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
Focalin (generic drugs available since 2013-11-18)
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
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 | OTC monograph not final | 2023-09-28 |
| arth arrest | C200263 | 2023-11-11 |
| arth rx topical analgesic | C200263 | 2023-11-06 |
| arthmed topical analgesic | C200263 | 2023-11-11 |
| arthritis pain relief | OTC monograph not final | 2023-10-03 |
| atomic balm | C200263 | 2023-11-05 |
| azstarys | New Drug Application | 2022-05-09 |
| dendracin neurodendraxcin | C200263 | 2023-12-21 |
| dexmethylphenidate hydrochloride | ANDA | 2024-02-01 |
| dexmethylphenidate hydrochloride dexmethylphenidate hydrochloride | ANDA | 2016-01-26 |
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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
651 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Actinic keratosis | D055623 | — | L57.0 | 1 | 4 | 12 | 7 | 10 | 32 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 6 | 1 | 3 | 2 | 15 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 2 | 4 | 7 | 1 | 14 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 5 | 3 | 1 | 2 | 4 | 14 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 4 | 4 | 2 | 1 | 3 | 13 |
| Basal cell carcinoma | D002280 | — | — | 1 | 2 | 6 | 1 | 3 | 12 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 2 | — | 3 | 2 | 8 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 4 | — | 1 | — | 6 |
| Bowen's disease | D001913 | — | D00-D09 | 2 | — | 1 | 1 | 2 | 6 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | 1 | 3 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 4 | 9 | 3 | — | — | 14 |
| Depression | D003863 | — | F33.9 | 3 | 4 | 1 | — | 3 | 11 |
| Basal cell neoplasms | D018295 | — | — | 1 | 3 | 6 | — | 3 | 11 |
| Chronic renal insufficiency | D051436 | — | N18 | 3 | 5 | 2 | — | — | 10 |
| Adenocarcinoma | D000230 | — | — | — | 6 | 4 | — | — | 9 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 6 | 3 | 1 | — | — | 8 |
| Glioblastoma | D005909 | EFO_0000515 | — | 6 | 1 | 1 | — | — | 7 |
| Lymphoma | D008223 | — | C85.9 | 3 | 4 | 1 | — | — | 6 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | 1 | — | 3 | 6 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 3 | 1 | — | 1 | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 22 | 2 | — | — | 8 | 32 |
| Neoplasms | D009369 | — | C80 | 12 | 6 | — | — | 2 | 19 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 14 | 11 | — | — | 2 | 18 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 5 | — | — | 1 | 8 |
| Myelodysplastic syndromes | D009190 | — | D46 | 4 | 5 | — | — | — | 7 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 2 | — | — | 3 | 7 |
| Multiple myeloma | D009101 | — | C90.0 | 5 | 1 | — | — | — | 6 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 4 | 3 | — | — | — | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 3 | 1 | — | — | 2 | 6 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 4 | — | — | 2 | 6 |
Show 136 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart disease risk factors | D000082742 | — | — | 3 | — | — | — | — | 3 |
| Vasoconstriction | D014661 | — | — | 3 | — | — | — | — | 3 |
| Shoulder pain | D020069 | HP_0030834 | M25.51 | 1 | — | — | — | 2 | 3 |
| Disease | D004194 | EFO_0000408 | R69 | 3 | — | — | — | — | 3 |
| Contraception | D003267 | — | — | 2 | — | — | — | — | 2 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | 1 | — | — | — | 1 | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 1 | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 2 | — | — | — | — | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | 1 | 2 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | — | — | — | — | 1 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 4 | 4 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 3 | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 2 | 2 |
| Anti-n-methyl-d-aspartate receptor encephalitis | D060426 | — | — | — | — | — | — | 2 | 2 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 2 | 2 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 1 | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Wound infection | D014946 | — | — | — | — | — | — | 1 | 1 |
Show 69 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: Azstarys, Dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride dexmethylphenidate hydrochloride, Dexmethylphenidate hydrochloride extended-release, Dfs 1.5%/ms 25%/menth 6%/cap 0.025% pak, Dfs 75mg dr/ms 25%/menth 6%/cap 0.025% pak, Diclovix, Diclovix m, Dyural 40 kit, Dyural 80 kit, Dyural 80-lm, Dyural lm kit, Focalin, Focalin xr, Focalinxr, Healthy mamabe well rounded, Nudroxipak, Nudroxipak dsdr-50, Nudroxipak dsdr-75, Nudroxipak e-400, Nudroxipak i-800, Nudroxipak m-15, Nudroxipak n-500, Physicians ez use m-pred, Prenate elite, Prenate essential, Varophen
Adverse Events
Top Adverse Reactions
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172,548 adverse events reported
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