Pemoline
Cylert (pemoline) is a small molecule pharmaceutical. Pemoline was first approved as Cylert on 1982-01-01. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pemoline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CYLERT | Abbott Biotherapeutics | N-016832 DISCN | 1982-01-01 | 3 products |
| CYLERT | Abbott Biotherapeutics | N-017703 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 2 in 1laxative stool softener and stiulant laxative | OTC monograph not final | 2022-01-03 |
| actoplus met | New Drug Application | 2025-03-27 |
| actos | New Drug Application | 2025-03-28 |
| alogliptin and pioglitazone | NDA authorized generic | 2025-07-28 |
| bekunis natures gentle stimulant laxative | OTC monograph not final | 2011-02-13 |
| bisac-10 bisacodyl stimulant laxative | OTC monograph not final | 2023-04-28 |
| bisacodyl | C200263 | 2025-09-26 |
| chocolate laxative | C200263 | 2024-12-23 |
| chocolated laxative | C200263 | 2024-12-23 |
| cvs health stool softener plus stimulant laxative softgel | C200263 | 2025-03-19 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
Agency Specific
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Clinical
Clinical Trials
616 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pemoline |
| INN | pemoline |
| Description | Pemoline is a member of the class of 1,3-oxazoles that is 1,3-oxazol-4(5H)-one which is substituted by an amino group at position 2 and by a phenyl group at position 5. A central nervous system stimulant, it was used to treat hyperactivity disorders in children, but withdrawn from use following reports of serious hepatotoxicity. It has a role as a central nervous system stimulant. |
| Classification | Small molecule |
| Drug class | Stimulant; Dopamine reuptake inhibitor; Dopamine releasing agent |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC1=NC(=O)C(c2ccccc2)O1 |
Identifiers
| PDB | — |
| CAS-ID | 2152-34-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1177 |
| ChEBI ID | 7953 |
| PubChem CID | 4723 |
| DrugBank | DB01230 |
| UNII ID | 7GAQ2332NK (ChemIDplus, GSRS) |
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Estimated US medical usage
Pemoline
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Trends
PubMed Central
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Additional graphs summarizing 432,312 documents
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Safety
Black-box Warning
Black-box warning for: Actoplus met, Actos, Alogliptin and pioglitazone, Duetact, Oseni, Pioglitazole and metformin hydrochloride, Pioglitazone, Pioglitazone and glimepiride, Pioglitazone and metformin, Pioglitazone and metformin hydrochloride, Pioglitazone hcl and metformin hcl, Pioglitazone hydrochloride, Pioglitazone hydrochloride and metformin hydrochloride, Pioglitazonehydrochloride
Adverse Events
Top Adverse Reactions
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177,545 adverse events reported
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