Regulatory Tracker

Where every major peptide actually
stands with the FDA

FDA status changes fast — sometimes month to month. We re-check every entry on this page on a set schedule and update it as soon as something changes, not weeks later.

  • AOD-9604

    Advanced Obesity Drug 9604, hGH fragment 177-191 (modified)

    Nomination withdrawn

    Not FDA-approved and not compoundable. Its compounding nomination was withdrawn, and it isn't under FDA evaluation.

    Verified Oct 2026

  • BPC-157

    HHS enforcement discretion

    Not FDA-approved. Available by prescription from state-licensed compounding pharmacies under a temporary HHS policy (Oct 2026).

    Verified Nov 2026

  • CJC-1295

    CJC-1295 with DAC, Mod GRF 1-29

    Nomination withdrawn

    Not FDA-approved and not compoundable. Its compounding nomination was withdrawn, and it isn't under FDA evaluation.

    Verified Oct 2026

  • DSIP (emideltide)

    Emideltide, delta sleep-inducing peptide, emideltide acetate

    Nomination withdrawn

    Not FDA-approved and not compoundable. FDA's advisory panel voted against adding it to the compounding list in July 2026.

    Verified Oct 2026

  • Epitalon

    Epithalon, Epitalon acetate

    PCAC recommended

    Not FDA-approved and not legally compoundable yet. An FDA advisory panel recommended adding it to the compounding list in July 2026; FDA hasn't acted.

    Verified Oct 2026

  • GHK-Cu

    Copper peptide, copper tripeptide-1

    Pending PCAC review

    Injectable GHK-Cu isn't approved or compoundable. FDA plans to take it to its advisory panel before the end of February 2027. Topical/non-injectable forms are back in FDA's Category 1.

    Verified Oct 2026

  • Ipamorelin

    Ipamorelin acetate

    503A/503B Category 2

    Not FDA-approved and not compoundable. Still on FDA's safety-risk list for outsourcing facilities; its pharmacy nomination was withdrawn.

    Verified Oct 2026

  • KPV

    KPV acetate, Lys-Pro-Val

    PCAC recommended

    Not FDA-approved and not legally compoundable yet. An FDA advisory panel recommended adding it to the compounding list in July 2026; FDA hasn't acted.

    Verified Oct 2026

  • LL-37

    Cathelicidin LL-37, CAP-18 (human)

    Nomination withdrawn

    Not FDA-approved and not compoundable. Reportedly slated for FDA advisory panel review before the end of February 2027.

    Verified Oct 2026

  • Melanotan II

    MT-II, MT2

    Nomination withdrawn

    Not FDA-approved and not compoundable. Reportedly slated for FDA advisory panel review before the end of February 2027.

    Verified Oct 2026

  • MOTS-c

    MOTs-C acetate, mitochondrial ORF of the 12S rRNA type-c

    PCAC recommended

    Not FDA-approved and not legally compoundable yet. An FDA advisory panel recommended adding it to the compounding list in July 2026; FDA hasn't acted.

    Verified Oct 2026

  • PT-141

    Bremelanotide, Vyleesi

    FDA-approved (NDA)

    FDA-approved as Vyleesi only for low sexual desire in premenopausal women. "PT-141" sold online is not the approved product.

    Verified Oct 2026

  • Retatrutide

    LY3437943

    Investigational — not approved

    Not FDA-approved for anything, and FDA says it cannot be used in compounding under federal law.

    Verified Oct 2026

  • Selank

    Selank acetate, TP-7

    Nomination withdrawn

    Not FDA-approved and not compoundable. Its compounding nomination was withdrawn, and it isn't under FDA evaluation.

    Verified Oct 2026

  • Semaglutide

    Ozempic, Wegovy, Rybelsus

    FDA-approved (NDA)

    FDA-approved for specific uses under three brand names. Compounded versions are not FDA-approved.

    Verified Oct 2026

  • Semax

    Semax acetate, Semax (heptapeptide)

    PCAC recommended

    Not FDA-approved and not legally compoundable yet. An FDA advisory panel recommended adding it to the compounding list in July 2026; FDA hasn't acted.

    Verified Oct 2026

  • Sermorelin

    Sermorelin acetate, Geref (discontinued)

    Discontinued — no current approval

    Once FDA-approved as Geref; discontinued and approval withdrawn in 2009. No approved product today.

    Verified Oct 2026

  • TB-500

    Thymosin beta-4 fragment (LKKTETQ), TB-500 acetate

    PCAC recommended

    Not FDA-approved and not legally compoundable yet. An FDA advisory panel recommended adding it to the compounding list in July 2026; FDA hasn't acted.

    Verified Oct 2026

  • Tesamorelin

    Egrifta WR, Egrifta SV

    FDA-approved (BLA)

    FDA-approved only to reduce excess belly fat in adults with HIV and lipodystrophy. Regulated as a biologic, so not compoundable.

    Verified Oct 2026

  • Thymosin Alpha-1

    Thymalfasin, Ta1, Zadaxin (outside the U.S.)

    Nomination withdrawn

    Not FDA-approved and not compoundable. Its compounding nomination was withdrawn, and it isn't under FDA evaluation.

    Verified Oct 2026

  • Tirzepatide

    Mounjaro, Zepbound

    FDA-approved (NDA)

    FDA-approved for specific uses as Mounjaro and Zepbound. Compounded versions are not FDA-approved.

    Verified Oct 2026