Custodiol-N — Competitive Intelligence Brief

Custodiol-N (Custodiol-N) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Organ preservation solution. Area: Transplantation.

phase 3 Organ preservation solution Transplantation Small molecule

Target snapshot

Custodiol-N (Custodiol-N) — Dr. F. Köhler Chemie GmbH. Custodiol-N is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing essential electrolytes, substrates, and buffering capacity.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Custodiol-N TARGET	Custodiol-N	Dr. F. Köhler Chemie GmbH	phase 3	Organ preservation solution
HTK Custodiol	HTK Custodiol	Rigshospitalet, Denmark	marketed	Organ preservation solution
Custodiol Htk Soln	Custodiol Htk Soln	Lourdes Montero Cruces	marketed	Organ preservation solution
Hydrogen-Rich Celsior Solution	Hydrogen-Rich Celsior Solution	RenJi Hospital	phase 3	Organ preservation solution	Reactive oxygen species (ROS), particularly hydroxyl radicals
Custodiol HTK	Custodiol HTK	Marc Sakwa, MD	phase 3	Organ preservation solution

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 (Organ preservation solution class)

1. Dr. F. Köhler Chemie GmbH · 1 drug in this class
2. Lourdes Montero Cruces · 1 drug in this class
3. Marc Sakwa, MD · 1 drug in this class
4. RenJi Hospital · 1 drug in this class
5. Rigshospitalet, Denmark · 1 drug in this class