Methylphenidate
Small molecule targets ABCB1
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tuzulby | — | 2025-02-28 | europa.eu ↗ |
| Label expansion | US (FDA) | ADHANSIA XR | — | 2021-06-28 | fda.gov ↗ |
| Label expansion | US (FDA) | APTENSIO XR | — | 2019-06-14 | fda.gov ↗ |
| Label expansion | US (FDA) | DAYTRANA | — | 2010-06-29 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | CONCERTA | — | 2004-10-21 – 2009-11-04 | fda.gov ↗ |
| Approved | US (FDA) | RITALIN | — | 1955-12-05 | fda.gov ↗ |
Trials 301 · started per year
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2024-11-19 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Mixed Salts of a Single-Entity Amphetamine Extended-Release Capsules lupin.com ↗ |
| 2023-10-26 | Aytu BioPharma, Inc. | Regulatory Aytu BioPharma Announces Approval of the Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Approval Supplement aytubio.com ↗
Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, announced receipt of U.S. Food & Drug Administration (FDA) approval of the Cotempla XR-ODT® ("Cotempla") Prior Approval Supplement (PAS). |
| 2023-07-10 | Aytu BioPharma, Inc. | Regulatory Aytu BioPharma Announces Submission of Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Approval Supplement aytubio.com ↗
Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on developing and commercializing novel therapeutics, has submitted the Cotempla XR-ODT® ("Cotempla") Prior Approval Supplement (PAS) to the U.S. Food & Drug Administration (FDA). |
| 2022-03-23 | Aytu BioPharma, Inc. | Regulatory Aytu BioPharma Announces FDA Orange Book Listing of Newly Issued Patent for Cotempla XR-ODT(R) aytubio.com ↗
The listing of this patent extends the Orange Book patent exclusivity for Cotempla XR-ODT by over five years. |
| 2019-07-19 | Zydus Lifesciences Limited | Regulatory Zydus Nesher Pharmaceuticals receives final approval from the USFDA zyduslife.com ↗
Zydus’ Nesher Pharmaceuticals receives final approval from the USFDA for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate ER Capsules |
| 2017-07-17 | Impax Laboratories, LLC | Regulatory Impax Announces FDA Approval of its AB Rated Generic Concerta® (Methylphenidate Hydrochloride) Extended-Release Tablets CII amneal.com ↗ |
| 2016-11-30 | Lannett Company, Inc. | Regulatory Lannett Provides Update On Methylphenidate ER Tablets investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) granted the company a 90-day extension to submit documentation concerning its Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. |
| 2016-10-19 | Lannett Company, Inc. | Regulatory Lannett Comments On FDA Proposal Regarding Methylphenidate Extended Release Tablets investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. |
| 2016-02-17 | Impax Laboratories, LLC | Regulatory Impax Receives FDA Approval for Generic Version of Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, CII amneal.com ↗
HAYWARD, Calif. , Feb. 17, 2016 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration ( FDA ) has approved its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg. |
| 2015-12-07 | Pfizer | Regulatory Pfizer Receives U.S. FDA Approval of New QuilliChew ER™ (methylphenidate hydrochloride) extended-release chewable tablets CII pfizer.com ↗
Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets. |
| 2014-07-17 | Takeda | Results Top-Line Results From Two Head-To-Head Studies Comparing Vyvanse® (Lisdexamfetamine Dimesylate), CII, With Concerta® (Methylphenidate Hcl), CII, In Adolescents With ADHD takeda.com ↗
In SPD489-406, the forced-dose titration study, Vyvanse was found to be statistically superior to Concerta on the primary efficacy analysis (p = 0.0013) with mean reductions on the ADHD RS-IV total score of 25.4 and 22.1 points, respectively. |
| 2004-06-25 | Eli Lilly and Company | Results Strattera Controlled Symptoms of ADHD with Minimal Effect on Sleep lilly.com ↗
Additionally, parent diaries showed children on Strattera were less irritable compared to methylphenidate. |
| 2003-11-19 | Impax Laboratories, LLC | Regulatory IMPAX ANDA Filing for Generic Version of Adderall XR Accepted by FDA amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the United States Food and Drug Administration (FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Adderall XR(R) 30mg Capsules. |
All press releases naming this drug 38 releases
Evidence & citations 76 cited values
