Evidence Snapshot
What this grade covers
D for a research profile supported by preclinical animal and tissue-model studies plus FDA and PCAC regulatory review materials; no identified human exposure, pharmacokinetic, safety, efficacy, controlled-trial, or long-term clinical evidence supports oral, topical, injectable, anti-inflammatory, gut-health, skin-healing, immune, recovery, or general wellness use in humans.
Regulatory Context
No FDA-approved KPV product was identified. FDA reports no identified human exposure data and insufficient human safety information. FDA staff recommended against adding KPV free base and acetate to the 503A Bulks List following its May 2026 evaluation. On July 23, 2026, the Pharmacy Compounding Advisory Committee voted 8-6 with one abstention to recommend possible 503A-list inclusion; the vote was advisory and nonbinding and did not create FDA approval, establish clinical safety or effectiveness, authorize a finished drug, or create an approved dosing regimen. Final FDA action was not identified as of 2026-07-26.
In Plain English
A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.
What is it?
KPV is the three-amino-acid sequence (lysine-proline-valine) that makes up the C-terminal end of alpha-melanocyte-stimulating hormone (α-MSH). Researchers isolated this fragment because animal and cell studies suggest it can carry some of α-MSH's anti-inflammatory activity without binding the melanocortin receptors that control skin pigmentation. Evidence describing α-MSH itself, or other melanocortin-derived peptides, is not the same as evidence for KPV specifically — this page covers only the exact KPV tripeptide.
Why are researchers interested in it?
Researchers have studied KPV mainly in cell cultures and animal models of intestinal and skin-related inflammation, exploring whether it can quiet inflammatory signaling (such as NF-κB activity) without the pigmentation effects of larger melanocortin peptides. Preclinical work has evaluated KPV in mouse colitis models, a rabbit corneal-healing model, and cell-uptake studies via the PepT1 transporter. Separately, KPV has been formally evaluated by FDA and its Pharmacy Compounding Advisory Committee (PCAC) as a candidate for the 503A compounding bulks list — a regulatory evaluation process, not a therapeutic trial.
What is it being studied for?
- Intestinal inflammationAnimal / Cell / Preclinical Data
- Anti-inflammatory cell signalingAnimal / Cell / Preclinical Data
- Corneal / wound healingAnimal / Cell / Preclinical Data
- FDA compounding (503A Bulks List) reviewRegulatory Documents & Official Trial Registries
What does the evidence look like?
No controlled human trial of KPV, by any route, was identified. All of the anti-inflammatory and wound-healing evidence for KPV itself comes from cell and animal studies — inflamed-mouse-colon models, a rabbit cornea model, and lab cell-signaling assays. FDA has separately stated it has not identified human exposure data for KPV drug products and lacks sufficient information to determine human safety. KPV's human evidence base sits at essentially the earliest preclinical stage, regardless of how the animal-model findings look.
Biggest things to know
KPV is not FDA-approved. FDA staff recommended against adding it to the 503A compounding bulks list after a May 2026 review, citing incomplete characterization and no human exposure data. On July 23, 2026, FDA's Pharmacy Compounding Advisory Committee voted 8–6 (one abstention) to recommend it for possible inclusion anyway — an advisory, nonbinding recommendation, not an approval, and no final FDA decision had been identified as of the last review. Every specific anti-inflammatory or healing benefit reported for KPV comes from animal or cell studies, not human trials. Because KPV shares its origin with α-MSH, marketing claims can blend in evidence about α-MSH or other melanocortin peptides — that evidence does not automatically apply to KPV itself.
What don't we know yet?
Whether KPV produces any of its preclinical anti-inflammatory or healing effects in humans, at any dose or by any route, is unknown — no human trial exists. Human pharmacokinetics, safety, and immunogenicity have not been studied. Where a final FDA compounding decision will land, and when, is also unknown.
Research status
Reviewed August 25, 2026
Research Takeaway
KPV is the Lys-Pro-Val C-terminal tripeptide sequence of alpha-MSH; evidence for alpha-MSH, KdPT, or other melanocortin analogs should not be treated as direct KPV evidence.
See all 8 evidence claims →Quick Summary
KPV is the Lys-Pro-Val tripeptide at the C-terminus of alpha-MSH. It has been studied in intestinal cell systems and animal models of colitis and corneal injury, where researchers reported anti-inflammatory signaling and tissue-specific effects. FDA states that it has not identified human exposure data for KPV drug products, so KPV should be presented as a preclinical research peptide rather than a demonstrated human anti-inflammatory treatment.
Mechanism & Research Overview
Preclinical studies suggest that KPV can enter certain intestinal and immune cells through PepT1 and influence NF-kB, MAP-kinase, and cytokine signaling. Other animal studies tested KPV in specialized colon-delivery and corneal-wound models. These findings are not evidence of human efficacy, safety, or route equivalence.
