Last update 18 Dec 2024

Methylphenidate Hydrochloride

Last update 18 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryMethylphenidate hydrochloride, a preeminent central nervous system (CNS) stimulant, which was initially sanctioned by the United States on the 5th of December, 1955, and skillfully engineered by the pharmacological powerhouse Novartis, is an efficacious medication that ameliorates the symptoms of narcolepsy, attention deficit disorder (ADD), and attention deficit disorder with hyperactivity (ADHD). The intricate mechanism by which this complex pharmacological agent operates is by augmenting the levels of neurotransmitters, specifically norepinephrine and dopamine, within the brain, which results in improved concentration, attentiveness, and a reduction in impulsive behavior. This pharmacological compound, which is also marketed under the brand names Ritalin and Concerta, is classified by its intricate chemical structure, namely methyl α-phenyl-2-piperidineacetate hydrochloride. Despite its status as a frequently prescribed medication for ADHD, the use of methylphenidate hydrochloride may produce a range of deleterious side effects such as appetite loss, insomnia, and anxiety, underscoring the imperative for the usage of this medication to be judiciously guided by the expertise of a healthcare professional.

Drug Type

Small molecule drug

Synonyms

D-MPH, Methyl phenidylacetate, methyl phenyl(piperidin-2-yl)acetate

+ [36]

Target

DAT

Mechanism

Dopamine reuptake inhibitors

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Attention Deficit Disorder With HyperactivityAttention Deficit DisorderNarcolepsy

Inactive Indication

Breast CancerCognitive DysfunctionDepressive Disorder, Major+ [2]

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Pharma AG

MEDICE Arzneimittel Pütter GmbH & Co. KG

Suzhou First Pharmaceutical Co., Ltd.

+ [16]

Inactive Organization

Novartis Pharmaceuticals Corp.

ALZA Corp.

Purdue Pharma LP

+ [6]

Drug Highest PhaseApproved

First Approval Date

US (05 Dec 1955),

Attention Deficit DisorderNarcolepsy

RegulationPriority Review (CN)

Structure

Molecular FormulaC14H20ClNO2

InChIKeyJUMYIBMBTDDLNG-UHFFFAOYSA-N

CAS Registry298-59-9

509

Clinical Trials associated with Methylphenidate Hydrochloride

CTIS2023-506202-40-01 / RecruitingIIT

Effectiveness of methylphenidate in children and adolescents with KBG syndrome: An N-of-1 series - 113883

Start Date13 Nov 2024

Sponsor / Collaborator-

NCT06580041 / Enrolling by invitationPhase 4IIT

Precision Care for Major Depressive Disorder

This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.

Start Date12 Nov 2024

Sponsor / Collaborator

The University of California, San Francisco

NCT06431256 / RecruitingPhase 3

Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and Pharmacokinetic Study of Evening Dosed Methylphenidate Hydrochloride Extended-Release Capsules (HLD200) in Children Aged 4 to 5 Years With ADHD

This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.

Start Date13 Sep 2024

Sponsor / Collaborator

Ironshore Pharmaceutical & Development, Inc.

[+1]

100 Clinical Results associated with Methylphenidate Hydrochloride

100 Translational Medicine associated with Methylphenidate Hydrochloride

100 Patents (Medical) associated with Methylphenidate Hydrochloride

8,496

Literatures (Medical) associated with Methylphenidate Hydrochloride

01 Jan 2025·NeuroImage-Clinical

Prediction of methylphenidate treatment response for ADHD using conventional and radiomics T1 and DTI features: Secondary analysis of a randomized clinical trial

Article

Author: Caan, Matthan W A ; van der Pal, Zarah ; Reneman, Liesbeth ; Kooij, Sandra J J ; Poirot, Maarten G ; Bottelier, Marco ; Chen, Mingshi ; Marquering, Henk A ; Schrantee, Anouk

BACKGROUND:

Attention-Deficit/Hyperactivity Disorder (ADHD) is commonly treated with methylphenidate (MPH). Although highly effective, MPH treatment still has a relatively high non-response rate of around 30%, highlighting the need for a better understanding of treatment response. Radiomics of T1-weighted images and Diffusion Tensor Imaging (DTI) combined with machine learning approaches could offer a novel method for assessing MPH treatment response.

