{"shortAnswer":"Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.","url":"https://peptideindex.ai/compound/tesamorelin","status":"fda-approved","statusCheckedAt":"2026-10-25T06:24:55.232Z","statusStale":false,"regulatoryAsOf":"2026-10-24","verified":"2026-10-25T17:34:41.505Z","primarySourceUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"1c1e3556-6f7b-4383-9436-bde3ca01e093","object":"compound","slug":"tesamorelin","name":"Tesamorelin","attrs":{"name":"Tesamorelin","class":"growth-hormone-axis","access":[{"type":"approved-product","detail":"Approved by FDA and sold with a prescription as a daily shot under the skin of the belly. It comes in two forms, Egrifta WR and Egrifta SV, which are not swapped for one another.","indication":"To reduce extra belly fat in adults with HIV who have lipodystrophy. Not for weight loss.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","brand_names":["Egrifta WR","Egrifta SV"],"manufacturer":"Theratechnologies Inc."}],"dosing":"From the Egrifta WR label and the Egrifta SV label. Both are shots under the skin of the belly once a day. Egrifta WR is 1.28 mg a day. The Egrifta SV label gives 1.4 mg a day. The two forms are not swapped for one another. The prescriber sets the dose.","trials":[{"nct":"NCT07481734","url":"https://clinicaltrials.gov/study/NCT07481734","phase":"Phase 2","title":"Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)","status":"recruiting","sponsor":"Hudson Biotech","countries":["China"],"us_states":[]},{"nct":"NCT06554717","url":"https://clinicaltrials.gov/study/NCT06554717","phase":"Phase 2","title":"Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV","status":"recruiting","sponsor":"Massachusetts General Hospital","countries":["United States"],"us_states":["Colorado","Massachusetts"]},{"nct":"NCT03150511","url":"https://clinicaltrials.gov/study/NCT03150511","phase":"Phase 2","title":"Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury","status":"recruiting","sponsor":"Johns Hopkins University","countries":["United States"],"us_states":["Maryland"]}],"aliases":["Egrifta","Egrifta WR","Egrifta SV"],"summary":"A prescription shot that makes the body release growth hormone. FDA approved it as Egrifta for extra belly fat in adults with HIV.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","tier":"primary","type":"regulatory","title":"Drugs@FDA: Egrifta, biologic license application 022505"},{"n":2,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","tier":"primary","type":"label","title":"DailyMed: Egrifta WR prescribing information, revised March 2025"},{"n":3,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224","tier":"primary","type":"label","title":"DailyMed: Egrifta SV prescribing information, revised 2024"},{"n":4,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf","tier":"primary","type":"regulatory","title":"FDA approval letter for Egrifta WR, supplement 020, 25 March 2025"},{"n":5,"url":"https://www.fda.gov/media/119229/download","tier":"primary","type":"regulatory","title":"FDA: approved applications for biological products deemed to be licenses on 23 March 2020"},{"n":6,"url":"https://www.fda.gov/media/90986/download","tier":"primary","type":"regulatory","title":"FDA guidance: mixing, diluting, or repackaging biological products outside the approved license, January 2018"},{"n":7,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":8,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":9,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":10,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":11,"url":"https://join.a4pc.org/hubfs/PDFs/2022-08-Prescriber-Briefing-Peptides_4-Aug-2022.pdf","tier":"legal-analysis","type":"legal-analysis","title":"Alliance for Pharmacy Compounding: compounding peptides, a briefing for prescribers, August 2022"},{"n":12,"url":"https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers","tier":"legal-analysis","type":"legal-analysis","title":"Sheppard Mullin: FDA warning letters to unlawful peptide sellers, 2026"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/18057338/","tier":"peer-reviewed","type":"rct","title":"Tesamorelin for belly fat in adults with HIV, first large trial, 2007"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/20101189/","tier":"peer-reviewed","type":"rct","title":"Tesamorelin in adults with HIV and belly fat, with a safety extension, 2010"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/25038357/","tier":"peer-reviewed","type":"rct","title":"Tesamorelin and belly and liver fat in adults with HIV, 2014"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/31611038/","tier":"peer-reviewed","type":"rct","title":"Tesamorelin and fatty liver disease in adults with HIV, 2019"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/42538058/","tier":"peer-reviewed","type":"systematic-review","title":"Review and meta-analysis: tesamorelin in people with HIV and lipodystrophy, 