{
  "meta": {
    "source": "Peptós.LIFE FDA Peptide Tracker",
    "url": "https://peptos.life/fda-tracker",
    "canonical_json": "https://peptos.life/fda-tracker.json",
    "last_updated": "2026-07-26",
    "license": "https://creativecommons.org/licenses/by/4.0/",
    "license_note": "CC BY 4.0 — reuse with attribution to Peptós.LIFE and a link to the tracker.",
    "two_signal_law": "Every molecule carries two independent signals: a verdict (can a patient actually get it) and a regulatory_status (what the rule says). They are never merged and neither is derived from the other.",
    "disclaimer": "Compounded medications are prepared for an individual patient and are not FDA-approved. A PCAC recommendation is not FDA approval and is not availability — placement on the 503A Bulks List requires FDA rulemaking. Nothing here is medical advice, and no molecule is offered for sale in this dataset.",
    "generated_by": "prerender.cjs · processTrackerJson (generated at deploy time from molecules.data.js — do not hand-edit)"
  },
  "molecules": [
    {
      "slug": "bpc-157",
      "name": "BPC-157",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-23",
      "descriptor": "Recovery peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/bpc-157"
    },
    {
      "slug": "tb-500",
      "name": "TB-500",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-23",
      "descriptor": "Soft-tissue recovery",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/tb-500"
    },
    {
      "slug": "kpv",
      "name": "KPV",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-23",
      "descriptor": "Gut anti-inflammatory",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/kpv"
    },
    {
      "slug": "mots-c",
      "name": "MOTS-c",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-23",
      "descriptor": "Mitochondrial metabolic peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/mots-c"
    },
    {
      "slug": "dsip",
      "name": "DSIP (Emideltide)",
      "regulatory_status": "PCAC declined · not on Bulks List path",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-24",
      "descriptor": "Sleep-regulating peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "No near-term FDA pathway",
        "date": "—"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/dsip"
    },
    {
      "slug": "semax",
      "name": "Semax",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-24",
      "descriptor": "Nootropic focus peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/semax"
    },
    {
      "slug": "epitalon",
      "name": "Epitalon",
      "regulatory_status": "PCAC recommended · rulemaking pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-24",
      "descriptor": "Longevity sleep peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "FDA rulemaking decision",
        "date": "Projected 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/epitalon"
    },
    {
      "slug": "cjc-1295",
      "name": "CJC-1295",
      "regulatory_status": "Category 2, not under current review",
      "verdict": "Not available",
      "last_reviewed": "2026-05-02",
      "descriptor": "GH peptide",
      "category": "Category 2",
      "next_milestone": {
        "label": "No scheduled FDA review",
        "date": ""
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/cjc-1295"
    },
    {
      "slug": "ipamorelin",
      "name": "Ipamorelin",
      "regulatory_status": "Category 2, not under current review",
      "verdict": "Not available",
      "last_reviewed": "2026-04-22",
      "descriptor": "GH peptide",
      "category": "Category 2",
      "next_milestone": {
        "label": "No scheduled FDA review",
        "date": ""
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/ipamorelin"
    },
    {
      "slug": "pt-141",
      "name": "PT-141",
      "regulatory_status": "Restricted",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-16",
      "descriptor": "Libido arousal peptide",
      "category": "Sexual health",
      "next_milestone": {
        "label": "Bulks rulemaking (projected)",
        "date": "2026–2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/pt-141"
    },
    {
      "slug": "sermorelin",
      "name": "Sermorelin",
      "regulatory_status": "503A eligible (Category 1)",
      "verdict": "Available now",
      "last_reviewed": "2026-06-16",
      "descriptor": "Hormone-support peptide",
      "category": "Hormone",
      "next_milestone": {
        "label": "Compoundable now",
        "date": "Current"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/sermorelin"