PURPOSE:

To evaluate the accuracy of both conventional and radiomics approaches in predicting treatment response based on baseline T1 and DTI data in stimulant-naive ADHD participants.

METHODS:

We performed a secondary analysis of a randomized clinical trial (ePOD-MPH), involving 47 stimulant-naive ADHD participants (23 boys aged 11.4 ± 0.4 years, 24 men aged 28.1 ± 4.3 years) who underwent 16 weeks of treatment with MPH. Baseline T1-weighted and DTI MRI scans were acquired. Treatment response was assessed at 8 weeks (during treatment) and one week after cessation of 16-week treatment (post-treatment) using the Clinical Global Impressions - Improvement scale as our primary outcome. We compared prediction accuracy using a conventional model and a radiomics model. The conventional approach included the volume of bilateral caudate, putamen, pallidum, accumbens, and hippocampus, and for DTI the mean fractional anisotropy (FA) of the entire brain white matter, bilateral Anterior Thalamic Radiation (ATR), and the splenium of the corpus callosum, totaling 14 regional features. For the radiomics approach, 380 features (shape-based and first-order statistics) were extracted from these 14 regions. XGBoost models with nested cross-validation were used and constructed for the total cohort (n = 47), as well as children (n = 23) and adults (n = 24) separately. Exact binomial tests were employed to compare model performance.

RESULTS:

For the conventional model, balanced accuracy (bAcc) in predicting treatment response during treatment was 63 % for the total cohort, 32 % for children, and 36 % for adults (Area Under the Receiver Operating Characteristic Curve (AUC-ROC): 0.69, 0.33, 0.41 respectively). Radiomics models demonstrated bAcc's of 68 %, 64 %, and 64 % during treatment (AUC-ROCs of 0.73, 0.62, 0.69 respectively). These predictions were better than chance for both conventional and radiomics models in the total cohort (p = 0.04, p = 0.003 respectively). The radiomics models outperformed the conventional models during treatment in children only (p = 0.02). At post-treatment, performance was markedly reduced.

CONCLUSION:

While conventional and radiomics models performed equally well in predicting clinical improvement across children and adults during treatment, radiomics features offered enhanced structural information beyond conventional region-based volume and FA averages in children. Prediction of symptom improvement one week after treatment cessation was poor, potentially due to the transient effects of stimulant treatment on symptom improvement.

01 Jan 2025·WATER RESEARCH

Pharmaceuticals in urban streams: A review of their detection and effects in the ecosystem

Review

Author: João Feio, Maria ; Rodrigues, Fernanda ; Silva, Liliana J G ; Simões, Nuno E.C. ; Silva, Liliana J.G. ; Pereira, André M. P.T. ; Simões, Nuno E C ; Durães, Luisa ; Pereira, André M P T ; Pereira, André M.P.T.

The presence of pharmaceuticals in urban freshwater has been considered an emerging issue. Although rivers are better studied, the streams crossing the cities, which are prone to higher concentrations of pharmaceuticals, and with a higher potential to affect animals, plant and human health, were never specifically addressed in a review. Thus, here we performed a literature review on the existing pharmaceutical contamination and impacts of these compounds in the urban stream ecosystems. To structure the review, 10 questions were designed. From a total of 206 scientific publications, only 51 addressed the issue of pharmaceuticals in urban streams compared to 180 studies in the larger urban rivers. In 49 urban streams located in 13 countries and four continents, 139 pharmaceuticals from ten therapeutic groups were found. Anti-inflammatories and anticonvulsants were detected in the largest number of countries and urban streams, but the latter was more frequent in the streams. Metabolites were also detected, sometimes in higher concentrations than the original pharmaceutical but they were seldom analysed. The pharmaceuticals that caused more effects in the aquatic organisms were 17β-estradiol, estriol, estrone, acetaminophen, caffeine, carbamazepine, diltiazem, diphenhydramine, fluoxetine, norfluoxetine, sertraline, desmethylsertraline, methylphenidate and ciprofloxacin. The effects were varied, from bioaccumulation, endocrine disruption, impaired growth, reproduction inhibition, increased mortality and hatching disorder to morphological alterations, and decreased gross primary production and biomass. Streams had a higher mixture risk compared to the rivers. Important knowledge gaps detected are the low frequency of analysis of metabolites, the inefficient treatment of urban sewage regarding pharmaceuticals and the reduced number of studies on the impacts of pharmaceuticals at the aquatic community/population and functional level.