2026"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/41545261/","tier":"peer-reviewed","type":"systematic-review","title":"Meta-analysis: tesamorelin and body fat, liver fat and safety in HIV lipodystrophy, 2026"},{"n":19,"url":"https://thepharmaletter.com/theratechnologies-secures-fda-approval-for-new-formulation-of-tesamorelin","tier":"established-news","type":"reference","title":"The Pharma Letter: new Egrifta form approved, 26 March 2025"},{"n":20,"url":"https://www.contractpharma.com/breaking-news/theratechnologies-receives-fda-approval-for-egrifta-wr/","tier":"established-news","type":"reference","title":"Contract Pharma: FDA approves Egrifta WR, 26 March 2025"},{"n":21,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances under evaluation, Category 1 and Category 2 lists"},{"n":22,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks, Category 2"},{"n":23,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"}],"known_risks":["It can raise blood sugar and the chance of diabetes. After 26 weeks in trials, 5% on it had a high long-term sugar reading. On a dummy shot, 1% did [^2].","It raises IGF-1, a growth signal in the blood. The label says not to use it with an active cancer, and to stop if a cancer comes back [^2].","It can make the body hold fluid. That can cause swelling, joint pain and a pinched nerve in the wrist [^2].","In trials, 4% had an allergic reaction such as itching or a rash. A quarter had redness, itching or pain where the shot went in. On a dummy shot, 14% did [^2].","The label says not to use it in pregnancy [^2]. In the first large trial, more people on it than on a dummy shot quit because of unwanted effects [^13].","Tesamorelin sold for research is not made under FDA rules. FDA warns that injected products skip some of the body's defenses against germs and toxins [^7]."],"short_answer":"Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.","evidence_grade":"moderate-human","open_questions":["Nobody knows how it affects the heart over many years. The label says long-term heart safety has not been shown [^2].","Nobody knows what years of high IGF-1 levels do to the body. The label says the effects are unknown [^2].","Nobody knows how long people need to take it. In one trial, the belly fat came back quickly after people stopped [^14].","It lowered liver fat in two small trials. Nobody knows yet if that prevents liver disease later on [^15] [^16].","No trial cited here tested it in people without HIV, or for healing or memory, uses some sellers claim [^9] [^13]. A 2026 review found lean body mass rose in people with HIV who took it. Nobody knows if that happens in people without HIV [^17]."],"section_routes":"The legal way to get tesamorelin is a prescription for Egrifta WR or Egrifta SV [^1] [^2] [^3]. The label is for adults with HIV who have extra belly fat from lipodystrophy [^2].\n\nThe two forms are not swapped for one another. They use different doses and are mixed in different ways [^2]. The maker said Egrifta WR will replace Egrifta SV [^19] [^20].\n\nBecause the law treats it as a biologic, pharmacies may not make their own copies [^5] [^6] [^11].","regulatory_as_of":"2026-10-24","section_channels":"Outside a prescription, tesamorelin reaches people through online sellers that label it for research use [^7] [^12]. On 24 August 2026, FDA sent warning letters to five such sellers [^7] [^8] [^9] [^10] [^23]. Each letter names tesamorelin [^7] [^8] [^9] [^10] [^23]. Two sellers also offered a mix of tesamorelin and another peptide [^7] [^9].\n\nThe sellers' labels said the products were for research only, or not for people [^7] [^8] [^9] [^10] [^23]. FDA said their websites showed the products were meant for people anyway [^7] [^8] [^9] [^10] [^23]. It called them unapproved new drugs, and sending them across state lines breaks federal law [^7]. FDA warns that injected products skip some of the body's defenses against germs and toxins [^7]. It is unclear where and how these products are made [^11].\n\nNo FDA page we found names tesamorelin at a clinic, an online prescriber, or as a fake or imported product. So this page does not describe those channels.","section_evidence":"The evidence grade is moderate-human: several trials in people agree that it shrinks deep belly fat in adults with HIV [^13] [^14] [^17] [^18]. All of the trials were in adults with HIV. Most lasted 6 to 12 months.\n\nIn a 26-week trial of 412 adults with HIV and extra belly fat, deep belly fat fell by 15.2% on it. On a dummy shot, it rose by 5.0% [^13]. Blood fats also improved [^13]. In a second trial of 404 adults with HIV, deep belly fat fell by 10.9% on it over 6 months. On a dummy shot, it fell by 0.6% [^14]. People who kept taking it for a year kept about 18% less deep belly fat. Those who switched to a dummy shot lost the gain quickly [^14].\n\nTwo smaller trials in adults with HIV found it also lowered liver fat. One had 50 people and one had 61 [^15] [^16]. A 2026 review of four trials with 909 people found less deep belly fat and a smaller waist [^17]. It also found more people stopped taking it, though that result was not certain [^17]. A second 2026 review of five trials found similar results [^18].