{"id":"tianeptine","rwe":[{"pmid":"41843701","year":"2026","title":"Improving Cognition in Bipolar Disorder: A Systematic Review of Current Pharmacological and Nutraceutical Approaches.","finding":"","journal":"Neuropsychobiology","studyType":"Clinical Study"},{"pmid":"41796936","year":"2026","title":"Differential inhibition of the diverse behavioural effects of mu-opioid receptor agonists by progressive receptor depletion.","finding":"","journal":"Neuropharmacology","studyType":"Clinical Study"},{"pmid":"41630828","year":"2026","title":"μ Opioid Modulation of Sensorimotor Functional Connectivity in Autism: Insights From a Pharmacological Neuroimaging Investigation Using Tianeptine.","finding":"","journal":"Biological psychiatry global open science","studyType":"Clinical Study"},{"pmid":"41576265","year":"2026","title":"Prediction of 12-Week Remission in Patients With Depressive Disorder Using Reasoning-Based Large Language Models: Model Development and Validation Study.","finding":"","journal":"JMIR mental health","studyType":"Clinical Study"},{"pmid":"41469760","year":"2025","title":"Targeting Cend1-Atp5f1b interaction rescues mitochondrial dysfunction and ameliorates ischemic brain injury.","finding":"","journal":"Communications biology","studyType":"Clinical Study"}],"tags":[{"label":"tianeptine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Mu-type opioid receptor","category":"target"},{"label":"OPRM1","category":"gene"},{"label":"N06AX14","category":"atc"},{"label":"Active","category":"status"},{"label":"Pfizer Inc.","category":"company"},{"label":"Antidepressive Agents","category":"pharmacology"},{"label":"Antidepressive Agents, Tricyclic","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"}],"phase":"marketed","fdaNDC":[{"route":[],"labeler":"Quimica Sintetica S.A.","brandName":"","packaging":[{"ndc":"53069-0940-5","description":"1 kg in 1 DRUM (53069-0940-5)","marketingStartDate":"12-DEC-08"}],"dosageForm":"POWDER","genericName":"Tianeptine Sodium","productType":"BULK INGREDIENT","activeIngredients":[{"name":"TIANEPTINE SODIUM","strength":"1 kg/kg"}],"marketingCategory":"BULK INGREDIENT"}],"safety":{"safetySignals":[{"llr":137.846,"date":"","count":46,"signal":"Serotonin syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=138)"},{"llr":73.88,"date":"","count":38,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=74)"},{"llr":65.56,"date":"","count":33,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=66)"},{"llr":61.885,"date":"","count":42,"signal":"Overdose","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=62)"},{"llr":49.574,"date":"","count":15,"signal":"Stress cardiomyopathy","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=50)"},{"llr":42.563,"date":"","count":30,"signal":"Drug abuse","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=43)"}],"commonSideEffects":[{"effect":"Somnolence","drugRate":"7.9%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":38,"totalAffected":3,"trialsReporting":1},{"effect":"Headache","drugRate":"5.3%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":38,"totalAffected":2,"trialsReporting":1}],"seriousAdverseEvents":[{"event":"Depression worsening requiring hospitalization","detail":"Psychiatric disorders. 1 trial(s).","severity":"serious","incidence":"2.6%"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T23:00:07.510648+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:00:21.068602+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:00:31.876015+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1289110/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:00:14.524019+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:33.255167+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:00:13.141546+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:00:14.143467+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:33.255153+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:33.255150+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T12:48:15.910610+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:00:33.255059+00:00"}},"allNames":"coaxil","offLabel":[],"synonyms":["tianeptine monosodium","tianeptine sodium","stablon","tianeptine","coaxil"],"timeline":[],"aiSummary":"Tianeptine, marketed as Coaxil by Pfizer, currently holds no approved indications and has not conducted any clinical trials, positioning it outside the mainstream antidepressant market. Its unique mechanism of action, involving the mu-type opioid receptor, distinguishes it from key competitors such as tryptophan, nomifensine, trazodone, nefazodone, and viloxazine. A significant risk is the lack of clinical data and approved indications, which may limit its market potential and adoption by healthcare providers. The pipeline outlook remains uncertain due to the