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methylphenidate

Generic: METHYLPHENIDATE HYDROCHLORIDE·Brand: ADHANSIA XR, APTENSIO XR, Aptensio, CONCERTA, COTEMPLA XR-ODT, Concerta, Cotempla, DAYTRANA, Daytrana, JORNAY PM, Jornay, METADATE CD, METADATE ER, METHYLIN, METHYLIN ER, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, Metadate, Methylin, QUILLICHEW ER, QUILLIVANT XR, QuilliChew, Quillivant, RELEXXII, RITALIN, RITALIN LA, RITALIN-SR, Relexxii, Ritalin

methylphenidate: sourced relationships with 3 companies · 10 clinical trials tracked · 3 FDA decisions.

methylphenidate evidence translation

What we can confirm

3 FDA records · 10 tracked trials

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about methylphenidate, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence6 indications · 0 study sponsors

Related indications

treatment of attention deficit hyperactivity disorder (ADHD)Treatment of ADHD in patients 6 to 17 years oldADHDDown SyndromeNicotine DependenceProstate Cancer

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (3)
CompanyDated record stage
AYTU BIOPHARMA, INC (AYTU)
owner · Reported 2024-09-26 · Current development: unknownSource
treatment of attention deficit hyperactivity disorder (ADHD)
Approved
Neos Therapeutics, Inc. (NEOS)
developer · Reported 2020-03-13 · Current development: unknownSource
Treatment of ADHD in patients 6 to 17 years old
Approved
DR REDDYS LABORATORIES LTD (RDY)
Reported 2011-12-01 · Current development: unknownSource
Approved
Clinical Trial Registry Records (10)

A Multimodal Imaging Study of Dopamine in Early Psychosis

NCT06977308Registry updated 2026-04-08·Phase 1
Not yet recruiting

Primary endpoint: Dopamine transmission

Interventionalopen115 targetStarted 2026-06Completion 2030-10New York State Psychiatric Institute

Use of JornayPM® to Treat ADHD in Pediatric Epilepsy

NCT07594652Registry updated 2026-07-29·Phase 4
Recruiting

Primary endpoint: Clinical Global Impression-Improvement

Interventionalopen25 targetStarted 2026-05Completion 2030-121 site · United StatesHugo W. Moser Research Institute at Kennedy Krieger, Inc.

A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults

NCT07314333Registry updated 2026-02-12·Phase 1
Recruiting

Primary endpoint: Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)

InterventionalRandomizedsingle42 targetStarted 2026-02Completion 2026-031 site · United StatesOtsuka Pharmaceutical Development & Commercialization, Inc.

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain (EASE Pain) Trial: A Randomized Controlled Pilot Trial

NCT07301632Registry updated 2026-02-13·Phase 2
Recruiting

Primary endpoint: The primary outcome of this pilot trial is to determine feasibility of a large-scale, multi-center trial.

InterventionalRandomizedtriple40 targetStarted 2026-01Completion 2028-121 site · CanadaUnity Health Toronto

Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints

NCT05776056Registry updated 2026-08-19·Phase 4
Recruiting

Primary endpoint: PTSD Symptom Checklist for DSM-5 (PCL-5)

InterventionalRandomizedquadruple70 targetStarted 2024-02Completion 2027-093 sites · United StatesVA Office of Research and Development

Orexin's Role in The Neurobiology of Substance Use Disorder

NCT05630781Registry updated 2026-02-19·N/A
Recruiting

Primary endpoint: fMRI - cue reactivity

InterventionalRandomizeddouble140 targetStarted 2023-02Completion 2027-121 site · United StatesNational Institute on Drug Abuse (NIDA)

Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome

NCT04219280Registry updated 2026-08-10·Phase 4
Active, not recruiting

Primary endpoint: Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]

InterventionalRandomizedtriple100 targetStarted 2020-10Completion 2026-084 sites · United StatesChildren's Hospital Medical Center, Cincinnati

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

NCT03511118Registry updated 2026-02-11·N/A
Recruiting

Primary endpoint: M/P ratio

Observational1,600 targetStarted 2018-10Completion 2027-0722 sites · Canada, United StatesDuke University

Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer

NCT01628029Registry updated 2026-05-22·Phase 2
Active, not recruiting

Primary endpoint: Pittsburgh Sleep Quality Index (PSQI) Score Change

InterventionalRandomizeddouble68 targetStarted 2014-01Completion 2028-121 site · United StatesM.D. Anderson Cancer Center

Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy

NCT01410942Registry updated 2026-02-20·Phase 2
Active, not recruiting

Primary endpoint: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores

InterventionalRandomizeddouble175 targetStarted 2012-02Completion 2026-091 site · United StatesM.D. Anderson Cancer Center
FDA Decisions3 records
Approval(RDY)FDA ↗
ANDA200886Not ApplicableOralCapsule, Extended Release
NDA205489Type 3 - New Dosage FormStandardOralTablet, Orally Disintegrating, Extended Release
Approval(RDY)FDA ↗
ANDA078458OralCapsule, Extended Release

Frequently asked questions

Which companies have sourced relationships with methylphenidate?

methylphenidate has dated SEC/FDA relationship records for AYTU BIOPHARMA, INC, Neos Therapeutics, Inc., DR REDDYS LABORATORIES LTD.

How many clinical trials involve methylphenidate?

BioSniper tracks 10 clinical trials involving methylphenidate.

What is methylphenidate's latest FDA decision?

The most recent tracked FDA decision for methylphenidate is Approval, dated February 26, 2018.