{"shortAnswer":"Tesofensine has no approved use in the US, and FDA says pharmacies may not use it to make drugs. The evidence grade is moderate-human. A trial in obese adults found weight loss over 24 weeks. But a journal later raised concern about that trial, and no larger trial has results in our sources.","url":"https://peptideindex.ai/compound/tesofensine","status":"no-approved-use","statusCheckedAt":"2026-10-26T13:39:12.998Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:39:13.025Z","primarySourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"c0c3dfbd-3699-4ea8-ab8e-90b6d72f8ec8","object":"compound","slug":"tesofensine","name":"Tesofensine","attrs":{"name":"Tesofensine","class":"non-peptide","access":[{"type":"none","detail":"There is no legal route to tesofensine in the US today. FDA says pharmacies may not use it to make drugs.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"}],"trials":[],"aliases":["NS-2330"],"summary":"A pill that blocks the brain from taking back three chemical messengers. It was tested as a drug for obesity.","citations":[{"n":1,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","tier":"primary","type":"regulatory","title":"FDA warning letter to a drug ingredient company that sent tesofensine to pharmacies, 8 December 2025"},{"n":2,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":3,"url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804320","tier":"primary","type":"regulatory","title":"FDA orphan drug record: tesofensine plus metoprolol for Prader-Willi syndrome, designated 2021"},{"n":4,"url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804220","tier":"primary","type":"regulatory","title":"FDA orphan drug record: tesofensine plus metoprolol for hypothalamic obesity, designated 2021"},{"n":5,"url":"https://pubmed.ncbi.nlm.nih.gov/18950853/","tier":"peer-reviewed","type":"rct","title":"Tesofensine and weight loss in obese adults, a 24-week trial, 2008"},{"n":6,"url":"https://pubmed.ncbi.nlm.nih.gov/23561987/","tier":"peer-reviewed","type":"reference","title":"The Lancet: expression of concern about the 2008 tesofensine trial, 2013"},{"n":7,"url":"https://pubmed.ncbi.nlm.nih.gov/20479765/","tier":"peer-reviewed","type":"rct","title":"Tesofensine, energy use and appetite in overweight and obese men, 2010"},{"n":8,"url":"https://pubmed.ncbi.nlm.nih.gov/21720440/","tier":"peer-reviewed","type":"rct","title":"Tesofensine and the feeling of fullness over time, 2012"},{"n":9,"url":"https://pubmed.ncbi.nlm.nih.gov/35294397/","tier":"peer-reviewed","type":"rct","title":"Tesofensine with metoprolol in adults with hypothalamic obesity, 2022"},{"n":10,"url":"https://pubmed.ncbi.nlm.nih.gov/23932919/","tier":"peer-reviewed","type":"animal","title":"Tesofensine, appetite and brain dopamine in obese rats, 2013"},{"n":11,"url":"https://pubmed.ncbi.nlm.nih.gov/21889317/","tier":"peer-reviewed","type":"animal","title":"Tesofensine, food intake and dopamine receptors in obese rats, 2012"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/19777399/","tier":"peer-reviewed","type":"reference","title":"Review: tesofensine as a drug for obesity, 2009"},{"n":13,"url":"https://clinicaltrials.gov/study/NCT00394667","tier":"primary","type":"reference","title":"ClinicalTrials.gov: tesofensine for weight loss in obesity, Denmark, started 2006"},{"n":14,"url":"https://clinicaltrials.gov/study/NCT00481104","tier":"primary","type":"reference","title":"ClinicalTrials.gov: long-term safety of tesofensine in obesity, Denmark, started 2007"},{"n":15,"url":"https://clinicaltrials.gov/study/NCT03845075","tier":"primary","type":"reference","title":"ClinicalTrials.gov: tesofensine with metoprolol in obesity after hypothalamic injury, Denmark, started 2019"},{"n":16,"url":"https://6abc.com/archive/6466750","tier":"established-news","type":"reference","title":"6abc News: a Danish trial of tesofensine for obesity, 2008"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/42320973/","tier":"peer-reviewed","type":"human-trial","title":"How the body breaks down and clears tesofensine, in six volunteers, 2026"}],"known_risks":["In the main trial, tesofensine raised heart rate. Dry mouth, nausea, constipation, diarrhea and trouble sleeping were common [^5].","A 2009 review says heart