Adhansia Xr

(Methylphenidate Hydrochloride)

ApprovedSmall molecule

Adhansia Xr is a small molecule that works as a Dopamine Transporter Inhibitor; Norepinephrine Transporter Inhibitor.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

Adhansia Xr is one of 81 small molecule programs targeting 22q11.2 deletion syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

22q11.2 Deletion SyndromeActive, not recruiting

Alzheimer DiseaseUnknown

Huntington DiseaseUnknown

Attention Deficit Disorder With HyperactivityRecruiting

Kbg SyndromeRecruiting

Sleep DisturbanceActive, not recruiting

Executive FunctionRecruiting

Anxiety DisorderCompleted

22q11.2 Deletion SyndromePreclinical

Active, not recruiting

Alzheimer DiseasePreclinical

Unknown

Huntington DiseasePreclinical

Unknown

Attention Deficit Disorder With HyperactivityApproved

Recruiting

Kbg SyndromeApproved

Recruiting

Sleep DisturbancePhase 2

Active, not recruiting

Executive FunctionApproved

Recruiting

Anxiety DisorderApproved

Completed

Competition

Competitive Landscape

100 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Adhansia Xr

Novartis

Approved

38 2

Dayvigo

Eisai

Approved

1 3

Lexapro

Calciferol

Azilect

Neupro

Evista

Niacor

Celebrex

PPhiladelphia Eye Associates

Approved

1 10

Kisunla

Eli Lilly

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

ApprovedRecruiting

Kbg Syndrome

NCT06465641

Phase 2Active, not recruiting

Sleep Disturbance

NCT01628029

Q4 2030

ApprovedRecruiting

Attention Deficit Disorder With Hyperactivity

NCT07594652

Clinical

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder7 trials

Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14

Completed· Novartis logo

Novartis·Phase 3·NCT00254878·130 enrolled

A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 3·NCT00326391·229 enrolled

A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 3·NCT00326300·560 enrolled

Show 4 more trials

An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 3·NCT00249353·220 enrolled

Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Completed·MMedice Arzneimittel Pütter GmbH & Co KG·Phase 3·NCT00730249·150 enrolled

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Completed· Takeda logo

Takeda·Phase 4·NCT01552902·549 enrolled

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Completed· Takeda logo

Takeda·Phase 4·NCT01552915·464 enrolled

Adult2 trials

A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults

Completed·MMassachusetts General Hospital·Phase 3·NCT00301639·40 enrolled

Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults

Completed·MMassachusetts General Hospital·Phase 3·NCT00302393·20 enrolled

Safety and Efficacy2 trials

Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

Completed· Takeda logo

Takeda·Phase 3·NCT00763971·336 enrolled

A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

Withdrawn· Pfizer logo

Pfizer·Phase 4·NCT03536390

Fatigue2 trials

Methylphenidate Treatment of Cancer-Related Fatigue

Completed·MMedice Arzneimittel Pütter GmbH & Co KG·Phase 2/3·NCT00758407·66 enrolled

Methylphenidate in Treating Patients With Fatigue Caused by Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00376675·148 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

Completed·RRhodes Pharmaceuticals, L.P.·Phase 3·NCT01239030·230 enrolled

Real World Evidence of the Efficacy and Safety of FOQUEST

Completed·PPurdue Pharma, Canada·Phase 4·NCT04152629·257 enrolled

22 more indications

Children2 trials

Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

Completed·RRhodes Pharmaceuticals, L.P.·Phase 3·NCT01269463·26 enrolled

Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00485550·14 enrolled

Prostate Cancer1 trial

Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

Terminated·UUniversity Health Network, Toronto·Phase 2·NCT00593853·33 enrolled

Attention Deficit Hyperactivity Disorder (ADHD)1 trial

A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01624649·289 enrolled

Sleep Disturbance1 trial

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01628029·68 enrolled

Pediatric1 trial

Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00486083·330 enrolled

Childhood Apraxia of Speech1 trial

Methylphenidate in Childhood Apraxia of Speech

Completed·MMurdoch Childrens Research Institute·Phase 2·NCT05185583·18 enrolled

Excessive Daytime Sleepiness1 trial

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

Terminated·UUniversity of South Florida·Phase 2·NCT01348607·1 enrolled

Anxiety Disorder1 trial

A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity

Completed·MMcMaster University·Phase 4·NCT03785223·60 enrolled

Trauma1 trial

Cognitive REmediation After Trauma Exposure Trial = CREATE Trial

Terminated·IINTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium·Phase 2·NCT01416948·32 enrolled