absence of ongoing clinical trials and the requirement for a PD-L1 companion diagnostic for several potential indications.","brandName":"Coaxil","ecosystem":[],"mechanism":{"target":"Mu-type opioid receptor","targets":[{"gene":"OPRM1","source":"DrugCentral","target":"Mu-type opioid receptor","protein":"Mu-type opioid receptor"}],"modality":"Small Molecule","drugClass":"tianeptine","explanation":"Imagine your brain has a special lockbox that controls how you feel pain and emotions. Tianeptine is a key that fits into this lockbox, which can help change how the lockbox works. This can lead to changes in how you feel pain and emotions, but it's not fully understood how it works.","oneSentence":"Tianeptine works by binding to the mu-type opioid receptor, which can affect the brain's response to pain and emotions.","technicalDetail":"Tianeptine acts as a partial agonist at the mu-type opioid receptor, which can lead to complex changes in the brain's reward and pain processing systems."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Tianeptine","title":"Tianeptine","extract":"Tianeptine, sold under the brand names Stablon, Tatinol, and Coaxil among others, is an atypical tricyclic antidepressant which is used mainly in the treatment of major depressive disorder, although it may also be used to treat anxiety, asthma, and irritable bowel syndrome.","wiki_history":"==History==\nTianeptine was introduced for medical use in France under the brand name Stablon in 1983.","wiki_society_and_culture":"==Society and culture==\nthumb|right|Stablon box and blister pack.\n\n===Approval and brand names===\nBrand names include:\n\n* Coaxil <small>(BG, CR, CZ, EE, HU, LT, LV, PL, RO, RU, SK UA)</small>\n* Salymbra <small>(EE)</small>\n* Stablon <small>(AR, AT, BR, FR, HK, IN, ID, MY, MX, PK, PT, SG, SK, TH, TT, TR, VE)</small>\n* Tatinol <small>(CN)</small>\n* Tianeurax <small>(DE)</small>\n* Tynept <small>(IN)</small>\n* Zinosal <small>(ES)</small>\n* Tianesal <small>(PL)</small>\n\n===Development===\nUnder the code names JNJ-39823277 and TPI-1062, tianeptine was previously under development for the treatment of major depressive disorder in the United States and Belgium. Phase I clinical trials were completed in Belgium and the United States in May and June 2009, respectively. An ongoing clinical trial, sponsored by the New York Psychiatric Institute, is examining tianeptine's use in treatment-resistant depression.\n\nU.S. National Poison Data System data on tianeptine showed a nationwide increase in tianeptine exposure calls and calls related to abuse and misuse during 2014–2017.\n\nBetween 1989 and 2004, in France 141 cases of recreational use were identified, correlating to an incidence of 1 to 3 cases per 1000 persons treated with tianeptine and 45 between 2006 and 2011. According to Servier, stopping of treatment with tianeptine is difficult, due to the possibility of withdrawal symptoms. The severity of the withdrawal is dependent on the daily dose, with high doses being extremely difficult to quit. An official DEA statement states that the withdrawal symptoms in humans typically result in: agitation, nausea, vomiting, tachycardia, hypertension, diarrhea, tremor, and diaphoresis, similar to other opioid drugs.\n\nIn 2007, according to French Health Products Safety Agency, tianeptine's manufacturer Servier agreed to modify the drug's label, following problems with dependency.\n\nTianeptine has been intravenously injected by drug users in Russia. This method of administration reportedly c"},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1289110","maxPhase":"3.0","chirality":0,"parenteral":false,"availability":null,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":1,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{},"fdaRecalls":[],"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2650","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=tianeptine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tianeptine","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Tianeptine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T07:00:29.633174","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T12:48:23.724363+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"tryptophan","drugSlug":"tryptophan","fdaApproval":"","relationship":"same-class"},{"drugName":"nomifensine","drugSlug":"nomifensine","fdaApproval":"","relationship":"same-class"},{"drugName":"trazodone","drugSlug":"trazodone","fdaApproval":"1981-12-24","patentExpiry":"Mar 27, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"nefazodone","drugSlug":"nefazodone","fdaApproval":"1994-12-22","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"viloxazine","drugSlug":"viloxazine","fdaApproval":"2021-04-02","patentExpiry":"Sep 4, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"mirtazapine","drugSlug":"mirtazapine","fdaApproval":"1996-06-14","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"bupropion","drugSlug":"bupropion","fdaApproval":"1985-12-30","patentExpiry":"Jun 27, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"venlafaxine","drugSlug":"venlafaxine","fdaApproval":"1993-12-28","genericCount":41,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"milnacipran","drugSlug":"milnacipran","fdaApproval":"2009-01-14","patentExpiry":"Sep 19, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"duloxetine","drugSlug":"duloxetine","fdaApproval":"2004-08-03","patentExpiry":"Apr 13, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"desvenlafaxine","drugSlug":"desvenlafaxine","fdaApproval":"2008-02-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"vilazodone","drugSlug":"vilazodone","fdaApproval":"2011-01-21","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"vortioxetine","drugSlug":"vortioxetine","fdaApproval":"2013-09-30","patentExpiry":"Sep 21, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"esketamine","drugSlug":"esketamine","fdaApproval":"2019-05-03","patentExpiry":"Sep 10, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levomilnacipran","drugSlug":"levomilnacipran","fdaApproval":"2013-07-25","patentExpiry":"May 23, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"brexanolone","drugSlug":"brexanolone","fdaApproval":"2019-03-19","patentExpiry":"Nov 27, 2033","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"tianeptine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"tryptophan","brandName":"tryptophan","genericName":"tryptophan","approvalYear":"","relationship":"same-class"},{"drugId":"nomifensine","brandName":"nomifensine","genericName":"nomifensine","approvalYear":"","relationship":"same-class"},{"drugId":"trazodone","brandName":"trazodone","genericName":"trazodone","approvalYear":"1981","relationship":"same-class"},{"drugId":"nefazodone","brandName":"nefazodone","genericName":"nefazodone","approvalYear":"1994","relationship":"same-class"},{"drugId":"viloxazine","brandName":"viloxazine","genericName":"viloxazine","approvalYear":"2021","relationship":"same-class"},{"drugId":"mirtazapine","brandName":"mirtazapine","genericName":"mirtazapine","approvalYear":"1996","relationship":"same-class"},{"drugId":"bupropion","brandName":"bupropion","genericName":"bupropion","approvalYear":"1985","relationship":"same-class"},{"drugId":"venlafaxine","brandName":"venlafaxine","genericName":"venlafaxine","approvalYear":"1993","relationship":"same-class"},{"drugId":"milnacipran","brandName":"milnacipran","genericName":"milnacipran","approvalYear":"2009","relationship":"same-class"},{"drugId":"duloxetine","brandName":"duloxetine","genericName":"duloxetine","approvalYear":"2004","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04249596","phase":"PHASE4","title":"Tianeptine for Treatment Resistant Depression","status":"","acronym":null,"sponsor":"Jonathan A. Javitch, MD, PhD","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":38,"indication":"Treatment Resistant Depression","endpointCount":3,"primaryPValue":"","completionDate":"","primaryEndpoint":"Hamilton Rating Scale for Depression, 24-item (HAMD-24)"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"NDDF":"005515","UNII":"0T493YFU8O","CHEBI":"CHEBI:91749","INN_ID":"4906","RXNORM":"38252","UMLSCUI":"C0076652","chemblId":"CHEMBL1289110","ChEMBL_ID":"CHEMBL1289110","KEGG_DRUG":"D02575","DRUGBANK_ID":"DB09289","PUBCHEM_CID":"68870","SNOMEDCT_US":"1172815007","IUPHAR_LIGAND_ID":"7558","SECONDARY_CAS_RN":"30123-17-2","MESH_SUPPLEMENTAL_RECORD_UI":"C050504"},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Pfizer","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"1.4 hours","clearance":"2.8 mL/min/kg","bioavailability":"99%","fractionUnbound":"0.05%","volumeOfDistribution":"0.3 L/kg"},"publicationCount":640,"therapeuticAreas":["Pain"],"atcClassification":{"source":"DrugCentral","atcCode":"N06AX14","allCodes":["N06AX14"]},"biosimilarFilings":[],"recentPublications":[{"pmid":"41956239","title":"The atypical antidepressant tianeptine causes opioid-receptor-dependent beta oscillations in the rat hippocampus.","authors":"Burt SG, Phillips GD, Lambert JJ, Martin SJ","journal":"Neuropharmacology","pubDate":"2026 Apr 7"},{"pmid":"41630828","title":"μ Opioid Modulation of Sensorimotor Functional Connectivity in Autism: Insights From a Pharmacological Neuroimaging Investigation Using Tianeptine.","authors":"Dimitrov M, Wong NML, Leaman S, França LGS, Valasakis I","journal":"Biol Psychiatry Glob Open Sci","pubDate":"2026 Mar"},{"pmid":"41136982","title":"Gas station heroin- tianeptine and its impact: a systematic review and exploratory analysis.","authors":"Parnia S, Jain L, Ali M, Sarfraz Z, Nasir