rate rose more as the amount given rose. Blood pressure rose at the highest amount tested [^12].","In a small trial of tesofensine with metoprolol, one person's anxiety got worse, and they stopped. Sleep problems, dry mouth and headache were more common than on a dummy pill [^9].","FDA found that a company that sent tesofensine to pharmacies did not check its suppliers well. FDA said the drug ingredients it handled were adulterated [^1].","A news report on the main trial says people lost lean body mass, not only fat [^16]."],"short_answer":"Tesofensine has no approved use in the US, and FDA says pharmacies may not use it to make drugs. The evidence grade is moderate-human. A trial in obese adults found weight loss over 24 weeks. But a journal later raised concern about that trial, and no larger trial has results in our sources.","evidence_grade":"moderate-human","open_questions":["In 2013, the journal that published the main trial raised an expression of concern about it. The record we hold does not say why [^6].","The trial's authors said larger, late-stage trials must confirm their results. Our sources hold no results from such trials [^5].","Nobody knows if the weight stays off. In one trial, the feeling of fullness faded over time and went away after people stopped [^8].","The longest controlled trials in our sources lasted 24 weeks. Nobody knows what years of use do [^5] [^9].","How tesofensine leads to weight loss in people is unclear. The brain dopamine results come from rats [^7] [^10] [^11]."],"section_routes":"No pharmacy may lawfully make tesofensine, and FDA has approved no use of it [^1] [^3]. There is no legal route to it in the US today.\n\nThe three studies of it in our sources took place in Denmark and ended by 2020 [^13] [^14] [^15]. Any open trial appears in the trials block below, with the date the official registry was last checked.","regulatory_as_of":"2026-10-26","section_channels":"One way of getting tesofensine shows up in federal records: pharmacies that make it although the law does not allow it [^1]. In December 2025, FDA sent a warning letter to a Florida company that sells drug ingredients [^1]. FDA says the company sent tesofensine to pharmacies that wanted to make drugs from it [^1]. FDA says tesofensine may not be used that way, so the company broke federal law [^1].\n\nFDA also found the company did not check its suppliers well [^1]. It said the drug ingredients the company handled were adulterated [^1]. Adulterated means not made under the quality rules the law requires [^1]. Our sources hold no federal record of other ways tesofensine reaches people.","section_evidence":"The evidence grade is moderate-human: one controlled trial in obese adults, published in full, found more weight loss than a dummy pill over 24 weeks [^5]. That trial later drew an expression of concern from its journal, so the main result is in question [^6].\n\nIn that trial, 203 obese adults in Denmark went on a low-calorie diet [^5]. They took tesofensine or a dummy pill for 24 weeks [^5]. People on tesofensine lost between 4.5% and 10.6% of their weight, against 2.0% on the dummy pill [^5]. The authors said larger trials must confirm the results [^5].\n\nIn 32 overweight or obese men, two weeks of tesofensine cut appetite [^7]. They lost 1.8 kg more than men on a dummy pill [^7]. In another trial, tesofensine made people feel fuller, but the effect faded as weight came off [^8]. In 21 adults with hypothalamic obesity, tesofensine with metoprolol led to 6.3% more weight loss than a dummy pill over 24 weeks [^9]. That trial was small, and its main goal was to look for harms [^9].\n\nIn obese rats, tesofensine cut food intake and weight and changed brain dopamine [^10] [^11]. When the rats stopped it, they ate more and gained weight again [^11]. These are animal results, not results in people.","regulatory_status":"no-approved-use","section_what_it_is":"Tesofensine is a drug taken by mouth [^12]. It blocks the brain from taking back three chemical messengers: noradrenaline, dopamine and serotonin [^5]. Chemical messengers carry signals between nerve cells. It is also called NS-2330 [^17].