fluciclovine (18F) 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5153 222727-39-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluciclovine F-18
  • fluciclovine (18F)
  • GE-148
  • NMK36
  • FACBC
  • axumin
a radiotracer containing a synthetic amino acid analogue of L-leucine radiolabeled with fluorine F 18 with diagnostic imaging use
  • Molecular weight: 132.13
  • Formula: C5H8FNO2
  • CLOGP: -2.52
  • LIPINSKI: None
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: 0.11
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
May 27, 2016 FDA BLUE EARTH DIAGNOSTICS LTD
March 23, 2021 PMDA Nihon Medi-Physics Co., Ltd.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
False negative investigation result 66.67 59.84 6 3 164 29574354

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
False negative investigation result 69.06 60.66 6 3 243 64498480

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V09IX12 VARIOUS
DIAGNOSTIC RADIOPHARMACEUTICALS
TUMOUR DETECTION
Other diagnostic radiopharmaceuticals for tumour detection
FDA MoA N0000175869 Positron Emitting Activity
FDA EPC N0000177914 Radioactive Diagnostic Agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Positron emission tomography indication 82918005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.29 acidic
pKa2 8.18 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 10953112 Nov. 28, 2026 METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 9387266 Nov. 28, 2026 METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 10124079 Dec. 30, 2035 POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 10716868 Dec. 30, 2035 POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 10933147 Dec. 30, 2035 POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT
9-221mCi/ML AXUMIN BLUE EARTH N208054 May 27, 2016 RX SOLUTION INTRAVENOUS 10967077 Dec. 30, 2035 POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4039164 VANDF
C1311253 UMLSCUI
CHEBI:134703 CHEBI
CHEMBL3707267 ChEMBL_ID
450601 PUBCHEM_CID
DB13146 DRUGBANK_ID
C117460 MESH_SUPPLEMENTAL_RECORD_UI
38R1Q0L1ZE UNII
1796118 RXNORM
241468 MMSL
31685 MMSL
d08439 MMSL
457000009 SNOMEDCT_US
457001008 SNOMEDCT_US
9243 INN_ID
016882 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Axumin HUMAN PRESCRIPTION DRUG LABEL 1 69932-001 INJECTION, SOLUTION 221 mCi INTRAVENOUS NDA 26 sections