Every value below carries the sentence it was read from. 472 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Methylphenidate | “Objective: To determine the safety and efficacy of PRC-063, a once-daily, multilayer, extended-release (ER) formulation of methylphenidate (MPH) hydrochloride, in the treatment...” PMID 33090921 ↗ Oct 2020383“Stimulant medications such as osmotic-release oral system methylphenidate (OROS-MPH) are first-line treatments in the general population, but they are under-prescribed in...” PMID 38178233 ↗ Jan 2024 “OBJECTIVE: This phase 3, laboratory classroom study assessed the efficacy and safety of methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) compared with...” PMID 28557548 ↗ May 2017 “A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy...” NCT02020200 ↗ “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ “OBJECTIVE: A preliminary study to examine the efficacy of osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) symptoms and...” PMID 19192455 ↗ Dec 2008 “Spheroidal Oral Drug Absorption System methylphenidate (SODAS-MPH) was administered twice daily, was titrated to ~1 mg/kg/d over 3 weeks, and was continued for 3 additional...” PMID 29617066 ↗ Mar 2018 “In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of...” NCT01962181 ↗ “Osmotic Release Oral System Methylphenidate Versus Atomoxetine for the Treatment of Attention-Deficit/Hyperactivity Disorder in Chinese Youth: 8-Week Comparative Efficacy and...” PMID 26779845 ↗ Jan 2016 “Students will receive either a long-acting methylphenidate preparation or a long-acting mixed amphetamine salts preparation based on parent consultation with the study physician.” NCT03511976 ↗ “NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study.” PMID 23289899 ↗ Jan 2013 |
| Known as | 298-59-9 | “Once-daily pharmacotherapy with methylphenidate (prolonged-release tablet, 298-59-9, SUB03254MIG), administered orally” NCT05957055 ↗ |
| Known as | Adhansia XR | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗2“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “long-acting methylphenidate formulation PRC-063 (Adhansia XR® in the USA; Foquest® in Canada)” PMID 34057707 ↗ May 2021 |
| Known as | Aptensio | “Aptensio” NCT03420339 ↗ |
| Known as | Aptensio XR | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗4“The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children...” NCT02677519 ↗ “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “A multilayer extended-release bead methylphenidate capsule (provisional name Aptensio XR™, MPH-MLR) with unique release properties is being investigated for the treatment of ADHD.” PMID 25877989 ↗ Apr 2015 |
| Known as | Azstarys | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Concerta | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗38“The purpose of this study is to evaluate the effects of the addition of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) or placebo in adult...” NCT00246233 ↗ “The purpose of this study is to determine the effectiveness and safety of OROS\*methylphenidate/CONCERTA\* vs. immediate release methylphenidate as a treatment for ADHD...” NCT00304681 ↗ “The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for...” NCT00249353 ↗ “The Formal Observation of Concerta versUs Strattera (FOCUS) study was conducted to assess, in children with ADHD, treatment outcomes with Concerta [OROS methylphenidate (MPH)],...” PMID 16350601 ↗ Oct 2005 “OBJECTIVE: To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the...” PMID 19440077 ↗ Jun 2009 “An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per...” NCT00326300 ↗ “A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915 ↗ “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “This approach produced a new product (OROS-methylphenidate or Concerta), which proved to have the predicted rapid onset (with 1-2 hours) and long duration of efficacy (10-12...” PMID 12578439 ↗ Feb 2003 “CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when...” NCT00799409 ↗ |
| Known as | Concerta-TM | “A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children...” NCT00485550 ↗ |
| Known as | CONCERTAÒ | “OROS MPH (CONCERTAÒ 90mg)” NCT00302354 ↗ |
| Known as | Cotempla XR-ODT | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | DAYTRANA | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗6“A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915 ↗ “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With...” NCT00434213 ↗ “Daytrana” NCT03420339 ↗ |
| Known as | DR/ER-MPH | “Delayed-release/extended-release methylphenidate (DR/ER-MPH) (formerly HLD200) is an evening-dosed agent used for the treatment of attention-deficit/hyperactivity disorder.” PMID 37770309 ↗ Sep 2023 |
| Known as | Extended Release Methylphenidate | “Extended Release Methylphenidate (OROS-Methylphenidate)” NCT00323947 ↗ |