01 Dec 2024·EUROPEAN JOURNAL OF NEUROLOGY

Pharmacotherapy for behavioural manifestations in frontotemporal dementia: An expert consensus from the European Reference Network for Rare Neurological Diseases (ERN‐RND)

Article

Author: Vandenberghe, Rik ; Saracino, Dario ; Djamshidian, Atbin ; Capellari, Sabina ; Boban, Marina ; De Winter, François‐Laurent ; Rohrer, Jonathan ; Wittebrood, Casper ; Rodriguez, Eloy Rodriguez ; Cagnin, Annchiara ; González, Manuel Menéndez ; Levin, Johannes ; Reetz, Kathrin ; Graessner, Holm ; Rusina, Robert ; Krajcovicova, Lenka ; Reinhard, Carola ; Seelar, Harro ; Krüger, Johanna ; Van Langenhove, Tim ; Houot, Marion ; Hjermind, Lena E.

Abstract:

Background and Purpose:

Frontotemporal dementia (FTD) is a neurodegenerative disorder characterized by pervasive personality and behavioural disturbances with severe impact on patients and caregivers. In current clinical practice, treatment is based on nonpharmacological and pharmacological approaches. Unfortunately, trial‐based evidence supporting symptomatic pharmacological treatment for the behavioural disturbances in FTD is scarce despite the significant burden this poses on the patients and caregivers.

Method:

The study examined drug management decisions for several behavioural disturbances in patients with FTD by 21 experts across European expert centres affiliated with the European Reference Network for Rare Neurological Diseases (ERN‐RND).

Results:

The study revealed the highest consensus on drug treatments for physical and verbal aggression, impulsivity and obsessive delusions. Antipsychotics (primarily quetiapine) were recommended for behaviours posing safety risks to both patients and caregivers (aggression, self‐injury and self‐harm) and nightly unrest. Selective serotonin reuptake inhibitors were recommended for perseverative somatic complaints, rigidity of thought, hyperphagia, loss of empathy and for impulsivity. Trazodone was specifically recommended for motor unrest, mirtazapine for nightly unrest, and bupropion and methylphenidate for apathy. Additionally, bupropion was strongly advised against in 10 out of the 14 behavioural symptoms, emphasizing a clear recommendation against its use in the majority of cases.

Conclusions:

The survey data can provide expert guidance that is helpful for healthcare professionals involved in the treatment of behavioural symptoms. Additionally, they offer insights that may inform prioritization and design of therapeutic studies, particularly for existing drugs targeting behavioural disturbances in FTD.

