{"id":"dmae","rwe":[{"pmid":"41796714","year":"2026","title":"In vitro inhibition of monoamine transport by amphetamine-like pre-workout supplement ingredients.","finding":"","journal":"Toxicology","studyType":"Clinical Study"},{"pmid":"41754727","year":"2026","title":"Polymer Gels Exhibiting High Pressure-Sensitive Adhesion to Polytetrafluoroethylene.","finding":"","journal":"Polymers","studyType":"Clinical Study"},{"pmid":"41486948","year":"2026","title":"A Topical Cosmeceutical Approach to Submental Fullness in Indian Women: 12-Week Prospective Study.","finding":"","journal":"Journal of cosmetic dermatology","studyType":"Clinical Study"},{"pmid":"40882038","year":"2025","title":"Ammonia Uptake from Ambient Air by Protonic Layered Metal Oxide as a Cause of the Gradual Degradation of Its Swelling Reactivity.","finding":"","journal":"Langmuir : the ACS journal of surfaces and colloids","studyType":"Clinical Study"},{"pmid":"40601454","year":"2025","title":"DMAE-EEG: A Pretraining Framework for EEG Spatiotemporal Representation Learning.","finding":"","journal":"IEEE transactions on neural networks and learning systems","studyType":"Clinical Study"}],"_fda":{"id":"67784bc4-bd5f-4fde-bee6-3e4282ff3fc0","set_id":"1984c58a-ea99-4c29-a026-6537f3828e89","openfda":{"unii":["2N6K9DRA24"],"route":["ORAL"],"spl_id":["67784bc4-bd5f-4fde-bee6-3e4282ff3fc0"],"brand_name":["DMAE 1549"],"spl_set_id":["1984c58a-ea99-4c29-a026-6537f3828e89"],"package_ndc":["63083-1549-1"],"product_ndc":["63083-1549"],"generic_name":["DMAE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["DEANOL"],"manufacturer_name":["Professional Complementary Health Formulas"],"is_original_packager":[true]},"purpose":["*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"version":"2","warnings":["WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use."],"questions":["QUESTIONS Professional Formulas PO Box 2034 Lake Oswego, OR 97035"],"effective_time":"20260108","active_ingredient":["ACTIVE INGREDIENTS Dimethylaminoethanol (DMAE) 9X, 12X, 30X, 60X"],"inactive_ingredient":["INACTIVE INGREDIENTS 20% ethanol, purified water."],"indications_and_usage":["INDICATIONS For the temporary relief of gas, bloating, occasional headache, insomnia, or irritability due to sensitivity to phenolic compounds found in foods or other products.*"],"other_safety_information":["OTHER INFORMATION Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat."],"dosage_and_administration":["DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age."],"spl_product_data_elements":["DMAE 1549 DMAE DEANOL DEANOL ALCOHOL WATER"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a healthcare professional before use."],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"package_label_principal_display_panel":["LABEL Est 1985 Professional Formulas Complementary Health DMAE Homeopathic Remedy 1 FL. OZ. (29.5 mL) Label image"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Oral","category":"route"},{"label":"Active","category":"status"},{"label":"bloating","category":"indication"},{"label":"headache","category":"indication"},{"label":"insomnia","category":"indication"},{"label":"irritability","category":"indication"},{"label":"Professional Complementary Health Formulas","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"DISTURBANCE IN ATTENTION","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"FEELING ABNORMAL","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"INFECTION","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"AMNESIA","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"AMPHETAMINES POSITIVE","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ARTHRITIS","source":"FDA FAERS","actionTaken":"2 reports"}]},"trials":[],"aliases":[],"company":"Professional Complementary Health Formulas","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DMAE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:49:43.844663+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:49:52.426552+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DMAE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:49:53.111736+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:42.575974+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:42.576008+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:49:54.610802+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1135/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:49:53.850179+00:00"}},"allNames":"dmae 1549","offLabel":[],"synonyms":["Dmae 1549","DEANOL"],"timeline":[],"approvals":[],"brandName":"Dmae 1549","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Dmae 1549 is believed to act as a mitochondrial stimulant, increasing the production of ATP (adenosine triphosphate) and enhancing the function of the electron transport chain, which is essential for cellular energy production."},"commercial":{},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"DMAE\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=dmae","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=dmae","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:31:59.237292","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:49:55.899671+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"dmae","indications":{"approved":[{"name":"bloating","source":"OpenFDA Label","regulator":"FDA"},{"name":"headache","source":"OpenFDA Label","regulator":"FDA"},{"name":"insomnia","source":"OpenFDA Label","regulator":"FDA"},{"name":"irritability","source":"OpenFDA Label","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07477288","phase":"PHASE2","title":"Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging","status":"COMPLETED","sponsor":"Hasanuddin University","startDate":"2025-03-12","conditions":["Skin Aging"],"enrollment":44,"completionDate":"2025-12-29"},{"nctId":"NCT07255560","phase":"NA","title":"DMAE Oleate for Facial Skin Firmness and Fine Lines in Healthy Adults","status":"COMPLETED","sponsor":"Bionos Biotech S.L.","startDate":"2025-09-09","conditions":["Skin Aging of Face and Hands","Facial Wrinkles - Rough Texture - Hyperpigmentation","Skin Laxity"],"enrollment":30,"completionDate":"2025-12-23"},{"nctId":"NCT02181959","phase":"PHASE2","title":"Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"1998-12","conditions":["Healthy"],"enrollment":138,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral"},"crossReferences":{"UNII":"2N6K9DRA24","SPL_ID":"67784bc4-bd5f-4fde-bee6-3e4282ff3fc0","chemblId":"CHEMBL1135"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Professional Complementary Health Formulas","relationship":"Original Developer"}],"publicationCount":216,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"originalDeveloper":"Professional Complementary Health Formulas","recentPublications":[{"date":"2026 Mar 6","pmid":"41796714","title":"In vitro inhibition of monoamine transport by amphetamine-like pre-workout supplement ingredients.","journal":"Toxicology"},{"date":"2026 Feb 22","pmid":"41754727","title":"Polymer Gels Exhibiting High Pressure-Sensitive Adhesion to Polytetrafluoroethylene.","journal":"Polymers"},{"date":"2026 Jan","pmid":"41486948","title":"A Topical Cosmeceutical Approach to Submental Fullness in Indian Women: 12-Week Prospective Study.","journal":"Journal of cosmetic dermatology"},{"date":"2025 Sep 16","pmid":"40882038","title":"Ammonia Uptake from Ambient Air by Protonic Layered Metal Oxide as a Cause of the Gradual Degradation of Its Swelling Reactivity.","journal":"Langmuir : the ACS journal of surfaces and colloids"},{"date":"2025 Oct","pmid":"40601454","title":"DMAE-EEG: A Pretraining Framework for EEG Spatiotemporal Representation Learning.","journal":"IEEE transactions on neural networks and learning systems"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Professional Complementary Health Formulas","companyId":"professional-complementary-health-formulas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:49:55.899671+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}