\n\nA drug company first tested it for brain diseases such as Alzheimer's disease [^12] [^16]. It did not help them, but some people lost weight they did not mean to lose [^12]. The company then tested it as a pill for obesity [^12]. A later company tested it combined with another drug, metoprolol, for rare kinds of obesity [^3] [^9]. One of these is hypothalamic obesity: fast weight gain after injury to the hypothalamus, a part of the brain [^9].","section_is_it_legal":"Tesofensine has no approved use in the US: FDA says it is not eligible for use in pharmacy compounding [^1]. That means no pharmacy may lawfully make drugs from it. It does not mean a seller may offer it for people, and FDA says a company that sent it to pharmacies broke federal law [^1]. Checked 26 October 2026.\n\nA pharmacy may make a drug from a bulk ingredient only in three cases [^2]. The ingredient has an official quality standard, is part of an FDA-approved drug, or is on a list FDA keeps [^2]. FDA's 2025 letter puts tesofensine among ingredients that are not eligible [^1].\n\nIn 2021, FDA gave orphan drug status to tesofensine combined with metoprolol [^3] [^4]. Orphan status marks a drug being developed for a rare disease [^3]. The two uses were Prader-Willi syndrome and hypothalamic obesity [^3] [^4]. That is not approval: both FDA records say the combination is not approved for these uses [^3] [^4].\n\nA 2009 review says FDA backed plans for larger obesity trials of tesofensine [^12]. A 2008 news report says its maker was seeking approval in the US and Europe [^16]. Backing a trial plan, or seeking approval, is not approval.","unofficial_channels":[{"type":"compounding-outside-the-rules","what_it_is":"Made by a pharmacy from bulk tesofensine sent by a drug ingredient company, although it may not be used in pharmacy compounding.","enforcement":[{"date":"2025-12-08","text":"FDA warning letter to a Florida drug ingredient company that sent tesofensine and other ingredients to compounding pharmacies.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"}],"legal_position":{"text":"FDA says tesofensine is not eligible for use in pharmacy compounding. A company that sends it to pharmacies for that use breaks federal law.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},"documented_risks":[{"text":"FDA found that a company that sent tesofensine to pharmacies did not check its suppliers well, and said its drug ingredients were adulterated.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},{"text":"In a trial in obese adults, tesofensine raised heart rate, and dry mouth, nausea and trouble sleeping were common.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18950853/"}]}]},"provenance":{"name":{"fact_id":"4b007dc6-9926-4a9e-b7dd-7378f302c2e4","source_url":"https://pubmed.ncbi.nlm.nih.gov/19777399/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:28.795Z","checked_at":"2026-10-26T13:39:13.009Z","confidence":1,"stale":false},"class":{"fact_id":"3bd8c39e-eb94-4410-9ef1-a306ff3ef0f9","source_url":"https://pubmed.ncbi.nlm.nih.gov/19777399/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:28.795Z","checked_at":"2026-10-26T13:39:12.990Z","confidence":1,"stale":false},"access":{"fact_id":"575ccdb5-d4df-4212-82ce-d1273c5e5ce3","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:12.978Z","confidence":1,"stale":false},"trials":{"fact_id":"10d955e1-53e4-479a-9d47-87f78423006c","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=tesofensine&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","source_type":"primary","captured_at":"2026-10-26T13:39:38.711Z","checked_at":"2026-10-26T13:39:38.711Z","confidence":1,"stale":false},"aliases":{"fact_id":"8a48897a-f41e-488c-8987-aaad9faee062","source_url":"https://pubmed.ncbi.nlm.nih.gov/42320973/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:18:55.590Z","checked_at":"2026-10-26T13:39:13.012Z","confidence":1,"stale":false},"summary":{"fact_id":"279a7dc7-6b6e-4289-87b0-45a52dc1c716","source_url":"https://pubmed.ncbi.nlm.nih.gov/19777399/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:28.795Z","checked_at":"2026-10-26T13:39:13.007Z","confidence":1,"stale":false},"citations":{"fact_id":"c2a3394f-360f-44c6-902f-962405459e83","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:13.025Z","confidence":1,"stale":false},"known_risks":{"fact_id":"65e92064-546b-4621-905e-dae249d8d8a8","source_url":"https://pubmed.ncbi.nlm.nih.gov/18950853/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:23.555Z","checked_at":"2026-10-26T13:39:13.014Z","confidence":1,"stale":false},"short_answer":{"fact_id":"a8cd5179-2457-4409-8e10-92d121412938","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T13:39:13.011Z","confidence":1,"stale":false,"label":"our