serdexmethylphenidate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5448 1996626-30-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • serdexmethylphenidate
  • serdexmethylphenidate chloride
  • azstarys
  • KP415 Cl
Serdexmethylphenidate is a prodrug of dexmethylphenidate (d-MPH). The mode of therapeutic action in ADHD is not known. Serdexmethylphenidate is not deemed to have pharmacological activity until converted to d-MPH. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant that blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
  • Molecular weight: 499.52
  • Formula: C25H29N3O8
  • CLOGP: -4.02
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 2
  • TPSA: 149.18
  • ALOGS: -4.96
  • ROTB: 11
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK 22
kinase-selectivity-class AXL,GRK2,TEK 3
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 2, 2021 FDA COMMCAVE THERAPEUTICS SA

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06BA15 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D002491 Central Nervous System Agents

Related Drugs by ATC class:

N06BA Centrally acting sympathomimetics 14 drugs
amfetaminearmodafinilatomoxetinedexamfetaminedexmethylphenidatefencamfaminfenetyllinefenozolonelisdexamfetaminemethamphetaminemethylphenidatemodafinil show all 14 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Attention deficit hyperactivity disorder indication 406506008




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10.4MG BASE;EQ 52.3MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10858341 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 10.4MG BASE;EQ 52.3MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10954213 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 5.2MG BASE;EQ 26.1MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10858341 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 5.2MG BASE;EQ 26.1MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10954213 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 7.8MG BASE;EQ 39.2MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10858341 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
EQ 7.8MG BASE;EQ 39.2MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL 10954213 Dec. 9, 2037 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10.4MG BASE;EQ 52.3MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL May 7, 2026 NEW CHEMICAL ENTITY
EQ 5.2MG BASE;EQ 26.1MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL May 7, 2026 NEW CHEMICAL ENTITY
EQ 7.8MG BASE;EQ 39.2MG BASE AZSTARYS COMMAVE SUB N212994 May 7, 2021 RX CAPSULE ORAL May 7, 2026 NEW CHEMICAL ENTITY

Bioactivity Summary:

None

External reference:

IDSource
D11401 KEGG_DRUG
0H8KZ470DW UNII
C5237972 UMLSCUI
CHEBI:757632 CHEBI
CHEMBL4301162 ChEMBL_ID
134823895 PUBCHEM_CID
DB16629 DRUGBANK_ID
CHEMBL4298139 ChEMBL_ID
10916 INN_ID
C000718174 MESH_SUPPLEMENTAL_RECORD_UI
11450 IUPHAR_LIGAND_ID
1179218001 SNOMEDCT_US
1179219009 SNOMEDCT_US
4040657 VANDF
344090 MMSL
39359 MMSL
d09719 MMSL
018662 NDDF
018663 NDDF
1996626-29-9 SECONDARY_CAS_RN
2562176 RXNORM
0H8KZ470DW INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-286 CAPSULE 26.10 mg ORAL NDA 32 sections
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-286 CAPSULE 26.10 mg ORAL NDA 32 sections
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-429 CAPSULE 39.20 mg ORAL NDA 32 sections
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-429 CAPSULE 39.20 mg ORAL NDA 32 sections
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-561 CAPSULE 52.30 mg ORAL NDA 32 sections
AZSTARYS HUMAN PRESCRIPTION DRUG LABEL 2 65038-561 CAPSULE 52.30 mg ORAL NDA 32 sections