Drugs / Serdexmethylphenidate
Serdexmethylphenidate
also known as
SDX · KP-415 INNER SALT · KP415 Cl · SERDEXMETHYLPHENIDATE CHLORIDE · Serdexmethylphenidate chloride component of azstarys · Serdexmetilfenidato
Small molecule targets SLC6A2, SLC6A3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AZSTARYS | — | 2021-03-02 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05668754 | Dec 2022 → Feb 2024 | idiopathic hypersomnia | Zevra Therapeutics | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03292952 | Dec 2017 → May 2018 | attention deficit-hyperactivity disorder | Zevra Therapeutics | Completed | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2024-09-24 | ZevraDenmark | Results Zevra Therapeutics to Present Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at Sleep Europe 2024 zevra.com ↗
KP1077 demonstrates clinically meaningful benefits for key IH symptoms |
| 2024-06-03 | ZevraDenmark | Results Zevra Therapeutics Announces Positive Final Results from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at SLEEP 2024 Annual Meeting zevra.com ↗
KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported assessments of daytime sleepiness, sleep inertia, and brain fog |
| 2024-03-26 | ZevraDenmark | Results Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia zevra.com ↗ |
| 2023-10-02 | ZevraDenmark | Results Zevra Therapeutics Announces Interim Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia zevra.com ↗
The interim data from the open-label portion of this trial demonstrate that KP1077 is well-tolerated at all dose levels and both dosing regimens with adverse events that are typical for stimulants and are mostly mild in severity. |
| 2023-09-09 | ZevraDenmark | Results Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023 zevra.com ↗ |
| 2023-05-03 | ZevraDenmark | Regulatory Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy zevra.com ↗
Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc. ), a rare disease therapeutics company, today announced the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) to begin a Phase 1 clinical trial of KP1077 in narcolepsy which is expected to provide additional information regarding the optimal dosing regimen. |
| 2023-04-04 | ZevraDenmark | Regulatory Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy zevra.com ↗ |
| 2022-11-18 | ZevraDenmark | Regulatory KemPharm Receives FDA Orphan Drug Designation for Serdexmethylphenidate (SDX) for the Treatment of Idiopathic Hypersomnia (IH) zevra.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation to serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), for the treatment of idiopathic hypersomnia (IH), a rare neurological sleep disorder. |
| 2022-09-28 | ZevraDenmark | Results KemPharm Announces Positive Topline Data from Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX) zevra.com ↗
today announced topline data from its exploratory Phase 1 clinical trial confirming the relative cardiovascular effects and pharmacokinetics of serdexmethylphenidate (SDX) compared to immediate-release and long-acting formulations of Ritalin ® (racemic methylphenidate), a commonly prescribed CNS stimulant. |
| 2022-06-01 | ZevraDenmark | Results KemPharm Announces Research Affirming Serdexmethylphenidate’s Lower Potential for Abuse Featured in Peer-Reviewed Publication, Current Medical Research & Opinion zevra.com ↗
The research concluded that SDX has significantly lower potential for abuse and minimal stimulant-like adverse events compared to d-MPH. |
| 2022-05-12 | ZevraDenmark | Regulatory KemPharm Reports First Quarter 2022 Financial Results and Corporate Updates zevra.com ↗
Filed Investigational New Drug (IND) application with U.S. Food and Drug Administration (FDA) for KP1077, a serdexmethylphenidate (SDX)-based product candidate for idiopathic hypersomnia (IH) |
| 2022-05-05 | ZevraDenmark | Regulatory KemPharm Announces Submission of Investigational New Drug Application for Phase 2 Trial of KP1077 in Idiopathic Hypersomnia (IH) zevra.com ↗ |
| 2022-03-21 | ZevraDenmark | Results KemPharm Announces Full Data Set from Higher-Dose Serdexmethylphenidate (SDX) Phase 1 Clinical Trial zevra.com ↗ |
| 2021-12-14 | ZevraDenmark | Results KemPharm, Inc. Announces Top-Line Results from Clinical Trial Evaluating the Safety and Pharmacokinetics of “Higher-Dose SDX” zevra.com ↗
Data from the study indicated that the 240 mg and 360 mg doses of SDX were well-tolerated and produced d-MPH exposure generally proportional to the dose. |
| 2021-11-05 | ZevraDenmark | Results KemPharm Announces AZSTARYS® Clinical Data to be Featured in Poster Presentation at the 2021 Virtual International Conference on ADHD zevra.com ↗
Results indicated that the trial’s primary endpoint was met, demonstrating significantly greater improvements from baseline on the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) scale in subjects treated with AZSTARYS versus a placebo (p<0.001). |
| 2021-10-27 | ZevraDenmark | Results AZSTARYS®, An Innovative ADHD Treatment Developed by KemPharm, to be Featured in a Poster Presentation at the 2021 Psych Congress zevra.com ↗
Data in the poster revealed that following a single dose of AZSTARYS (SDX/d-MPH capsules), d-MPH plasma concentrations increased rapidly and were sustained through late-day time points. |
| 2021-10-20 | ZevraDenmark | Results KemPharm Announces Research Involving AZSTARYS® and Serdexmethylphenidate to be Featured in Poster Presentations at Multiple Medical Conferences during ADHD Awareness Month (October) zevra.com ↗
Researchers demonstrated that the shape of the PK curves in children and adolescents was similar to that in adults. |
| 2021-05-26 | ZevraDenmark | Regulatory KemPharm, Inc. Announces Orange Book Listing for Six Patents Covering Serdexmethylphenidate (SDX) and Confirmation of NCE Status zevra.com ↗
In addition, the Orange Book listing confirms the status of SDX, which is the primary API in AZSTARYS, as a new chemical entity (NCE), which provides at least five years of market exclusivity. |
| 2021-05-07 | ZevraDenmark | Regulatory KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA zevra.com ↗
today announced that serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the primary active pharmaceutical ingredient (API) in AZSTARYS™, has been classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA). |
| 2021-03-02 | ZevraDenmark | Regulatory KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD zevra.com ↗ |
All press releases naming this drug 24 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Serdexmethylphenidate | “KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952 ↗ |
| 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)” NCT05721235 ↗ “Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05685732 ↗ |
| 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 ↗ |