Delving into the Latest Updates on Methylphenidate Hydrochloride with Synapse

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

+ [39]

Target

DAT

Action-

Mechanism

Dopamine reuptake inhibitors

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Attention Deficit Disorder With HyperactivityAttention Deficit DisorderNarcolepsy

Inactive Indication

Brain CancerBreast CancerCognitive Dysfunction+ [3]

Originator Organization

Novartis Pharma AG

Active Organization

Tris Pharma, Inc.

NextWave Pharmaceuticals, Inc.Neuraxpharm Pharmaceuticals S.L.

+ [15]

Inactive Organization

Novartis Pharmaceuticals Corp.Janssen-Cilag International NV

ALZA Corp.

+ [10]

License Organization

Ironshore Therapeutics, Inc.

Noven Pharmaceuticals, Inc.KYE Pharmaceuticals, Inc.

+ [8]

Drug Highest PhaseApproved

First Approval Date

United States (05 Dec 1955),

Attention Deficit DisorderNarcolepsy

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC14H20ClNO2

InChIKeyJUMYIBMBTDDLNG-UHFFFAOYSA-N

CAS Registry298-59-9

The development of new treatments for psychosis, a psychiatric condition that is prevalent and highly disabling despite antipsychotic medications, has been limited, in part, by a lack of information from brain imaging studies during the period that leads to the development of psychotic symptoms. In this project the investigators will use Positron Emission Tomography (PET) and neuromelanin-sensitive magnetic resonance imaging (NM-MRI) to examine a brain chemical that is involved in schizophrenia called dopamine and where it first becomes abnormal. The investigators will use multimodal PET/MR imaging (i.e., [11C]raclopride w/MPH challenge and NM-MRI) in the same CHR patients. The investigators will recruit 115 clinical high risk individuals. All subjects will undergo [11C]raclopride w/methylphenidate challenge and neuromelanin-MRI imaging along with clinical assessments. Patients will be followed every 3 months for two years or until conversion to psychosis, whichever comes first, to assess for conversion to psychosis and clinical outcomes.

Start Date01 Oct 2025

Sponsor / Collaborator

The New York State Psychiatric Institute

[+3]

NCT06905587

/ Not yet recruitingPhase 3IIT

Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial

Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.
The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD).
If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.

Start Date01 Jun 2025

Sponsor / Collaborator

Odense University Hospital

[+4]

NCT06577779

/ RecruitingPhase 4IIT

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

The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.

Start Date29 Jan 2025

Sponsor / Collaborator

NYU Langone Health

100 Clinical Results associated with Methylphenidate Hydrochloride

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100 Translational Medicine associated with Methylphenidate Hydrochloride

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100 Patents (Medical) associated with Methylphenidate Hydrochloride

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11,002

Literatures (Medical) associated with Methylphenidate Hydrochloride

01 Oct 2025·JOURNAL OF AFFECTIVE DISORDERS

Efficacy and safety of add-on dextromethorphan on irritability in children with ADHD treated with methylphenidate: A randomized double-blind controlled trial

Article

Author: Pan, Pei-Yin ; Yeh, Chin-Bin

OBJECTIVE:

Converging evidence suggests that childhood irritability is prospectively associated with major depressive disorder. Dextromethorphan has shown efficacious in improving depressive symptomatology in adults. This trial aimed to investigate the efficacy and safety of add-on dextromethorphan on irritability in children with attention-deficit/hyperactivity disorder (ADHD) receiving methylphenidate treatment.

METHODS:

This randomized, double-blind, parallel-group trial evaluated dextromethorphan/methylphenidate versus placebo/methylphenidate in patients 7-17 years old with ADHD and comorbid irritability, which defined by the score of the Affective Reactivity Index (ARI) parent-report form ≥6. Patients were randomly assigned to receive optimal dose of methylphenidate and either dextromethorphan or placebo, 30 mg once daily for the first 2 weeks and 60 mg once daily thereafter, for a total of 8 weeks. The primary outcome was the change from baseline to week 8 in the ARI score.

RESULTS:

A total of 19 patients were randomized (dextromethorphan, N = 8; placebo, N = 11), and Dextromethorphan was significantly superior to the placebo in reducing the ARI score at Week 2 (-5.82 points vs. -0.32 points; least-squares mean difference - 5.50; 95 % CI -8.13, -2.87), Week 4 (-6.49 points vs. -1.96 points; least-squares mean difference - 4.53; 95 % CI -7.13, -1.94), and Week 8 (-4.98 points vs. -2.21 points; least-squares mean difference - 2.77; 95 % CI -5.29, -0.24). The effects of treatment by time interaction were significant at week 2, week 4, and week 8 (p < 0.001, p < 0.001, and p = 0.015, respectively).

