{"id":"mydayis","rwe":[{"pmid":"41495166","year":"2026","title":"Quantum and thermodynamic evaluation of C(24) fullerene-based nanosensors for detection of mydayis in biomedical and drug detection applications.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"40839413","year":"2025","title":"Drugs for ADHD.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"},{"pmid":"36397191","year":"2022","title":"In brief: Alternatives to Adderall.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"},{"pmid":"33185468","year":"2020","title":"A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.","finding":"","journal":"Journal of child and adolescent psychopharmacology","studyType":"Clinical Study"},{"pmid":"31999670","year":"2020","title":"Drugs for ADHD.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"NYU Langone Health","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: ABUSE, MISUSE, AND ADDICTION MYDAYIS has 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 MYDAYIS, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing MYDAYIS, assess each patient’s risk for abuse, misuse, and addiction. Educate "],"commonSideEffects":[{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased appetite","drugRate":"","severity":"common","organSystem":""},{"effect":"Dry mouth","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased weight","drugRate":"","severity":"common","organSystem":""},{"effect":"Heart rate increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Anxiety","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain upper","drugRate":"","severity":"common","organSystem":""},{"effect":"Irritability","drugRate":"","severity":"common","organSystem":""},{"effect":"Weight decreased","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Blood pressure increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Depression","drugRate":"","severity":"common","organSystem":""},{"effect":"Viral infection","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Stevens-Johnson syndrome","drugRate":"","severity":"serious"},{"effect":"Toxic epidermal necrolysis","drugRate":"","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Angioedema","drugRate":"","severity":"serious"},{"effect":"Hypersensitivity reactions","drugRate":"","severity":"serious"}]},"trials":[],"aliases":["d-amphetamine / l-amphetamine"],"company":"NYU Langone Health","patents":[],"pricing":[],"allNames":["mydayis"],"offLabel":[],"synonyms":[],"timeline":[],"aiSummary":"mydayis is a small molecule developed by NYU Langone Health, but its target, drug class, and approved indications are unknown. As a small molecule, it is a type of medication that can be taken orally and is typically made up of a single compound. The commercial status of mydayis is unclear, and it is owned by NYU Langone Health. There is limited information available on its safety considerations, half-life, bioavailability, and generic manufacturers. Further research is needed to understand the full scope of mydayis.","approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"Imagine your body's cells have locks on them, and mydayis has a key that fits into those locks. When the key (mydayis) binds to the lock, it sends a signal that tells the cell to do something, like make a certain protein or block a certain process. This is a simplified explanation of how mydayis works at a molecular level.","oneSentence":"mydayis works by interacting with a specific target in the body to produce a desired effect.","technicalDetail":"mydayis is a small molecule that binds to a specific target, such as a receptor or enzyme, to produce its therapeutic effect. The exact mechanism of action is unknown, but it is thought to involve modulation of a specific signaling pathway."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=mydayis","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=mydayis","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:40:02.697975","biosimilars":[],"competitors":[],"dataSources":[],"genericName":"mydayis","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05916339","phase":"PHASE4","title":"AWARE: Management of ADHD in Autism Spectrum Disorder","status":"RECRUITING","sponsor":"Daniel Coury","startDate":"2023-10-01","conditions":["ADHD","Autism Spectrum Disorder"],"enrollment":500,"completionDate":"2027-12-30"},{"nctId":"NCT04235686","phase":"PHASE2","title":"8 Week Multi-site Study of MYDAYIS® for Bipolar Depression","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2020-07-17","conditions":["Bipolar Depression"],"enrollment":74,"completionDate":"2025-07-25"},{"nctId":"NCT03945175","phase":"PHASE3","title":"Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2020-07-15","conditions":["Attention Deficit-Hyperactivity"],"enrollment":52,"completionDate":"2022-05-11"},{"nctId":"NCT00573859","phase":"PHASE1,PHASE2","title":"The Reinforcing Mechanisms of Smoking in Adult ADHD","status":"COMPLETED","sponsor":"University of California, Irvine","startDate":"2006-09","conditions":["ADHD"],"enrollment":27,"completionDate":"2010-06"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"NYU Langone Health","relationship":"Original Developer"}],"publicationCount":6,"therapeuticAreas":["Other"],"biosimilarFilings":[],"originalDeveloper":"NYU Langone Health","recentPublications":[{"date":"2026 Jan 6","pmid":"41495166","title":"Quantum and thermodynamic evaluation of C(24) fullerene-based nanosensors for detection of mydayis in biomedical and drug detection applications.","journal":"Scientific reports"},{"date":"2025 Sep 1","pmid":"40839413","title":"Drugs for ADHD.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2022 Nov 28","pmid":"36397191","title":"In brief: Alternatives to Adderall.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2020 Nov","pmid":"33185468","title":"A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.","journal":"Journal of child and adolescent psychopharmacology"},{"date":"2020 Jan 27","pmid":"31999670","title":"Drugs for ADHD.","journal":"The Medical letter on drugs and therapeutics"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"MYDAYIS","companyName":"NYU Langone Health","companyId":"nyu-langone-health","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}