138

News (Medical) associated with Methylphenidate Hydrochloride

20 Nov 2024

·www.pharmaceutical-technology.com

Tris Pharma receives ex-US approvals for ADHD treatments

An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD. Credit: MGARCIA_CREATIVE/Shutterstock. Tris Pharma has received additional ex-US approvals for its attention deficit hyperactivity disorder (ADHD) treatments, Quillivant XR and QuilliChew ER. The Saudi Food and Drug Authority approved Quillivant XR Suspension and Quillivant XR prolonged-release tablets, in October 2024, to treat patients aged six years and above. China’s National Medical Products Administration has also approved the usage of Quillivant XR as methylphenidate hydrochloride for sustained-release suspension and QuilliChew ER as methylphenidate hydrochloride extended-release chewable tablets to treat ADHD, and Israel’s Ministry of Health Pharmaceutical Division approved Quillivant XR in early 2024. The company is actively pursuing distribution partnerships to increase its accessibility in Israel. These developments follow Health Canada’s 2023 authorisation of the use of Quillivant ER and Quillivant ER for treating the condition in children between the ages of six and 12. Manufactured in the US, the therapies are currently available in several countries following approvals. Quillivant XR is known for its rapid onset of action, which can be as soon as 45 minutes, and allows for personalised dosing. The QuilliChew ER tablets offer flexibility with scored tablets suitable for paediatric patients. Both therapies leverage the company’s LiquiXR technology. An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD. Tris Pharma CEO and founder Ketan Mehta stated: “These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.”

Drug Approval

19 Nov 2024

·www.businesswire.com

Tris Pharma Secures Additional ex-US Approvals to Expand Global Availability of Quillivant XR and QuilliChew ER for the Treatment of Attention Deficit Hyperactivity Disorder

MONMOUTH JUNCTION, N.J.--( BUSINESS WIRE )--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced additional ex-US regulatory approvals of Quillivant ® XR (methylphenidate HCl extended-release oral suspension) and QuilliChew ® ER (methylphenidate HCl extended-release chewable tablets) for the treatment of ADHD. In October, the Saudi Food & Drug Authority (SFDA) approved these products as Quillivant XR Suspension and Quillivant XR Prolonged-Release Tablets for the treatment of ADHD in patients six years and above. Earlier this year, the National Medical Products Administration (NMPA) in China approved Quillivant XR as Methylphenidate Hydrochloride for Sustained-Release Suspension for the treatment of ADHD in patients six years and above; this follows last year’s NMPA approval of QuilliChew ER as Methylphenidate Hydrochloride Extended-Release Chewable Tablets for the treatment of ADHD in patients six years and above. Additionally, Quillivant XR received approval from the Pharmaceutical Division of the Ministry of Health in Israel for the treatment of ADHD earlier this year. Tris Pharma is actively seeking partnerships to facilitate the distribution and availability of Quillivant XR in Israel. The additional regulatory clearances expand the international availability of these medications beyond Canada, where last year Health Canada authorized the use of these products as Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets for the treatment of ADHD in children ages six to 12. These medications are manufactured in the United States and exported to countries where each has received regulatory approval. “These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs,” said Ketan Mehta, founder and CEO at Tris Pharma. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.” Quillivant XR has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant XR oral suspension allows for personalized dosing with ease of titration and the QuilliChew ER chewable tablets have scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR ® technology. ADHD diagnosis rates continue to rise globally, likely driven by increased awareness and better diagnostic practices. It is estimated that approximately 129 million children and adolescents aged 5-19 and more than 366 million adults worldwide have ADHD. 1-2 About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @ TrisPharma . References 1 General Prevalence of ADHD. Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). 2 Song P, Zha M, Yang Q, et al. The prevalence of adult attention-deficit hyperactivity disorder: A global systematic review and meta-analysis. Journal of Global Health. 2021;11:04009. IMPORTANT SAFETY INFORMATION WARNING: ABUSE, MISUSE, AND ADDICTION Quillivant XR, QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Quillivant XR and QuilliChew ER are contraindicated: in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported. during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with Quillivant XR and QuilliChew ER, assess for the presence of cardiac disease. Avoid Quillivant XR and QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR and QuilliChew ER. CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia. Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating Quillivant XR and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR, and QuilliChew ER. Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR and QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections. CNS stimulants including Quillivant XR and QuilliChew ER used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Quillivant XR and QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR and QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER. Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. Quillivant XR and QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary. CNS stimulants, including methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR and QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: Appetite decreased. Insomnia Nausea Vomiting Dyspepsia Abdominal pain Weight decreased Anxiety Dizziness Irritability Affect lability Tachycardia Blood pressure increased There is limited experience with Quillivant XR and QuilliChew ER in controlled trials. Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%). QuilliChew ER : The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6-12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%). There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch INDICATION Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Please see Full Prescribing Information for Quillivant XR and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

