Request Demo

Last update 19 Jul 2026

Methylphenidate Hydrochloride

Last update 19 Jul 2026

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

AVERSA Methylphenidate, D-MPH, Methyl phenidylacetate

+ [41]

Target

DAT

Action-

Mechanism

Dopamine reuptake inhibitors

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Attention Deficit Disorder With HyperactivityAttention Deficit DisorderNarcolepsy+ [1]

Inactive Indication

Breast CancerCognitive DysfunctionDepressive Disorder+ [3]

Originator Organization

Novartis Pharma AG

Active Organization

Suzhou First Pharmaceutical Co., Ltd.

Janssen Pharmaceutica NVSandoz, Inc.

+ [19]

Inactive Organization

Novartis Pharmaceuticals Corp.Janssen-Cilag International NV

ALZA Corp.

+ [10]

License Organization

Ironshore Therapeutics, Inc.

Noven Pharmaceuticals, Inc.KYE Pharmaceuticals, Inc.

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (05 Dec 1955),

Attention Deficit DisorderNarcolepsy

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC14H20ClNO2

InChIKeyJUMYIBMBTDDLNG-UHFFFAOYSA-N

CAS Registry298-59-9

562

Clinical Trials associated with Methylphenidate Hydrochloride

NCT06977308

/ Not yet recruitingPhase 1IIT

A Multimodal Imaging Study of Dopamine in Early Psychosis

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 2026

Sponsor / Collaborator

The New York State Psychiatric Institute

[+2]

NCT07650643

/ Not yet recruitingPhase 4IIT

EEG Biomarkers for Pediatric ADHD Treatment Stratification

Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, >50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result.
This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines.
220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications >6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before.
Study Participation Includes:
1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher.
2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication.
3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week.
5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits.
7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy.
8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.

Start Date15 Sep 2026

Sponsor / Collaborator

The Children's Hospital Corp.

[+2]

NCT07710014

/ Not yet recruitingPhase 4

Evaluation of Foquest® (Multilayer-Release Methylphenidate) in Adults ≥ 65 Years With ADHD: An Open-Label, Investigator-Initiated Trial

This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older.
ADHD can persist into older age and is associated with reduced quality of life and difficulties with executive function. Foquest is currently approved in Canada for the treatment of ADHD in adults up to age 65, but there is very limited research on its use in older adults. People over 65 may respond differently to stimulant medications due to age-related changes in how the body processes drugs, other medical conditions, and increased sensitivity to cardiovascular side effects.
This is an open-label study, meaning all participants will know they are receiving the study medication. There is no placebo group. Participants will take Foquest once daily for approximately 10 weeks, including a 6-week dose adjustment period, a 2-week maintenance period, and a 2-week follow-up period. The dose will start at 25 mg daily and may be increased weekly up to a maximum of 100 mg daily based on how well the participant responds and tolerates the medication.
The main goal of the study is to measure changes in ADHD symptoms using a clinician-rated scale called the Adult ADHD Investigator Symptom Rating Scale (AISRS). The study will also assess changes in executive function, overall clinical improvement, and cardiovascular safety measures including blood pressure, heart rate, and electrocardiograms (ECGs). Safety will be closely monitored throughout the study, with enhanced cardiovascular monitoring during the first 6 weeks of treatment.

Start Date01 Jul 2026

Sponsor / Collaborator-

100 Clinical Results associated with Methylphenidate Hydrochloride

100 Translational Medicine associated with Methylphenidate Hydrochloride

100 Patents (Medical) associated with Methylphenidate Hydrochloride

9,297

Literatures (Medical) associated with Methylphenidate Hydrochloride

01 Jun 2026·PSYCHIATRY RESEARCH

Steroid/thyroid hormones and inflammatory markers in adolescents with ADHD: comparisons with healthy controls and modifications by methylphenidate

Article

Author: González-Villén, Raquel ; Contreras-Chova, Francisco ; Tortosa-Pinto, Pilar ; Aguado-Rivas, Raquel ; Checa-Ros, Ana ; Fernández-Ibañez, Ana ; Molina-Carballo, Antonio ; Fernández-López, Luisa

BACKGROUND:

Increasing evidence suggests that neuroendocrine and inflammatory mechanisms may contribute to attention-deficit/hyperactivity disorder (ADHD) pathophysiology, although findings in adolescents and the effects of methylphenidate (MPH) remain limited.