\n\nThe trials tested the approved drug in adults with HIV. They tell us nothing about tesamorelin sold for research, which FDA has not approved [^7].","regulatory_status":"fda-approved","section_what_it_is":"Tesamorelin is a prescription drug. It is a lab-made copy of a natural hormone that tells the body to release growth hormone [^2]. Growth hormone then raises IGF-1, a growth signal in the blood [^2]. FDA first approved it in November 2010, under the brand name Egrifta [^1].\n\nIt is a daily shot under the skin of the belly [^2] [^3]. It is approved for adults with HIV who have lipodystrophy. That is a shift in body fat that some HIV medicines can cause, with extra fat deep in the belly [^2] [^17]. The label says it is not for weight loss, because it does not change body weight [^2].\n\nToday it comes in two forms, Egrifta WR and Egrifta SV [^2] [^3]. FDA approved the WR form in March 2025 [^4] [^19].","section_is_it_legal":"Tesamorelin is FDA-approved: FDA approved it as Egrifta in November 2010 to reduce extra belly fat in adults with HIV who have lipodystrophy [^1] [^2]. That covers Egrifta WR and Egrifta SV, with a prescription, for that one use. It does not cover weight loss, and it does not make tesamorelin sold for research legal [^2] [^7]. Checked 24 October 2026.\n\nThere is a gap between the approved use and what sellers offer it for. The label names one use, belly fat in adults with HIV [^2]. In July 2026, FDA reviewed five seller websites [^7] [^8] [^9] [^10] [^23]. They described it for body shape, fat loss, muscle, tissue repair, memory and liver health [^7] [^8] [^9] [^10] [^23]. FDA called every one of those products an unapproved new drug [^7] [^8] [^9] [^10] [^23].\n\nSince March 2020, the law has treated tesamorelin as a biologic, a type of protein drug [^1] [^5]. FDA says the federal compounding rules do not cover biologics [^6]. So pharmacies may not make their own copies of it [^6] [^11]. Tesamorelin is not on FDA's Category 1 or Category 2 lists of raw ingredients for compounding [^21] [^22].","unofficial_channels":[{"type":"research-use-seller","what_it_is":"Sold online labeled for research use or not for people, sometimes mixed with another peptide.","enforcement":[{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including tesamorelin.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including tesamorelin.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including tesamorelin.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026"}],"legal_position":{"text":"FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026"},"documented_risks":[{"text":"FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"},{"text":"FDA says no approved application covers these products, so their safety and benefit for the sellers' uses have not been shown.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026"}]}]},"provenance":{"name":{"fact_id":"f0636ac7-2ede-4493-ba67-101a99351aa0","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.243Z","confidence":1,"stale":false},"class":{"fact_id":"955398ac-c212-4cc7-9d31-cc9c7fda322d","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.245Z","confidence":1,"stale":false},"access":{"fact_id":"6808e8e4-1e7f-48f8-948b-8d8adb471db9","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","source_type":"primary","captured_at":"2026-10-25T01:09:47.439Z","checked_at":"2026-10-25T06:24:55.209Z","confidence":1,"stale":false},"dosing":{"fact_id":"293b952a-453c-4f39-8d51-f92966633719","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.221Z","confidence":1,"stale":false},"trials":{"fact_id":"200fa9d9-acb5-4ad4-8062-1b04b536b5aa","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=tesamorelin+OR+Egrifta&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":"2026-10-25T06:25:01.711Z","checked_at":"2026-10-25T06:25:01.711Z","confidence":1,"stale":false},"aliases":{"fact_id":"620c3def-1fd0-4411-abb2-74c28776e371","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.218Z","confidence":1,"stale":false},"summary":{"fact_id":"190a7fff-4dc6-4c5d-b09b-8b830829154d","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.247Z","confidence":1,"stale":false},"citations":{"fact_id":"b3e19a1a-edc5-41f9-a96e-1152bb935150","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T17:34:41.505Z","confidence":1,"stale":false},"known_risks":{"fact_id":"8815b117-61c2-490d-86a5-ada23697b862","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75","source_type":"primary","captured_at":"2026-10-25T01:09:47.003Z","checked_at":"2026-10-25T06:24:55.252Z","confidence":1,"stale":false},"short_answer":{"fact_id":"ad511373-5682-40c0-8eb9-1969ae564969","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-25T06:24:55.248Z","confidence":1,"stale":false,"label":"our 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