KPV: where it stands with the FDA, and what it costs
No FDA-approved drug contains it.
Prices by form:capsules (9)cream (6)injections (6)
Go to clinicLowest per monthKPV capsules (125mcg)
Padgett Medical Center · $90 (for 30 days)
Go to clinicLowest at a clinic we link toKPV injection (10mg)
Pepti · $229/mo (≈ $245 per 30 days with its fees)
Where KPV stands today
No FDA-approved drug contains KPV. FDA had it in 503A Category 2 from September 2023 until April 22, 2026 (nomination withdrawn). On July 23, 2026 the advisory committee voted 8-6 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers KPV acetate in topical and oral dosage forms only, single-ingredient, under ten conditions (an oral form needs documented oral bioavailability); it does not cover 503B facilities.
For pharmacies compounding one patient's prescription (section 503A)
Not on the 503A bulks list and in no FDA category (removed from Category 2 on April 22, 2026 after its nominations were withdrawn). Since Oct 30, 2026 it is one of six peptides in HHS's interim enforcement discretion policy for 503A compounding, limited to the form and routes below and ten conditions.
“Bulk drug substances nominated but withdrawn ... KPV FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration.”
““KPV” has been removed from category 2 because the nomination was withdrawn by the nominator.”
HHS interim enforcement discretion policy (Office of the Secretary, not FDA)
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.”
Form and routes HHS covers
“Based on the identified updated information, enforcement discretion for KPV acetate is appropriate for topical and oral dosage forms that are compounded from API accompanied by a CoA meeting the conditions of this policy.”
“KPV (free base) and KPV acetate were in Category 2 from September 2023 until April 22, 2026, and neither the placement nor the removal changed their status under section 503A; CDER recommended against listing either form, and the PCAC voted in favor of inclusion.”
One of the ten conditions: single-ingredient products only (no blends)
“The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.”
The Federal Register notice calls the policy a draft; written comments closed two weeks after publication
“HHS is announcing the availability of a draft”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The HHS policy names 503A compounders only; it does not cover 503B outsourcing facilities
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician”
The FDA's compounding advisory committee
23 July 2026: Should KPV (free base) and KPV acetate be placed on the 503A bulks list? (use FDA reviewed: wound healing and inflammatory conditions). Vote: 8 yes, 6 no, 1 abstention (both forms), per law-firm reports. Committee recommended inclusion, against FDA staff's proposal; no FDA rule yet; HHS cited the vote in its Oct 30, 2026 interim policy
“VOTE: Should KPV (free base) be placed on the list? ... VOTE: Should KPV acetate be placed on the list?”
Our reading
A 503A pharmacy can compound KPV acetate as a topical or oral product for a patient-specific prescription under HHS's enforcement discretion if every condition is met; injectable KPV and blends fall outside it.
Every source above was checked again on 14 November 2026.
What 23 clinics charge
- Padgett Medical CenterKPV capsules (125mcg)$90for 30 days
- Bon HealthKPV cream$104/mo
- EnhancedKPV capsulesfrom $109/mo
- EverlifeKPV injection (10mg)from $145/mo
- HuHealthKPV capsules$149/mo
What KPV is
- What it is
- Tripeptide (from alpha-MSH)
- How it works
- The last three amino acids of alpha-melanocyte-stimulating hormone, studied for inflammation.
- How it is given
- Subcutaneous injection; also oral capsules
- Also called
- lysine-proline-valine
KPV side by side
About KPV
Is KPV FDA-approved?
No. No FDA-approved drug contains KPV. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is KPV legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains KPV. FDA had it in 503A Category 2 from September 2023 until April 22, 2026 (nomination withdrawn). On July 23, 2026 the advisory committee voted 8-6 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers KPV acetate in topical and oral dosage forms only, single-ingredient, under ten conditions (an oral form needs documented oral bioavailability); it does not cover 503B facilities.
How much does KPV cost?
23 clinics publish a price. The lowest that compares per month is $90 for 30 days at Padgett Medical Center, and the middle of 19 clinics' lowest monthly prices is about $189. What a month buys differs by clinic, so each price lists what it includes. every KPV price
What forms does KPV come in?
Clinics sell it as capsules (9 prices), cream (6 prices), injection (6 prices), other (6 prices).