| Known as | Extended-Release Methylphenidate Hydrochloride | “A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride Augmented With Either Extended-Release Methylphenidate Hydrochloride (Concerta-TM) or Placebo in Children...” NCT00485550 ↗ |
| Known as | Focalin | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Focalin XR | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Foquest | “The drug being evaluated in this study is controlled release methylphenidate HCl control (Foquest®).” NCT04741516 ↗1“long-acting methylphenidate formulation PRC-063 (Adhansia XR® in the USA; Foquest® in Canada)” PMID 34057707 ↗ May 2021 |
| Known as | HLD200 | “This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.” NCT01907360 ↗2“The investigational drug for this study is HLD200 MPH MR capsules comprised of the active pharmaceutical ingredient (MPH) in a dual-coated drug-layered core.” NCT02493777 ↗ “HLD200 methylphenidate hydrochloride capsules” NCT06431256 ↗ |
| Known as | Immediate-release Methylphenidate | “This study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD)...” NCT00758160 ↗2“A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults” NCT00302458 ↗ “a short immediate release-methylphenidate hydrochloride (IR-MPH)” NCT00302393 ↗ |
| Known as | IR-MPH | “Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to improve driving performance in adolescents with ADHD.” NCT00572026 ↗1“a short immediate release-methylphenidate hydrochloride (IR-MPH)” NCT00302393 ↗ |
| Known as | Jornay PM | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗2“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “methylphenidate hydrochloride (Jornay PM)” NCT07594652 ↗ |
| Known as | Metadate | “This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological...” NCT03519022 ↗1“Metadate” NCT03420339 ↗ |
| Known as | Metadate CD | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Methilphenidate | “Methilphenidate” NCT05551689 ↗ |
| Known as | Methylin | “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Methylin (liquid) | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗ |
| Known as | methylphenidate HCL | “The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with...” NCT00326391 ↗19“The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity...” NCT00326300 ↗ “CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when...” NCT00799409 ↗ “OROS methylphenidate HCL (MPH) is a recently developed long-acting stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD).” PMID 14595084 ↗ Nov 2003 “Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.” NCT01074294 ↗ “Part I of this study will evaluate the safety and effectiveness of OROS® (methylphenidate HCl) for a period of one year in children with ADHD.” NCT00269815 ↗ “OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days” NCT00880217 ↗ “The drug being evaluated in this study is controlled release methylphenidate HCl control (Foquest®).” NCT04741516 ↗ “CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.” NCT00901576 ↗ “Ritalin (methylphenidate HCl); Ritalin LA, Ritalin SR Strattera (atomoxetine HCl)” NCT05635318 ↗ “CONCERTA (methylphenidate HCl) or placebo” NCT00799487 ↗ |
| Known as | Methylphenidate Hydrochloride | “The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data...” NCT02536105 ↗30“The purpose of this study is to evaluate the effects of the addition of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) or placebo in adult...” NCT00246233 ↗ “This is a prospective, open-label, within-subject (pre-post), investigator-initiated Phase IV trial evaluating the safety and efficacy of Foquest (multilayer-release...” NCT07710014 ↗ “The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for...” NCT00249353 ↗ “OBJECTIVE: This phase 3, laboratory classroom study assessed the efficacy and safety of methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) compared with...” PMID 28557548 ↗ May 2017 “A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With...” NCT02470234 ↗ “OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 kilogram (kg) and 27 mg for those...” NCT01012622 ↗ “Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks.” NCT02194075 ↗ “The active agents is racemic methylphenidate hydrochloride, modified release, a mild central nervous system stimulant (pharmacotherapeutic group: psychostimulants).” NCT01879202 ↗ “This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.” NCT01907360 ↗ “pms-METHYLPHENIDATE (methylphenidate hydrochloride) is a racemate consisting of a 1:1 mixture of d-methylphenidate (d-MPH) and l-methylphenidate (l-MPH).” NCT02754258 ↗ |
