Updated August 2026
Melanotan-1 (Afamelanotide) Dosage: SCENESSE Label, Injection Research, and Study Protocol
Research note: Melanotan-1 = afamelanotide ([Nle⁴,D-Phe⁷]-α-MSH). FDA-established dose: SCENESSE 16 mg controlled-release implant every 2 months for adult EPP — not a reconstituted tanning vial. Historical injection research: 0.08–0.16 mg/kg SC (0.16 mg/kg = 12 mg at 75 kg, not 0.16 mg). Online 50–500 mcg schedules are 12–48× lower than trial amounts. Implant ≠ bolus. ≠ Melanotan II.
Afamelanotide binds predominantly to MC1R and increases cutaneous eumelanin. Formulation governs exposure: a PLGA implant, soluble SC injection, and online reconstituted vial are not interchangeable.
The approved product SCENESSE delivers 16 mg over controlled release (median Tmax 36 h, apparent t½ ~15 h). Early soluble injections had terminal half-lives of 0.8–1.7 hours but pigmentation persisted after dosing ended.
Increased pigmentation does not make deliberate UV or sunbed exposure safe. The EPP label requires continued sun and light protection measures.
Melanotan-1 dosage in 30 seconds
| Question | Current answer |
|---|---|
| Approved product | SCENESSE 16 mg implant |
| Approved schedule | Every 2 months · adult EPP |
| Injection research range | 0.08–0.16 mg/kg SC |
| Tanning plateau | 0.16 mg/kg — no gain above (n=8) |
| Online fixed dose | ~0.05–2 mg · anecdotal |
| Oral / intranasal | Not validated |
| 16 mg implant = injection? | No — release kinetics differ |
| ≠ | Melanotan II · cosmetic vial dose |
Compound identity
Reproducible records require full modified sequence, free peptide vs acetate, peptide content, intact mass, purity, and formulation-specific release data.
Identity gate
Afamelanotide (MT-1) vs MT-II · PT-141 · online vial
This page's subject — [Nle⁴,D-Phe⁷]-α-MSH · MC1R agonist
MW ~1646.85 Da · 13-mer · approved as SCENESSE 16 mg controlled-release implant for adult EPP. Development names: MT-1, MT-I.
Melanotan-1 is not Melanotan II
Isoform comparison
Melanotan-1 / afamelanotide vs Melanotan II
| Feature | MT-1 | MT-II |
|---|---|---|
| Structure | Linear 13-mer · acetylated/amidated | Cyclic heptapeptide |
| MW | ~1646.85 Da | ~1024.18 Da |
| Receptor profile | Predominantly MC1R | Broader melanocortin receptors |
| U.S. approval | SCENESSE for adult EPP | None |
| Typical online form | Lyophilized vial/spray | Lyophilized vial/spray |
Case reports involving illicit 'melanotan' often describe MT-II or uncertain products — attribution to MT-1 requires verified identity.
Dose and unit mathematics
Five common errors: mcg vs mg; mg/kg vs fixed mg; implant mass vs bolus; base vs acetate/vial mass; syringe units without verified concentration.
Unit math
nmol ↔ mcg · mg/kg weight table (MW ~1646.85 g/mol)
| mg/kg | 60 kg | 75 kg | 90 kg |
|---|---|---|---|
| 0.08 mg/kg | 4.8 mg | 6 mg | 7.2 mg |
| 0.16 mg/kg | 9.6 mg | 12 mg | 14.4 mg |
| 0.21 mg/kg | 12.6 mg | 15.75 mg | 18.9 mg |
| 0.26 mg/kg | 15.6 mg | 19.5 mg | 23.4 mg |
| 0.4 mg/kg | 24 mg | 30 mg | 36 mg |
≈ mcg free base
1.65 mcg
16 mg ≈ 9.72 µmol · SCENESSE active moiety
Weight-based injection calculator
Weight-based injection
mg/kg → total mg per administration (historical trial doses)
mg/kg
0.16 mg/kg
Total per dose
12.00 mg
(12,000 mcg)
vs 500 mcg online
24× higher
Historical study arithmetic only — not personal-use or implant dosing.
At 75 kg, 0.16 mg/kg = 12 mg per injection — explaining why online 250–500 mcg schedules are not simplified trial doses.