Drug ApprovalPhase 3Clinical Result

29 Oct 2024

·www.globenewswire.com

Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy

LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease. Previously, an exploratory microdose clinical trial in healthy volunteers demonstrated successful activation of PRX-P4-003 upon oral administration, the intended therapeutic route. “Apathy remains one of the most frequently observed symptoms in the Alzheimer’s Disease with no FDA-approved therapy,” stated Jeffrey Cummings, MD, ScD, director of the Chambers-Grundy Center for Transformative Neuroscience and Professor of Brain Sciences at the University of Nevada Las Vegas, “PRX-P4-003 has chemical properties and preliminary clinical validation that support its potential to build upon the pioneering studies in treating apathy led by the NIH-funded ADMET group.” PRX-P4-003, a selectively bioavailable dopamine and norepinephrine reuptake inhibitor, is a new chemical entity discovered by Praxis Bioresearch. The compound was designed to be activated by pancreatic lipase, an enzyme that is only present in the digestive system. “This is an important milestone for us,” said Sandeep Patil, MD PhD, CEO/Cofounder of Praxis Bioresearch, “I am particularly proud of our team in successfully delivering a high-quality IND package. In the next phase of development, we are deeply committed to demonstrating the effectiveness of our compound in improving the symptoms of apathy in the clinical trials." About PRX-P4-003 PRX-P4-003 is a new chemical entity developed by Praxis Bioresearch that delivers an active isomer of fencamfamine. Fencamfamine is a Schedule IV stimulant that was originally developed and marketed by E. Merck KG, located in Darmstadt, Germany. This prodrug, unlike current stimulants such as methylphenidate and amphetamines, is designed to only be orally active potentially decreasing the risk of abuse. There is a medical need for alternatives to current Schedule II stimulant medications in neuropsychiatric indications as diversion is a significant concern. About Apathy in Alzheimer’s Disease Apathy is the most prevalent neuropsychiatric symptom of Alzheimer’s dementia, affecting nearly 71% of patients over the course of the disease. Apathy has been associated with patient suffering, caregiver distress, and excess disability. There is no approved treatment for apathy in Alzheimer’s Disease. Disclaimer: Research reported in this publication was supported in part by the National Institute of Aging of the National Institutes of Health under Award Number R44AG066378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contact: info@praxisbioresearch.com

IND

100 Deals associated with Methylphenidate Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01296	Methylphenidate Hydrochloride	N06BA04	DB00422

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	CN	Suzhou First Pharmaceutical Co., Ltd.	01 Jan 1982
Attention Deficit Disorder	US	Sandoz, Inc.	05 Dec 1955
Narcolepsy	US	Sandoz, Inc.	05 Dec 1955