Executive Function1 trial

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening

Recruiting·NNYU Langone Health·Phase 4·NCT06577779·30 enrolled

SPD1 trial

SPD544 High Strength Bioequivalence Study

Completed· Takeda logo

Takeda·Phase 1·NCT01183234·28 enrolled

Radiation Therapy1 trial

Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

Terminated·WWake Forest University Health Sciences·Phase 3·NCT00031798

Double-blind1 trial

Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD

Completed·MMedice Arzneimittel Pütter GmbH & Co KG·Phase 3·NCT00619840·363 enrolled

Effectiveness1 trial

A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00246220·402 enrolled

Adult Subject1 trial

Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate

Completed·MMassachusetts General Hospital·Phase 4·NCT00302406·50 enrolled

Pain1 trial

The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects

Completed·RRambam Health Care Campus·Phase 2·NCT01914822·41 enrolled

Alcohol1 trial

FASST - Fetal Alcohol Spectrum Stimulant Trial

Unknown status·MMonash Medical Centre·Phase 4·NCT04968522·20 enrolled

Melanoma1 trial

Methylphenidate in Treating Patients With Melanoma

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003266·200 enrolled

Oral1 trial

Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder

Withdrawn·NNational Institute of Mental Health (NIMH)·Phase 1/2·NCT02247986

Kbg Syndrome1 trial

Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series

Recruiting·RRadboud University Medical Center·Approved·NCT06465641·15 enrolled

Attention Deficit Disorder With Hyperactivity1 trial

Use of JornayPM® to Treat ADHD in Pediatric Epilepsy

Recruiting·HHugo W. Moser Research Institute at Kennedy Krieger, Inc.·Approved·NCT07594652·25 enrolled

Unspecified1 trial

An Open Label Phase I/II Study of Dopamine Transporter Receptor Occupancy With OROS and Immediate Release Methylphenidate as Measured With C-11 Altropane in Human Subjects

Completed·MMassachusetts General Hospital·Phase 4·NCT00302367·20 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

RITALIN

NDA NDA010187

Mar 30, 1982

RITALIN-SR

NDA NDA018029

Aug 1, 2000

CONCERTA

NDA NDA021121

Dec 19, 2002

METHYLIN

NDA NDA021419

Apr 15, 2003

METHYLIN

NDA NDA021475

May 27, 2003

METADATE CD

NDA NDA021259

Apr 10, 2004

RITALIN LA

NDA NDA021284

Apr 6, 2006

DAYTRANA

NDA NDA021514

Sep 27, 2012

QUILLIVANT XR

NDA NDA202100

Apr 17, 2015

APTENSIO XR

NDA NDA205831

Dec 4, 2015

QUILLICHEW ER

NDA NDA207960

Jun 19, 2017

COTEMPLA XR-ODT

NDA NDA205489

Aug 8, 2018

JORNAY PM

NDA NDA209311

Feb 27, 2019

ADHANSIA XR

NDA NDA212038

Jun 23, 2022

RELEXXII

NDA NDA216117

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Methylphenidate Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Methylphenidate Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Methylphenidate Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216117). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine Transporter Inhibitor; Norepinephrine Transporter Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Adhansia Xr

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q4 2030

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder7 trials

Adult2 trials

Safety and Efficacy2 trials

Fatigue2 trials

Efficacy and Safety2 trials

Children2 trials

Prostate Cancer1 trial

Attention Deficit Hyperactivity Disorder (ADHD)1 trial

Sleep Disturbance1 trial

Pediatric1 trial

Childhood Apraxia of Speech1 trial

Excessive Daytime Sleepiness1 trial

Anxiety Disorder1 trial

Trauma1 trial

Executive Function1 trial

SPD1 trial

Radiation Therapy1 trial

Double-blind1 trial

Effectiveness1 trial

Adult Subject1 trial

Pain1 trial

Alcohol1 trial

Melanoma1 trial

Oral1 trial

Kbg Syndrome1 trial

Attention Deficit Disorder With Hyperactivity1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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