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 |
|---|---|---|
| 1st medxpatch | C200263 | 2024-10-31 |
| 365 whole foods market anticavity/antigingivitis mouthwash | OTC monograph not final | 2022-05-12 |
| 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 |
| aboniki balm - ultra strength topical pain relief balm - white | C200263 | 2024-10-23 |
| advanced antiseptic citrus | OTC monograph not final | 2012-04-02 |
| advanced citrus antiseptic | OTC monograph not final | 2012-03-26 |
| advil targeted relief | C200263 | 2024-02-08 |
| ageless pain relief | C200263 | 2023-12-12 |
| air sinsin pas | OTC monograph final | 2011-06-06 |
Show 700 more
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
678 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 15 | 16 | 8 | 1 | 5 | 39 |
| Actinic keratosis | D055623 | — | L57.0 | 1 | 4 | 12 | 7 | 13 | 35 |
| Keratosis | D007642 | — | — | 1 | 4 | 12 | 7 | 13 | 35 |
| Depression | D003863 | — | F33.9 | 6 | 10 | 2 | 2 | 6 | 25 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 7 | 8 | 1 | 2 | 7 | 24 |
| Syndrome | D013577 | — | — | 5 | 13 | 5 | 2 | 5 | 23 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 7 | 6 | 1 | 2 | 5 | 20 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 3 | 6 | 1 | 6 | 2 | 18 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 2 | 7 | 8 | 1 | 18 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 7 | 1 | 4 | 2 | 17 |
Show 99 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 17 | 15 | 1 | — | 2 | 31 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 17 | 6 | — | — | 24 |
| Adenocarcinoma | D000230 | — | — | 7 | 15 | 5 | — | — | 20 |
| Recurrence | D012008 | — | — | 7 | 9 | 2 | — | — | 17 |
| Lymphoma | D008223 | — | C85.9 | 7 | 10 | 2 | — | — | 16 |
| Leukemia | D007938 | — | C95 | 9 | 7 | 1 | — | — | 14 |
| Basal cell neoplasms | D018295 | — | — | 1 | 3 | 6 | — | 3 | 11 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 8 | 3 | 1 | — | — | 10 |
| Myeloid leukemia | D007951 | — | C92 | 8 | 3 | 1 | — | — | 10 |
| Glioblastoma | D005909 | EFO_0000515 | — | 8 | 1 | 1 | — | 1 | 10 |
Show 68 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 25 | 3 | — | — | 9 | 37 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 14 | 11 | — | — | 2 | 18 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 8 | — | — | 1 | 12 |
| Squamous cell carcinoma | D002294 | — | — | 5 | 6 | — | — | 1 | 9 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 6 | 4 | — | — | 1 | 9 |
| Fibrosis | D005355 | — | — | — | 2 | — | — | 6 | 8 |
| Myelodysplastic syndromes | D009190 | — | D46 | 4 | 5 | — | — | — | 7 |
| Multiple myeloma | D009101 | — | C90.0 | 5 | 2 | — | — | — | 7 |
| Glioma | D005910 | EFO_0000520 | — | 5 | 3 | — | — | — | 7 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 2 | — | — | 3 | 7 |
Show 198 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Shoulder pain | D020069 | HP_0030834 | M25.51 | 2 | — | — | — | 2 | 4 |
| Heart disease risk factors | D000082742 | — | — | 3 | — | — | — | — | 3 |
| Vasoconstriction | D014661 | — | — | 3 | — | — | — | — | 3 |
| Disease | D004194 | EFO_0000408 | R69 | 3 | — | — | — | — | 3 |
| Bursitis | D002062 | EFO_1000941 | M71.9 | 1 | — | — | — | 1 | 2 |
| Contraception | D003267 | — | — | 2 | — | — | — | — | 2 |
| Serous cystadenocarcinoma | D018284 | — | — | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | 1 | — | — | — | 1 | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 1 | 2 |
Show 58 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 4 | 4 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 4 | 4 |
| Trigger finger disorder | D052582 | — | M65.3 | — | — | — | — | 3 | 3 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 3 | 3 |
| Dystocia | D004420 | EFO_1000911 | O66.9 | — | — | — | — | 2 | 2 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | — | — | — | 2 | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 2 | 2 |
| Anti-n-methyl-d-aspartate receptor encephalitis | D060426 | — | — | — | — | — | — | 2 | 2 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 2 | 2 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 2 | 2 |
Show 118 more
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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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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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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, Diclovix m, Dyural 40 kit, Dyural 80 kit, Dyural 80-lm, Dyural lm kit, Eemt, Eemt eemt, Esterified estrogens and methyltestosterone, Estratest f.s., Estratest f.s. estratest h.s., Fenovar, Focalin, Focalin xr, Focalinxr, Healthy mamabe well rounded, Hycodan, Hydrocodone bitartrate and homatropine methylbromide, Hydromet, Jornay pm, Metadate cd, Metadate er, Methylene blue, Methylene blue inj, Methylin, Methylphenidate, Methylphenidate hydrochloride, Methylphenidate hydrochloride (la), Methylphenidate hydrochloride extended release, Methylphenidate transdermal system, 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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213,266 adverse events reported
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