CONCLUSIONS:

Adjunctive dextromethorphan might be efficacious in the treatment of irritability in children with ADHD treated with methylphenidate.

01 Sep 2025·Reproductive Biology

Frequent use of methylphenidate causes reduction in sperm production and sperm quality in adult balb/c mice

Article

Author: Dias, Fernanda Carolina Ribeiro ; Matta, Sérgio Luis Pinto da ; Rodrigues, Grasielle Avelar Vieira ; Martins, Ana Luiza Pereira ; de Oliveira, Elizabeth Lopes

Methylphenidate is a psychostimulant used mainly in the treatment of attention deficit hyperactivity disorder (ADHD). The present study evaluated the effects of the drug on the testicles of adult mice, through morphological, histometric, hormonal, and sperm evaluations. Twenty-four Balb /c mice were randomly divided into three experimental groups (n = 8). Group 01: control (distilled water); Group 02: 20 mg/kg/day of methylphenidate; Group 03: 40 mg/kg/day of methylphenidate. The treatment caused a reduction in body weight that may indicate toxic effects caused by prolonged use of the drug. Regarding the percentage of tubular components, there was an increase in the percentage of tubule and epithelium, but the percentage of lumen and tunica propria decreased. The diameters of spermatogonia A and Sertoli cells decreased in stage 1 of the cycle. There were reductions in the percentage of lymphatic space, connective tissue, and macrophages, with a consequent reduction in the percentage of intertubules. Methylphenidate treatment during adulthood decreased plasma testosterone concentrations and compromised the spermatogenic process leading to a reduction in the number of spermatids and spermatozoa, sperm production, and sperm transit time in the epididymis. This allowed us to demonstrate that methylphenidate can impair male fertility.

01 Sep 2025·JOURNAL OF PSYCHIATRIC RESEARCH

Effect of methylphenidate exposure on glutamate and glutamate-related metabolites in patients with ADHD: a systematic review

Article

Author: Rao, Pradeep ; Richards, Tobias ; Morandini, Hugo A E

BACKGROUND:

Dysfunctional glutamatergic neurotransmission has been implicated in the underlying pathogenesis of Attention Deficit Hyperactivity Disorder (ADHD). The psychostimulant methylphenidate (MPH), which is used as a first line treatment for ADHD, has been shown to have both acute and chronic effects on prefrontal cortex glutamatergic afferents. Animal studies have also identified an effect of MPH and glutamate in prefrontal areas. Despite this there are ongoing questions as to the extent and direction of this effect, as well as its impact on other neurobiological processes.

METHODS:

A systematic literature search was conducted following the PRISMA guidelines through the databases Embase, ScienceDirect and PubMed. Studies following pre/post and prospective designs were reviewed. Brain regions, metabolites of interest and phenotypical information were extracted from the relevant studies. Quality assessment tools of the National Heart, Lung, and Blood Institute were used to evaluate the risk of bias.

RESULTS:

There were 10 studies that met criteria for inclusion. Three studies in children with ADHD identified a statistically significant decrease in glutamate level within fronto-cerebellar circuit and amygdala after MPH treatment. Most studies investigating adults with ADHD did not show a significant change in glutamate and glutamate-related metabolites after MPH exposure.

CONCLUSION:

A trend for decreased glutamate levels after MPH exposure were observed in studies involving children with ADHD. Future studies investigating the effects of MPH in children and adults with ADHD should utilise higher magnet field strength with larger sample sizes and over a longer duration of time with blinding and control group research design.

