Radiopharmaceutical 18F-Fluorocholine — Competitive Intelligence Brief

Radiopharmaceutical 18F-Fluorocholine (Radiopharmaceutical 18F-Fluorocholine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Radiopharmaceutical. Area: Oncology.

phase 3 Radiopharmaceutical Choline transporter Oncology Small molecule

Target snapshot

Radiopharmaceutical 18F-Fluorocholine (Radiopharmaceutical 18F-Fluorocholine) — ITEL Telecomunicazioni Srl. 18F-Fluorocholine is a radiopharmaceutical that accumulates in cells with high choline uptake, allowing for imaging of cancer cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Radiopharmaceutical 18F-Fluorocholine TARGET	Radiopharmaceutical 18F-Fluorocholine	ITEL Telecomunicazioni Srl	phase 3	Radiopharmaceutical	Choline transporter
Choline C-11	CHOLINE C-11	Mcprf	marketed	Radioactive Diagnostic Agent [EPC]	High affinity choline transporter 1	2012-01-01
F-18-Fluorocholine	F-18-Fluorocholine	ABX advanced biochemical compounds GmbH	phase 3	PET imaging agent	Choline transporters; Choline kinase
11C-choline	11C-choline	University of Michigan	phase 3	PET imaging agent	Choline transporter
F-choline intravenous injection	F-choline intravenous injection	Centre hospitalier de l'Université de Montréal (CHUM)	phase 3	PET imaging agent	Choline transporters
Copper Cu 64 Dotatate	Copper Cu 64 Dotatate	Vanderbilt-Ingram Cancer Center	marketed	Radiopharmaceutical; somatostatin receptor agonist imaging agent	Somatostatin receptor 2 (SSTR2)
Sr-89	Sr-89	Peking Union Medical College Hospital	marketed	Radiopharmaceutical; beta-emitting radioisotope	Bone hydroxyapatite (calcium analog); osteoblasts in areas of increased bone metabolism

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 (Radiopharmaceutical class)

1. Amsterdam UMC, location VUmc · 1 drug in this class
2. Blue Earth Diagnostics · 1 drug in this class
3. Brigham and Women's Hospital · 1 drug in this class
4. Genzyme, a Sanofi Company · 1 drug in this class
5. Gustave Roussy, Cancer Campus, Grand Paris · 1 drug in this class
6. HTA Co., Ltd. · 1 drug in this class
7. IRCCS San Raffaele · 1 drug in this class
8. ITEL Telecomunicazioni Srl · 1 drug in this class
9. M.D. Anderson Cancer Center · 1 drug in this class
10. Michael C Roarke, MD · 1 drug in this class