    },
    {
      "slug": "gonadorelin",
      "name": "Gonadorelin",
      "regulatory_status": "503A eligible (Category 1)",
      "verdict": "Available now",
      "last_reviewed": "2026-06-18",
      "descriptor": "Hormone-support peptide",
      "category": "Hormone",
      "next_milestone": {
        "label": "Compoundable now",
        "date": "Current"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/gonadorelin"
    },
    {
      "slug": "nad",
      "name": "NAD+",
      "regulatory_status": "503A eligible (Category 1)",
      "verdict": "Available now",
      "last_reviewed": "2026-06-16",
      "descriptor": "Cellular-energy coenzyme",
      "category": "Longevity",
      "next_milestone": {
        "label": "Compoundable now",
        "date": "Current"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/nad"
    },
    {
      "slug": "b12",
      "name": "Vitamin B12",
      "regulatory_status": "503A eligible (Category 1)",
      "verdict": "Available now",
      "last_reviewed": "2026-06-16",
      "descriptor": "Methylcobalamin injection",
      "category": "Hormone",
      "next_milestone": {
        "label": "Compoundable now",
        "date": "Current"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/b12"
    },
    {
      "slug": "ghk-cu-topical",
      "name": "GHK-Cu (topical)",
      "regulatory_status": "Legal, cosmetic / topical",
      "verdict": "Available now",
      "last_reviewed": "2026-06-16",
      "descriptor": "Topical copper peptide",
      "category": "Cosmetic",
      "next_milestone": {
        "label": "Cosmetic use, unaffected",
        "date": "Ongoing"
      },
      "source_url": "https://www.fda.gov/cosmetics",
      "url": "https://peptos.life/fda-tracker/ghk-cu-topical"
    },
    {
      "slug": "ghk-cu-injectable",
      "name": "GHK-Cu (injectable)",
      "regulatory_status": "Under PCAC review, 2nd batch",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-16",
      "descriptor": "Injectable copper peptide",
      "category": "Cosmetic",
      "next_milestone": {
        "label": "Second PCAC review",
        "date": "By end of Feb 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/ghk-cu-injectable"
    },
    {
      "slug": "rapamycin",
      "name": "Rapamycin",
      "regulatory_status": "503A eligible",
      "verdict": "Available now",
      "last_reviewed": "2026-06-16",
      "descriptor": "mTOR longevity drug",
      "category": "Longevity",
      "next_milestone": {
        "label": "Compoundable now",
        "date": "Current"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/rapamycin"
    },
    {
      "slug": "trt-enclomiphene",
      "name": "TRT / Enclomiphene",
      "regulatory_status": "503A eligible · SKU pending",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-16",
      "descriptor": "Testosterone hormone therapy",
      "category": "Hormone",
      "next_milestone": {
        "label": "Fulfillment confirmation (pending)",
        "date": "2026"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/trt-enclomiphene"
    },
    {
      "slug": "semaglutide",
      "name": "Semaglutide",
      "regulatory_status": "503A / shortage-exception pathway",
      "verdict": "Available now",
      "last_reviewed": "2026-05-20",
      "descriptor": "GLP-1 weight-loss",
      "category": "GLP-1",
      "next_milestone": {
        "label": "503B comments close",
        "date": "Jun 29, 2026"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/semaglutide"
    },
    {
      "slug": "tirzepatide",
      "name": "Tirzepatide",
      "regulatory_status": "503A / shortage-exception pathway",
      "verdict": "Available now",
      "last_reviewed": "2026-05-20",
      "descriptor": "Dual GIP/GLP-1",
      "category": "GLP-1",
      "next_milestone": {
        "label": "503B comments close",
        "date": "Jun 29, 2026"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/tirzepatide"
    },
    {
      "slug": "liraglutide",
      "name": "Liraglutide",
      "regulatory_status": "503A / shortage-exception pathway",
      "verdict": "Available now",
      "last_reviewed": "2026-05-20",
      "descriptor": "GLP-1 weight-loss",
      "category": "GLP-1",
      "next_milestone": {
        "label": "503B comments close",
        "date": "Jun 29, 2026"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/liraglutide"
    },
    {
      "slug": "melanotan-2",
      "name": "Melanotan II",
      "regulatory_status": "Expected to stay restricted",
      "verdict": "Not available",
      "last_reviewed": "2026-06-16",