Controlled-release implant versus soluble injection
Never convert 16 mg implant to daily injection by dividing by 60 days. That ignores PLGA release kinetics and creates an unvalidated bridge.
Formulation split
SCENESSE implant vs historical soluble SC injection
SCENESSE 16 mg controlled-release implant
FDA-approved · EPP · every 2 months
- Dose
- 16 mg afamelanotide (18 mg acetate) in PLGA
- Cmax
- 3.7 ± 1.3 ng/mL (mean)
- Tmax
- Median 36 hours
- Apparent t½
- ~15 hours
- Measurable plasma
- Last detectable ~96 h in most subjects
- Procedure
- Healthcare professional · supra-iliac crest
Historical soluble SC injection
Investigational · short-acting · not current approved dose
- Common range
- 0.08–0.16 mg/kg per dose
- Absorption t½
- 0.07–0.79 hours
- Terminal t½
- 0.8–1.7 hours
- Typical course
- 10–20 SC doses over 2–4 weeks
- Pigment peak
- ~1 week after course; persists weeks
- ≠ implant
- 16 mg ÷ 60 days is not a valid conversion
Regulatory context
U.S.: SCENESSE approved 2019 for adult EPP — 16 mg implant q2mo by trained HCP, 30-min post-observation. EU: similar with seasonal guidance (max 4 implants/year in EPAR). Accurate statement: afamelanotide is approved as the named implant for EPP; online injectable tanning products are not that approved use.
Dosage in human clinical research
> Study exposure — not a universal schedule. Formulation, route, population, and light exposure are integral to every result.
Human clinical research
Injection pigmentation studies → EPP implant pivotal trials
| Study | Dose | Route | n | Finding |
|---|---|---|---|---|
| Levine 1991 | 0.08 mg/kg | SC × 10/12 d | 28 men | First controlled evidence MT-1 darkens human skin |
| Ugwu 1997 | 0.08–0.21 mg/kg SC/IV; oral | SC/IV/oral crossover | 3 men | SC ~complete bioavailability; oral undetectable; pigment persists |
| Levine 1999 | 0.16 / 0.26 / 0.40 mg/kg | SC daily × 10 d | 8 men | No better tanning above 0.16 mg/kg; more GI/fatigue higher |
| Dorr 2000 | 0.16 mg/kg/day | SC M–F × 2 wk | 7 volunteers | Eumelanin +49% forehead, +98% forearm at 1 wk post |
| Dorr 2004 | 0.08–0.16 mg/kg/day | SC + UV-B/sunlight protocols | Multiple protocols | Photoprotection endpoints; small phase 1 studies |
| Barnetson 2006 | 0.16 mg/kg | 3 × 10-d SC cycles/3 mo | 65 fair-skinned | Increased melanin density; reduced UV DNA damage endpoints |
| CUV039 | 16 mg implant | SC q60 d × 3 | 93 EPP adults | 64.1 vs 40.5 h pain-free direct sun (median) |
| CUV029 | 16 mg implant | SC q60 d × 5 | 74 EPP adults | 6.0 vs 0.75 h narrower sun endpoint (median) |
| Lim 2015 vitiligo | 16 mg implant | Monthly × 4 mo + NB-UVB | 55 adults | Faster repigmentation vs NB-UVB alone — investigational interval |
| Biolcati 2015 | 16 mg implant | Long-term EPP care | 115 · 1,023 implants | Sustained QoL up to 8 years; mostly minor AEs |
The 0.16 mg/kg plateau
Levine 1999: 0.16, 0.26, and 0.40 mg/kg daily × 10 days in eight men — all tanned, but no improvement above 0.16 mg/kg. Higher doses increased GI upset and fatigue.
