Skip to content
Serdexmethylphenidate
Azstarys (serdexmethylphenidate) is a small molecule pharmaceutical. Serdexmethylphenidate was first approved as Azstarys on 2021-05-07. It is used to treat attention deficit disorder with hyperactivity in the USA.
Download report
Favorite
FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
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
+
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 Application2021-12-10
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
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Attention deficit disorder with hyperactivityD001289EFO_0003888F90———2—2
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Idiopathic hypersomniaD020177G47.11—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameSERDEXMETHYLPHENIDATE
INNserdexmethylphenidate
Description
Serdexmethylphenidate is a prodrug of dexmethylphenidate created by the pharmaceutical company KemPharm. The compound was first approved by the FDA as one of the active ingredients in Azstarys for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults in March 2021. Serdexmethylphenidate is a prodrug which has a delayed onset of action and a prolonged duration of effects compared to dexmethylphenidate, its parent compound.
Classification
Small molecule
Drug class-
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COC(=O)[C@H](c1ccccc1)[C@H]1CCCCN1C(=O)OC[n+]1cccc(C(=O)N[C@@H](CO)C(=O)O)c1
Identifiers
PDB—
CAS-ID1996626-29-9
RxCUI—
ChEMBL IDCHEMBL4301162
ChEBI ID—
PubChem CID34823895
DrugBankDB16629
UNII ID0H8KZ470DW (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 12 documents
View more details
Safety
Black-box Warning
Black-box warning for: Azstarys
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
71,876 adverse events reported
View more details