OBJECTIVE:

To quantify the baseline profile of activating hormones and levels of pro- and anti-inflammatory cytokines and their changes after treatment with methylphenidate (MPH) in adolescents with ADHD, in comparison with controls.

METHODS:

Eighty-one adolescents (40 with ADHD and 41 healthy controls) were evaluated. Morning serum concentrations of cortisol, thyroid-stimulating hormone (TSH), dehydroepiandrosterone sulfate (DHEAS), S100B, and seven cytokines were measured. Patients with ADHD were reassessed after approximately four months of MPH treatment. Analyses considered ADHD presentation and oppositional defiant disorder (ODD) symptoms. Multivariable regression models were used to adjust biomarker associations for demographic and clinical variables.

RESULTS:

Adolescents with ADHD showed significantly lower morning cortisol concentrations than controls. Several pro- and anti-inflammatory cytokines (IL-1β, IL-4, IL-5, IL-6, IL-10, and IL-13) were increased, particularly in males, whereas TNF-α and S100B did not differ between groups. Multivariable analyses confirmed independent associations between lower cortisol and higher cytokine levels with ADHD. TSH and DHEAS showed minor variations related to ODD symptoms but no consistent differences between ADHD presentations. MPH treatment improved clinical symptoms but produced no significant overall changes in hormonal or cytokine profiles CONCLUSION: Adolescents with ADHD exhibit an altered immune-hormonal profile characterized by reduced cortisol and increased circulating cytokines. These alterations appear largely independent of demographic and clinical confounders and only minimally influenced by short-term MPH treatment, suggesting persistent neuroendocrine-immune dysregulation during adolescence.

01 Jun 2026·The Lancet Psychiatry

Pharmacological interventions for ADHD: a systematic review and dose–effect network meta-analysis

Review

Author: Nourredine, Mikail ; Cortese, Samuele ; Hamza, Tasnim ; Subtil, Fabien ; Efthimiou, Orestis ; Cipriani, Andrea ; Farhat, Luis C ; Jurek, Lucie ; Veronesi, Guilherme Fusetto ; Salanti, Georgia ; Parlatini, Valeria

BACKGROUND:

Optimising the dosage of pharmacological treatments for ADHD is key to maximising their benefits, yet most clinical guidelines provide only limited information on this issue. Dose-effect relationships have not been comprehensively assessed across all ADHD medications and age groups, despite growing concerns about subtherapeutic prescribing. We aimed to estimate dose-effect curves for efficacy and tolerability of ADHD medications (stimulants and non-stimulants) across age groups.

METHODS:

We conducted a systematic review and dose-effect network meta-analysis of double-blind randomised controlled trials (RCTs) evaluating oral monotherapy (stimulants and non-stimulants) in individuals aged 5 years and older meeting standardised ADHD criteria. Studies involving genetic syndromes, treatment-resistant populations, or withdrawal-phase designs were excluded. We retrieved eligible studies from the MED-ADHD database, updated on Feb 17, 2025, without language restrictions. We included published and unpublished aggregated-level data. The primary outcome was efficacy (measured using validated clinical scales) and the secondary outcome was tolerability (discontinuation due to adverse events). Within-study bias was assessed with the Cochrane Risk of Bias Tool (version 2). We summarised dose-effect associations using a hierarchical Bayesian model with restricted cubic splines. Separate analyses were conducted for children or adolescents (aged <18 years) and adults (aged ≥18 years). The distribution of key effect modifiers was used to examine transitivity of the network. People with lived experience were involved in the conceptualisation and design of the study, and in the interpretation of the findings. The protocol was pre-registered on OSF.