Evidence Grade Breakdown
A single letter grade can't capture how evidence quality differs across approved use, off-label use, and unsupported claims. The categories below break that down -- none of them grade this compound "overall."
Overall Research Grade
KPV has several preclinical studies involving colitis, peptide transport, corneal repair, and specialized delivery systems, along with FDA and PCAC materials documenting the absence of identified human exposure data and unresolved compounding-safety concerns. These sources support a preclinical research profile and regulatory evidence boundaries, but they do not establish human pharmacology, safety, therapeutic efficacy, dosing, or long-term outcomes.
CPreclinical and Mechanistic Evidence
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Preclinical and Mechanistic Evidence
Several animal and tissue-model studies examine KPV-related anti-inflammatory activity, peptide transport, colitis models, corneal repair, and specialized delivery systems. These findings are preclinical and do not establish comparable effects in humans.
FDirect Human Clinical Evidence
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Direct Human Clinical Evidence
No identified human exposure, pharmacokinetic, controlled-trial, observational, or therapeutic-outcome evidence is present in the reviewed source graph.
FHuman Safety Evidence
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Human Safety Evidence
Human safety, immunogenicity, pharmacokinetics, route-specific tolerability, and long-term effects have not been established. FDA materials identify the absence of human exposure data and unresolved safety concerns relevant to compounded KPV products.
FApproved Clinical Indications
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Approved Clinical Indications
No FDA-approved KPV product or approved anti-inflammatory, gastrointestinal, dermatologic, immune, recovery, or wellness indication is established.
FTherapeutic and Off-Label Outcomes
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Therapeutic and Off-Label Outcomes
Preclinical colitis, corneal, inflammatory, and delivery-system findings do not establish therapeutic efficacy for oral, topical, injectable, or other human use.
FBiohacking and Wellness Claims
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Biohacking and Wellness Claims
The reviewed evidence does not establish anti-inflammatory, gut-health, skin-healing, immune, recovery, longevity, performance, or general wellness benefit in humans. Evidence involving alpha-MSH, KdPT, or related analogs must not be transferred automatically to exact KPV.
Evidence reviewed
- Regulatory documents
- 4
- Preclinical studies
- 5
- Primary sources reviewed
- 8 of 10
Study counts describe the reviewed evidence base. They do not independently determine evidence quality.
How MitoCore grades evidence
Grade definitions
- A
- Strong and directly applicable evidence, generally including regulatory support or multiple high-quality replicated human trials for the exact claim and population.
- A-
- Strong human evidence with limited uncertainty, narrower applicability, or incomplete replication.
- B+
- Moderately strong evidence with meaningful human support but important scope, duration, safety, or generalizability limitations.
- B
- Credible evidence with notable uncertainty, limited replication, or mixed results.
- C
- Preliminary or inconsistent evidence, usually limited human data or strong indirect evidence.
- D
- Weak, indirect, population-limited, or largely unsupported evidence for the specific use being graded.
- F
- No credible supporting evidence, evidence contradicting the claim, or claims based primarily on speculation or marketing.
Confidence definitions
- High
- The evidence classification is unlikely to change substantially with ordinary additional research.
- Moderate
- The classification is reasonably supported but could change with additional high-quality evidence.
- Low
- The evidence base is sparse, indirect, inconsistent, or dependent on uncertain assumptions.
- Very Low
- The evidence base is extremely limited, speculative, or unsuitable for firm conclusions.
Scope
The grade evaluates the evidence supporting the specific category or claim. A grade does not evaluate product purity, supplier quality, personal suitability, treatment appropriateness, individual outcomes, legality, or medical safety for a specific person.
These grades and confidence levels describe the research evidence itself. They are not medical recommendations, and they do not evaluate any specific product, supplier, or individual's situation.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
KPV is the Lys-Pro-Val C-terminal tripeptide sequence of alpha-MSH; evidence for alpha-MSH, KdPT, or other melanocortin analogs should not be treated as direct KPV evidence.
Sources: PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation
Supported
Cell and mouse studies report PepT1-mediated uptake, inhibition of NF-kB/MAP-kinase signaling, and reduced inflammatory findings in experimental colitis.
Sources: PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation
Supported
A colon-targeted nanoparticle formulation reduced inflammatory findings in a mouse colitis model, but the specialized delivery system and animal model do not establish human oral or injectable efficacy.
Supported
Rabbit experiments reported facilitated corneal epithelial wound healing after KPV exposure; this is preclinical, tissue-specific evidence.
Supported
FDA states that it has not identified human exposure data for KPV drug products by any route and lacks sufficient information to determine human safety.
Sources: Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks
Supported
As of 2026-07-19, FDA staff had proposed that KPV free base and acetate not be added to the 503A Bulks List, but the July 2026 advisory review had not yet produced a final FDA determination.
