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Dexmethylphenidate
Azstarys, 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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FDA Novel Drug Approvals 2021
Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Focalin (generic drugs available since 2013-11-18)
Combinations
Azstarys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexmethylphenidate hydrochloride
Tradename
Company
Number
Date
Products
FOCALINNovartisN-021278 RX2001-11-13
3 products, RLD, RS
FOCALIN XRNovartisN-021802 RX2005-05-26
8 products, RLD
Dexmethylphenidate hydrochloride
+
Serdexmethylphenidate chloride
Tradename
Company
Number
Date
Products
AZSTARYSCommave TherapeuticsN-212994 RX2021-05-07
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
azstarysNew Drug Application2021-08-24
dexmethylphenidate hydrochlorideANDA2023-03-30
focalinNew Drug Application2022-10-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
attention deficit disorder with hyperactivityEFO_0003888D001289F90
Agency Specific
FDA
EMA
Expiration
Code
DEXMETHYLPHENIDATE HYDROCHLORIDE / SERDEXMETHYLPHENIDATE CHLORIDE, AZSTARYS, COMMAVE THERAP
2026-05-07NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Dexmethylphenidate Hydrochloride / Serdexmethylphenidate Chloride, Azstarys, Commave Therap
105841122037-12-09DS, DP
105841132037-12-09DP
107597782037-12-09DP
108583412037-12-09U-3094
109542132037-12-09U-3094
90799282032-07-27DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA11: Dexmethylphenidate
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Mock data
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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 hyperactivityD001289EFO_0003888F90——3418
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80—1———1
FatigueD005221HP_0012378R53.83—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDEXMETHYLPHENIDATE
INNdexmethylphenidate
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-ID40431-64-9
RxCUI352372
ChEMBL IDCHEMBL827
ChEBI ID51860
PubChem CID154101
DrugBankDB06701
UNII IDM32RH9MFGP (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A3
SLC6A3
Organism
Homo sapiens
Gene name
SLC6A3
Gene synonyms
DAT1
NCBI Gene ID
6531
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
Q14996
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
6530
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
Q96KH8
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 721 documents
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Safety
Black-box Warning
Black-box warning for: Azstarys, Dexmethylphenidate hydrochloride, Focalin
Adverse Events
Top Adverse Reactions
0 adverse events reported
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