Synthetic alpha-MSH analogue and predominant MC1R agonist
MT-1 is a common name for afamelanotide. The FDA-approved version is SCENESSE, a clinician-placed implant used for one rare condition— erythropoietic protoporphyria—to help adults tolerate more light without pain. Research also describes pigmentation, vitiligo combination therapy, and EPP-related liver questions, but those are not the same as an approved cosmetic tanning product or a general-use injectable peptide.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Afamelanotide has controlled pivotal trials, an approved product, pharmacokinetic data, postauthorization cohorts, and investigational dermatology research.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Controlled trials and current labeling support increased pain-free light exposure in adults with EPP; confidence does not extend to cosmetic tanning or unapproved formulations.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: Approval is tied to the sterile controlled-release implant, professional placement, adult EPP population, and defined endpoint. It does not validate injectable solution, powder, nasal products, cosmetic tanning, or unsupervised implantation. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
The short version
MT-1 is a common name for afamelanotide. The FDA-approved version is SCENESSE, a clinician-placed implant used for one rare condition— erythropoietic protoporphyria—to help adults tolerate more light without pain. Research also describes pigmentation, vitiligo combination therapy, and EPP-related liver questions, but those are not the same as an approved cosmetic tanning product or a general-use injectable peptide.
Evidence checked through July 25, 2026. Includes the current May 2026 DailyMed label, pivotal controlled EPP trials, postauthorization cohorts, a randomized vitiligo combination study, and clearly separated observational liver and vitamin-D research.
What the evidence says
Two randomized, double-blind, placebo-controlled EPP trials involving 168 adults, supported by the current FDA label and postauthorization cohorts of 117 and 200 patients.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
How long-term rare safety, pigmentary surveillance, pediatric use, off-label skin indications, liver outcomes, and non-implant formulations compare with the well-defined SCENESSE evidence record.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
Current labeling confines approval to a 16 mg controlled-release implant for increasing pain-free light exposure in adults with EPP and adds product-specific hypersensitivity and skin-monitoring boundaries.
Quality-of-life scores increased from baseline and 91% of participants who began treatment were still receiving it at the analysis cutoff. The reported safety pattern was consistent with the clinical-trial profile.
Afamelanotide alone was not associated with a significant average vitamin-D increase. Cholecalciferol-containing groups had higher levels.
More recent and more frequent implant exposure was associated with lower protoporphyrin and selected liver-test values in the statistical models.
During treatment, participants reported about 6.1 more hours outside per week and improved EPP-specific quality of life. Phototoxic reactions were reported as less painful, while their number and duration did not significantly change.
Administration and handling
For its approved adult EPP indication, the current label describes one 16 mg SCENESSE implant placed subcutaneously above the anterior supra-iliac crest every two months by a trained healthcare professional using an aseptic implantation procedure. Patients are still advised to maintain sun and light protection. These are product- and indication-specific label facts, not an individualized recommendation and not a dose, route, schedule, conversion, or self-administration method for powders, vials, nasal products, solutions, or other materials sold as MT-1. The vitiligo study used four monthly 16 mg implants together with narrowband UV-B under a research protocol; that is off-label combination evidence, not dosing guidance.
The current SCENESSE label says to refrigerate the sealed 16 mg implant at 2°C to 8°C (36°F to 46°F) and protect it from light. The product is a sterile bioresorbable rod and requires no reconstitution. These instructions apply only to SCENESSE and do not establish identity, sterility, concentration, stability, beyond-use dating, or reconstitution conditions for powders, sprays, solutions, compounded products, or unapproved implants labeled MT-1.
Primary-source ledger
2026-05-11 · NCT01605136; NCT00979745
2025-03-01 · PMID 40082741 · EUPAS13004 · DOI 10.1111/phpp.13012
2024-04-18 · PMID 38634774 · DOI 10.1093/bjd/ljae148
2023-04-21 · PMID 37109595 · DOI 10.3390/life13041066
2020-03-18 · PMID 32186677 · DOI 10.1001/jamadermatol.2020.0352
2015-07-02 · PMID 26132941 · NCT01605136; NCT00979745 · DOI 10.1056/NEJMoa1411481
2014-09-17 · PMID 25230094 · NCT01430195 · DOI 10.1001/jamadermatol.2014.1875