Saturday, July 11, 2026

Drug profile · INN

fluciclovine f-18

fluciclovine f-18 (AXUMIN) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — fluciclovine f-18
US status
approved
Class
Route
INTRAVENOUS
Patents
0
Programs
3
Data quality
0.84

Quick answer

fluciclovine f-18 (AXUMIN) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN fluciclovine f-18
Brand AXUMIN
Mechanism Diagnostic agent
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Diagnostic agent

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 18F fluciclovine Phase 3 · Chongqing Precision Biotech · Brain Metastases
  2. Axumin PET/CT Phase 2 · HALOZYME THERAPEUTICS · Prostate Cancer
  3. Fluciclovine F18 Phase 2 · Telix Innovations · Prostate Adenocarcinoma

Frequently asked questions

What is fluciclovine f-18?

fluciclovine f-18 (AXUMIN) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for fluciclovine f-18?

AXUMIN is a marketed brand name for fluciclovine f-18. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fluciclovine f-18?

fluciclovine f-18 has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.