FINDINGS:

Our 2017 search identified 9948 potential references for inclusion and our Feb 17, 2025 search identified 5148 references. Of these 15 096 references, 8467 were excluded after title and abstract screening, and a further 5862 references were excluded after a full-text read. Of the 767 remaining reports, 164 were included in the systematic review and 113 RCTs (45 in adults and 68 in children and adolescents) were included in the dose-effect network meta-analysis. The 68 RCTs on children and adolescents included 14 138 participants (9981 [70·6%] males and 4157 [29·4%] females) and the 45 RCTs on adults included 11 016 participants (5958 [54·0%] males and 5056 [46·0%] females). Data on ethnicity or race were inconsistently reported across RCTs. We found distinct dose-effect patterns by medication class and age group. In children and adolescents, methylphenidate, amphetamines, and guanfacine showed increasing median efficacy up to 45 mg/day, 25 mg/day and 4 mg/day, respectively, with no evidence of additional benefit at higher doses, although estimates at higher doses were characterised by wide credible intervals. In adults, amphetamines showed a plateau above approximatively 50 mg/day, whereas methylphenidate efficacy increased without evidence of a plateau, possibly due to sparse data. Dose-dependent increases in discontinuation probability due to adverse events were observed for amphetamines (above 25 mg/day for children and 50 mg/day for adults) and methylphenidate (above 50 mg/day for adults, with no clear dose-dependent risk for children). We found no evidence of dose-effect patterns for atomoxetine (in fixed-doses studies) and modafinil. Multiple sensitivity analyses confirmed the robustness of these findings. We found no evidence of intransitivity.

INTERPRETATION:

Our findings challenge both therapeutic inertia-accepting suboptimal response without further dose titration-and uncritical dose escalation beyond licensed limits, when potential harms outweigh expected benefits. Our findings can inform clinical guidelines and should support shared decision making regarding ADHD medication dosage.

FUNDING:

National Institute for Health and Care Research (NIHR303122).

01 Jun 2026·Progress in Neuro-Psychopharmacology

Long-term consequences of adolescent methylphenidate exposure on sustained attention and prelimbic PV+ interneuron maturation in rats

Article

Author: Vargas, Juan Pedro ; Díaz, Estrella ; Pérez-Colorado, Antonio ; López, Juan Carlos ; Martínez-Marín, Reyes

Adolescence is a sensitive period for the maturation of prefrontal GABAergic circuitry, particularly involving parvalbumin-expressing (PV+) interneurons that regulate excitatory-inhibitory balance and support attentional control. Methylphenidate (MPH), widely prescribed for attention-deficit/hyperactivity disorder (ADHD, is commonly administered throughout adolescence, yet its long-term impact on PV+ interneuron development remains unclear. Here, we examined whether chronic MPH exposure during distinct adolescent windows (PD35-55, PD42-62, PD49-69) alters PV+ interneuron maturation in the prelimbic (PrL) cortex and produces enduring attentional impairments. Male and female Wistar rats received 5 mg/kg MPH for 20 consecutive days and, in adulthood (PD100), were tested in a sustained attention task (SAT) and its distractor variant (dSAT). MPH exposure produced a reduction in PV+ interneuron density in the PrL, but only treatment during late adolescence (PD49-69) disrupted the normal developmental increase in PV+ cells. This PV+ reduction interneurons was accompanied by persistent deficits in sustained attention, reflected by decreased hit rates and poor recovery under high attentional demand, while correct rejections remained intact. These findings identify late adolescence as a critical vulnerability window in which MPH disrupts prefrontal inhibitory maturation and is associated with altered adult attentional performance, highlighting the importance of developmental timing in psychostimulant exposure.

204

News (Medical) associated with Methylphenidate Hydrochloride

17 Jul 2026

·www.drugs.com

More Weight Loss Reported With Dexamphetamine Versus Methylphenidate for ADHD

FRIDAY, July 17, 2026 -- For children and adolescents with attention-deficit/hyperactivity disorder (ADHD), comparable, significant symptom improvement is seen with dexamphetamine and methylphenidate, but weight loss is greater with dexamphetamine at three months, according to a study published online July 7 in the Journal of Paediatrics and Child Health . Alison Poulton, M.D., from The University of Sydney, and colleagues conducted an open-label study involving 100 stimulant-naive children and adolescents with ADHD. Participants were randomly assigned to receive dexamphetamine or methylphenidate and followed for 12 months. The researchers found that at all time periods, there were significant ADHD symptom improvements on either medication, with no significant difference seen between the groups. Sixty-two of the participants remained on their allocated medication at 12 months, with no significant difference between methylphenidate and dexamphetamine (68 versus 56 percent). Weight loss was seen in association with both medications, with greater weight loss on dexamphetamine at three months (−1.44 versus −0.31 kg). "Both medications worked equally well for improving ADHD symptoms, and a year later most children were still taking their original stimulant, suggesting a comparable level of satisfaction with either medication," Poulton said in a statement. "The main difference was that children taking dexamphetamine experienced greater weight loss, which is an important consideration when choosing treatment and monitoring growth." One author disclosed ties to the pharmaceutical and publishing industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

