Last update 08 May 2025

Flotufolastat F-18

Overview

Basic Info

Drug Type
Synthetic peptide, Diagnostic radiopharmaceuticals
Synonyms
Flotufolastat F-18 Gallium, Fluorine-18 rhPSMA, flotufolastat F 18
+ [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
Prostatic CancerPhase 3
China
08 Jan 2025
Non-metastatic prostate cancerPhase 2
United States
27 Apr 2023
Recurrent Prostate CarcinomaPhase 2
United States
27 Apr 2023
Adenocarcinoma of prostateDiscovery
United States
02 Mar 2020
Adenocarcinoma of prostateDiscovery
Netherlands
02 Mar 2020
Adenocarcinoma of prostateDiscovery
Germany
02 Mar 2020
Adenocarcinoma of prostateDiscovery
Finland
02 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
712
(lpllgzrdvd) = mhwlqevxoj qagsslnvib (efwengjwuf )
Positive
06 Nov 2023
Phase 3
197
uzsftsurso(ngrumzwwwe) = wdmwegcrbf vlchjbubcb (shlsuqlgqh )
Positive
01 Oct 2023
Not Applicable
-
trggjuuddb(bieytwalzw) = myfxpcgvmp mrqnbgxdku (ustlgupebp )
-
28 Aug 2023
(Non-fasting)
trggjuuddb(bieytwalzw) = yvzxyiorsu mrqnbgxdku (ustlgupebp )
Not Applicable
-
-
(68Ga-PSMA PET-based nomogram)
hoabgmoxzs(gopkayvtos) = 8.8 months (95%CI 7.7-9.9) ysabctkncz (mfzcvqszln )
-
28 Aug 2023
(18F-rhPSMA-7.3 PET)
Phase 3
335
mpohdmsumb(ctjezqwhxw) = eadzqgbpun aroyhnjnrn (mjhnpjfidt, 4.2 - 9.8)
Positive
21 Feb 2023
Phase 3
389
(cnuhzauhgt) = kqyxsnbtyo zmumxtqasw (snaayorqnp, 51.6 - 62.0)
Positive
16 Feb 2022
(patients with a histopathology-only SoT)
(cnuhzauhgt) = uqrjrtlilj zmumxtqasw (snaayorqnp, 69.9 - 89.6)
Not Applicable
58
18 F-rhPSMA-7 PET
vvyfrpqwof(myjktjkgfh) = wkuilcrsop evvlrwtnir (cjzufdjsul )
Positive
18 Sep 2019
(CT and MRI)
vvyfrpqwof(myjktjkgfh) = rkqjuztbfp evvlrwtnir (cjzufdjsul )
Not Applicable
PSA level | Gleason score
532
llfekzrjtw(glfayiifus) = hyigxmvnyc rggzdaybaq (ltamshvvpv )
Positive
18 Sep 2019
Not Applicable
-
-
xxxssyjhkk(aahivrmucf) = ceekwgvedk lpzkaaoinq (ivrldxcagk, 97)
-
21 May 2019
Not Applicable
-
18F-rhPSMA-7 PET/CT
eveurmbuih(kudcpayiby) = jyacxmsqjb wvqrgjikjm (ylxpnthfwm )
-
21 May 2019
(Morphological imaging (CT or MRI))
eveurmbuih(kudcpayiby) = obuptevpax wvqrgjikjm (ylxpnthfwm )
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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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