assessment"},"evidence_grade":{"fact_id":"875d8297-1e64-4849-888d-66d827d4b326","source_url":"https://peptideindex.ai/methodology#evidence-grade","source_type":"reference","captured_at":"2026-10-25T00:14:45.193Z","checked_at":"2026-10-26T13:39:12.993Z","confidence":1,"stale":false,"label":"our assessment"},"open_questions":{"fact_id":"38d0bdab-11c1-4eea-9cf7-70a1091d63f8","source_url":"https://pubmed.ncbi.nlm.nih.gov/18950853/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:23.555Z","checked_at":"2026-10-26T13:39:13.015Z","confidence":1,"stale":false},"section_routes":{"fact_id":"282dff88-2a35-43d2-b27b-0e5b3e00754a","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:13.020Z","confidence":1,"stale":false},"regulatory_as_of":{"fact_id":"fbc32b45-07c0-446e-8501-e6347c3d2552","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:12.995Z","confidence":1,"stale":false},"section_channels":{"fact_id":"b173dc84-eda8-4aa0-a345-df7cb275cf99","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:13.021Z","confidence":1,"stale":false},"section_evidence":{"fact_id":"712d0b42-146c-4392-922b-121b153dc18b","source_url":"https://pubmed.ncbi.nlm.nih.gov/18950853/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:23.555Z","checked_at":"2026-10-26T13:39:13.019Z","confidence":1,"stale":false},"regulatory_status":{"fact_id":"75b1170d-f14e-4d7e-9caf-eeac6cb6a35c","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:12.998Z","confidence":1,"stale":false},"section_what_it_is":{"fact_id":"dcc93d04-4a89-4610-9ee2-d3b0d654172c","source_url":"https://pubmed.ncbi.nlm.nih.gov/19777399/","source_type":"peer-reviewed","captured_at":"2026-10-26T09:11:28.795Z","checked_at":"2026-10-26T13:39:13.002Z","confidence":1,"stale":false},"section_is_it_legal":{"fact_id":"e254ce47-33b2-4bb6-8e05-52abb2992ba6","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:13.017Z","confidence":1,"stale":false},"unofficial_channels":{"fact_id":"68383f4c-d217-4cec-9ea2-04dbe9e8d11d","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","source_type":"primary","captured_at":"2026-10-26T09:10:52.562Z","checked_at":"2026-10-26T13:39:13.023Z","confidence":1,"stale":false}},"citationsBySection":{"known_risks":[{"n":5,"title":"Tesofensine and weight loss in obese adults, a 24-week trial, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/18950853/"},{"n":12,"title":"Review: tesofensine as a drug for obesity, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19777399/"},{"n":9,"title":"Tesofensine with metoprolol in adults with hypothalamic obesity, 2022","url":"https://pubmed.ncbi.nlm.nih.gov/35294397/"},{"n":1,"title":"FDA warning letter to a drug ingredient company that sent tesofensine to pharmacies, 8 December 2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},{"n":16,"title":"6abc News: a Danish trial of tesofensine for obesity, 2008","url":"https://6abc.com/archive/6466750"}],"open_questions":[{"n":6,"title":"The Lancet: expression of concern about the 2008 tesofensine trial, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23561987/"},{"n":5,"title":"Tesofensine and weight loss in obese adults, a 24-week trial, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/18950853/"},{"n":8,"title":"Tesofensine and the feeling of fullness over time, 2012","url":"https://pubmed.ncbi.nlm.nih.gov/21720440/"},{"n":9,"title":"Tesofensine with metoprolol in adults with hypothalamic obesity, 2022","url":"https://pubmed.ncbi.nlm.nih.gov/35294397/"},{"n":7,"title":"Tesofensine, energy use and appetite in overweight and obese men, 2010","url":"https://pubmed.ncbi.nlm.nih.gov/20479765/"},{"n":10,"title":"Tesofensine, appetite and brain dopamine in obese rats, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23932919/"},{"n":11,"title":"Tesofensine, food intake and dopamine receptors in obese rats, 2012","url":"https://pubmed.ncbi.nlm.nih.gov/21889317/"}],"section_routes":[{"n":1,"title":"FDA