Overview

Flotufolastat F-18 (F-rhPSMA-7.3) is an F-labeled ligand that targets the prostate-specific membrane antigen (PSMA). In patients with recurrent prostate cancer that require localized treatment, the use of F-labeled ligands for positron emission tomography (PET) offers accurate diagnostic imaging. Unlike Ga-labeled PSMA-targeting ligands, F-labeled compounds targeting this protein have a longer half-life and can be produced in larger batches. Flotufolastat F-18 is a diastereoisomer of F-rhPSMA-7, and compared to the other diastereoisomers of this compound, flotufolastat F-18 has a faster clearance from blood pool, liver, and kidney, and a high level of accumulation in tumors. In May 2023, the FDA approved the use of flotufolastat F-18 for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This is the first FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid (rh) technology. Additional studies have shown that in patients with primary prostate cancer, the use of flotufolastat F-18 shows led to low interreader variation and a good distinction between primary-tumor activity and bladder background activity.

Indication

Flotufolastat F-18 is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Associated Conditions

Prostate Cancer

Research Report

Published: Oct 29, 2025

An In-Depth Review of Flotufolastat F-18 (Posluma®): Pharmacology, Clinical Efficacy, and Positioning in PSMA-PET Imaging for Prostate Cancer

Compound Profile and Physicochemical Characteristics

Identification and Nomenclature

Flotufolastat F-18 is a small molecule radiopharmaceutical diagnostic agent that has been developed for advanced imaging of prostate cancer.[1] To provide a comprehensive reference, it is essential to collate its various identifiers used in clinical, regulatory, and research contexts. In the clinical setting, it is marketed under the brand name Posluma®.[1] Its non-proprietary or generic name is Flotufolastat F-18, where the "(18F)" or "F 18" suffix specifies the use of the radioactive isotope fluorine-18.[1]

During its development, the compound was widely known by the code 18F-rhPSMA-7.3, a designation that reflects its novel radiohybrid (rh) molecular structure and its position within a series of developmental compounds targeting the Prostate-Specific Membrane Antigen (PSMA).[2] Other synonyms and codes used in various databases and literature include flotufolastatum (18F), rhPSMA-7.3C, and the United States Adopted Name (USAN) designation flotufolastat F18.[3]

For unambiguous identification across global scientific and regulatory databases, the compound is assigned several unique codes. These are summarized in Table 1, providing a centralized reference for researchers and clinicians. The Anatomical Therapeutic Chemical (ATC) classification code, V09IX18, formally categorizes Flotufolastat F-18 within the class of "Other diagnostic radiopharmaceuticals for tumour detection," situating it within the broader pharmacopeia of oncologic imaging agents.[3]

Chemical Structure and Properties

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions	2025/10/24	NCT07220720	Not Applicable	Not yet recruiting	University of Florida
Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment	2025/06/08	NCT07011342	Not Applicable	Recruiting	Hackensack Meridian Health
Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC	2025/03/18	NCT06881823	Phase 1	Not yet recruiting	Novartis Pharmaceuticals
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	2024/09/27	NCT06617481	Phase 2	Recruiting	AdventHealth
Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy	2024/09/19	NCT06604442	Phase 4	Completed	Blue Earth Diagnostics
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer	2024/06/28	NCT06479187	Phase 4	Active, not recruiting	Brigham and Women's Hospital
18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: A Pilot Study	2023/01/31	NCT05707182	Early Phase 1	Recruiting	University of Alabama at Birmingham

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
POSLUMA	Blue Earth Diagnostics	69932-002	INTRAVENOUS	158 mCi in 1 mL	12/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

PSMA PET Imaging Transforms Prostate Cancer Management with Multiple FDA-Approved Agents

5 months ago

PSMA PET imaging has revolutionized prostate cancer detection and management, particularly in biochemical recurrence settings, with multiple FDA-approved agents now available including gallium-68 PSMA-11, piflufolastat F 18, and flotufolastat F 18.

FDA Approves Posluma, First Radiohybrid PSMA-Targeted PET Imaging Agent for Prostate Cancer

2 years ago

The FDA has approved flotufolastat F 18 injection (Posluma) for PET imaging of PSMA-positive lesions in prostate cancer patients, aiding in metastasis detection and recurrence assessment.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Flotufolastat F-18