{"shortAnswer":"MK-677 is on FDA's Category 2 list, so no pharmacy may lawfully make it. It is in no approved drug. The evidence grade is moderate-human: trials show it raises growth hormone, but it did not build strength or slow Alzheimer's disease.","url":"https://peptideindex.ai/compound/mk-677","status":"category-2","statusCheckedAt":"2026-10-26T13:39:12.164Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T20:24:55.616Z","primarySourceUrl":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"ccb7cd34-263b-4dbb-8260-d5e542bcd02c","object":"compound","slug":"mk-677","name":"MK-677","attrs":{"name":"MK-677","pcac":{"vote":{"no":13,"yes":1,"abstain":0},"outcome":"The committee recommended against adding ibutamoren mesylate to the 503A bulks list, as FDA had proposed","meeting_date":"2024-10-29","indication_reviewed":"Growth hormone shortage, weak bones, hip fracture, muscle loss with age, obesity and Alzheimer's disease"},"class":"non-peptide","access":[{"type":"clinical-trial","detail":"A phase 3 trial of LUM-201 is recruiting children with growth hormone deficiency at US sites. Open trials are listed in the trials block below, with the date the official registry was last checked.","source_url":"https://clinicaltrials.gov/study/NCT06948214"}],"trials":[{"nct":"NCT07754045","url":"https://clinicaltrials.gov/study/NCT07754045","phase":"Phase 2","title":"Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults","status":"not-yet-recruiting","sponsor":"Lumos Pharma","countries":[],"us_states":[]},{"nct":"NCT07129759","url":"https://clinicaltrials.gov/study/NCT07129759","phase":"Phase 3","title":"Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency","status":"not-yet-recruiting","sponsor":"Lumos Pharma","countries":[],"us_states":[]},{"nct":"NCT06948214","url":"https://clinicaltrials.gov/study/NCT06948214","phase":"Phase 3","title":"Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency","status":"recruiting","sponsor":"Lumos Pharma","countries":["United States","Argentina","Australia","Chile","India","New Zealand","Thailand","United Kingdom"],"us_states":["Alabama","California","Colorado","District of Columbia","Florida","Georgia","Indiana","Iowa","Louisiana","Minnesota","Missouri","Nevada","New Jersey","New York","Ohio","Oklahoma","South Carolina","Texas","Virginia","Washington"]}],"aliases":["ibutamoren","ibutamoren mesylate","MK-0677","LUM-201"],"summary":"A lab-made small molecule, not a peptide, that makes the body release growth hormone. It is in no FDA-approved drug and is sold online for muscle.","citations":[{"n":1,"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, with ibutamoren mesylate added in 2022 and 2023"},{"n":2,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026"},{"n":3,"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":4,"url":"https://www.fda.gov/media/94164/download","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances nominated under section 503B, list updated 21 March 2025"},{"n":5,"url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-29-2024-meeting-pharmacy-compounding-advisory-committee-10292024","tier":"primary","type":"regulatory","title":"FDA: Pharmacy Compounding Advisory Committee meeting, 29 October 2024"},{"n":6,"url":"https://www.fda.gov/media/182087/download","tier":"primary","type":"regulatory","title":"FDA briefing document on ibutamoren mesylate for the committee, 2024"},{"n":7,"url":"https://www.fda.gov/media/185412/download","tier":"primary","type":"regulatory","title":"FDA: final summary minutes of the committee meeting of 29 October 2024"},{"n":8,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of SARMs that listed MK-677, 12 June 2023"},{"n":9,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-health-group-dba-sarms-america-719257-12122025","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of SARMs that listed MK-677, 12 December 2025"},{"n":10,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025","tier":"primary","type":"regulatory","title":"FDA warning letter on a children's growth product with hidden ibutamoren, 19 December 2025"},{"n":11,"url":"https://www.fda.gov/drugs/medication-health-fraud-notifications/agebox-ikids-growth-day-formula-may-be-harmful-due-hidden-ingredient","tier":"primary","type":"regulatory","title":"FDA health fraud notice: hidden ibutamoren in a children's growth product, 2025"},{"n":12,"url":"https://djholtlaw.com/navigating-the-2026-peptide-regulatory-landscape-federal-compliance-state-enforcement-and-the-legal-liabilities-of-healthcare-providers/","tier":"legal-analysis","type":"legal-analysis","title":"Holt Law: the 2026 federal rules on peptides and the risks for