Dexmethylphenidate
Azstarys, Dexmethylphenidate, Focalin (dexmethylphenidate) is a small molecule pharmaceutical. Dexmethylphenidate was first approved as Focalin on 2001-11-13. It is used to treat attention deficit disorder with hyperactivity in the USA. The pharmaceutical is active against sodium-dependent dopamine transporter. In addition, it is known to target sodium-dependent noradrenaline transporter.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Dexmethylphenidate, Focalin (discontinued: Dexmethylphenidate)
CombinationsAzstarys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexmethylphenidate hydrochloride
+
Serdexmethylphenidate chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AZSTARYS | Commave Therapeutics | N-212994 RX | 2021-05-07 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 10% methyl salicylate pain relief patch | C200263 | 2024-06-27 |
| 1st medxpatch | unapproved drug other | 2025-10-31 |
| 365 whole foods market anticavity/antigingivitis mouthwash | OTC monograph not final | 2022-05-12 |
| 5kind dmso | C200263 | 2025-12-02 |
| 701 dieda zhengtong yaogao medicated | OTC monograph not final | 2019-11-13 |
| 701 dieda zhengtong yaogao medicated plaster | OTC monograph not final | 2014-06-26 |
| abejas y viboras roll on | C200263 | 2025-07-22 |
| absolut skin spf 50 moisturizing sunscreen | C200263 | 2025-06-19 |
| advanced antiseptic citrus | C200263 | 2025-02-20 |
| advanced citrus antiseptic | C200263 | 2025-01-10 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE / SERDEXMETHYLPHENIDATE CHLORIDE, AZSTARYS, COMMAVE THERAP | |||
| 2026-05-07 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 2 | 7 | 10 | 1 | 20 |
| Hyperkinesis | D006948 | — | — | — | 1 | 4 | 3 | 1 | 9 |
| Problem behavior | D000066553 | — | — | — | — | — | 1 | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | 1 | — | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | — | — | 1 | — | 1 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | — | R53.83 | — | 1 | 1 | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | 1 | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | — | — | 1 | — | — | 1 |
| Nervous system neoplasms | D009423 | — | — | — | — | 1 | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | 1 | — | — | — | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | 1 | — | — | — | 1 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 1 | — | — | — | 1 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | — | 1 | — | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dexmethylphenidate |
| INN | dexmethylphenidate |
| Description | Dexmethylphenidate is a methyl phenyl(piperidin-2-yl)acetate in which both stereocentres have R configuration. It is the active enantiomer in the racemic drug methylphenidate. It has a role as an adrenergic agent. It is an enantiomer of a methyl (S)-phenyl[(S)-piperidin-2-yl]acetate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1 |
Identifiers
| PDB | — |
| CAS-ID | 40431-64-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL827 |
| ChEBI ID | 51860 |
| PubChem CID | 154101 |
| DrugBank | DB06701 |
| UNII ID | M32RH9MFGP (ChemIDplus, GSRS) |
Target
Agency Approved
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)
Alternate
SLC6A2
SLC6A2
Organism
Homo sapiens
Gene name
SLC6A2
Gene synonyms
NAT1, NET1, SLC6A5
NCBI Gene ID
Protein name
sodium-dependent noradrenaline transporter
Protein synonyms
NET, neurotransmitter transporter, Norepinephrine transporter, solute carrier family 6 (neurotransmitter transporter), member 2, solute carrier family 6 (neurotransmitter transporter, noradrenalin), member 2, Solute carrier family 6 member 2, solute carrier family 6 member 5
Uniprot ID
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Variants
No data
Financial
Revenue by drug
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Methylphenidate – RVL Pharmaceuticals
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Daytrana – Shire
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Tabular view
Estimated US medical usage
Dexmethylphenidate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Aptensio xr, Azstarys, Concerta, Cotempla xr-odt, Covaryx, Covaryx covaryx, Daytrana, Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride extended-release, Diclovix m, Dyural 40 kit, Dyural 80 kit, Dyural 80-lm, Dyural lm kit, Eemt, Eemt eemt, Esterified estrogens and methyltestosterone, Esterified estrogens and methyltestosterone full strength esterified estrogens and methyltestosterone half strength, Estratest f.s., Estratest f.s. estratest h.s., Estratest fs estratest hs, Fenovar, Focalin, Focalin xr, Focalinxr, Healthy mamabe well rounded, Hycodan, Hydrocodone bitartrate and homatropine methylbromide, Hydromet, Jornay pm, Metadate cd, Metadate er, Methylene blue, Methylin, Methylphenidate, Methylphenidate hydrochloride, Methylphenidate hydrochloride (la), Methylphenidate hydrochloride cd, Methylphenidate hydrochloride extended release, Methylphenidate transdermal system, Orthaphen, Perseris, Physicians ez use m-pred, Prenate elite, Prenate essential, Provayblue, Quillichew er, Quillivant, Relexxii, Ritalin, Varophen
Adverse Events
Top Adverse Reactions
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241,502 adverse events reported
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