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 disorders | D001523 |
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 |
|---|---|---|---|---|
| AZSTARYS | Commave Therapeutics | N-212994 RX | 2021-05-07 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azstarys | New Drug Application | 2021-12-10 |
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 | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
View more details
Mock data
Subscribe for the real 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 hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | 2 | — | 2 |
Indications Phases 3
No data
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 name | SERDEXMETHYLPHENIDATE |
| INN | serdexmethylphenidate |
| 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-ID | 1996626-29-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4301162 |
| ChEBI ID | — |
| PubChem CID | 34823895 |
| DrugBank | DB16629 |
| UNII ID | 0H8KZ470DW (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
Subscribe for the real data
Additional graphs summarizing 13 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
Subscribe for the real data
52,944 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more