| Known as | Methylphenidate Hydrochloride (Hcl) | “A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release...” NCT03580005 ↗1“The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill...” NCT01060150 ↗ |
| Known as | methylphenidate hydrochloride- extended release | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗ |
| Known as | methylphenidate hydrochloride- immediate release | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗ |
| Known as | Methylphenidate Oral Tablet | “Drug: Methylphenidate Oral Tablet” NCT03411434 ↗ |
| Known as | Methylphenidate Transdermal System | “A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915 ↗4“This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD.” PMID 16481664 ↗ Feb 2006 “methylphenidate transdermal system patch plus placebo capsule” PMID 18312050 ↗ Jan 2008 “Drug: Methylphenidate Transdermal System” NCT00151970 ↗ “Drug: Methylphenidate Transdermal System” NCT00541346 ↗ |
| Known as | Methylphenidate Transdermal System (MTS) | “This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD.” NCT00506285 ↗ |
| Known as | MPD | “repeated dosing with methylphenidate hydrochloride (MPD) (Ritalin; Novartis Pharmaceuticals, East Hanover, NJ), an inhibitor of the dopamine transporter” PMID 17353373 ↗ Mar 20072“This study was conducted to evaluate the cardiovascular risk of prescribing up to 90 mg of methylphenidate (MPD) daily for treating cocaine dependence.” NCT00015067 ↗ “Methylphenidate (MPD)” NCT00526630 ↗ |
| Known as | MPH | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗65“Objective: To determine the safety and efficacy of PRC-063, a once-daily, multilayer, extended-release (ER) formulation of methylphenidate (MPH) hydrochloride, in the treatment...” PMID 33090921 ↗ Oct 2020 “We, the researchers at Hospices Civils de Lyon, designed a randomized, double blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to evaluate...” NCT00169611 ↗ “The safety and efficacy of methylphenidate (MPH) in 60 children and adolescents with PDD and behavioral difficulties (such as hyperactivity, impulsiveness and distractibility)...” NCT00025779 ↗ “three modified-release formulations of methylphenidate (MPH) marketed in Canada, two of which meet the criteria for assuming bioequivalence as defined by Health Canada: MPH...” PMID 22512898 ↗ Apr 2012 “This study will evaluate the effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as Ritalin ) when combined (or not combined) with the...” NCT00794040 ↗ “A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy...” NCT02020200 ↗ “The purpose of this study was to investigate the interaction effects between dopamine receptor D4 (DRD4) methylation and prenatal maternal stress on the methylphenidate (MPH)...” PMID 29905488 ↗ Jun 2018 “To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in...” PMID 21488750 ↗ Apr 2011 “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “This study aimed to assess the efficacy and tolerability of methylphenidate (MPH) treatment in children and adolescents who met the Diagnostic and Statistical Manual of Mental...” PMID 21586916 ↗ May 2011 |
| Known as | MPH ERCT | “OBJECTIVE: This phase 3, laboratory classroom study assessed the efficacy and safety of methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) compared with...” PMID 28557548 ↗ May 2017 |
| Known as | MPH-ER | “This treatment trial is aimed at assessing the short-term tolerability and efficacy of liquid-formulation extended-release methylphenidate (MPH-ER) for the treatment of...” PMID 31607204 ↗ Dec 2019 |
| Known as | Mph-IR | “generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®)” NCT01377662 ↗1“10 mg methylphenidate immediate release (Mph-IR)” NCT01290276 ↗ |
| Known as | MPH-LA | “methylphenidate modified-release long-acting formulation (MPH-LA) at 40-80 mg/day controlled ADHD symptoms as well as decreased functional impairment with a good tolerability...” PMID 25183661 ↗ Oct 2014 |
| Known as | MPH-MLR | “A multilayer extended-release bead methylphenidate capsule (provisional name Aptensio XR™, MPH-MLR) with unique release properties is being investigated for the treatment of ADHD.” PMID 25877989 ↗ Apr 2015 |
| Known as | MTP | “In recent years, studies using methylphenidate (MTP) in the treatment of CRF in solid cancer have been conducted” NCT03218254 ↗ |
| Known as | MTS | “This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD.” PMID 16481664 ↗ Feb 20062“methylphenidate transdermal delivery system (MTS)” PMID 25575616 ↗ Jan 2015 “the methylphenidate transdermal system (MTS)” PMID 20973707 ↗ Oct 2010 |
| Known as | NWP06 | “NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study.” PMID 23289899 ↗ Jan 2013 |