prescribers"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/18981485/","tier":"peer-reviewed","type":"rct","title":"MK-677 for up to two years in healthy older adults, 2008"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/21067829/","tier":"peer-reviewed","type":"rct","title":"MK-0677 in older people recovering from hip fracture, stopped early, 2011"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/19015485/","tier":"peer-reviewed","type":"rct","title":"MK-677 for a year in people with Alzheimer's disease, 2008"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/28400207/","tier":"peer-reviewed","type":"reference","title":"Review: the safety and efficacy of growth hormone secretagogues, ibutamoren among them, 2018"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/8940347/","tier":"peer-reviewed","type":"animal","title":"MK-0677 by mouth and by vein in beagles, 1996"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/29912176/","tier":"peer-reviewed","type":"animal","title":"MK-0677 and brain plaque in mice bred to model Alzheimer's disease, 2018"},{"n":19,"url":"https://clinicaltrials.gov/study/NCT06948214","tier":"primary","type":"reference","title":"ClinicalTrials.gov: phase 3 trial of LUM-201, a name for ibutamoren, in children short of growth hormone"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT05364684","tier":"primary","type":"reference","title":"ClinicalTrials.gov: ibutamoren in fatty liver disease"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT00128115","tier":"primary","type":"reference","title":"ClinicalTrials.gov: MK-0677 after hip fracture, stopped early"},{"n":22,"url":"https://www.nbcnews.com/id/wbna27524685","tier":"established-news","type":"reference","title":"NBC News: MK-677 and muscle in older adults, 2008"}],"known_risks":["FDA put MK-677 on Category 2 because it may cause congestive heart failure in some patients. That is when the heart cannot pump enough blood [^1].","A trial in older people recovering from a broken hip was stopped early after some had heart failure [^14].","In a trial in healthy older adults, MK-677 raised blood sugar and made the body respond less to insulin [^13].","The most common problems in that trial were more hunger, mild leg swelling and muscle pain [^13].","FDA's review lists high blood sugar, raised liver enzymes and fluid build-up in people who took MK-677 in trials [^6].","In 2025, FDA lab tests found MK-677 hidden in a growth product sold for children. Its label did not list it [^10] [^11]."],"short_answer":"MK-677 is on FDA's Category 2 list, so no pharmacy may lawfully make it. It is in no approved drug. The evidence grade is moderate-human: trials show it raises growth hormone, but it did not build strength or slow Alzheimer's disease.","evidence_grade":"moderate-human","open_questions":["Nobody knows what years of use do. FDA says its long-term effects are unknown [^10].","A rise in growth hormone or IGF-1 on a blood test is a lab marker. In older adults, more lean mass did not bring more strength or better function [^13].","High IGF-1 in older people has been tied to disease, death and cancer. FDA says safety data on that risk for MK-677 are lacking [^6].","A 2018 review says few long-term, well-controlled studies exist. Cancer and death rates with long use still need study [^16].","Nobody knows if the brain results in mice apply to people. A year-long trial in Alzheimer's disease found no slowing [^18] [^15].","A phase 3 trial in children short of growth hormone is still recruiting, so its results are not known [^19]."],"section_routes":"No approved drug in the US contains MK-677, and no pharmacy may lawfully make it [^6] [^1]. It cannot be sold as a dietary supplement [^10].\n\nThe only legal route is a clinical trial. A phase 3 trial of LUM-201, another name for MK-677, is recruiting children short of growth hormone at US sites [^19]. Open trials are listed in the trials block below, with the date the official registry was last checked.","regulatory_as_of":"2026-10-26","section_channels":"Three ways of getting MK-677 show up in FDA's records [^6] [^8] [^10]. The first is online sellers that list it beside SARMs, often as a research product. FDA sent warning letters to such sellers in June 2023 and December 2025 [^8] [^9]. FDA said their products are unapproved new drugs, whatever the label says [^8] [^9].\n\nThe second is products sold as supplements with MK-677 hidden inside. In 2025, FDA lab tests found it in a growth product for children whose label did not list it [^10] [^11].\n\nThe third is pharmacies. FDA found websites that say a compounding pharmacy supplies their MK-677. FDA could not tell if any pharmacy still sells it [^6]. A pharmacy that makes it now is outside the rules, because it is on Category 2 [^1] [^2].