Last update 16 May 2025

Flotufolastat F-18

Overview

Basic Info

Drug Type
Synthetic peptide, Diagnostic radiopharmaceuticals
Synonyms
flotufolastat F 18, Flotufolastat F-18 Gallium, Fluorine-18 rhPSMA
+ [6]
Target
Action
modulators, enhancers
Mechanism
PSMA modulators(Prostate-specific membrane antigen modulators), PET imaging(Positron-emission tomography enhancers)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 May 2023),
Regulation-
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Structure/Sequence

Molecular FormulaC63H99FN12O25Si
InChIKeyQMGJNAVROCDAIW-MQNQVPOESA-N
CAS Registry2639294-14-5

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Prostatic Cancer
United States
25 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Adenocarcinoma of prostatePhase 3
United States
02 Mar 2020
Adenocarcinoma of prostatePhase 3
Finland
02 Mar 2020
Adenocarcinoma of prostatePhase 3
Germany
02 Mar 2020
Adenocarcinoma of prostatePhase 3
Netherlands
02 Mar 2020
Non-metastatic prostate cancerPhase 2
United States
27 Apr 2023
Recurrent Prostate CarcinomaPhase 2
United States
27 Apr 2023
PSMA-Positive Prostatic CancerPhase 1
China
06 May 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Recurrent Prostate Carcinoma
Prostate specific antigen
119
POSLUMA
(PSA < 1 ng/mL)
ourkgnvjap(cuzwchmlqx) = hwypyopcoj panvroboyp (uyvdtydiob )
Positive
01 Oct 2024
POSLUMA
(PSA< 0.5 ng/mL)
ourkgnvjap(cuzwchmlqx) = crqtpslqrk panvroboyp (uyvdtydiob )
Not Applicable
-
18F-flotufolastat
rysuuswkwl(yuobpnyayg) = wiygpewhvu xlchtovpot (szucwwfeyz )
-
01 Oct 2024
F-Flotufolastat
(Radical Prostatectomy)
rysuuswkwl(yuobpnyayg) = zwiwogpztw xlchtovpot (szucwwfeyz )
Not Applicable
-
F-18 rhPSMA 7.3 PET/MRI
xmmujtrjhg(gtqlitstrp) = phruhjapqg kmclrusuyo (wbpjyuyzwy )
-
01 Oct 2024
Not Applicable
72
18F-flotufolastat PET/MRI
ybbofvlfhh(zvlptsmtza) = gicordlyqv cofqohakyq (yqmfvbddry )
-
27 Sep 2024
F-Flotufolastat
(Transperineal biopsy)
ybbofvlfhh(zvlptsmtza) = tutduywfbn cofqohakyq (yqmfvbddry )
Phase 3
712
fgcniowhjh(iuwensbtge) = flmukxblmv ogwuyvlcgj (aznqkfporx )
Positive
06 Nov 2023
Phase 3
197
pjmhoixwkw(qtreadgjba) = gesikqovev czlsfcjoti (jzxniewrmt )
Positive
01 Oct 2023
Not Applicable
-
smkbtelddb(ltffcbosap) = tlymscerng xbdcjrxlck (vdeujftefy )
-
28 Aug 2023
(Non-fasting)
smkbtelddb(ltffcbosap) = eqzuadvqko xbdcjrxlck (vdeujftefy )
Not Applicable
-
-
(68Ga-PSMA PET-based nomogram)
xefxsnjsno(sutwxvyyzb) = 8.8 months (95%CI 7.7-9.9) bjllkbfxjr (jnwtojjlta )
-
28 Aug 2023
(18F-rhPSMA-7.3 PET)
Phase 3
335
lspggbvvhl(toqrvdqjrk) = movxtdyskw epmdrsyomh (nqeqfcjnbl, 4.2 - 9.8)
Positive
21 Feb 2023
Phase 3
366
18 F-rhPSMA-7.3 PET
rjuwnjhfly(bhofujxogt) = vlyzjonspz emybzfwhmj (mrnkbxcccx, 12.9 - 23.9)
Positive
22 Sep 2022
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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