| Known as | ORADUR-methylphenidate | “ORADUR®-methylphenidate is a new extended-release preparation of methylphenidate.” PMID 36251766 ↗ Oct 2022 |
| Known as | OROS Methylphenidate | “Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of...” NCT01060150 ↗20“OBJECTIVE: To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the...” PMID 19440077 ↗ Jun 2009 “To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in...” PMID 21488750 ↗ Apr 2011 “OBJECTIVE: To evaluate the efficacy, safety, and tolerability of adjunctive osmotic-release oral system (OROS) methylphenidate in outpatients with major depressive disorder...” PMID 18312042 ↗ Jan 2008 “OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and...” PMID 16456216 ↗ Jan 2006 “The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure...” NCT00307684 ↗ “OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 kilogram (kg) and 27 mg for those...” NCT01012622 ↗ “This community-based study was designed to evaluate treatment outcomes with OROS methylphenidate (MPH) and atomoxetine in children with attentiondeficit/hyperactivity disorder (ADHD)” PMID 16418159 ↗ Sep 2005 “This multicenter, open-label, dose-titration, flexible dose study enrolled adults with ADHD for 6 or 12 months of treatment with OROS methylphenidate.” PMID 21192153 ↗ Feb 2011 “OROS methylphenidate HCL (MPH) is a recently developed long-acting stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD).” PMID 14595084 ↗ Nov 2003 “Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks.” NCT00758160 ↗ |
| Known as | OROS Methylphenidate HCl | “Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of...” NCT01060150 ↗3“The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal,...” NCT00516269 ↗ “A Comparative Effectiveness Study Evaluating OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder...” NCT00269789 ↗ “OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days” NCT00880217 ↗ |
| Known as | OROS methylphenidate hydrochloride | “Participants were randomly assigned equally to one of six treatment groups: placebo, bavisant 1 mg/day, 3 mg/day or 10 mg/day, atomoxetine hydrochloride 80 mg/day or...” PMID 22519922 ↗ May 20124“OBJECTIVE: To evaluate the efficacy and safety of individualized dosing within the approved dose range for osmotic-release oral system (OROS) methylphenidate hydrochloride in...” PMID 27487193 ↗ Jan 2017 “OROS methylphenidate hydrochloride (CONCERTA)” NCT00302406 ↗ “CONCERTA (OROS methylphenidate hydrochloride)” NCT00246207 ↗ “OROS methylphenidate hydrochloride” NCT00302393 ↗ |
| Known as | OROS methylphenidate hydrochloride (HCL) | “OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 kilogram (kg) and 27 mg for those...” NCT01012622 ↗ |
| Known as | OROS-MPH | “three modified-release formulations of methylphenidate (MPH) marketed in Canada, two of which meet the criteria for assuming bioequivalence as defined by Health Canada: MPH...” PMID 22512898 ↗ Apr 201219“Osmotic release oral system-methylphenidate (OROS-MPH) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial...” PMID 21798108 ↗ Jul 2011 “This pilot, uncontrolled, open-label study evaluated the safety/tolerability and potential effectiveness of OROS-methylphenidate (OROS-MPH) in adult attention deficit...” PMID 17166338 ↗ Dec 2006 “The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.” NCT00264797 ↗ “a USA study compared different doses of the stimulant drug osmotic-release oral system methylphenidate (OROS-MPH) with a placebo in 33 children” PMID 35844168 ↗ Jul 2022 “A new once-a-day methylphenidate (MPH) formulation, Concerta (methylphenidate HCl) extended-release tablets (OROS MPH), has been developed.” PMID 11581440 ↗ Oct 2001 “or osmotic-release oral system methylphenidate (OROS MPH) (18-54 mg/day based on body weight) arms in a 1:1:1:1:1 ratio” PMID 24840045 ↗ May 2014 “OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH.” NCT00758160 ↗ “Participants will receive OROS-MPH (Concerta® available in Switzerland as first-line treatment for ADHD).” NCT05842330 ↗ “Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference arm.” PMID 23332456 ↗ Jan 2013 “Concerta (Osmotic Release Oral System Extended Release Methylphenidate HCL, OROS MPH)” NCT01065259 ↗ |
| Known as | Osmotic Release Methylphenidate | “Open-Label Concerta (Osmotic Release Methylphenidate)” NCT01063153 ↗ |
| Known as | Osmotic Release Oral Delivery System (OROS) methylphenidate | “Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks.” NCT00758160 ↗ |
| Known as | osmotic release oral system-methylphenidate | “or osmotic-release oral system methylphenidate (OROS MPH) (18-54 mg/day based on body weight) arms in a 1:1:1:1:1 ratio” PMID 24840045 ↗ May 20141“treated with osmotic release oral system-methylphenidate (OROS-MPH) for 12 wk” PMID 21733227 ↗ Jun 2011 |
