Melanotan I

Areas of active research — not promised effects

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Afamelanotide is a fully approved pharmaceutical in the United States, indicated to increase pain-free light exposure in adults with erythropoietic protoporphyria. It is available only by prescription and must be administered by trained healthcare professionals in a clinical setting; patients cannot self-administer or obtain it through consumer channels. As an approved product, it is not subject to FDA 503A compounding bulk drug substance restrictions applicable to unapproved peptides such as Melanotan II.

Confirmed high-severity market-integrity event (enforcement / recall / counterfeit)

Transparent blend · bci-1.0 · never paid-placement

Primary name

Melanotan I

Origin

Afamelanotide is a synthetic 13-amino-acid peptide analog of endogenous alpha-melanocyte-stimulating hormone (alpha-MSH). It incorporates two key substitutions relative to native alpha-MSH — a D-phenylalanine at position 7 and a norvaline at position 4 — that confer enhanced MC1R binding affinity and metabolic stability. It was developed at the University of Arizona and later advanced clinically by Clinuvel Pharmaceuticals; approved by the EMA in 2014 and by the FDA in October 2019 under the brand name Scenesse. CAS 75921-69-6; molecular formula C78H111N21O19; MW 1646.8 Da.

Registry IDs

PubChem CID

16197727

CAS

75921-69-6

InChIKey

UAHFGYDRQSXQEB-LEBBXHLNSA-N

DrugBank

DB04931

ChEMBL

CHEMBL441738

Molecular formula

C78H111N21O19

Molar mass

1646.8 g/mol

Monoisotopic

1645.83651040 Da

InChIKey

UAHFGYDRQSXQEB-LEBBXHLNSA-N

Appearance

White to off-white lyophilized powder (bulk peptide form); commercially available as a biodegradable poly(D,L-lactide-co-glycolide) implant rod (Scenesse)

Solubility

Soluble in aqueous buffers at physiological pH; solubility favored at slightly a…

Sequence not available in current seed.

Stability: The D-Phe7 and Nle4 substitutions relative to native alpha-MSH substantially improve metabolic stability versus the endogenous peptide. Susceptible to oxidation

Vial sizes

16 mg · null mg

Purity grades

pharmaceutical grade (NDA/SmPC)

Salt forms

Free base (primary)

• GHS hazard class on file
• PPE & spill response
• Disposal guidance
• Not-for-human-consumption posture

How much research exists, and of what maturity — never a verdict on whether it works.

Mechanism of action

• Afamelanotide acts as a potent agonist at the melanocortin-1 receptor (MC1R) on epidermal melanocytes, triggering adenylate cyclase-mediated elevation of intracellular cyclic AMP and subsequent activation of the PKA-CREB signaling axis
• CREB phosphorylation upregulates microphthalmia-associated transcription factor (MITF), which drives transcription of key melanogenic enzymes — tyrosinase, TRP-1, and TRP-2 — resulting in a dose-dependent shift in pigmentation toward eumelanin, the brown-black photoprotective form, over the pro-oxidant pheomelanin
• Beyond pigmentation, cAMP-mediated signaling has been shown to enhance nucleotide excision repair of UV-induced DNA photoproducts and to upregulate cytoprotective enzymes including heme oxygenase-1 (HO-1) and superoxide dismutase, providing photoprotection mechanisms independent of bulk pigment deposition
• Additional anti-inflammatory effects have been attributed to NF-κB modulation, reducing pro-inflammatory cytokine production in UV-exposed skin

Pharmacokinetics (ADME)

Half-life

Apparent terminal half-life approximately 15 hours following single 16 mg subcutaneous biodegradable implant (n=12 healthy adults); approximately 30 minutes when administered by non-implant subcutaneous injection routes (from Wikipedia/literature)

Clearance

Not formally characterized; peptide hydrolysis to constituent amino acids is the presumed primary route. >90% of drug released from implant by day 5; plasma levels undetectable by day 10 post-implant. Renal/hepatic clearance pathways not fully quantified in published data.

