Fluorodopa f 18
Fluorodopa f 18 is a small molecule pharmaceutical. Fluorodopa f 18 was first approved as Fluorodopa f18 on 2019-10-10.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
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Trade Name
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EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorodopa f-18
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FLUORODOPA F18 | Feinstein Institutes for Medical Research | N-200655 RX | 2019-10-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluorodopa | New Drug Application | 2021-01-15 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FLUORODOPA F-18, FLUORODOPA F18, FEINSTEIN | |||
| 2024-10-10 | NCE, W | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | 2 | 3 | 1 | — | 3 | 9 | |
| Congenital hyperinsulinism | D044903 | 1 | 2 | 2 | — | 2 | 7 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 2 | — | 3 | 7 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | 1 | — | 2 | 4 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 1 | 2 | — | 1 | 4 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | 2 | — | 1 | 3 | |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | 2 | 1 | — | — | 3 | 6 | |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 2 | — | — | — | 2 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulinoma | D007340 | 1 | — | — | — | 2 | 3 | ||
| Gliosarcoma | D018316 | 1 | — | — | — | 1 | 2 | ||
| Ependymoma | D004806 | 1 | — | — | — | 1 | 2 | ||
| Astrocytoma | D001254 | EFO_0000271 | 1 | — | — | — | 1 | 2 | |
| Oligodendroglioma | D009837 | EFO_0000631 | 1 | — | — | — | 1 | 2 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Aids dementia complex | D015526 | EFO_0002608 | 1 | — | — | — | — | 1 | |
| Depression | D003863 | F33.9 | 1 | — | — | — | — | 1 | |
| Subependymal glioma | D018315 | EFO_1001197 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Papillary thyroid cancer | D000077273 | — | — | — | — | 3 | 3 | ||
| Pure autonomic failure | D054970 | — | — | — | — | 2 | 2 | ||
| Parathyroid neoplasms | D010282 | — | — | — | — | 1 | 1 | ||
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | — | — | 1 | 1 |
| Hypercalcemia | D006934 | E83.52 | — | — | — | — | 1 | 1 | |
| Multiple endocrine neoplasia | D009377 | E31.2 | — | — | — | — | 1 | 1 | |
| Multiple system atrophy | D019578 | — | — | — | — | 1 | 1 | ||
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | — | 1 | 1 |
| Hepatitis c | D006526 | B19.2 | — | — | — | — | 1 | 1 | |
| Hepatitis b | D006509 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FLUORODOPA F 18 |
| INN | fluorodopa (18f) |
| Description | 6-fluoro-L-dopa is a non-proteinognic L-alpha-amino acid that is L-alanine in which one of the hydrogens of the methyl group has been replaced by a 2-fluoro-4,5-dihydroxyphenyl group. It is a fluorophenol, a non-proteinogenic L-alpha-amino acid and a member of catechols. It is functionally related to a L-dopa. |
| Classification | Small molecule |
| Drug class | dopamine receptor agonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | N[C@@H](Cc1cc(O)c(O)cc1[18F])C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 75290-51-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3400972 |
| ChEBI ID | 49166 |
| PubChem CID | 107730 |
| DrugBank | DB13848 |
| UNII ID | 2C598205QX (ChemIDplus, GSRS) |
Target
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Alternate
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Variants
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Trends
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Safety
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Adverse Events
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467 adverse events reported
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