{"shortAnswer":"LL-37 is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is limited-human: a few trials put it on skin sores, with mixed results. FDA says it lacks the safety information to know whether it would harm people.","url":"https://peptideindex.ai/compound/ll-37","status":"limbo","statusCheckedAt":"2026-10-25T23:55:30.146Z","statusStale":false,"regulatoryAsOf":"2026-10-23","verified":"2026-10-26T03:03:21.588Z","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":"80b8137c-e1aa-4409-918b-c45eb4032daf","object":"compound","slug":"ll-37","name":"LL-37","attrs":{"name":"LL-37","class":"antimicrobial","access":[{"type":"none","detail":"There is no legal route to LL-37 in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"}],"trials":[],"aliases":["Cathelicidin LL-37","Ropocamptide"],"summary":"A chain of 37 amino acids that human skin makes to fight germs. It has been tested on skin sores and injected into skin tumors.","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bulk drug substances that may present significant safety risks, including those withdrawn from Category 2"},{"n":2,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: categories of bulk drug substances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/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","tier":"primary","type":"regulatory","title":"FDA: Pharmacy Compounding Advisory Committee meeting before the end of February 2027"},{"n":5,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","tier":"primary","type":"regulatory","title":"FDA warning letter to a compounding pharmacy, 1 April 2020"},{"n":6,"url":"https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution","tier":"primary","type":"regulatory","title":"US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020"},{"n":7,"url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/","tier":"legal-analysis","type":"legal-analysis","title":"McDermott Will & Schulte: what the July 2026 committee votes on peptides mean"},{"n":8,"url":"https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides","tier":"legal-analysis","type":"legal-analysis","title":"Goodwin: FDA signals a possible change in its stance on compounding some peptides"},{"n":9,"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 pairs its peptide policy with action against unlawful sellers"},{"n":10,"url":"https://pubmed.ncbi.nlm.nih.gov/25041740/","tier":"peer-reviewed","type":"rct","title":"LL-37 on hard-to-heal leg ulcers in 34 adults, placebo-controlled, 2014"},{"n":11,"url":"https://pubmed.ncbi.nlm.nih.gov/34687253/","tier":"peer-reviewed","type":"rct","title":"LL-37 on hard-to-heal leg ulcers in 148 adults, placebo-controlled, 2021"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/37480520/","tier":"peer-reviewed","type":"rct","title":"LL-37 cream on diabetic foot ulcers, double-blind, Jakarta, 2023"},{"n":13,"url":"https://clinicaltrials.gov/study/NCT04098562","tier":"primary","type":"reference","title":"ClinicalTrials.gov record NCT04098562: LL-37 cream on diabetic foot ulcers"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/29665030/","tier":"peer-reviewed","type":"human-trial","title":"Skin harm after LL-37 was injected into melanoma: a report of one woman, 2018"},{"n":15,"url":"https://clinicaltrials.gov/study/NCT02225366","tier":"primary","type":"reference","title":"ClinicalTrials.gov record NCT02225366: LL-37 injected into melanoma"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/38423213/","tier":"peer-reviewed","type":"animal","title":"LL-37 and wound healing in diabetic mice, 2024"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/19234121/","tier":"peer-reviewed","type":"animal","title":"LL-37 and ovarian tumor growth in mice, 2009"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/15609314/","tier":"peer-reviewed","type":"in-vitro","title":"LL-37 in breast cancer tissue and the growth of human cells in the lab, 2005"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/20521250/","tier":"peer-reviewed","type":"reference","title":"Review: the roles of LL-37 in human cancer, 2010"},{"n":20,"url":"https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879","tier":"established-news","type":"reference","title":"NBC News: FDA panel recommends easing peptide limits despite agency scientists"}],"known_risks":["FDA warns that LL-37 given by some routes may set off the immune