination)	NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin)
statins, ezetimibe	statins, ezetimibe	Korea University Anam Hospital	marketed	HMG-CoA reductase inhibitor and cholesterol absorption inhibitor combination	HMG-CoA reductase; NPC1L1 transporter
atorvastatin plus ezetimibe	atorvastatin plus ezetimibe	Shanghai Jiao Tong University School of Medicine	marketed	Statin plus cholesterol absorption inhibitor combination	HMG-CoA reductase; NPC1L1 transporter
Fixed combination simvastatin/ezetimibe	Fixed combination simvastatin/ezetimibe	Novartis	marketed	Statin/cholesterol absorption inhibitor combination	HMG-CoA reductase (simvastatin); Niemann-Pick C1-like 1 protein (ezetimibe)
Atorvastatin, Ezetimibe	Atorvastatin, Ezetimibe	Abant Izzet Baysal University	marketed	Statin and cholesterol absorption inhibitor combination	HMG-CoA reductase; NPC1L1 transporter
statin + ezetimibe	statin + ezetimibe	University of Roma La Sapienza	marketed	Lipid-lowering agent combination (statin + cholesterol absorption inhibitor)	HMG-CoA reductase; NPC1L1 transporter

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 (Cholesterol absorption inhibitor class)

1. Amgen · 1 drug in this class
2. NewAmsterdam Pharma · 1 drug in this class
3. Organon and Co · 1 drug in this class