Axumin(fluciclovine f18)
Axumin (fluciclovine f18) is a small molecule pharmaceutical. Fluciclovine f18 was first approved as Axumin on 2016-05-27. It has been approved in Europe to treat prostatic neoplasms and radionuclide imaging.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| diagnosis | D003933 |
Trade Name
FDA
EMA
Axumin
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluciclovine f-18
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AXUMIN | Blue Earth Therapeutics | N-208054 RX | 2016-05-27 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| axumin | New Drug Application | 2020-08-31 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| A9588 | Fluciclovine f-18, diagnostic, 1 millicurie |
Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 1 | 13 | 3 | 2 | 9 | 26 | |
| Uterine cervical neoplasms | D002583 | — | — | — | 2 | — | 2 | ||
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | — | — | 1 | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | — | 1 | — | 1 | |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 4 | 1 | — | 4 | 11 |
| Adenocarcinoma | D000230 | — | 1 | 1 | — | 2 | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | 1 | — | — | 2 | 5 | |
| Glioblastoma | D005909 | EFO_0000515 | 3 | 1 | — | — | — | 4 | |
| Castration-resistant prostatic neoplasms | D064129 | — | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | 4 | — | — | — | 1 | 5 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | — | — | — | 2 | 5 |
| Head and neck neoplasms | D006258 | 1 | — | — | — | 1 | 2 | ||
| Invasive hydatidiform mole | D002820 | D39.2 | 1 | — | — | — | — | 1 | |
| Urologic neoplasms | D014571 | C64-C68 | 1 | — | — | — | — | 1 | |
| Urinary bladder neoplasms | D001749 | C67 | 1 | — | — | — | — | 1 | |
| Squamous cell carcinoma of head and neck | D000077195 | 1 | — | — | — | — | 1 | ||
| Squamous cell carcinoma | D002294 | 1 | — | — | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | 1 | — | — | — | — | 1 | |
| Graft pancreatitis | D055589 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | — | — | 2 | 2 | ||
| Pneumocephalus | D011007 | EFO_1001398 | — | — | — | — | 1 | 1 | |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | — | 1 | 1 | ||
| Testicular neoplasms | D013736 | C62 | — | — | — | — | 1 | 1 | |
| Testicular diseases | D013733 | — | — | — | — | 1 | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | — | — | — | — | 1 | 1 | |
| Parathyroid diseases | D010279 | E21.5 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FLUCICLOVINE F18 |
| INN | fluciclovine (18f) |
| Description | Fluciclovine ((18)F) is a member of the class of cyclobutanes that is cyclobutane which carries a carboxy, amino and ((18)F)fluoro groups at positions 1, 1 and 3, respectively (the 1r,3r-stereoisomer). It is a positron emission tomography (PET) radiotracer for visualizing prostate cancer. It has a role as a radioactive imaging agent. It is a (18)F radiopharmaceutical, an alpha-amino acid, a member of cyclobutanes, a fluoroamino acid, a monocarboxylic acid and a primary amino compound. |
| Classification | Small molecule |
| Drug class | vinca alkaloids |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]1([18F])C[C@@](N)(C(=O)O)C1 |
Identifiers
| PDB | — |
| CAS-ID | 222727-39-1 |
| RxCUI | 1796118 |
| ChEMBL ID | CHEMBL3707267 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13146 |
| UNII ID | 38R1Q0L1ZE (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 158 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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81,557 adverse events reported
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