Sources: FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, July 23–24, 2026
Supported
The Associated Press reported that on July 23, 2026, the FDA Pharmacy Compounding Advisory Committee voted 8–6, with one abstention, to recommend possible inclusion of KPV on the 503A Bulks List. The available secondary report did not distinguish between the free-base and acetate voting questions. The recommendation was advisory and nonbinding. It did not itself place KPV on the 503A Bulks List, create FDA approval, establish clinical safety or effectiveness, authorize a finished drug, or create an approved dosing regimen. No subsequent final FDA action was identified in the sources reviewed as of July 26, 2026.
Supported
FDA's May 2026 evaluation of KPV found inadequate physicochemical and quality characterization, inconsistent naming, no human pharmacokinetic or pharmacodynamic studies, and unresolved immunogenicity and aggregation concerns, supporting its recommendation against 503A-list inclusion.
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
FDA reports no identified human exposure data for KPV drug products by any route.Safety Consideration
Human safety, immunogenicity, pharmacokinetics, and long-term effects are not established.Safety Consideration
Specialized animal delivery systems do not validate commercial oral, topical, or injectable products.Safety Consideration
Evidence for alpha-MSH, KdPT, or other analogs should not be transferred to exact KPV.Safety Consideration
Unverified products may have identity, purity, sterility, and formulation risks.Safety Consideration
The 8-6 advisory-committee vote favoring possible 503A-list inclusion did not create FDA approval, establish clinical safety or effectiveness, or create an approved dosing regimen. Final FDA action was not identified as of 2026-07-26.
Research Areas Being Studied
Published preclinical work includes intestinal epithelial and immune-cell signaling, mouse colitis models, specialized colon delivery, and a rabbit corneal-wound model.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
No Human Study Findings Listed Yet
See preclinical, regulatory, and review sources below.
Study Tables by Evidence Type
Human Studies & Clinical Data
No Human Studies & Clinical Data Listed Yet
This section will be updated as sources are added.
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Drug-loaded nanoparticles targeted to the colon with polysaccharide hydrogel reduce colitis in a mouse model | 2010 | Mouse colitis model | Colon-targeted KPV nanoparticle delivery. | Delivery-system and animal findings do not establish human oral, topical, or injectable efficacy. | |
| PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation | 2008 | Human cell lines and mouse colitis models | Cellular uptake, inflammatory signaling, and murine colitis experiments. | Preclinical study; it does not establish a human treatment effect. | |
| Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease | 2007 | Murine colitis models | Preclinical — Reported significant anti-inflammatory effects in murine colitis models. | Preclinical only; animal/cell findings do not establish human safety or efficacy. | |
| Effects of the COOH-terminal tripeptide alpha-MSH(11-13) on corneal epithelial wound healing: role of nitric oxide | 2006 | Rabbit corneal wound model | Topical/preclinical corneal-healing experiment. | Animal model; not human efficacy or general wound-healing evidence. | |
| KPV anti-inflammatory comparison | 2003 | Preclinical | Inflammatory models — Analyzed KPV anti-inflammatory effects relative to other MSH peptides. | Preclinical only; animal/cell findings do not establish human safety or efficacy. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks | 2026 | FDA safety and compounding review | No human exposure data identified by FDA. | Official absence-of-human-safety-data statement. | |
| FDA Advisory Panel Vote on Unapproved Peptides | 2026 | On July 23, 2026, the FDA Pharmacy Compounding Advisory Committee voted 8-6 with one abstention to recommend possible 503A-list inclusion for TB-500, KPV, and BPC-157. The vote was advisory and nonbinding and did not create FDA approval or an approved indication for any of the substances. | |||
| FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, July 23–24, 2026 | 2026 | FDA advisory-committee review | Staff proposal pending advisory process. | The July 23–24, 2026 meeting was upcoming on the research-review date. | |
| FDA Evaluation of KPV-Related Bulk Drug Substances | 2026 | FDA's May 2026 evaluation of KPV free base and acetate for the 503A Bulks List found inadequate physicochemical and quality characterization, inconsistent naming, no identified human administration data, no clinical evidence for wound healing or inflammatory conditions, no human pharmacokinetic or pharmacodynamic studies, insufficient clinical and nonclinical safety information, and unresolved immunogenicity and aggregation concerns. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Alpha-MSH related peptides review | 2007 | Review | Anti-inflammatory mechanisms — Summarizes alpha-MSH/KPV anti-inflammatory pathways. | Secondary source; useful for context but not a substitute for primary study review. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
KPV's published evidence is preclinical. Cell and animal findings should not be presented as proof that KPV treats inflammatory bowel disease, skin disease, systemic inflammation, or wounds in humans.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-26.
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