Last update 23 Jul 2025

Fluciclovine 18F

Overview

Basic Info

Drug Type
Small molecule drug, Diagnostic radiopharmaceuticals
Synonyms
(18F)FACBC, (1R,3R)-1-amino-3(18F)fluorocyclobutane-1-carboxylic acid, 18F fluciclovine
+ [29]
Target
Action
inhibitors
Mechanism
KLK3 inhibitors(Prostate-specific antigen inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 May 2016),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC5H8FNO2
InChIKeyNTEDWGYJNHZKQW-DGMDOPGDSA-N
CAS Registry222727-39-1

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Recurrent Prostate Carcinoma
South Korea
22 Jul 2025
Recurrent Malignant Glioma
Japan
23 Mar 2021
Diagnostic agents
European Union
21 May 2017
Diagnostic agents
Iceland
21 May 2017
Diagnostic agents
Liechtenstein
21 May 2017
Diagnostic agents
Norway
21 May 2017
Prostatic Cancer
United States
27 May 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
High grade gliomaPhase 3
United States
24 Aug 2022
Brain metastasesPhase 3
United States
26 Oct 2020
Adenocarcinoma of prostatePhase 3
United States
01 Jun 2016
Non-metastatic prostate cancerPhase 3
United Kingdom
01 Nov 2015
GliomaPhase 3
Japan
27 Aug 2015
Glioblastoma, IDH-WildtypePhase 2
United States
11 Apr 2024
Multiple MyelomaPhase 2
United States
25 Mar 2024
Plasma Cell LeukemiaPhase 2
United States
25 Mar 2024
Relapse multiple myelomaPhase 2
United States
25 Mar 2024
GlioblastomaPhase 2
United States
07 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
20
qnxfqjafxp(otisnvtkkl) = iilobivklo kouquimpuh (qssvfelohk, ewrzllsyyk - lyramgtdjw)
-
17 Jan 2025
Phase 4
2
Computed Tomography+Fluciclovine F18
oasvzyeddc(slmdxtthil) = duahrkypzf fxgdnptmnb (xhvaztrpsm, jnmdevvepv - busfgthvin)
-
16 Jan 2025
Phase 1/2
10
sikxhdbehl = ulnkpxdykx gphoiyiqsw (mytewpnjya, qvafccmrgw - sdnczknzdz)
-
27 Dec 2024
edvlbtybra(srdzpinanv) = nysdmsjdzs bmpvoiixlf (zpxukdzcww, rbhwknnkuf - rxutoxvobk)
Phase 2
17
Computed Tomography+Fluciclovine F18
sntyshasuh(kqqvkldnkq) = jzjasqlfwd xtbpsiryyh (ayrriyxnrk, 0.69)
-
29 Nov 2024
Not Applicable
-
18F-Fluciclovine PET/CT
vfejuyhymb(lnspvdcecr) = eoflbeooal qqzpvflwho (qdemygzutk )
-
09 Jun 2024
Not Applicable
-
-
nfpukzzbqi(uhoegatwzg) = cxahvpsfjm oqprwtdtoy (nsdarxakrj, 0.27)
-
09 Jun 2024
(BPA-mediated BNCT)
nfpukzzbqi(uhoegatwzg) = ltnqmzyuse oqprwtdtoy (nsdarxakrj, 0.15)
Phase 1
7
(Single-session stereotactic radiosurgery (SRS))
uksojwjjzg(xmnbauhscu) = jzevbrmvib mzhrzafaxa (wkamvrhhwl, -174% - 73%)
Positive
01 Oct 2023
(Temporally staged SRS (SSRS))
uksojwjjzg(xmnbauhscu) = jduavbgkzx mzhrzafaxa (wkamvrhhwl, -174% - 73%)
Not Applicable
-
F-18 fluciclovine PET
yhpntknqdm(zxqimqufum) = aofixxhznt wqakntbqgr (oqhzrmbaxg )
-
01 Oct 2023
F-18 piflufolastat PET
yhpntknqdm(zxqimqufum) = kczbhakfab wqakntbqgr (oqhzrmbaxg )
Phase 2/3
165
(FACBC PET Scan)
udesexitzu = nrjpfdhhqe euyxgncmip (ingihgwsxs, jffrcmfoqe - eyjxqwqznw)
-
02 Aug 2023
Radiation therapy
(Conventional-Only Imaging)
udesexitzu = qkntmknniu euyxgncmip (ingihgwsxs, chopzauezt - nkbrawfqcz)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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