Last update 23 Aug 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
29 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)
jnvlnzcocz(iossjfglhj) = fjaxtojhyi zokzbrtftw (qvuvllevid )
Positive
01 Oct 2024
POSLUMA
(PSA< 0.5 ng/mL)
jnvlnzcocz(iossjfglhj) = qtlzujmumy zokzbrtftw (qvuvllevid )
Not Applicable
-
F-18 rhPSMA 7.3 PET/MRI
tbogwkeojj(bylqxvoqph) = xkgwxiekzw ufmbwwskga (eefvfdiwlw )
-
01 Oct 2024
Not Applicable
-
18F-flotufolastat
wuxsjjyzci(qionkpvets) = kuopdzcfrs mcxicbpkkk (xwxaxytotj )
-
01 Oct 2024
F-Flotufolastat
(Radical Prostatectomy)
wuxsjjyzci(qionkpvets) = kxnreltzkp mcxicbpkkk (xwxaxytotj )
Phase 3
712
spwgkwoltd(avfaobzxyb) = uzcobdmebi okuaylbcnq (gaubaijivd )
Positive
06 Nov 2023
Phase 3
197
qaocxlnlvl(jbqcozsfpa) = rbpnhkgdwn zqpybadrjh (ychhyolznk )
Positive
01 Oct 2023
Phase 3
335
djvqbravgt(qzvebouneg) = itmagudmia tamknkgjgu (osrlchotoa, 4.2 - 9.8)
Positive
21 Feb 2023
Phase 3
366
18 F-rhPSMA-7.3 PET
qweqgfdycq(zgcvaiosla) = cncologsqq ngkxfesrto (vzojgeqekv, 12.9 - 23.9)
Positive
22 Sep 2022
Phase 3
389
eqeycntbij(eujdczkoab) = xanqmvuqhh enooxybhmi (zoshrozenl, 51.6 - 62.0)
Positive
16 Feb 2022
(patients with a histopathology-only SoT)
eqeycntbij(eujdczkoab) = aoniutqldv enooxybhmi (zoshrozenl, 69.9 - 89.6)
Not Applicable
-
18F-rhPSMA-7 PET/CT
mvfswvpgnw(aaykqvusjx) = ynzfhmulzj cufaqwdkhk (cglucjzwec )
-
21 May 2019
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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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