| Known as | osmotic-release oral system (OROS) methylphenidate hydrochloride | “Participants were randomly assigned equally to one of six treatment groups: placebo, bavisant 1 mg/day, 3 mg/day or 10 mg/day, atomoxetine hydrochloride 80 mg/day or...” PMID 22519922 ↗ May 2012 |
| Known as | Osmotic-release oral system methylphenidate (OROS MPH) | “Osmotic-release oral system methylphenidate (OROS MPH)” NCT00889915 ↗ |
| Known as | PR OROS Methylphenidate | “PR OROS Methylphenidate given orally once daily for 5 weeks.” NCT00482313 ↗ |
| Known as | PRC-063 | “Objective: To determine the safety and efficacy of PRC-063, a once-daily, multilayer, extended-release (ER) formulation of methylphenidate (MPH) hydrochloride, in the treatment...” PMID 33090921 ↗ Oct 20206“long-acting methylphenidate formulation PRC-063 (Adhansia XR® in the USA; Foquest® in Canada)” PMID 34057707 ↗ May 2021 “long-acting methylphenidate formulation PRC-063” PMID 34637343 ↗ Oct 2021 |
| Known as | Quillichew ER | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | Quillivant | “Quillivant” NCT03420339 ↗ |
| Known as | Quillivant XR | “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗2“XRMPH in oral suspension supplied as Quillivant XR in 5 mg/ml (Tris Pharma, Monmouth Junction, NJ) will be the active treatment.” NCT05301361 ↗ “Participants in the first Arm will complete a 3-week titration of Methylphenidate HCl (Quillivant XR, 25mg/5mL).” NCT07650643 ↗ |
| Known as | Quillivant XR (liquid) | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗ |
| Known as | Relexxii | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗ |
| Known as | Ritalin | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗39“The purpose of this study is to determine if methylphenidate (a common brand name is Ritalin), a medicine used for treating older children with Attention Deficit and...” NCT00517504 ↗ “This study will evaluate the effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as Ritalin ) when combined (or not combined) with the...” NCT00794040 ↗ “Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ “The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin,...” NCT07306078 ↗ “A Comparative Effectiveness Study Evaluating OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder...” NCT00269789 ↗ “A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder” NCT00269802 ↗ “The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).” NCT00018863 ↗ “Methylphenidate drugs, such as Ritalin or Concerta, have been shown on tests to improve the ability to rapidly absorb information; these tests are called "reaction time tests".” NCT01599975 ↗ “Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD).” NCT00025779 ↗ “The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects” NCT01914822 ↗ |
| Known as | Ritalin (methylphenidate hydrochloride) | “Ritalin (methylphenidate hydrochloride)” NCT01290276 ↗ |
| Known as | Ritalin LA | “Methylphenidate (MPH) medication brand names include: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD,...” NCT07300956 ↗1“Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid),...” NCT05916339 ↗ |
| Known as | RITALIN LAÒ | “SODOS-MPH (RITALIN LAÒ)” NCT00302354 ↗ |
| Known as | Ritaline LP 10 | “Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks” NCT03280251 ↗ |
| Known as | RT2CK17 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03388164 ↗ |
| Known as | SODOS-MPH | “SODOS-MPH (RITALIN LAÒ)” NCT00302354 ↗ |
| Known as | SUB03254MIG | “Once-daily pharmacotherapy with methylphenidate (prolonged-release tablet, 298-59-9, SUB03254MIG), administered orally” NCT05957055 ↗ |
| Known as | t-MPH | “The specific primary aim of this open label study is to determine if use of transdermal Methylphenidate (t-MPH) causes a reduction in fall risk in patients with dementia.” NCT01825577 ↗ |
| Known as | XRMPH | “This study is a randomized, double-blind, placebo-controlled, crossover trial of extended-release liquid methylphenidate (XRMPH) to evaluate the sensitivity of the NIH Toolbox...” NCT05301361 ↗ |
| Action | Inhibit | “an inhibitor of the dopamine transporter” PMID 17353373 ↗ Mar 2007 |
| Modality | Small molecule | “the amphetamine, methylphenidate” PMID 29347996 ↗ Jan 2018 |
| Route | Oral | “Patients receive oral methylphenidate twice daily.” NCT00003266 ↗ |
| Target | ABCB1 | “It suggested that methylphenidate was a P-glycoprotein(encoded by MDR1 gene)substrate and showed inhibitory effects on the P-glycoprotein efflux function. Single nucleotide...” NCT00842127 ↗ |