Modafinil
Provigil (modafinil) is a small molecule pharmaceutical. Modafinil was first approved as Provigil on 1998-12-24. It is used to treat attention deficit disorder with hyperactivity, fatigue, narcolepsy, and obstructive sleep apnea in the USA. It is known to target sodium-dependent dopamine transporter.
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Commercial
Trade Name
FDA
EMA
Provigil (generic drugs available since 2012-09-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Modafinil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROVIGIL | Cephalon | N-020717 RX | 1998-12-24 | 2 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
| fatigue | HP_0012378 | D005221 | R53.83 |
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
| obstructive sleep apnea | EFO_0003918 | D020181 | G47.33 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Modafinil, Provigil, Cephalon | |||
| 7297346 | 2023-11-29 | DP | |
HCPCS
No data
Clinical
Clinical Trials
411 clinical trials
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Mock data
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postpartum hemorrhage | D006473 | O72 | 1 | 7 | 9 | 11 | 18 | 44 | |
| Induced labor | D007751 | 2 | 7 | 7 | 9 | 13 | 38 | ||
| Induced abortion | D000028 | — | 1 | 3 | 6 | 16 | 26 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 3 | 4 | 7 | 8 | 21 |
| Cervical ripening | D020070 | — | 4 | 6 | 6 | 3 | 19 | ||
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | 6 | 5 | 3 | 8 | 18 |
| Missed abortion | D000030 | O02.1 | 2 | 6 | 2 | 7 | 1 | 17 | |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 3 | 5 | 3 | 2 | 13 |
| Contraception | D003267 | — | — | 3 | 1 | 5 | 9 | ||
| Cesarean section | D002585 | 1 | 2 | 2 | 1 | 1 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Incomplete abortion | D000027 | EFO_1001799 | 1 | — | 1 | — | 9 | 11 | |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 4 | 1 | — | 2 | 7 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 2 | — | 3 | 6 |
| Uterine hemorrhage | D014592 | — | — | 2 | — | 2 | 4 | ||
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 1 | — | 1 | 2 |
| Transient tachypnea of the newborn | D059245 | P22.1 | — | — | 1 | — | 1 | 2 | |
| Infertility | D007246 | EFO_0000545 | — | 1 | 1 | — | — | 2 | |
| Labor pain | D048949 | — | — | 1 | — | 1 | 2 | ||
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retained placenta | D018457 | O72.0 | 1 | 1 | — | — | 1 | 3 | |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | 1 | — | — | — | 1 | |
| First pregnancy trimester | D011261 | — | 1 | — | — | — | 1 | ||
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 | |
| High-risk pregnancy | D018566 | — | — | — | — | 1 | 1 | ||
| Myoma | D009214 | D21 | — | — | — | — | 1 | 1 | |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | — | — | 1 | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | — | — | — | 1 | 1 |
| Intrauterine devices | D007434 | — | — | — | — | 1 | 1 | ||
| Postcoital contraception | D044363 | — | — | — | — | 1 | 1 | ||
| Postoperative pain | D010149 | G89.18 | — | — | — | — | 1 | 1 | |
| Hysteroscopy | D015907 | — | — | — | — | 1 | 1 | ||
| Asphyxia | D001237 | R09.01 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MODAFINIL |
| INN | modafinil |
| Description | 2-[(diphenylmethyl)sulfinyl]acetamide is a sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group. It is a sulfoxide and a monocarboxylic acid amide. |
| Classification | Small molecule |
| Drug class | CNS stimulant |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)C[S+]([O-])C(c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 112111-43-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1373 |
| ChEBI ID | 77585 |
| PubChem CID | 4236 |
| DrugBank | DB00745 |
| UNII ID | R3UK8X3U3D (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLC6A3
SLC6A3
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
Protein name
sodium-dependent dopamine transporter
Protein synonyms
DA transporter, dopamine transporter 1, solute carrier family 6 (neurotransmitter transporter), member 3, solute carrier family 6 (neurotransmitter transporter, dopamine), member 3, Solute carrier family 6 member 3
Uniprot ID
Mouse ortholog
Slc6a3 (13162)
sodium-dependent dopamine transporter (Q9R1I2)
Variants
Clinical Variant
No data
Financial
Provigil - Cephalon
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,998 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,067 adverse events reported
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