Evidence hierarchy for dose selection
Evidence hierarchy
Label Tier A · trials · injection PK · online Tier E
| Tier | Evidence | Supports |
|---|---|---|
| Tier A — U.S. approved label | SCENESSE 16 mg q2mo · EPP | Established clinical use of named product |
| Tier B — Randomized trials | CUV039/CUV029 EPP; vitiligo combo | Investigational in studied populations |
| Tier C — Small PK/dose-ranging | 0.08–0.40 mg/kg injection studies | Hypothesis generation · bounded selection |
| Tier D — Preclinical | Rat toxicology to 20 mg/kg/day | Mechanism/toxicology · not human schedule |
| Tier E — Online/commercial | 0.05–2 mg fixed SC claims | Documents practice · not proof of safety/efficacy |
Commonly reported online protocols
Reported protocols
Online fixed boluses · SCENESSE label · proposed 12 vs 16 mg trial
- Amount
- 250–500 mcg SC
- Frequency
- Daily 7–14 days
- Duration
- 1–2 weeks
- Evidence basis
- Commercial/community · 12–48× lower than 0.16 mg/kg at 75 kg
Cumulative exposure examples
Cumulative exposure
Online mcg courses vs trial mg/kg vs implant mass
Schedule
250 mcg QD × 10 d
Nominal total mass
2.5 mg
Implant vs injection totals are not pharmacokinetically equivalent
Anecdotal versus clinically studied dosing
Evidence split
Weight-based injection / implant record vs online fixed mcg
Human research record
Formulation-specific · weight-based injection or fixed implant
- Approved implant
- 16 mg q2mo · EPP adults
- Injection range
- 0.08–0.16 mg/kg · 10–20 doses
- Dose plateau
- 0.16 mg/kg — no added tanning above (n=8)
- Oral route
- No detectable levels (n=3)
- Intranasal
- None validated
Online fixed-dose conventions
Often 12–48× lower than historical mg/kg trials
- Typical per dose
- 0.05–2 mg (50–2000 mcg)
- Loading
- 7–21 days common
- Maintenance
- 1–3× weekly indefinite
- UV pairing
- Often sun/sunbeds — not label recommendation
- Product identity
- Frequently unverified vs MT-II
Preclinical research dosage
Preclinical anchors
Rat toxicology to 20 mg/kg/day — not human cosmetic conversion
| Model | Dose | Outcome |
|---|---|---|
| Rat embryofetal | 0.2–20 mg/kg/day SC | No adverse effect through 20 mg/kg/day in label studies |
| Rat pre/postnatal | 0.2–20 mg/kg/day SC | No treatment-related developmental effect |
| Rat fertility | Up to 20 mg/kg/day SC | No adverse fertility effect in label package |
| Genotoxicity | Assay-specific | Negative Ames, lymphoma, micronucleus — carcinogenicity not conducted |
Mechanism relevant to dosage
MC1R → cAMP → melanogenic machinery → eumelanin → melanosome transfer. Pigment outlasts plasma drug after soluble injection. MC1R activation does not instantly deposit color — pre-UV bolus claims lack support.
Labeled adverse reactions (EPP implant trials)
SCENESSE label
Adverse reactions >2% in three EPP vehicle-controlled trials
| Reaction | Afamelanotide | Vehicle |
|---|---|---|
| Implant-site reaction | 21% | 10% |
| Nausea | 19% | 14% |
| Oropharyngeal pain | 7% | 5% |
| Cough | 6% | 3% |
| Fatigue | 6% | 3% |
| Skin hyperpigmentation | 4% | 0% |
| Dizziness | 4% | 3% |
| Melanocytic nevus | 4% | 2% |
n = 125 afamelanotide · 119 vehicle · 16 mg implant q2mo. Full-body skin exam twice yearly recommended per label.
Safety, side effects, and monitoring
Safety monitoring
Label AEs · hypersensitivity · pigment surveillance · illicit vial risks
- Labeled implant trials (EPP)
- Implant-site reaction 21%, nausea 19%, fatigue 6%, skin hyperpigmentation 4%, melanocytic nevus 4% — vs vehicle in 3 RCTs
- Hypersensitivity
- Postmarketing urticaria, angioedema, anaphylaxis — 30-min observation required; discontinue after serious reaction
- Pigment surveillance
- Full-body skin exam twice yearly recommended — nevi and freckles may darken; new lesions require assessment
- Online vial risks
- MT-II substitution, potency errors, endotoxin/contamination, concentration confusion — not captured by SCENESSE label alone
Dose escalation
Historical injection evidence argues against open-ended escalation above 0.16 mg/kg. The approved implant has no labeled titration. 'Start low and add until tan' is not a research rule — pigment is a delayed endpoint.
Complete proposed dose-optimization protocol
AFM-EPP-OPT: Phase 2b randomized, double-blind, active-controlled trial — 12 mg vs 16 mg controlled-release implant every 56 days × 4 over 32 weeks in adults with EPP. Primary: noninferior pain-free light exposure. 12 mg rod must be separately manufactured — never cut a 16 mg implant.
