Nafamostat Mesilate — Competitive Intelligence Brief

Nafamostat Mesilate (Nafamostat Mesilate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Serine protease inhibitor. Area: Anticoagulation / Hemostasis.

marketed Serine protease inhibitor Serine proteases (thrombin, factor Xa, kallikrein, trypsin) Anticoagulation / Hemostasis Small molecule

Target snapshot

Nafamostat Mesilate (Nafamostat Mesilate) — Chong Kun Dang Pharmaceutical. Nafamostat mesilate is a serine protease inhibitor that blocks multiple coagulation and inflammatory proteases to prevent thrombosis and inflammation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Nafamostat Mesilate TARGET	Nafamostat Mesilate	Chong Kun Dang Pharmaceutical	marketed	Serine protease inhibitor	Serine proteases (thrombin, factor Xa, kallikrein, trypsin)
C1 inhibitor (human) [C1 INH]	C1 inhibitor (human) [C1 INH]	Shire	marketed	Complement inhibitor / Serine protease inhibitor	C1s protease / Classical complement pathway
C1 Esterase Inhibitor (Human)	C1 Esterase Inhibitor (Human)	Shire	marketed	Serine protease inhibitor; complement regulator	C1 esterase inhibitor (C1-INH); Factor XIIa; plasma kallikrein
Low-volume C1-esterase inhibitor	Low-volume C1-esterase inhibitor	CSL Behring	phase 3	Serine protease inhibitor / Complement regulator	C1-esterase inhibitor (C1-INH protein)
Human plasma derived antithrombin	Human plasma derived antithrombin	Octapharma	phase 3	Anticoagulant; serine protease inhibitor	Thrombin (Factor IIa), Factor Xa, and other activated coagulation factors
Aprotinin (inhaled)	Aprotinin (inhaled)	Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion	phase 3	Serine protease inhibitor	Kallikrein, plasmin, trypsin, and other serine proteases
Higher-volume C1-esterase inhibitor	Higher-volume C1-esterase inhibitor	CSL Behring	phase 3	Serine protease inhibitor / Complement regulator	C1-esterase (C1s), Factor XIIa, Plasma kallikrein

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 (Serine protease inhibitor class)

1. Chong Kun Dang Pharmaceutical · 1 drug in this class
2. Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion · 1 drug in this class
3. Seoul National University Hospital · 1 drug in this class