system. It also warns of impurities from how the peptide is made [^1].","FDA says tests in animals point to harm to a male's ability to have children [^1].","FDA says LL-37 may help tumors grow in some tissues. In mice, LL-37 helped ovarian tumors grow [^1] [^17].","A woman given LL-37 shots into her melanoma grew many wart-like skin growths and a blister. They went away within 2 months after the shots stopped [^14].","FDA says it does not have enough safety information to know whether LL-37 would harm people [^1]."],"short_answer":"LL-37 is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is limited-human: a few trials put it on skin sores, with mixed results. FDA says it lacks the safety information to know whether it would harm people.","evidence_grade":"limited-human","open_questions":["Nobody knows whether LL-37 would harm people who take it. FDA says it lacks the safety information to judge [^1].","Nobody knows whether LL-37 helps leg sores heal. The largest trial found no clear benefit across the whole group [^11].","Scientists do not know why LL-37 seems to feed some cancers and hold back others [^19].","FDA has not set a date for its committee to meet on LL-37. Its notice does not say which use the committee will review [^4].","Nobody knows whether LL-37 cream helps foot sores heal for good. The one trial followed people for only 4 weeks [^12]."],"section_routes":"There is no legal way to get LL-37 in the US today [^2] [^5]. No approved drug contains it. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. LL-37 is neither [^3] [^5]. FDA could add it by writing a rule after its committee meets [^4] [^7].\n\nNo trial that gives LL-37 is open now. Of the two registry records that give it, one study is complete and the other has an unknown status [^13] [^15]. Any open trial would appear in the trials block below, with the date the official registry was last checked.","regulatory_as_of":"2026-10-23","section_channels":"Pharmacies are the one channel for LL-37 that federal records name [^5] [^6]. In 2020, FDA warned a compounder that its LL-37 products did not meet the rules for compounding [^5]. The same year, that compounding pharmacy pleaded guilty to distributing unapproved new drugs, LL-37 among them [^6]. It agreed to give up its 2019 sales of those products [^6].\n\nWith a product made outside the rules, nobody checks what is in it the way FDA checks an approved drug. FDA warns that LL-37 products may hold impurities and may set off the immune system [^1]. We found no federal record that names LL-37 sold by websites or clinics, so this page does not describe those channels.","section_evidence":"The evidence grade is limited-human: three trials in people put LL-37 on skin sores, and their results are mixed [^10] [^11] [^12]. FDA says it lacks the safety information to know whether LL-37 would harm people [^1]. The body makes its own LL-37, and some studies only measure how much of it a person has [^12] [^19]. A level found in the body does not show that taking LL-37 helps.\n\nLeg sores: in a 2014 trial, 34 adults with hard-to-heal leg ulcers had LL-37 or a placebo, a dummy treatment, put on the wound [^10]. Two of the three LL-37 groups healed faster than the placebo group [^10]. A larger 2021 trial in 148 adults found no clear benefit over placebo across the whole group [^11]. A later look found a gain in people with large sores, and the authors say a new trial must test that [^11]. People in both trials tolerated LL-37 on the skin well [^10] [^11].\n\nFoot sores: in a 2023 trial in Jakarta, adults with diabetes and mildly infected foot sores used LL-37 cream or a placebo cream [^12] [^13]. New healing tissue grew faster with LL-37, but germs on the wound did not drop more than with placebo [^12].\n\nShots: one small US study injected LL-37 into melanoma tumors in the skin [^15]. A 2018 report describes a 63-year-old woman whose injected tumors shrank. About 45 days in, she grew many skin growths, which went away after the shots stopped [^14].\n\nAnimals and cells: in diabetic mice, LL-37 helped wounds close [^16]. In mice with ovarian tumors, blocking the body's own LL-37 slowed tumor growth [^17]. In lab dishes, LL-37 made human cells grow faster [^18]. A 2010 review says LL-37 seems to feed some cancers and hold back others [^19].","regulatory_status":"limbo","section_what_it_is":"LL-37 is a chain of 37 amino acids that the human body makes [^14]. Amino acids are the building blocks of proteins. LL-37 is part of the skin's first defense against germs [^14]. White blood cells and the lining of some organs make it too [^19]. It kills some germs and also steers the immune system [^19].