05 Jun 2026

·www.biospace.com

Collegium Pharmaceutical Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - June 5, 2026

STOUGHTON, Mass., June 05, 2026 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it awarded inducement grants on June 1, 2026 under the Company's 2026 Inducement Plan (the 2026 Inducement Plan). The Company granted 50,305 restricted stock units (RSUs), in aggregate, as a material inducement to the employment of 34 non-executive individuals newly hired by the Company. Each RSU represents a contingent right to receive one share of the Company’s common stock. One-third of the RSUs shall vest on June 10, 2027, with the balance of the RSUs vesting in equal annual installments over the following two-year period, subject to the employee’s continued service with the Company through each applicable vesting date. The RSUs will be settled on each applicable vesting date in shares of the Company’s common stock. The above-described RSUs were granted outside of the Company's stockholder-approved equity incentive plan pursuant to the 2026 Inducement Plan, which was adopted by the Company's board of directors (the Board) on May 11, 2026 as a material inducement to the individuals entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). About Collegium Pharmaceutical, Inc. Collegium Pharmaceutical is a dynamic, biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex central nervous system and pain conditions. Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine what treatment looks like in categories too often shaped by complexity and misconceptions. With a portfolio of differentiated ADHD medications, anchored by JORNAY PM® (methylphenidate HCl) and AZSTARYS® (serdexmethylphenidate and dexmethylphenidate), and an established leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver treatment options around how people live their lives. For more information, please visit  collegiumpharma.com or find us on LinkedIn . Investor Contact: Ian Karp Head of Investor Relations ir@collegiumpharma.com Media Contact: Jessica Cotrone Senior Vice President, Corporate Communications & Corporate Affairs communications@collegiumpharma.com

20 May 2026

·www.prnewswire.com

Vertical Pharmaceuticals Partners with Medfinder to Help Patients Find Relexxii® During Ongoing ADHD Medication Shortages

