No human dataKPV is not FDA-approved.[1] The FDA wrote that it "has not identified any human exposure data on drug products containing KPV administered via any route of administration."[2] The calculator does arithmetic only.
What is the KPV peptide?
KPV is the tripeptide lysine-proline-valine, the last three amino acids (11–13) of α-melanocyte-stimulating hormone.[10]
- Sequence
- H-Lys-Pro-Val-OH, α-MSH(11–13)[10]
- Formula and weight
- C16H30N4O4, 342.43 g/mol; acetate salt 402.51 g/mol
- Name
- FDA: "KPV is a common name and not a United States Adopted Name (USAN)."[4]
Regulatory status in November 2026
KPV is not approved, but since October 30, 2026 a non-binding HHS policy has covered compounding of topical and oral KPV.
| Date | What happened |
|---|---|
| Sept 29, 2023 | Placed in 503A Category 2[3] |
| Apr 22, 2026 | Removed after the nomination was withdrawn; FDA keeps it in its "nominated but withdrawn" safety table |
| July 23, 2026[4][5] | FDA proposes not adding KPV to the 503A bulks list |
| Oct 30, 2026[6] | HHS policy covers KPV acetate in topical and oral forms only, under ten conditions |
- FDA's main concern: "the lack of any human data on drug products containing these substances administered via any route of administration, including lack of information to assess immunogenicity or aggregation".[4]
- HHS's reasoning: it says the FDA's safety conclusion "reflects an absence of information rather than an observed signal".[6] The policy does not cover injected KPV.
- In practice: an FDA inspection record of a Texas compounder lists lots labeled "BPC157/TB500/KPV 3/3/3MG/ML", a three-ingredient product the HHS policy's single-ingredient rule does not cover. A Form 483 records observations, not a final FDA decision.[7][6]
- Sport: KPV is not named on the WADA 2026 list.[8] From 2027, the list names "peptides" in general under S0.[9]
KPV dosage and side effects: what the evidence says
There is no human evidence to report: no published trial, no human pharmacokinetic data and no adverse event reports, so KPV's side effects in people are simply unknown.
- FDA: "The nomination did not include, and FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration."[4]
- The FDA's adverse event and complaint databases held no KPV reports through December 2025.[4]
- A laboratory study cited by the FDA found that KPV "does not permeate well" through human skin samples, which matters for the topical form the nomination proposed.[4]
With no human data, there is no KPV dosage to report from any study or label.
KPV peptide dosage chart (concentration only)
This chart shows what one syringe unit holds. KPV is a very small molecule, so 100 mcg is 292 nmol, about four times as many molecules as 100 mcg of BPC-157.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 2 mg + 1 mL | 2 | 20 | 58.41 | 5 |
| 2 mg + 2 mL | 1 | 10 | 29.2 | 10 |
| 2 mg + 3 mL | 0.667 | 6.67 | 19.47 | 15 |
| 5 mg + 1 mL | 5 | 50 | 146.02 | 2 |
| 5 mg + 2 mL | 2.5 | 25 | 73.01 | 4 |
| 5 mg + 3 mL | 1.667 | 16.67 | 48.67 | 6 |
| 10 mg + 1 mL | 10 | 100 | 292.03 | 1 |
| 10 mg + 2 mL | 5 | 50 | 146.02 | 2 |
| 10 mg + 3 mL | 3.333 | 33.33 | 97.34 | 3 |
Example arithmetic: a 5 mg vial with 2 mL holds 25 mcg per unit, so 100 mcg is 4 units. See the peptide dosage calculator for any other mix.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
- BPC-157 + TB-500 blendNot approved Two peptides in one vial: the arithmetic of a fixed ratio.
- GHK-CuNot approved Copper peptide. Studied on skin; injectable use has no published trials.
- LL-37Not approved Human cathelicidin. Topical wound trials; FDA cites tumor concerns.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
Frequently asked questions
What is the KPV dosage?
None has been established. No human study of KPV by any route was found, by us or by the FDA.[4]
What does KPV stand for?
The one-letter codes of its three amino acids: K for lysine, P for proline and V for valine.[10]
Can pharmacies compound KPV?
KPV is not on the 503A bulks list. A draft HHS policy from October 30, 2026 covers KPV acetate in topical and oral forms only, under ten conditions.[6] See are peptides legal?
Is KPV FDA-approved?
No. There is no FDA application for KPV.[1]
Sources
- openFDA Drugs@FDA searches for AOD-9604, KPV, epitalon, semax, selank, cagrilintide, melanotan and NAD (no application found)
- Certain bulk drug substances for use in compounding that may present significant safety risks
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- FDA briefing document: KPV-related bulk drug substances
- Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026
- Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526)
- FDA Form 483, Texas compounding pharmacy (inspection August 17 – September 9, 2026)
- World Anti-Doping Code: Prohibited List 2026
- Athlete advisory: what's new on the 2027 WADA Prohibited List
- PubChem CID 125672: KPV (Lys-Pro-Val)