Proposed AFM-EPP-OPT design
12 mg vs 16 mg controlled-release implant · every 56 days × 4
Phase 2b · 120 participants · 32-week treatment · EPP adults · noninferiority margin 0.80 on pain-free light exposure
| Arm | Dose | Schedule | Total mass |
|---|---|---|---|
| A — investigational | 12 mg CR implant | Day 0, 56, 112, 168 | 48 mg |
| B — active control | 16 mg CR implant | Day 0, 56, 112, 168 | 64 mg |
12 mg is a separately manufactured GMP implant — a 16 mg rod must not be cut. Soluble injections, intranasal products, and deliberate UV tanning are excluded from this protocol.
Claims versus evidence
Claim checker
Common Melanotan-1 claims vs the evidence record
Melanotan-1 is FDA approved for tanning
Misleading
Afamelanotide is approved only as SCENESSE 16 mg implant for adult EPP — not reconstituted vial cosmetic tanning.
Dosage evidence ladder
Dosage evidence ladder
SCENESSE label strongest · online fixed mcg unvalidated
| Level | Evidence | Status |
|---|---|---|
| U.S. label + EPP RCTs | 16 mg implant q2mo | Established |
| Other dermatologic RCTs | Monthly 16 mg + NB-UVB vitiligo | Investigational |
| Early injection PK/dose-ranging | 0.08–0.16 mg/kg repeated SC | Historical · small samples |
| Long-term observational EPP | 16 mg implant cohorts | Supports tolerability |
| Preclinical toxicology | Rat studies to 20 mg/kg/day | Mechanistic · not consumer dose |
| Online fixed-dose protocols | 0.05–2 mg SC claims | Not validated |
Bottom line
Melanotan-1 and afamelanotide are the same peptide, but product names do not make formulations interchangeable. The only FDA-established dosage is SCENESSE 16 mg every 2 months for adult EPP.
Classic injection literature used 0.08–0.16 mg/kg short courses — not the 0.25–1 mg fixed doses commonly promoted online. A defensible next study optimizes the controlled-release implant (12 vs 16 mg), not a home injection schedule inferred from vial size.
16 mg implant q2mo · 0.16 mg/kg SC plateau · online mcg ≠ trial mg/kg · implant ≠ bolus.
Frequently asked questions
Is Melanotan-1 the same as afamelanotide?
Yes. Melanotan-1 was the development name. The approved product is SCENESSE.
Is Melanotan-1 FDA approved?
Afamelanotide is FDA approved only as the 16 mg SCENESSE implant for adults with EPP. Online vials for tanning are not that product.
What is the approved dose?
One 16 mg controlled-release implant subcutaneously every 2 months by a trained healthcare professional.
Is the 16 mg implant equivalent to a 16 mg injection?
No. PLGA formulation changes release rate, peak concentration, and half-life.
What injection dose was used in human trials?
Most often 0.08–0.16 mg/kg SC for 10–20 doses. One dose-ranging trial tested up to 0.40 mg/kg with no added tanning above 0.16 mg/kg.
Did research use 250–500 mcg daily?
Not in key published trials. Those microgram amounts are common online but much lower than weight-based milligram doses for an average adult.
Does it work without UV?
The U.S. label states eumelanin increases independently of sunlight or artificial UV.
Can Melanotan-1 be combined with Melanotan II?
No validated combination dose or demonstrated benefit-risk advantage exists.
Can a 16 mg implant be cut for a lower dose?
No. A lower-dose arm requires a separately manufactured and tested implant.
Does a 10 mg vial mean a 10 mg dose?
No. Vial mass is inventory. Complete dose requires verified identity, concentration, route, and schedule.
References
DailyMed
SCENESSE prescribing information16 mg implant · EPP · PK · adverse reactions.
Levine N et al.
MT-1 dose-ranging 19990.16 mg/kg plateau · GI/fatigue at higher doses.
Ugwu SO et al.
MT-1 PK and pigmentation 1997SC bioavailability · oral undetectable.
Langendonk JG et al.
Afamelanotide for EPP (CUV039)16 mg implant q60 d · NEJM 2015.
Lim HW et al.
Vitiligo + NB-UVB trial 2015Monthly 16 mg × 4 — investigational interval.
TGA
Melanotan tanning product warningCounterfeit/poor quality risk.