warning letter to a drug ingredient company that sent tesofensine to pharmacies, 8 December 2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},{"n":3,"title":"FDA orphan drug record: tesofensine plus metoprolol for Prader-Willi syndrome, designated 2021","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804320"},{"n":13,"title":"ClinicalTrials.gov: tesofensine for weight loss in obesity, Denmark, started 2006","url":"https://clinicaltrials.gov/study/NCT00394667"},{"n":14,"title":"ClinicalTrials.gov: long-term safety of tesofensine in obesity, Denmark, started 2007","url":"https://clinicaltrials.gov/study/NCT00481104"},{"n":15,"title":"ClinicalTrials.gov: tesofensine with metoprolol in obesity after hypothalamic injury, Denmark, started 2019","url":"https://clinicaltrials.gov/study/NCT03845075"}],"section_channels":[{"n":1,"title":"FDA warning letter to a drug ingredient company that sent tesofensine to pharmacies, 8 December 2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"}],"section_evidence":[{"n":5,"title":"Tesofensine and weight loss in obese adults, a 24-week trial, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/18950853/"},{"n":6,"title":"The Lancet: expression of concern about the 2008 tesofensine trial, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23561987/"},{"n":7,"title":"Tesofensine, energy use and appetite in overweight and obese men, 2010","url":"https://pubmed.ncbi.nlm.nih.gov/20479765/"},{"n":8,"title":"Tesofensine and the feeling of fullness over time, 2012","url":"https://pubmed.ncbi.nlm.nih.gov/21720440/"},{"n":9,"title":"Tesofensine with metoprolol in adults with hypothalamic obesity, 2022","url":"https://pubmed.ncbi.nlm.nih.gov/35294397/"},{"n":10,"title":"Tesofensine, appetite and brain dopamine in obese rats, 2013","url":"https://pubmed.ncbi.nlm.nih.gov/23932919/"},{"n":11,"title":"Tesofensine, food intake and dopamine receptors in obese rats, 2012","url":"https://pubmed.ncbi.nlm.nih.gov/21889317/"}],"section_what_it_is":[{"n":12,"title":"Review: tesofensine as a drug for obesity, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19777399/"},{"n":5,"title":"Tesofensine and weight loss in obese adults, a 24-week trial, 2008","url":"https://pubmed.ncbi.nlm.nih.gov/18950853/"},{"n":17,"title":"How the body breaks down and clears tesofensine, in six volunteers, 2026","url":"https://pubmed.ncbi.nlm.nih.gov/42320973/"},{"n":16,"title":"6abc News: a Danish trial of tesofensine for obesity, 2008","url":"https://6abc.com/archive/6466750"},{"n":3,"title":"FDA orphan drug record: tesofensine plus metoprolol for Prader-Willi syndrome, designated 2021","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804320"},{"n":9,"title":"Tesofensine with metoprolol in adults with hypothalamic obesity, 2022","url":"https://pubmed.ncbi.nlm.nih.gov/35294397/"}],"section_is_it_legal":[{"n":1,"title":"FDA warning letter to a drug ingredient company that sent tesofensine to pharmacies, 8 December 2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},{"n":2,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":3,"title":"FDA orphan drug record: tesofensine plus metoprolol for Prader-Willi syndrome, designated 2021","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804320"},{"n":4,"title":"FDA orphan drug record: tesofensine plus metoprolol for hypothalamic obesity, designated 2021","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=804220"},{"n":12,"title":"Review: tesofensine as a drug for obesity, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19777399/"},{"n":16,"title":"6abc News: a Danish trial of tesofensine for obesity, 2008","url":"https://6abc.com/archive/6466750"}]},"channelsOpener":"This section describes what happens and is not a recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=tesofensine&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://pubmed.ncbi.nlm.nih.gov/18950853/","https://pubmed.ncbi.nlm.nih.gov/19777399/","https://pubmed.ncbi.nlm.nih.gov/42320973/","https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"],"verified_at":"2026-10-26T13:39:13.025Z","published_at":"2026-10-26T13:49:29.653Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-26T13:39:38.711Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}