PK–PD note: Single 16 mg SC implant: median Tmax 36 hours, mean Cmax 3.7 ± 1.3 ng/mL, mean AUC0-inf 138.9 ± 42.6 h·ng/mL (FDA label data). The biodegradable implant vehicle provides extended, controlled drug rele…

Reading the evidence

• Evidence quality and gaps vary by application — see the cited grades above.
• Indexed-article counts span all evidence tiers, not only completed human trials.
• No first-party human-dosing, efficacy, or benefit claims are made here.

Key reviews & evidence-gap sources

• Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders — Clinical Pharmacokinetics, 2016 — Peer-reviewed pharmacology review; describes MC1R binding, cAMP/PKA/CREB cascade, melanogenesis, anti-inflammatory and antioxidant mechanisms.
• A Review and Update on Melanocyte Stimulating Hormone Therapy: Afamelanotide — Journal of Drugs in Dermatology — Reviews α-MSH/MC1R signaling pathway and afamelanotide development history.
• An unhealthy glow? A review of melanotan use and associated clinical outcomes — Systematic review per CASP guidelines — Systematic review of Melanotan I and II clinical trial research and case presentations; bremelanotide excluded. Could not retrieve full text (HTTP 403); title/abstract confirmed via search result.
• Afamelanotide for Erythropoietic Protoporphyria — New England Journal of Medicine, 2015 — Pivotal Phase 3 RCT report covering NCT01605136 and NCT00979745; could not retrieve full text (HTTP 403); identifiers and context confirmed via search results and ScienceDirect Topics overview.
• Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria — Expert Opinion on Pharmacotherapy, 2021 — Review of chemical properties, pharmacokinetics, preclinical data, and clinical trials of afamelanotide in EPP; PubMed search terms included 'Melanotan-1' and 'NDP-MSH'.

No registered human trials found for this compound.

Status

No registered trials found

Summary (literature)

The approved FDA label (NDA 210797) and pivotal trial data identify nausea and headache as very common adverse effects (>10% incidence). Common reactions (1-10%) include implant-site pain, erythema and discoloration, back pain, upper respiratory tract infections, darkening of pre…

WADA status

Not specifically listed by name in the WADA 2026 Prohibited List. Alpha-MSH analogs and melanocortin receptor agonists do not appear as named substances in the …

Dominant research route: Subcutaneous (SC) — both the comparative human PK trial concluded SC is efficacious, and the FDA/EMA-approved product is a subcutaneous implant

Comparative crossover PK trial in 3 healthy male human volunteers (0.08–0.21 mg/kg); FDA-approved 16 mg subcutaneous implant (SCENESSE) studied in adult EPP patients

Bioavailability: SC dose reported as completely bioavailable relative to IV; absorption-phase half-life 0.07–0.79 h, beta-phase half-life 0.8–1.7 h; clearance 0.12–0.19 L/kg/h; ≤3.9% recovered in urine

Authors concluded SC administration is an efficacious delivery method; the FDA-approved product (SCENESSE, afamelanotide 16 mg) is a bioresorbable rod implanted subcutaneously above the anterior supra-iliac crest every 2 months, releasing drug over ~60 days

Comparative crossover PK trial in 3 healthy male human volunteers (0.16 mg/kg)

Bioavailability: Served as the 100% bioavailability reference for the crossover comparison; significant tanning of forehead, arms, and neck noted following IV dosing

IV was used as the reference route to quantify SC relative bioavailability in the same trial; not a marketed/clinical delivery route

Comparative crossover PK trial in 3 healthy male human volunteers (0.16 mg/kg)

Bioavailability: No detectable drug levels were observed following PO dosing (plasma levels below RIA detection)

Oral route was studied head-to-head with IV and SC in the same human crossover trial; produced no measurable plasma exposure, and no oral formulation has been pursued clinically

Animal & human figures are kept visibly separate so studied animal doses are never misread as human guidance.

Sorted A–Z by vendor — never by price

Weekly median $/mg from the live vendor crawl.

Researched storefront prices, bucketed

p25 $3.80 · median $4.50 · p75 $5.50 · 9 researched vendors

Legit, COA-backed band: $3.80–$5.60/mg.

Value rule: don't just buy the cheapest — a price under $3/mg is a red flag. Pair price with COA and independent-test grade.

