Drugs / Serdexmethylphenidate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) AZSTARYS 2021-03-02 fda.gov

Trials 4 · a red edge is where a trial was stopped

201820192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT05668754 Dec 2022 → Feb 2024 idiopathic hypersomnia Zevra Therapeutics Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03292952 Dec 2017 → May 2018 attention deficit-hyperactivity disorder Zevra Therapeutics Completed No outcome recorded
Phase 42 trials
Phase 4 NCT05721235 Jun 2023 → Jul 2025 attention deficit-hyperactivity disorder Corium, Inc. Completed No outcome recorded
Phase 4 NCT05685732 Mar 2023 → May 2024 attention deficit-hyperactivity disorder Corium, Inc. Completed No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as serdexmethylphenidate “KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952
3

NCT05685732

NCT05721235

NCT05668754

Known as KP-415 INNER SALT ChEMBL registry synonym — accepted as the source's own label CHEMBL4301162
Known as KP415 Cl ChEMBL registry synonym — accepted as the source's own label CHEMBL4301162
Known as SDX “KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952
2

“Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05685732

“Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05721235

Known as SERDEXMETHYLPHENIDATE CHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL4301162
Known as Serdexmethylphenidate chloride component of azstarys ChEMBL registry synonym — accepted as the source's own label CHEMBL4301162
Known as Serdexmetilfenidato ChEMBL registry synonym — accepted as the source's own label CHEMBL4301162
Action Inhibit “Norepinephrine transporter inhibitor” CHEMBL4301162
1

“Dopamine transporter inhibitor” CHEMBL4301162

Modality Small molecule CHEMBL4301162
Route Oral “KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952
Target SLC6A2 “Norepinephrine transporter inhibitor” CHEMBL4301162
Target SLC6A3 “Dopamine transporter inhibitor” CHEMBL4301162