MJ","journal":"BMC Public Health","pubDate":"2025 Oct 24"},{"pmid":"41132482","title":"Gas Station Heroin: A Case Report of Tianeptine Use Disorder and a Literature Review.","authors":"Kandra K, Gajagowni R, Fernandez GA, Polechonski N, Blewett BP","journal":"Cureus","pubDate":"2025 Oct"},{"pmid":"41127130","title":"Concomitant Tianeptine and Alcohol Use Disorders: Diagnosis and Treatment with Buprenorphine-Naloxone.","authors":"Krause Q, Sieger ML, Sethi R","journal":"Kans J Med","pubDate":"2025 Sep-Oct"},{"pmid":"41084181","title":"Tianeptine Products: Public Health Threat or Niche Substance use?","authors":"Smith KE, Hill K, Bergeria CL, Strickland JC","journal":"J Psychoactive Drugs","pubDate":"2025 Oct 13"},{"pmid":"40750657","title":"The molecular mechanism of the protective effect of tianeptine against ovarian ischemia-reperfusion injury.","authors":"Kalkan B, Yavuzer B, Aliyev A, Cakir OK, Gozen F","journal":"Sci Rep","pubDate":"2025 Aug 1"},{"pmid":"40722762","title":"Investigation into the Effects of Tramadol, Citalopram, Tianeptine, and Their Combinations on Rat Brain Tissue.","authors":"Ates I, Isik B, Gozen F, Yazici GN, Gulaboglu M","journal":"Biomedicines","pubDate":"2025 Jul 10"},{"pmid":"40339337","title":"Tianeptine: enantiomeric separations, structural assignment, and biological interactions.","authors":"Aslani S, Nafie J, Wahab MF, Armstrong DW","journal":"Talanta","pubDate":"2025 Nov 1"},{"pmid":"40280952","title":"Effects of tianeptine on mTORC1-mediated neuronal autophagy in primary rat hippocampal neurons under nutrient deprivation.","authors":"Seo MK, Kim H, Choi AJ, Seog DH, Kho WG","journal":"Sci Rep","pubDate":"2025 Apr 25"}],"participantFlowData":[{"nctId":"NCT04249596","groups":[{"id":"FG000","title":"Tianeptine Sodium 12.5mg TID Treatment","description":"Open-label tianeptine sodium 12.5mg three times daily for 8 weeks"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"38"}},{"type":"COMPLETED","counts":{"FG000":"30"}},{"type":"NOT COMPLETED","counts":{"FG000":"8"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"5"}},{"type":"Lost to Follow-up","counts":{"FG000":"3"}}]}],"recruitment":"Participants were recruited from outpatient clinics at three academic medical centers: New York State Psychiatric Institute, Icahn School of Medicine at Mount Sinai, and Stanford University. Recruitment occurred from October 2020 to August 2024. Study was terminated early due to inadequate recruitment (38 of 75 target enrolled).","preAssignment":"Baseline assessments (HAMD-24, ARSQ) were performed prior to treatment initiation. Participants on antidepressants completed a taper period before baseline. Some participants who consented did not initiate treatment due to screen failure, consent withdrawal, or loss to follow-up during the screening period. Per protocol, enrollment was defined as initiation of study medication; participants who did not receive study drug were not considered enrolled."}],"companionDiagnostics":[],"structuredTrialResults":[{"nctId":"NCT04249596","phase":"PHASE4","title":"Tianeptine for Treatment Resistant Depression","acronym":null,"sponsor":"Jonathan A. Javitch, MD, PhD","isPivotal":false,"conditions":["Treatment Resistant Depression"],"enrollment":38,"otherEndpoints":[],"primaryEndpoints":[{"type":"PRIMARY","title":"Hamilton Rating Scale for Depression, 24-item (HAMD-24)","results":[{"value":"-5.2","spread":"9.8","groupId":"OG000","groupTitle":"Tianeptine Sodium 12.5mg TID Treatment","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"MEAN","timeFrame":"8 weeks","description":"Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.","unitOfMeasure":"units on a scale","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Response Rate","results":[{"value":"7","spread":"","groupId":"OG000","groupTitle":"Tianeptine Sodium 12.5mg TID Treatment","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"8 weeks","description":"Proportion of participants achieving ≥50% reduction in HAMD-24 score from baseline","unitOfMeasure":"Participants","reportingStatus":"POSTED"},{"type":"SECONDARY","title":"Remission Rate","results":[{"value":"6","spread":"","groupId":"OG000","groupTitle":"Tianeptine Sodium 12.5mg TID Treatment","lowerLimit":"","upperLimit":""}],"analyses":[],"paramType":"COUNT_OF_PARTICIPANTS","timeFrame":"8 weeks","description":"Proportion of participants achieving HAMD-24 score ≤10 at Week 8","unitOfMeasure":"Participants","reportingStatus":"POSTED"}]}],"genericManufacturerList":[],"status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Small Molecule","firstApprovalDate":"","enrichmentLevel":5,"visitCount":9,"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},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T12:48:23.724363+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}