Collaboration offers patients prescribed Relexxii access to Medfinder's pharmacy search service at no cost ALPHARETTA, Ga., May 20, 2026 /PRNewswire/ -- Vertical Pharmaceuticals, an Alora Pharmaceuticals company, has proudly partnered with Medfinder, an AI-enabled medication locating service, to help patients prescribed Relexxii (methylphenidate hydrochloride extended-release tablets) more easily locate pharmacies that report available inventory or the ability to order their prescribed strength during the ongoing ADHD medication shortage.1 Continue Reading Locate RELEXXII at a pharmacy near you with Medfinder. Pharmacy availability of stimulant medications has fluctuated in recent years, creating challenges for patients and care partners seeking uninterrupted access to prescribed treatment. Through this partnership, patients prescribed Relexxii may use Medfinder's pharmacy search service at no cost to help reduce time and effort in locating available inventory. Supporting Patients During ADHD Medication Supply Challenges According to the American Academy of Child and Adolescent Psychiatry (AACAP) and American Psychiatric Association (APA), families across the country have reported difficulty locating pharmacies with available ADHD stimulant medications.2 In some cases, families and care partners may spend hours contacting multiple pharmacies to check inventory, only to find availability changes before a prescription can be filled.2 Relexxii is available to pharmacies nationwide and may be ordered by pharmacies in the prescribed strength, even if not currently stocked. Pharmacy ordering practices and product availability may vary by location. As with all prescription medications, patients should consult their healthcare provider to understand the appropriate treatment options for their individual needs, including the benefits and risks associated with those treatments. Helping Reduce the Burden of Pharmacy Search "We recognize how disruptive medication access challenges can be for families managing ADHD," said Shannon Faught, Chief Commercial Officer, Alora Pharmaceuticals. "Our partnership with Medfinder is one way we are working to help patients access Relexxii when prescribed by their healthcare provider." "We started Medfinder after experiencing firsthand how difficult it can be to find a prescribed medication in stock," said Peter Daggett, Co-Founder & CEO of Medfinder. "Our goal is to help reduce the time, uncertainty, and frustration involved in locating a pharmacy that can fill a prescription. Through this partnership, Relexxii patients can access that support at no cost." How the Relexxii + Medfinder Partnership Works Patients and care partners looking for Relexxii in-stock may use Medfinder at no cost to: Identify pharmacies that report available inventory or the ability to order the prescribed strength Reduce time spent contacting or visiting pharmacy locations Once a pharmacy confirms it can fill the prescription or order the prescribed strength, patients or care partners coordinate directly with their healthcare provider to send the prescription to the selected pharmacy for fulfillment. Since launching the partnership, Medfinder has processed over 18,000 Relexxii pharmacy stock checks. Patients, care partners and prescribers can learn more about the program by visiting the Relexxii Medfinder resource page. About Relexxii ® For more information about Relexxii extended-release methylphenidate for the treatment of ADHD please visit relexxii.com. See below for Important Safety Information or visit relexxii.com/isi. For full Prescribing Information, including BOXED WARNING, visit relexxii.com/pi. For U.S. residents only. About Medfinder Medfinder is an AI-enabled medication locating service that helps patients and care partners identify pharmacies that report available inventory for prescribed medications, helping reduce the time and effort required to search across multiple pharmacy locations. For media inquiries, please contact [email protected]. About Alora Pharmaceuticals, LLC Headquartered in Alpharetta, GA, Alora Pharmaceuticals is a pharmaceutical company driven by a commitment to quality, reliability, and affordability. Alora Pharmaceuticals is the parent company of seven specialty pharmaceutical and pharmaceutical manufacturing companies with facilities in Texas and Georgia. The Alora family of companies includes Acella Pharmaceuticals, Avion Pharmaceuticals, Neuvosyn Laboratories, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, and Vertical Pharmaceuticals. With more than 550 employees, the Alora family of companies is proud to manufacture medicines in the United States, supporting domestic production, supply chain resilience, and patient access to affordable treatments. INDICATION & IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING INDICATION RELEXXII is a central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older. RELEXXII is not recommended for use in children under 6 years of age as higher plasma exposure may lead to a higher incidence of adverse reactions. RELEXXII is contraindicated in patients with known hypersensitivity to methylphenidate or other components of RELEXXII. RELEXXII is contraindicated in patients with concurrent treatment of monoamine oxidase inhibitor (MAOI) or using MAOI within the preceding 14 days. Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Monitor all RELEXXII-treated patients for hypertension and tachycardia. Psychiatric Adverse Reactions: Prior to initiating RELEXXII, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing RELEXXII. Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. Peripheral Vasculopathy, including Raynaud's Phenomenon: Careful observation for digital changes is necessary during RELEXXII treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. Gastrointestinal Obstruction: Avoid use with preexisting GI narrowing. Acute Angle Closure Glaucoma: RELEXXII treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe RELEXXII to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Before initiating RELEXXII, 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. DRUG INTERACTIONS Concomitant use of Monoamine oxidase Inhibitor's (MAOIs) and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer RELEXXII concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. RELEXXII may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Concomitant use of halogenated anesthetics and RELEXXII may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of RELEXXII in patients being treated with anesthetics on the day of surgery. Combined use of methylphenidate with risperidone when there is a change in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor patients on RELEXII for signs of EPS with concomitant use of risperidone with associated changes in dosage. You may report side effects to Vertical Pharmaceuticals, LLC at 1-800-444-5164 or to the FDA at 1-800-FDA-1088. For full Prescribing Information, including BOXED WARNING, visit relexxii.com/pi . Individual depicted is a model used for illustrative purposes only. Relexxii® is a registered trademark of Vertical Pharmaceuticals, LLC. Medfinder is a trademark of Insito Health. REFERENCES: 1. U.S. Food and Drug Administration. Drug Shortages Database (methylphenidate hydrochloride tablet, extended release shortage information). Available at: . Accessed May 1, 2026. 2. American Academy of Child and Adolescent Psychiatry; American Psychiatric Association. Ongoing stimulant medication shortages [letter to Administrator Anne Milgram, Drug Enforcement Administration]. March 24, 2023. 4236-v1.1 SOURCE Alora Pharmaceuticals, LLC 21% more press release views with Request a Demo

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.

to view more data

Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	China	Suzhou First Pharmaceutical Co., Ltd.	01 Jan 1982
Depressive Disorder	Japan	Novartis Pharma AG	08 Oct 1957
Attention Deficit Disorder	United States	Sandoz, Inc.	05 Dec 1955
Narcolepsy	United States	Sandoz, Inc.	05 Dec 1955

