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 |
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FDA
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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)
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 |
Show 48 more
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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EMA
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Clinical
Clinical Trials
624 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | 1 | — | 1 | 21 | 24 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 2 | 2 | 4 | 9 | 16 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 3 | 1 | 3 | 10 | 16 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 2 | 1 | 10 | 13 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | 1 | 9 | 11 |
| Syndrome | D013577 | — | — | — | — | — | 2 | 5 | 7 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 1 | 1 | 5 | 7 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 2 | 2 | 2 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | 1 | 4 | 6 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | 1 | 5 | 6 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 1 | — | 1 | — | 8 | 10 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | 7 | 8 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | 1 | — | 4 | 6 |
| Lymphatic metastasis | D008207 | EFO_1001364 | — | — | — | 1 | — | 2 | 3 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | 2 | — | — | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | 1 | — | 1 | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | 1 | 2 |
| Vulvar neoplasms | D014846 | — | C51 | — | — | 1 | — | 1 | 2 |
| Neoadjuvant therapy | D020360 | — | — | — | — | 1 | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | — | 1 | — | — | 1 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 1 | — | — | 12 | 13 |
| Critical illness | D016638 | — | — | — | 1 | — | — | 7 | 8 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 1 | — | — | 3 | 4 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | — | — | 3 | 4 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | 2 | 4 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | 2 | 3 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | 2 | 3 |
| Cocaine-related disorders | D019970 | — | F14 | — | 3 | — | — | — | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | 1 | 2 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | 1 | — | — | 1 | 2 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | 1 | — | — | — | 9 | 10 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | 6 | 7 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | 5 | 6 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | 3 | 4 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | 3 | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | 2 | 3 |
| Psychological trauma | D000067073 | — | — | 1 | — | — | — | 2 | 3 |
| Health behavior | D015438 | — | — | 1 | — | — | — | 2 | 3 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | 1 | — | — | — | 1 | 2 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | — | — | — | 1 | 2 |
Show 19 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 19 | 19 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 14 | 14 |
| Emergencies | D004630 | — | — | — | — | — | — | 14 | 14 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 12 | 12 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 11 | 11 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 9 | 9 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 8 | 8 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 7 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 7 | 7 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 7 | 7 |
Show 416 more
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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Financial
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Estimated US medical usage
Pemoline
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Trends
PubMed Central
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Additional graphs summarizing 434,953 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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180,075 adverse events reported
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