\n\nFDA warns that MK-677 may cause heart failure in some people. FDA also says its long-term effects are unknown [^1] [^10].","section_evidence":"The evidence grade is moderate-human: controlled trials show MK-677 raises growth hormone and lean mass [^13] [^14] [^15]. None showed a gain in strength or health, and most measures of function did not change [^13] [^14].\n\nIn 65 healthy adults aged 60 to 81, a year of MK-677 raised growth hormone to young-adult levels [^13]. Lean mass rose by about 1 kilogram, but strength and function did not change [^13]. Body weight rose by 2.7 kilograms, against 0.8 on placebo, a dummy pill [^13] [^22].\n\nIn 123 older people after a broken hip, MK-677 raised IGF-1 but did not improve most measures of function [^14]. That trial stopped early over heart failure [^14] [^21]. In 563 people with mild to moderate Alzheimer's disease, a year of MK-677 did not slow the disease [^15]. A small US study tested it in adults with fatty liver disease. It is complete, and this page holds no result from it [^20].\n\nIn beagles, one dose by mouth raised growth hormone for up to six hours [^17]. In mice bred to model Alzheimer's disease, it reduced plaque in the brain [^18]. These are animal results, not results in people.\n\nA rise in growth hormone or IGF-1 is a lab marker. It does not by itself show a benefit [^15] [^16]. FDA's 2024 review found too little evidence that it helps any of the six uses it reviewed [^6].","regulatory_status":"category-2","section_what_it_is":"MK-677 is a lab-made small molecule, not a peptide [^6] [^16]. Its drug name is ibutamoren. It also goes by MK-0677 and LUM-201 [^6]. It copies ghrelin, a hormone made mostly in the stomach. It makes the pituitary gland release growth hormone [^6] [^11] [^18]. The pituitary is a small gland at the base of the brain. MK-677 is made to be taken by mouth [^6] [^17].\n\nA drug company made it in 1995 and stopped work on it in 1999 [^6]. Another company now studies it as LUM-201 in children short of growth hormone [^6] [^19]. Online, it is sold to build muscle, lose fat, sleep better and slow aging [^6]. Some sellers call it a SARM. A SARM is a different kind of drug that acts on male hormone receptors. FDA says MK-677 is not a SARM [^6].","section_is_it_legal":"MK-677 is on Category 2, FDA's list of substances that may present significant safety risks in compounding [^1] [^2]. That means no pharmacy may lawfully make it [^3]. It is also in no FDA-approved drug [^6]. Being on the list does not mean FDA has finished its review [^3]. Checked 26 October 2026.\n\nFDA keeps lists for two kinds of compounders. A pharmacy is covered by section 503A of the law. An outsourcing facility is covered by section 503B [^3] [^4]. FDA put ibutamoren mesylate on the outsourcing Category 2 list on 29 December 2022. It added it to the pharmacy list on 29 September 2023 [^1]. FDA gave the reason as possible heart failure in some patients [^1]. FDA's pharmacy list of 14 May 2026 still names it in Category 2 [^2]. So does its outsourcing list of 21 March 2025 [^4]. A law firm notes that pharmacies are strictly limited in making any Category 2 substance [^12].\n\nOn 29 October 2024, FDA's Pharmacy Compounding Advisory Committee reviewed it for six uses [^5] [^7]. These included growth hormone shortage, weak bones and Alzheimer's disease [^7]. FDA proposed leaving it off the list of substances pharmacies may use. The committee voted 13 to 1 against adding it [^7]. A vote is a recommendation. The final decision is FDA's, made through rulemaking [^3].\n\nMK-677 is not a lawful dietary supplement either. FDA says it was studied as a new drug before anyone sold it as a supplement. That rules it out as a supplement ingredient [^10]. FDA treats products sold for muscle or growth as unapproved new drugs [^8] [^10]. It was reviewed for growth hormone shortage and diseases of aging. It is sold online for muscle and anti-aging [^6] [^7].","unofficial_channels":[{"type":"research-use-seller","what_it_is":"Sold online, often labeled for research only and listed beside SARMs, to people seeking muscle or anti-aging.","enforcement":[{"date":"2023-06-12","text":"FDA warning letter to an online seller of products sold as SARMs, including MK-677.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023"},{"date":"2025-12-12","text":"FDA warning letter to an online seller of products sold as SARMs, including MK-677.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-health-group-dba-sarms-america-719257-12122025"}],"legal_position":{"text":"FDA says these products are new drugs that need its approval, and none is approved. A research-only label does not change that.