167

News (Medical) associated with Methylphenidate Hydrochloride

07 Jul 2025

·www.globenewswire.com

Collegium Announces $150 Million Share Repurchase Program

STOUGHTON, Mass., July 07, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced its Board of Directors has authorized a new share repurchase program to repurchase up to $150 million in common stock through December 31, 2026. This program replaces a previous $150 million share repurchase program authorized in January 2024 which expired on June 30, 2025, and had $65 million remaining under the program. “Collegium’s strong financial position provides us with significant flexibility in executing our capital allocation strategy,” said Colleen Tupper, Chief Financial Officer. “The Board’s authorization of a new $150 million share repurchase program further supports our commitment to returning value to shareholders. We remain confident in our future growth trajectory and are committed to generating additional value as we invest in our key product growth drivers, diversify our portfolio through disciplined business development, rapidly pay down debt and opportunistically repurchase shares.” Collegium has returned $222 million in value to shareholders under its share repurchase programs since 2021, including $25 million repurchased through an accelerated share repurchase program that was initiated in May 2025 and is expected to be completed in the third quarter of 2025. As of March 31, 2025, Collegium had approximately 32.1 million shares outstanding. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and recently acquired Jornay PM®, a treatment for ADHD, establishing a presence in neuropsychiatry. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contacts:Ian KarpHead of Investor Relationsir@collegiumpharma.com Danielle JesseDirector, Investor Relationsir@collegiumpharma.com Media Contact:Cheryl WheelerHead of Corporate Communicationscommunications@collegiumpharma.com

Acquisition

01 Jul 2025

·firstwordpharma.com

FDA mandates label updates for ADHD stimulants over weight loss risk in young children

The FDA issued mandatory labelling revisions for all extended-release stimulant medications used in the treatment of attention deficit hyperactivity disorder (ADHD) after clinical data highlighted increased weight loss risks and adverse reactions in younger children.The decision specifically targets the common off-label practice of prescribing extended-release formulations of stimulants to children below six years of age, although not approved for this age group.Following a comprehensive assessment of clinical trial data from extended-release amphetamine and methylphenidate formulations, the FDA noted that recipients under six years carried a greater risk of weight loss compared with their older paediatric counterparts receiving identical dosages of these products. “Clinically significant weight loss (at least 10% decrease in the Centers for Disease Control and Prevention weight percentile) was observed in both short- and long-term studies,” the US regulator stated.Moreover, younger children exhibited significantly higher plasma exposures and elevated adverse reaction rates than older children. The agency concluded that the risk-benefit profile may not favour extended-release stimulant use in this vulnerable population, prompting the mandatory labelling requirements.The FDA now requires manufacturers to incorporate a “Limitation of Use” section within the prescribing information of these products if not present, while labels already carrying it need revision to maintain consistency across the drug class.Meanwhile, healthcare professionals are advised to monitor growth and development closely in affected patients, considering treatment discontinuation or switching to alternative therapies, including immediate-release formulations or behavioural interventions, when weight loss or other adverse events occur.

01 Jul 2025

·pharma.economictimes.indiatimes.com

US FDA to revise ADHD stimulants labels to warn of weight loss risk in children under 6

Bengaluru: The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about the risk of weight loss and other side effects in patients under six years old. The FDA said that it is requiring a "limitation of use" section in the prescribing information of all extended-release stimulants to include a statement on higher rates of adverse reactions in children younger than six years. ADHD is a disorder, common among children, that affects the ability to pay attention, follow directions and complete tasks. The FDA has approved two types of medications - stimulants and non-stimulants - to help reduce ADHD symptoms. Stimulants, sold under brand names Ritalin by Novartis and Concerta by Johnson & Johnson's unit Janssen, are commonly prescribed by healthcare professionals. These stimulants function by increasing levels of dopamine and norepinephrine in the brain, two neurotransmitters linked to motivation, attention and impulse control. This new FDA requirement is not applicable to Concerta, a J&J spokesperson said. Extended-release stimulants are not approved for children younger than six years, but healthcare professionals can prescribe them "off label" to treat ADHD, the FDA said. The agency said it assessed data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment, finding that, compared to older children, patients younger than six years have higher levels of the drug in their bodies as well as higher rates of side effects. For these reasons, the benefits of extended-release stimulants may not outweigh the risks in patients younger than six years, the FDA said in a statement. "Stimulants are a proven treatment for children and adolescents with ADHD ... As with any medications, parents need to weigh the risks and benefits for their child," the American Psychiatric Association said in a statement. An estimated seven million children in the United States, aged between three and 17 years, have been diagnosed with ADHD, according to the FDA. (Reporting by Sneha S K and Puyaan Singh in Bengaluru; Editing by Alan Barona and Mohammed Safi Shamsi)

Drug Approval

100 Deals associated with Methylphenidate Hydrochloride

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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	China	Suzhou First Pharmaceutical Co., Ltd.	01 Jan 1982
Attention Deficit Disorder	United States	Sandoz, Inc.	05 Dec 1955
Narcolepsy	United States	Sandoz, Inc.	05 Dec 1955