Estimated cost of research (10 mg)

Vial (best researched price)

$34

Bacteriostatic water (generic estimate)

$6

Syringes / supplies (generic estimate)

$12

What each test proves — general guidance, plus this compound's researched purity data

Independent labs cited for this compound

No formal FDA/MHRA drug RECALL (market withdrawal) specific to Melanotan I was found in the retrieved sources. Enforcement actions located are warning letters, debarment, seizures, and counterfeit warnings rather than Class I/II/III recalls. (Melanotan I as afamelanotide/Scenesse is an FDA/EMA-approved prescription product; the gray-market 'Melanotan I' powders are unapproved and not subject to recall mechanisms.)

Buyer red-flag checklist

• Unlicensed 'Melanotan I' powders sold online are not the FDA/EMA-approved afamelanotide (Scenesse) implant; Clinuvel warns online 'melanotan' products are not afamelanotide and may be counterfeit.
• Multiple regulators (FDA, MHRA, TGA, Danish/Norwegian/Swedish/Irish agencies) have issued warnings against products labeled 'melanotan' (I and II).
• No independent lab-test aggregate (Janoshik/MZ Biolabs/Finnrick) for Melanotan I was retrievable; purity/underdosing data therefore unavailable — buyers cannot verify contents without third-party COA.
• INTERPOL Pangea XVII (2025) explicitly lists melanotan among unapproved peptide supplements subject to seizure in global enforcement.
• FDA Import Alert 66-41 enables DWPE of unapproved new drugs; gray-market Melanotan I with disease/cosmetic claims is exposed to import detention.
• Prior felony conviction and debarment of a Melanotan distributor (Manookian/Melanocorp) demonstrates criminal enforcement risk in this peptide category (though that case concerned Melanotan II).

GMP vs research-grade: the chemistry (SPPS + HPLC + MS) is identical — the difference is the quality system.

Underdosing / mislabeling: No independent third-party lab test aggregate (Janoshik/MZ Biolabs/Finnrick) specific to Melanotan I could be retrieved within budget. Janoshik's public-tests portal returned HTTP 403 and no MT1-specific COA was located. Vendor self-claims of '99% purity' (e.g., Core Peptides) are first-party marketing, not independent verification, and are excluded per RUO firewall. A community anecdote referencing a source '50% underdosed, purity <80%' was unattributed to a named lab and is omitted.

• Detention Without Physical Examination (DWPE) of Unapproved New Drugs Promoted In The U.S. This is a GENERAL import alert covering all unapproved new drugs marketed/promoted in the U.S.; it is not Melanotan-I-specific. Gray-market Melanotan I sold with structure/function or disease-treatment claims would fall under this alert as an unapproved new drug. Latest revision noted 05/19/2026; published 06/24/2026.FDA Import Alert 66-41
• An RUO label is not an import exemption — CBP judges actual intended use.
• Lyophilized powder is ambient-stable in transit; temperature control needed for > 7-day transit.
• US-warehouse vendors dodge import scrutiny — they cost more but ship more reliably.

Every item dated & sourced

No granted patents identified in current seed. Composition-of-matter coverage is limited given the peptide's synthetic origin.

• IACUC / IRB research context
• RUO buyer responsibilities & documentation
• Veterinary / alternative-use where lawful
• Jurisdiction-aware "who may lawfully obtain"

What people discuss

Reported concerns — discussion, not established effects

Reading caveats

• self-experimentation community
• survivorship / self-selection bias
• vendor-affiliated posters and affiliate links
• anecdotal-only evidence
• MT-1 frequently conflated with MT-2 in discourse

Manually researched from reddit, youtube, x— theme weights are research estimates, not live counts; aggregated & de-identified. No individual posts, quotes, or usernames are ever shown.

Relative research / market volume — populated once the activity stream is wired

Inline tooltips for lyophilized, RUO, EU/mg, SPPS, 503A and more.

Toggle plain-language ↔ scientific in the header.

• How to read a COA
• Free base vs acetate
• Understanding evidence grades

FDA-approved (2019) synthetic alpha-MSH analog that activates MC1R to drive eumelanin synthesis; indicated for erythropoietic protoporphyria photoprotection. Approximately 19 articles are indexed (literature last scanned 2026-05-29). US regulatory status: FDA-approved prescription drug (Scenesse, NDA 210797); restricted distribution program. Research use only.

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