      "descriptor": "Tanning melanocortin peptide",
      "category": "Cosmetic",
      "next_milestone": {
        "label": "Second PCAC review",
        "date": "By end of Feb 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/melanotan-2"
    },
    {
      "slug": "ghrp",
      "name": "GHRP-2 / GHRP-6",
      "regulatory_status": "Expected to stay restricted",
      "verdict": "Not available",
      "last_reviewed": "2026-06-16",
      "descriptor": "GH-releasing peptides",
      "category": "RFK-14",
      "next_milestone": {
        "label": "Status review (projected)",
        "date": "2026–2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/ghrp"
    },
    {
      "slug": "dihexa",
      "name": "Dihexa",
      "regulatory_status": "Under PCAC review, 2nd batch (projected Feb 2027)",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-07-26",
      "descriptor": "Research-stage cognition peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "Second PCAC review",
        "date": "By end of Feb 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2025-N-6895",
      "url": "https://peptos.life/fda-tracker/dihexa"
    },
    {
      "slug": "ll-37",
      "name": "LL-37",
      "regulatory_status": "Expected to stay restricted",
      "verdict": "Not available",
      "last_reviewed": "2026-06-18",
      "descriptor": "Antimicrobial host peptide",
      "category": "RFK-14",
      "next_milestone": {
        "label": "Second PCAC review",
        "date": "By end of Feb 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/ll-37"
    },
    {
      "slug": "peg-mgf",
      "name": "PEG-MGF",
      "regulatory_status": "Expected to stay restricted",
      "verdict": "Not available",
      "last_reviewed": "2026-06-18",
      "descriptor": "Muscle growth factor",
      "category": "RFK-14",
      "next_milestone": {
        "label": "Second PCAC review",
        "date": "By end of Feb 2027"
      },
      "source_url": "https://www.regulations.gov/docket/FDA-2026-N-2979",
      "url": "https://peptos.life/fda-tracker/peg-mgf"
    },
    {
      "slug": "retatrutide",
      "name": "Retatrutide",
      "regulatory_status": "Investigational (Phase 3)",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-18",
      "descriptor": "Triple GLP-1/GIP/glucagon",
      "category": "Investigational",
      "next_milestone": {
        "label": "TRIUMPH Phase-3 readout (projected)",
        "date": "2026–2027"
      },
      "source_url": "https://clinicaltrials.gov/",
      "url": "https://peptos.life/fda-tracker/retatrutide"
    },
    {
      "slug": "cagrilintide",
      "name": "Cagrilintide",
      "regulatory_status": "Investigational (Phase 3)",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-18",
      "descriptor": "Long-acting amylin analog",
      "category": "Investigational",
      "next_milestone": {
        "label": "CagriSema / REDEFINE readouts",
        "date": "2026–2027"
      },
      "source_url": "https://clinicaltrials.gov/",
      "url": "https://peptos.life/fda-tracker/cagrilintide"
    },
    {
      "slug": "survodutide",
      "name": "Survodutide",
      "regulatory_status": "Investigational (Phase 3)",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-18",
      "descriptor": "GLP-1/glucagon · MASH",
      "category": "Investigational",
      "next_milestone": {
        "label": "SYNCHRONIZE Phase-3 (projected)",
        "date": "2026–2027"
      },
      "source_url": "https://clinicaltrials.gov/",
      "url": "https://peptos.life/fda-tracker/survodutide"
    },
    {
      "slug": "vk2735",
      "name": "VK2735 (Viking)",
      "regulatory_status": "Investigational (Phase 2/3)",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-18",
      "descriptor": "Dual GLP-1/GIP · oral",
      "category": "Investigational",
      "next_milestone": {
        "label": "VANQUISH program (projected)",
        "date": "2026–2027"
      },
      "source_url": "https://clinicaltrials.gov/",
      "url": "https://peptos.life/fda-tracker/vk2735"
    },
    {
      "slug": "ss-31",
      "name": "SS-31 / Elamipretide",
      "regulatory_status": "Approved (Barth) · off-label otherwise",
      "verdict": "Waitlist / coming",
      "last_reviewed": "2026-06-18",
      "descriptor": "Mitochondrial cardiolipin binder",
      "category": "Approved (narrow)",
      "next_milestone": {
        "label": "Longevity use remains off-label",
        "date": "Ongoing"
      },
      "source_url": "https://www.fda.gov/drugs",
      "url": "https://peptos.life/fda-tracker/ss-31"
    }
  ]
}