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-health-group-dba-sarms-america-719257-12122025"},"documented_risks":[{"text":"FDA says MK-677 may cause congestive heart failure in some patients.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"text":"FDA says use may raise hunger, cause water retention and muscle pain, and change blood sugar control.","source_url":"https://www.fda.gov/drugs/medication-health-fraud-notifications/agebox-ikids-growth-day-formula-may-be-harmful-due-hidden-ingredient"}]},{"type":"counterfeit-or-diverted","what_it_is":"Sold as a dietary supplement with MK-677 hidden inside and not listed on the label.","enforcement":[{"date":"2025-09-23","text":"FDA health fraud notice on a children's growth product found by FDA testing to hold hidden ibutamoren.","source_url":"https://www.fda.gov/drugs/medication-health-fraud-notifications/agebox-ikids-growth-day-formula-may-be-harmful-due-hidden-ingredient"},{"date":"2025-12-19","text":"FDA warning letter to the seller of a children's growth product that held undeclared ibutamoren mesylate.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025"}],"legal_position":{"text":"FDA says ibutamoren is excluded from the definition of a dietary supplement, so a product holding it is an unapproved new drug.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025"},"documented_risks":[{"text":"FDA says parents may give such a product to children without knowing it holds an ingredient that may cause serious harm.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025"}]},{"type":"compounding-outside-the-rules","what_it_is":"Made by a pharmacy from bulk MK-677 powder, which its Category 2 listing does not allow.","legal_position":{"text":"FDA says its interim policy for pharmacies does not cover Category 2 substances. It may act against a compounder who uses one.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},"documented_risks":[{"text":"FDA says MK-677 may cause congestive heart failure in some patients.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"text":"FDA found the bulk powder is not well characterized, with no data on its purity or impurities.","source_url":"https://www.fda.gov/media/182087/download"}]}]},"provenance":{"name":{"fact_id":"f502e737-6bf9-4be1-a64c-2d2d107d4fff","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.848Z","checked_at":"2026-10-26T13:39:12.185Z","confidence":1,"stale":false},"pcac":{"fact_id":"5029e79c-9a73-409c-a117-08d4248b19f2","source_url":"https://www.fda.gov/media/185412/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.099Z","checked_at":"2026-10-26T20:24:55.603Z","confidence":1,"stale":false},"class":{"fact_id":"4edb5f66-acef-42be-9641-97a52bbea94e","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.848Z","checked_at":"2026-10-26T13:39:12.189Z","confidence":1,"stale":false},"access":{"fact_id":"ffb440d8-d35e-442f-babd-a0ea499c4b0f","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.848Z","checked_at":"2026-10-26T13:39:12.138Z","confidence":1,"stale":false},"trials":{"fact_id":"ef56b632-e109-46db-9a21-e1759303541e","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=ibutamoren+OR+MK-677+OR+MK-0677+OR+LUM-201&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":"2026-10-26T13:39:36.975Z","checked_at":"2026-10-26T13:39:36.975Z","confidence":1,"stale":false},"aliases":{"fact_id":"201f1e52-a05b-4ad5-92ab-74a93d4c17c1","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.848Z","checked_at":"2026-10-26T13:39:12.187Z","confidence":1,"stale":false},"summary":{"fact_id":"00201ddb-3411-493e-b29a-89a57e3179e9","source_url":"https://www.fda.gov/media/182087/download","source_type":"primary","captured_at":"2026-10-26T08:50:15.848Z","checked_at":"2026-10-26T13:39:12.191Z","confidence":1,"stale":false},"citations":{"fact_id":"9fbbb689-508f-4b1f-986d-8084da621073","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","captured_at":"2026-10-24T03:43:00.387Z","checked_at":"2026-10-26T13:39:12.201Z","confidence":1,"stale":false},"known_risks":{"fact_id":"b097c799-253c-4d5c-9d42-16eafd7d7675","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","source_type":"primary","captured_at":"2026-10-24T03:43:00.387Z","checked_at":"2026-10-26T13:39:12.193Z","confidence":1,"stale":false},"short_answer":{"fact_id":"b29b4735-4f2b-4b49-a5b0-2163bb5baad7","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T13:39:12.178Z","confidence":1,"stale":false,"label":"our 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listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}