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 15 · a red edge is where a trial was stopped
| 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 36 trials | ||||||
| Phase 3 | NCT05924594 | Jul 2023 → Feb 2027 | attention deficit-hyperactivity disorder | Cingulate Therapeutics | Suspended | No outcome recorded |
| Phase 3 | NCT03292952 | Dec 2017 → May 2018 | attention deficit-hyperactivity disorder | Zevra Therapeutics | Completed | 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 46 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 |
| 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 | No outcome recorded |
| Phase 4 | NCT00564954 | Oct → Nov 2007 | attention deficit-hyperactivity disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00361387 | Jun 2006 → Jun 2007 | sarcoidosis | University of Cincinnati | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 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 21 trial | ||||||
| Phase 2 | NCT01399827 Comparator | Feb 2012 → Nov 2017 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02204410 Background | Jul 2014 → May 2016 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2007-01-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approval for Generic Focalin™ Tablets tevapharm.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 24 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-methylphenidate | “KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952 ↗ |
| Known as | d-MPH | “We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis-associated fatigue.” PMID 18263672 ↗ Feb 20084“KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule:” NCT03292952 ↗ “Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)” NCT05685732 ↗ “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 | “We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis-associated fatigue.” PMID 18263672 ↗ Feb 2008 |
| 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 | “oral dosing for 8 weeks then cross over to placebo in random order” NCT00361387 ↗ |