Drugs / dexmethylphenidate
dexmethylphenidate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | FOCALIN XR | — | 2006-04-11 – 2009-10-23 | fda.gov ↗ |
| Approved | US (FDA) | FOCALIN | — | 2001-11-13 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04138498 | Dec 2019 → Mar 2020 | attention deficit-hyperactivity disorder | Cingulate Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT00593138 | Dec 2006 → Dec 2007 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00047476 | Jun 2002 → Mar 2004 | neoplasm | Celgene Corporation | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05924594 | Jul 2023 → Feb 2027 | attention deficit-hyperactivity disorder | Cingulate Therapeutics | Suspended | No outcome recorded |
| Phase 3 | NCT00301236 | Feb → Nov 2006 | attention deficit-hyperactivity disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00393042 | Jan 2006 → Feb 2009 | attention deficit-hyperactivity disorder | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00141063 | Jun → Aug 2005 | attention deficit-hyperactivity disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00141050 | May → Jul 2005 | attention deficit-hyperactivity disorder | Novartis | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| 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 |
| Phase 4 | NCT03420339 | Oct 2018 → Mar 2027 expected | attention deficit-hyperactivity disorder | Matthew J O'Brien, PhD, BCBA-D | Recruiting | No outcome recorded |
| Phase 4 | NCT00776009 | Oct → Dec 2008 | attention deficit-hyperactivity disorder | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT00564954 | Oct → Nov 2007 | attention deficit-hyperactivity disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT07119073 Comparator | Oct → Dec 2024 | — | Cingulate Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04449250 Comparator | Sep → Oct 2022 | — | Cingulate Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00829673 Comparator | Jun 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00829712 Comparator | Jun 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 2 | NCT01399827 Comparator | Feb 2012 → Nov 2017 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02204410 Background | Jul 2014 → May 2016 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-08-06 | BDD Pharma Ltd | Regulatory NDA Filing for Advanced ADHD Treatment, CTx-1301 underpinned by BDD’s OralogiK™ Platform. bddpharma.com ↗
NDA Filing for Advanced ADHD Treatment, CTx-1301 underpinned by BDD’s OralogiK™ Platform. |
| 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 ↗
The study results affirm that SDX is safe and well-tolerated at higher doses and has no greater cardiovascular safety risk than other methylphenidate products currently being used off-label for the treatment of IH while providing higher overall exposure levels of d-MPH. |
| 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. |
| 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 ↗
Pharmacokinetic data from two clinical studies of AZSTARYS demonstrated its rapid onset of action and long duration of effect |
| 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. |
| 2021-03-02 | 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 ↗ |
| 2017-09-26 | Lannett Company, Inc. | Regulatory Lannett Receives Approval For Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg And 10 mg investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg, and 10 mg, the therapeutic equivalent to the reference listed drug, Focalin® Tablets, 2.5 mg, 5 mg, and 10 mg, of Novartis Pharmaceuticals Corporation. |
| 2017-07-05 | Impax Laboratories, LLC | Regulatory Impax Announces FDA Approval and Launch of Additional Strengths of Generic Focalin XR® (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII amneal.com ↗
today announced it has received final U.S. Food and Drug Administration (" FDA ") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Focalin XR ® (dexmethylphenidate hydrochloride) extended-release capsules CII, 25 and 35 mg. |
| 2007-01-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Approval for Generic Focalin™ Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Focalin™ (Dexmethylphenidate Hydrochloride) Tablets, 2.5 mg, 5 mg, and 10 mg. |
All press releases naming this drug 10 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dexmethylphenidate | “The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH)...” NCT00141050 ↗15“The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH)...” NCT00141063 ↗ “OBJECTIVE: Pediatric studies of the long-acting formulation (spheroidal oral drug absorption system [SODAS]) of the isomer dexmethylphenidate have shown a dose-dependent...” PMID 22154896 ↗ Nov 2011 “Dexmethylphenidate” NCT01399827 ↗ |
| Known as | CTx-1301 | “An Open-label, Randomized, Single-dose, Two-period, Two-treatment (Fed vs Fasted), Two-sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the...” NCT04449250 ↗2“A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Laboratory Classroom Study in Children (6-12) With...” NCT05924594 ↗ “An Open-label, Randomized, Single-dose, Two-period, Two Treatment (Fed vs Fasted), Two Sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the...” NCT07119073 ↗ |
| Known as | d-MPH | “Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05685732 ↗2“Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05721235 ↗ “dexmethylphenidate(d-mph)” NCT00047476 ↗ |
| Known as | D-MPH-ER | “dexmethylphenidate extended-release (d-MPH-ER) 30 versus 20 mg in children” PMID 22926597 ↗ Oct 2012 |
| Known as | Dex-Methylphenidate hydrochloride Extended Release | “Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)” NCT00776009 ↗ |
| Known as | Dexmethylphenidate extended-release | “dexmethylphenidate extended-release (d-MPH-ER) 30 versus 20 mg in children” PMID 22926597 ↗ Oct 2012 |
| Known as | Dexmethylphenidate HCl | “Dexmethylphenidate HCl extended-release capsules” NCT00301236 ↗ |
| Known as | Dexmethylphenidate Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00829712 ↗ |
| Known as | Focalin | “Focalin” NCT03420339 ↗ |
| Known as | Focalin XR | “Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)” NCT00776009 ↗ |
| Known as | Focalin XR (dexmethylphenidate) 5 mg Capsule | “Focalin XR (dexmethylphenidate) 5 mg Capsule” NCT04138498 ↗ |
| Route | Oral | “20 mg capsule orally once a day for 7 days” NCT00564954 ↗ |