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fatigue	Phase 3	US	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Feb 2008
Solid tumor	Phase 3	US	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Feb 2008
Depressive Disorder, Major	Phase 3	-	Janssen, Inc.	01 Jun 2005
Breast Cancer	Phase 2	CA	Purdue Pharma LP	09 Oct 2017
Cognitive Dysfunction	Phase 2	CA	Purdue Pharma LP	09 Oct 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01351272 (BEAS, CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	41	Methylphenidate, non-retard	axvvedtqsm(ktgfjptuuu) = qihemqoumm luovpzjdul (akhvwkohck, niwioqdros - mpssgzlyoi) View more	-	15 Aug 2024
NCT03326245 (CTgov)	Phase 1	-	25	Oral Placebo+Intravenous methylphenidate (Arm B: Oral Placebo Followed by Intravenous Methylphenidate)	rnmxqmajnq(pewmwufrlt) = vvbgvszxur bbtthbpryc (atemytounj, wguzxrhyqx - mbxetcjtse) View more	-	28 May 2024
				Intravenous Placebo (Arm C: Oral Placebo Followed by Intravenous Placebo)	rnmxqmajnq(pewmwufrlt) = alkmekzyhn bbtthbpryc (atemytounj, beweswmpqd - jcsvuotiwu) View more
NCT02346201 (ADMET 2, Pubmed \| Int Psychogeriatr)	Phase 3	Dementia	167	Methylphenidate	qvhtlrhvsz(ebzcojheut) = Utility improved with methylphenidate treatment as there was a group by time interaction rbdqtcmoln (nlgxbozxdo )	Positive	01 Nov 2023
				Placebo
NCT02473185 (Pubmed \| BMC Psychiatry)	Phase 4	Attention Deficit Disorder With Hyperactivity	40	Methylphenidate 20 mg immediate release	fnuhcebtqc(bvyhranvzt) = vuwbdhktpf mxygkhmswl (dvtpxvsfmh )	Positive	17 Oct 2023
				Placebo	fnuhcebtqc(bvyhranvzt) = vrxighjtfu mxygkhmswl (dvtpxvsfmh )
NCT04987762 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	103	Adhansia XR	cdakvjgckq(qycdmgcxzk) = cbhkafdosw fxvolaupxu (txgcgjrdeo, wdygiwiyld - usewisfosn) View more	-	22 Aug 2023
NCT04507204 (RE-DAX, CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	267	Adhansia XR (Adhansia XR)	vrkywhjiff(mgfsnlcamd) = nlkcywcnbh buwbafvfbm (pqmulwsncv, ullzkhpimh - vrgmxwrben) View more	-	27 Jul 2023
				Concerta (Concerta)	drzuyvtlid(qdgdkdajqk) = kdyxdjaexh togcpazxfx (ibpalkkoru, ajcsfxkkzk - koxcukapvr) View more
NCT02346201 (ADMET2 \| ADMET 2, CTgov)	Phase 3	Alzheimer Disease \| nothing matters (symptom)	200	Methylphenidate (Methylphenidate)	byrbgqbsrv(aokzjbhldy) = mmpcgxiafu atbvyfnioa (eodmuhtiaz, cvennibnyc - zbflbamkwr) View more	-	13 Jun 2023
				Placebo (Placebo)	byrbgqbsrv(aokzjbhldy) = tzcsehyqco atbvyfnioa (eodmuhtiaz, jzzjxncrkr - teoxejjgzc) View more
NCT00424099 (CTgov)	Phase 2/3	Fatigue \| Advanced cancer	197	Methylphenidate (MP) (Methylphenidate (MP) + Nursing Telephone Intervention (NTI))	frqrxhcilx(xjwgvdrard) = gkekibfahd erqnpwxpcv (vkdztxqumv, pxnaxndiii - szdyaxkvmt) View more	-	01 Jun 2023
				Methylphenidate (MP) (Methylphenidate (MP) + Control Telephone Intervention (CTI))	frqrxhcilx(xjwgvdrard) = vtbrcevlce erqnpwxpcv (vkdztxqumv, csbgotyckh - uxiiafjfrh) View more
NCT02153944 (CTgov)	Phase 4	Anxiety Disorders	142	Methylphenidate (Behavioral: Drug Challenge With Methylphenidate)	lhqntjthws(fzenzgshxi) = ljbkzqykuh xmqbtlxzto (cxnbcavtqi, lizsemzbnu - ekmsmtxmpw) View more	-	11 Apr 2023
				Placebo (Behavioral: Drug Challenge With Placebo)	lhqntjthws(fzenzgshxi) = xdsujyfpwo xmqbtlxzto (cxnbcavtqi, oqowavehud - egviibkkjf) View more
Pubmed \| Cochrane Database Syst Rev	Not Applicable	Attention Deficit Disorder With Hyperactivity	-	Methylphenidate	jbbijijisy(jhcaymahri) = kzocbfhecv tfxxmuwldt (knayixrkur )	-	27 Mar 2023

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