\n\nFDA calls it cathelicidin LL-37 [^1]. It is part of no FDA-approved drug and has no official US quality standard [^5]. A drug company has tested it as a treatment for leg sores, under the name ropocamptide [^11]. Doctors in one US study injected it into melanoma, a skin cancer [^14] [^15].","section_is_it_legal":"LL-37 is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. Checked 23 October 2026.\n\nCategory 2 is FDA's list of substances that raise significant safety concerns. Category 1 is the list of substances under evaluation, which pharmacies may use while FDA reviews them [^3]. In April 2026, the groups that nominated LL-37 withdrew, so it came off Category 2 [^1] [^7]. Taking a substance off Category 2 does not by itself let pharmacies use it [^8].\n\nFDA says its Pharmacy Compounding Advisory Committee will discuss LL-37 at a meeting before the end of February 2027 [^4] [^9]. FDA has posted no date for that meeting and no review of LL-37 for it [^4]. The committee gives advice only. FDA decides by writing a rule, after public comment [^7] [^20].\n\nUntil FDA acts, a pharmacy that makes LL-37 is outside federal law [^3] [^5]. In 2020, FDA warned a compounder that LL-37 was not eligible for compounding [^5]. The same year, that compounding pharmacy pleaded guilty to distributing unapproved new drugs, LL-37 among them [^6].","unofficial_channels":[{"type":"compounding-outside-the-rules","what_it_is":"Made by a pharmacy from bulk LL-37, which is not on the list of substances pharmacies may use.","enforcement":[{"date":"2020-04-01","text":"FDA warning letter to a compounding pharmacy: LL-37 was among bulk substances that made its products ineligible under section 503A.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},{"date":"2020-10-29","text":"US Department of Justice: a Kentucky compounding pharmacy and its owner pleaded guilty to distributing unapproved new drugs, LL-37 among them.","source_url":"https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution"}],"legal_position":{"text":"LL-37 has no official quality standard, is in no approved drug and is not on the federal list, so a pharmacy may not compound it under section 503A.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},"documented_risks":[{"text":"FDA warns that compounded LL-37 may set off the immune system for some routes and may hold impurities.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"text":"FDA says it lacks the safety information to know whether LL-37 would harm people.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"}]}]},"provenance":{"name":{"fact_id":"fc8a6f10-8e68-4c90-ac69-b3975aeee0fc","source_url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","source_type":"primary","captured_at":"2026-10-25T22:00:38.424Z","checked_at":"2026-10-25T23:55:30.159Z","confidence":1,"stale":false},"class":{"fact_id":"b7ece228-52e2-4770-babf-0e79cf272427","source_url":"https://pubmed.ncbi.nlm.nih.gov/29665030/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:58.071Z","checked_at":"2026-10-25T23:55:30.161Z","confidence":1,"stale":false},"access":{"fact_id":"e89da8cc-86d2-4b8d-9b89-8b96b70089bb","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","captured_at":"2026-10-25T21:20:09.871Z","checked_at":"2026-10-25T23:55:30.128Z","confidence":1,"stale":false},"trials":{"fact_id":"633dc784-4c7b-4970-ae8e-1f63aa823e80","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=ropocamptide&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":"2026-10-25T23:55:34.993Z","checked_at":"2026-10-25T23:55:34.993Z","confidence":1,"stale":false},"aliases":{"fact_id":"1ec4b030-75ed-430c-8f89-e38c56700fc3","source_url":"https://pubmed.ncbi.nlm.nih.gov/34687253/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:56.588Z","checked_at":"2026-10-25T23:55:30.134Z","confidence":1,"stale":false},"summary":{"fact_id":"9621d1c7-aa39-4387-8010-3d7f9c22f7e2","source_url":"https://pubmed.ncbi.nlm.nih.gov/29665030/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:58.071Z","checked_at":"2026-10-25T23:55:30.156Z","confidence":1,"stale":false},"citations":{"fact_id":"97e9859f-a538-4827-a18e-d94e6b094edf","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":"2026-10-25T23:55:30.176Z","confidence":1,"stale":false},"known_risks":{"fact_id":"596d7391-c4b0-4d3e-b48c-6f38ba3fd6f1","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":"2026-10-26T03:03:21.532Z","confidence":1,"stale":false},"short_answer":{"fact_id":"ffd92a11-a418-4af4-9fc6-28f8920e9a4b","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-25T23:55:30.153Z","confidence":1,"stale":false,"label":"our assessment"},"evidence_grade":{"fact_id":"567dde60-2400-4212-bc06-59a0398d8938","source_url":"https://peptideindex.ai/methodology#evidence-grade","source_type":"reference","captured_at":"2026-10-25T00:14:45.193Z","checked_at":"2026-10-25T23:55:30.165Z","confidence":1,"stale":false,"label":"our assessment"},"open_questions":{"fact_id":"dd8977ef-4131-4bbd-a070-daa4a872e75e","source_url":"https://pubmed.ncbi.nlm.nih.gov/34687253/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:56.588Z","checked_at":"2026-10-25T23:55:30.143Z","confidence":1,"stale":false},"section_routes":{"fact_id":"d587415e-f7c4-4bf6-86d4-7daaa6d86c65","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","captured_at":"2026-10-25T21:20:09.871Z","checked_at":"2026-10-25T23:55:30.169Z","confidence":1,"stale":false},"regulatory_as_of":{"fact_id":"1dd9d0ed-959c-4d22-ab90-0e892099ae20","source_url":"https://www.fda.gov/media/94155/download","source_type":"primary","captured_at":"2026-10-25T22:01:55.068Z","checked_at":"2026-10-25T23:55:30.162Z","confidence":1,"stale":false},"section_channels":{"fact_id":"29897a42-3ff8-4b2b-9bb0-69948f027e2c","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","captured_at":"2026-10-25T21:20:09.871Z","checked_at":"2026-10-25T23:55:30.171Z","confidence":1,"stale":false},"section_evidence":{"fact_id":"b63c5e24-6e91-4094-8980-2af1cc4004bd","source_url":"https://pubmed.ncbi.nlm.nih.gov/34687253/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:56.588Z","checked_at":"2026-10-26T03:03:21.588Z","confidence":1,"stale":false},"regulatory_status":{"fact_id":"6bd26372-eeaf-4986-b493-9ac717de1558","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":"2026-10-25T23:55:30.146Z","confidence":1,"stale":false},"section_what_it_is":{"fact_id":"a9459f24-b60b-4bcf-aa2b-cf6d17dd9fc2","source_url":"https://pubmed.ncbi.nlm.nih.gov/29665030/","source_type":"peer-reviewed","captured_at":"2026-10-25T22:01:58.071Z","checked_at":"2026-10-25T23:55:30.166Z","confidence":1,"stale":false},"section_is_it_legal":{"fact_id":"9cabe2ce-1d3b-4455-a205-a1a5bce884c0","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":"2026-10-25T23:55:30.168Z","confidence":1,"stale":false},"unofficial_channels":{"fact_id":"5eae5447-f12f-4d43-b800-6d69fca859ce","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","source_type":"primary","captured_at":"2026-10-25T21:20:09.871Z","checked_at":"2026-10-25T23:55:30.172Z","confidence":1,"stale":false}},"citationsBySection":{"known_risks":[{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":17,"title":"LL-37 and ovarian tumor growth in mice, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19234121/"},{"n":14,"title":"Skin harm after LL-37 was injected into melanoma: a report of one woman, 2018","url":"https://pubmed.ncbi.nlm.nih.gov/29665030/"}],"open_questions":[{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":11,"title":"LL-37 on hard-to-heal leg ulcers in 148 adults, placebo-controlled, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34687253/"},{"n":19,"title":"Review: the roles of LL-37 in human cancer, 2010","url":"https://pubmed.ncbi.nlm.nih.gov/20521250/"},{"n":4,"title":"FDA: Pharmacy Compounding Advisory Committee meeting before the end of February 2027","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee"},{"n":12,"title":"LL-37 cream on diabetic foot ulcers, double-blind, Jakarta, 2023","url":"https://pubmed.ncbi.nlm.nih.gov/37480520/"}],"section_routes":[{"n":2,"title":"FDA: categories of bulk drug substances nominated under section 503A, list updated 14 May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":5,"title":"FDA warning letter to a compounding pharmacy, 1 April 2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},{"n":3,"title":"FDA: bulk drug substances used in compounding under section 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2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},{"n":6,"title":"US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020","url":"https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution"},{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"}],"section_evidence":[{"n":10,"title":"LL-37 on hard-to-heal leg ulcers in 34 adults, placebo-controlled, 2014","url":"https://pubmed.ncbi.nlm.nih.gov/25041740/"},{"n":11,"title":"LL-37 on hard-to-heal leg ulcers in 148 adults, placebo-controlled, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34687253/"},{"n":12,"title":"LL-37 cream on diabetic foot ulcers, double-blind, Jakarta, 2023","url":"https://pubmed.ncbi.nlm.nih.gov/37480520/"},{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":19,"title":"Review: the roles of LL-37 in human cancer, 2010","url":"https://pubmed.ncbi.nlm.nih.gov/20521250/"},{"n":13,"title":"ClinicalTrials.gov record NCT04098562: LL-37 cream on diabetic foot ulcers","url":"https://clinicaltrials.gov/study/NCT04098562"},{"n":15,"title":"ClinicalTrials.gov record NCT02225366: LL-37 injected into melanoma","url":"https://clinicaltrials.gov/study/NCT02225366"},{"n":14,"title":"Skin harm after LL-37 was injected into melanoma: a report of one woman, 2018","url":"https://pubmed.ncbi.nlm.nih.gov/29665030/"},{"n":16,"title":"LL-37 and wound healing in diabetic mice, 2024","url":"https://pubmed.ncbi.nlm.nih.gov/38423213/"},{"n":17,"title":"LL-37 and ovarian tumor growth in mice, 2009","url":"https://pubmed.ncbi.nlm.nih.gov/19234121/"},{"n":18,"title":"LL-37 in breast cancer tissue and the growth of human cells in the lab, 2005","url":"https://pubmed.ncbi.nlm.nih.gov/15609314/"}],"section_what_it_is":[{"n":14,"title":"Skin harm after LL-37 was injected into melanoma: a report of one woman, 2018","url":"https://pubmed.ncbi.nlm.nih.gov/29665030/"},{"n":19,"title":"Review: the roles of LL-37 in human cancer, 2010","url":"https://pubmed.ncbi.nlm.nih.gov/20521250/"},{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":5,"title":"FDA warning letter to a compounding pharmacy, 1 April 2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},{"n":11,"title":"LL-37 on hard-to-heal leg ulcers in 148 adults, placebo-controlled, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34687253/"},{"n":15,"title":"ClinicalTrials.gov record NCT02225366: LL-37 injected into melanoma","url":"https://clinicaltrials.gov/study/NCT02225366"}],"section_is_it_legal":[{"n":1,"title":"FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks"},{"n":2,"title":"FDA: categories of bulk drug substances nominated under section 503A, list updated 14 May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":3,"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":7,"title":"McDermott Will & Schulte: what the July 2026 committee votes on peptides mean","url":"https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/"},{"n":8,"title":"Goodwin: FDA signals a possible change in its stance on compounding some peptides","url":"https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides"},{"n":4,"title":"FDA: Pharmacy Compounding Advisory Committee meeting before the end of February 2027","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee"},{"n":9,"title":"Sheppard Mullin: FDA pairs its peptide policy with action against unlawful sellers","url":"https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers"},{"n":20,"title":"NBC News: FDA panel recommends easing peptide limits despite agency scientists","url":"https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879"},{"n":5,"title":"FDA warning letter to a compounding pharmacy, 1 April 2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020"},{"n":6,"title":"US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020","url":"https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution"}]},"channelsOpener":"This section describes what happens and is not a recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=ropocamptide&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/29665030/","https://pubmed.ncbi.nlm.nih.gov/34687253/","https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020","https://www.fda.gov/media/94155/download"],"verified_at":"2026-10-26T03:03:21.588Z","published_at":"2026-10-26T03:03:24.967Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-25T23:55:34.993Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}