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Brain Cancer	Phase 3	United States	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Feb 2008
Solid tumor	Phase 3	United States	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Feb 2008
Fatigue	Phase 3	Germany	MEDICE Arzneimittel Pütter GmbH & Co. KG	01 Aug 2006
Depressive Disorder, Major	Phase 3	-	Janssen, Inc.	01 Jun 2005
Breast Cancer	Phase 2	Canada	Purdue Pharma LP	09 Oct 2017
Cognitive Dysfunction	Phase 2	Canada	Purdue Pharma LP	09 Oct 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04885257 (CTgov)	Phase 1/2	Stroke \| Stress Disorders, Post-Traumatic \| Ischemic stroke	20	Placebo (Placebo)	wejbwarpwv(ypnlbaaatw) = uljynidboz zsrwcgayiz (tnpymmycif, 0.53) View more	-	22 Jun 2025
				Methylphenidate (Methylphenidate)	wejbwarpwv(ypnlbaaatw) = tuekltvevw zsrwcgayiz (tnpymmycif, 1.08) View more
NCT03218254 (MICRO Trial, EHA2025)	Phase 3	Hematologic Neoplasms	152	Methylphenidate 10mg	rqpfbrpkzl(jbueesnsii) = rulvdplohu agqewhwvrh (ymdovvulld, 0.1 - 1.3)	Positive	14 May 2025
NCT01351272 (BEAS, CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	41	Methylphenidate	rsovgymwtu(vlosrywmqw) = lyldsjntss vicegfwnrb (fgyqjdfhfo, 0.09) View more	-	15 Aug 2024
NCT02346201 (ADMET 2, Pubmed \| Int Psychogeriatr)	Phase 3	Dementia	167	Methylphenidate	kpdayohncp(eogtanthoz) = Utility improved with methylphenidate treatment as there was a group by time interaction ovcevliyax (nyucsvqnls )	Positive	01 Nov 2023
				Placebo
NCT02473185 (Pubmed \| BMC Psychiatry)	Phase 4	Attention Deficit Disorder With Hyperactivity	40	Methylphenidate 20 mg immediate release	pmoftrpwek(pbqdbjsvpf) = cyhnizbglz cwcpbakzef (jegipgzisy )	Positive	17 Oct 2023
				Placebo	pmoftrpwek(pbqdbjsvpf) = njarkghqnu cwcpbakzef (jegipgzisy )
NCT04987762 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	103	Adhansia XR	ahgrsbdtzj = jjxhcpbshq twjiwrfszf (pdwnaoktmp, gubnylzwgg - xkrnsfftpa) View more	-	22 Aug 2023
NCT04507204 (RE-DAX, CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	267	Adhansia XR (Adhansia XR)	wvjeqclyak(okqzmrncaj) = rtleobulwb lnijxnvmay (qqpxgsnfbq, 8.60) View more	-	27 Jul 2023
				Concerta (Concerta)	tufpqcweel(smbsihqmly) = ryqjokmfbg uioahxxnou (dlgipfufmw, 0.88) View more
NCT02346201 (ADMET2 \| ADMET 2, CTgov)	Phase 3	Alzheimer Disease \| Apathy	200	Methylphenidate (Methylphenidate)	bvkkmgdoub(whruvqigpn) = eyvvabcjlc vgdllhijin (gjyhmpcozn, 4.1) View more	-	13 Jun 2023
				Placebo (Placebo)	bvkkmgdoub(whruvqigpn) = iachzndutp vgdllhijin (gjyhmpcozn, 3.6) View more
NCT00424099 (CTgov)	Phase 2/3	Fatigue \| Advanced cancer	197	Methylphenidate (MP) (Methylphenidate (MP) + Nursing Telephone Intervention (NTI))	aoqghjmvbn(xhvdkpctjj) = qmunpgtwca sudngloopo (errtohmafl, ztvhjzsdvg - ovvuaxqwem) View more	-	01 Jun 2023
				Methylphenidate (MP) (Methylphenidate (MP) + Control Telephone Intervention (CTI))	aoqghjmvbn(xhvdkpctjj) = caoemavdvt sudngloopo (errtohmafl, mtxcfkkngl - egkgnpbzfj) View more
NCT02153944 (CTgov)	Phase 4	Anxiety Disorders	142	Methylphenidate (Behavioral: Drug Challenge With Methylphenidate)	mlpkegsboz(adjjghkyfl) = awrdqjkfsy nmqjxlzvzk (pzlvqpzhkc, 0.556162) View more	-	11 Apr 2023
				Placebo (Behavioral: Drug Challenge With Placebo)	mlpkegsboz(adjjghkyfl) = ckgqgkopwr nmqjxlzvzk (pzlvqpzhkc, 0.471667) View more