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nervous System Diseases	NDA/BLA	Canada	Lupin Pharma Canada Ltd.	01 May 2026
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03772834 (ASCO2026)	Phase 3	Prostatic Cancer	161	Exercise + Methylphenidate	erubtbrmco(yrkkggczuw) = tmtgdjawlc okjrqlypmn (tgrotuqwik )	Negative	29 May 2026
				Exercise + Placebo	-
ASCO2026	Not Applicable	Advanced cancer	8,739	Methylphenidate	ybfqwaxzkk(uxgugaaikk) = qvgfdeaeqf kxxidcguuf (zbqyxjhylc ) View more	Positive	29 May 2026
NCT01628029 (CTgov)	Phase 2	Dyssomnias \| Malignant Solid Neoplasm \| Hematologic Neoplasms	68	Placebo (Dim Red Light + Placebo + Placebo)	dchgoalwtb(xpabnfmhir) = mggsrsvset jmshctgwet (eqhwrbcfdw, ncgbcgieru - nucnwayepf) View more	-	04 Feb 2026
				Placebo+Melatonin (Bright White Light Therpay + Melatonin + Placebo)	dchgoalwtb(xpabnfmhir) = epiakhsfor jmshctgwet (eqhwrbcfdw, yodduozhcp - mlxoozbcpz) View more
NCT03652740 (CTgov)	Phase 1	-	25	Placebo+Nicotine+Methylphenidate (Caffeine Chooser)	vbbeqprtcn(chvjieimcg) = ablniihnxk zknocwopcv (fcwxllvrpy, 1.20) View more	-	02 Feb 2026
				Placebo+Nicotine+Methylphenidate (Caffeine Non-Chooser)	vbbeqprtcn(chvjieimcg) = jneutawybj zknocwopcv (fcwxllvrpy, 0.60) View more
NCT05880342 (Pubmed \| Eur J Sport Sci)	Phase 3	-	18	Methylphenidate (MPH); 20 mg	wgjmjbhvqq(svncbsumta) = increased mfuprzqmge (sbhbbuwvct ) View more	Positive	01 Feb 2026
				Placebo (10 mg lactose)
NCT03814356 (STIMPACT, CTgov)	Phase 1	Hypoxia, Brain \| Coma \| Brain Injuries, Traumatic	10	Methylphenidate	mlzanqkoem = dygqnzrofd xdjrqrhsbb (mhtqbtawpp, ujpucyeglu - rerbjuseqi) View more	-	29 Oct 2025
NCT04885257 (CTgov)	Phase 1/2	Stroke \| Stress Disorders, Post-Traumatic \| Ischemic stroke	20	Placebo (Placebo)	qkuwhqqitu(ohxubbndhi) = rmwnvubamd djheplbkdx (hqriwnsxkf, 0.53) View more	-	22 Jun 2025
				Methylphenidate (Methylphenidate)	qkuwhqqitu(ohxubbndhi) = hkstmyyoed djheplbkdx (hqriwnsxkf, 1.08) View more
EAN2025	Not Applicable	Consciousness Disorders	50	Apomorphine	dqvlyelqmr(rotqpumtfn) = tvvrkugddz liaarnvtmj (elvrxyomfg )	Positive	21 Jun 2025
				Methylphenidate	dqvlyelqmr(rotqpumtfn) = zwbskdoedi liaarnvtmj (elvrxyomfg )
NCT03218254 (MICRO Trial, EHA2025)	Phase 3	Hematologic Neoplasms	152	Methylphenidate 10mg	hsvagnexac(imswgezwts) = jocjjgwzuy chwyjamlob (ojbzbqheuj, 0.1 - 1.3)	Positive	14 May 2025
CTR20180056 (MICCA, Pubmed \| CNS Drugs)	Phase 4	Attention Deficit Disorder With Hyperactivity	221	MPH-MR	dlrhoqdcqz(ilouwlmalq) = rbbpbftzyp xbeseeuexu (tepcnwxzmr ) View more	Positive	01 Mar 2025
				Placebo	dlrhoqdcqz(ilouwlmalq) = kvwpweqfrk xbeseeuexu (tepcnwxzmr ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Methylphenidate Hydrochloride

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation