{
 "checked": "2026-10-24 (America/New_York)",
 "page": "https://jabbitapp.com/research/ll-37-cathelicidin-peptide-evidence-teardown.html",
 "fda": {
  "category2_page": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
  "category2_status": "Cathelicidin LL-37 is listed under 'Bulk drug substances nominated but withdrawn'. Page content current as of 04/22/2026.",
  "category2_text": "Compounded drugs containing cathelicidin LL-37 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA lacks sufficient safety-related information regarding cathelicidin LL-37 to know whether the drug would cause harm when administered to humans. Nonclinical research findings suggest detrimental effects on male reproduction and that this drug can be protumorigenic in some tissues.",
  "pcac_page": "https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee",
  "pcac_status": "Agenda: Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF, 'being considered for inclusion on the 503A bulks list'; meeting 'before the end of February 2027'; content current as of 04/15/2026.",
  "oira": "RIN 0910-ZD94, Interim Access Policy for Compounding Using Certain Peptides, received 10/14/2026, pending; text not public. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964",
  "faers_counts_by_medicinalproduct": {
   "LL-37": 0,
   "LL37": 0,
   "CATHELICIDIN": 0,
   "ROPOCAMPTIDE": 1
  },
  "faers_ropocamptide_report": {
   "receivedate": "20260122",
   "serious": false,
   "country": "US",
   "n_products_listed": 26,
   "n_distinct_products": 23,
   "reactions": [
    "Muscle twitching",
    "Paraesthesia",
    "Muscle spasms",
    "Drug ineffective"
   ]
  },
  "faers_note": "One FAERS report codes ropocamptide; it lists it among many products and cannot show cause. Zero or few reports is not evidence of safety.",
  "drugsfda": {
   "LL-37": "No matches found!",
   "cathelicidin": "No matches found!"
  }
 },
 "registry": {
  "queries": [
   "LL-37",
   "LL37",
   "cathelicidin",
   "ropocamptide"
  ],
  "api": "ClinicalTrials.gov API v2, query.term, pageSize 100, 2026-10-24",
  "unique_studies": 98,
  "studies_giving_ll37": [
   {
    "nct": "NCT02225366",
    "title": "Induction of Antitumor Response in Melanoma Patients Using the Antimicrobial Peptide LL37",
    "status": "COMPLETED",
    "phases": [
     "PHASE1",
     "PHASE2"
    ],
    "enrollment": 4,
    "enrollment_type": "ACTUAL",
    "start": "2015-07-08",
    "lead_sponsor": "M.D. Anderson Cancer Center",
    "interventions": "LL37"
   },
   {
    "nct": "NCT04098562",
    "title": "The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers",
    "status": "UNKNOWN",
    "phases": [
     "PHASE2"
    ],
    "enrollment": 40,
    "enrollment_type": "ESTIMATED",
    "start": "2019-10",
    "lead_sponsor": "Fakultas Kedokteran Universitas Indonesia",
    "interventions": "LL37"
   }
  ],
  "note": "The other records measure LL-37 levels (often in vitamin D or periodontal studies) rather than giving LL-37. Promore Pharma's venous leg ulcer trials are registered in the EU Clinical Trials Register (HEAL LL-37: EudraCT 2018-000536-10).",
  "nct02225366_results": {
   "participants_started": 3,
   "results_first_posted": "2021-12-09",
   "other_adverse_events": [
    {
     "term": "Squamous Cell Carcinoma",
     "participants": 1
    },
    {
     "term": "Actinic Keratosis",
     "participants": 1
    },
    {
     "term": "Anemia",
     "participants": 2
    },
    {
     "term": "Skin hypopigmentation",
     "participants": 1
    },
    {
     "term": "Hypothyroidism",
     "participants": 1
    },
    {
     "term": "Lymphocyte Count Decrease",
     "participants": 1
    },
    {
     "term": "White blood cell decrease",
     "participants": 1
    },
    {
     "term": "Blood bilirubin increase",
     "participants": 1
    }
   ],
   "serious_adverse_events_listed": 0
  }
 },
 "trials": {
  "gronberg_2014": {
   "pmid": "25041740",
   "doi": "10.1111/wrr.12211",
   "design": "first-in-man randomized double-blind placebo-controlled phase I/II, 3 strengths vs placebo, 4 weeks after a 3-week placebo run-in",
   "n": 34,
   "result": "Healing rate constants about 6x (lowest strength, p=0.003) and 3x (middle strength, p=0.088) placebo; mean ulcer area fell 68% and 50%; highest strength no different from placebo; no safety concerns reported."
  },
  "heal_ll37_2021": {
   "pmid": "34687253",
   "pmcid": "PMC9298190",
   "doi": "10.1111/wrr.12977",
   "eudract": "2018-000536-10",
   "sponsor": "Promore Pharma AB",
   "n_randomized": 148,
   "n_fas": 144,
   "primary_full_population_closure_pct": {
    "lower_strength": 26.5,
    "higher_strength": 24.7,
    "placebo": 25.3,
    "p_lower_vs_placebo": 0.4453,
    "p_higher_vs_placebo": 0.5274
   },
   "post_hoc_large_wounds_closure_pct": {
    "lower_strength": 28.1,
    "higher_strength": 19.6,
    "placebo": 8.1,
    "p_lower_vs_placebo": 0.0458,
    "n": [
     21,
     21,
     24
    ]
   },
   "safety": "122 AEs in 64 patients (43.2%); 12 non-fatal SAEs in 11 patients (7.4%), none assessed as related; no deaths",
   "coi": "Three authors were Promore Pharma employees at the time; one a minority shareholder. Funded by Promore Pharma.",
   "company_clarification_2020_11_20": "https://storage.mfn.se/a9041841-95d2-40fa-8919-9cb79e748aef/clarification-of-outcome-in-the-clinical-trial-heal-ll-37.pdf",
   "company_clarification_quote": "This subgroup analysis regarding efficacy was not part of the original statistical analysis plan"
  },
  "miranda_2023": {
   "pmid": "37480520",
   "pmcid": "PMC10514151",
   "doi": "10.1007/s00403-023-02657-8",
   "registry": "NCT04098562",
   "n": 25,
   "condition": "diabetic foot ulcer with mild infection",
   "result": "Granulation index rose more with LL-37 cream on days 7-28 (p=0.031 to 0.037); no significant effect on IL-1alpha, TNF-alpha or aerobic bacterial counts; no side effect attributed to the cream; one mild irritant contact dermatitis.",
   "funding": "Universitas Indonesia research grant"
  },
  "dolkar_2018": {
   "pmid": "29665030",
   "doi": "10.1111/cup.13262",
   "summary": "Case report from the MD Anderson intratumoral LL-37 melanoma trial: verrucous, keratoacanthoma-like skin lesions with atypia about 45 days after starting injections; resolved within 2 months of stopping."
  }
 },
 "promore": {
  "name_change": "Promore Pharma AB, under name change to PMD Device Solutions AB (Nasdaq notice, Jan 11, 2024)",
  "nasdaq_notice": "https://www.nasdaq.com/press-release/the-observation-status-for-promore-pharma-ab-under-name-change-to-pmd-device",
  "nasdaq_quote": "the Company's board of directors had assessed that the opportunities to raise the capital needed to develop the Company's program for ropocamptide were limited"
 },
 "patent": {
  "number": "US9125875B2",
  "title": "Use of the cathelicidin LL-37 and derivatives thereof for wound healing",
  "priority": "2003-01-29",
  "granted": "2015-09-08",
  "assignee_original": "Lipopeptide AB",
  "assignee_current": "Promore Pharma AB",
  "status": "Expired - Fee Related; anticipated expiration 2024-01-28 (Google Patents)",
  "url": "https://patents.google.com/patent/US9125875B2/en",
  "abstract_quote": "The cytotoxic effect of LL-37 may be reduced by including a bilayer-forming polar lipid"
 },
 "pubmed": {
  "query": "\"LL-37\"[tiab] OR \"LL37\"[tiab] OR cathelicidin[tiab]",
  "count": 4707,
  "key_pmids": {
   "7529412": {
    "first_author": "Agerberth B",
    "year": "1995",
    "journal": "Proc Natl Acad Sci U S A",
    "title": "FALL-39, a putative human peptide antibiotic, is cysteine-free and expressed in bone marrow and testis."
   },
   "17873860": {
    "first_author": "Lande R",
    "year": "2007",
    "journal": "Nature",
    "title": "Plasmacytoid dendritic cells sense self-DNA coupled with antimicrobial peptide."
   },
   "17676051": {
    "first_author": "Yamasaki K",
    "year": "2007",
    "journal": "Nat Med",
    "title": "Increased serine protease activity and cathelicidin promotes skin inflammation in rosacea."
   },
   "21389263": {
    "first_author": "Lande R",
    "year": "2011",
    "journal": "Sci Transl Med",
    "title": "Neutrophils activate plasmacytoid dendritic cells by releasing self-DNA-peptide complexes in systemic lupus erythematosus."
   },
   "25470744": {
    "first_author": "Lande R",
    "year": "2014",
    "journal": "Nat Commun",
    "title": "The antimicrobial peptide LL37 is a T-cell autoantigen in psoriasis."
   },
   "16497887": {
    "first_author": "Liu PT",
    "year": "2006",
    "journal": "Science",
    "title": "Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response."
   },
   "15985530": {
    "first_author": "Gombart AF",
    "year": "2005",
    "journal": "FASEB J",
    "title": "Human cathelicidin antimicrobial peptide (CAMP) gene is a direct target of the vitamin D receptor and is strongly up-regulated in myeloid cells by 1,25-dihydroxyvitamin D3."
   },
   "19234121": {
    "first_author": "Coffelt SB",
    "year": "2009",
    "journal": "Proc Natl Acad Sci U S A",
    "title": "The pro-inflammatory peptide LL-37 promotes ovarian tumor progression through recruitment of multipotent mesenchymal stromal cells."
   },
   "15609314": {
    "first_author": "Heilborn JD",
    "year": "2005",
    "journal": "Int J Cancer",
    "title": "Antimicrobial protein hCAP18/LL-37 is highly expressed in breast cancer and is a putative growth factor for epithelial cells."
   },
   "23100468": {
    "first_author": "Ren SX",
    "year": "2012",
    "journal": "Cancer Res",
    "title": "Host immune defense peptide LL-37 activates caspase-independent apoptosis and suppresses colon cancer."
   },
   "20521250": {
    "first_author": "Wu WK",
    "year": "2010",
    "journal": "Int J Cancer",
    "title": "Emerging roles of the host defense peptide LL-37 in human cancer and its potential therapeutic applications."
   },
   "24549217": {
    "first_author": "Srakaew N",
    "year": "2014",
    "journal": "Hum Reprod",
    "title": "Antimicrobial host defence peptide, LL-37, as a potential vaginal contraceptive."
   },
   "29665030": {
    "first_author": "Dolkar T",
    "year": "2018",
    "journal": "J Cutan Pathol",
    "title": "Dermatologic toxicity from novel therapy using antimicrobial peptide LL-37 in melanoma: A detailed examination of the clinicopathologic features."
   },
   "37480520": {
    "first_author": "Miranda E",
    "year": "2023",
    "journal": "Arch Dermatol Res",
    "title": "Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial."
   }
  }
 },
 "analysis": {
  "human_trials_giving_ll37_found": 4,
  "of_which_placebo_controlled_published": 3,
  "largest_trial_met_primary_endpoint": false,
  "injected_or_systemic_controlled_trials": 0,
  "note": "Jabbit tally: Grönberg 2014, HEAL LL-37 (2021) and Miranda 2023 are topical, placebo-controlled and published; NCT02225366 is an uncontrolled intratumoral trial in melanoma. We found no controlled human trial of injected (subcutaneous) or oral LL-37."
 }
}