Melanotan I / Afamelanotide FDA-approved · specialist care

Skin

Melanotan I / Afamelanotide

An implant approved for a rare light-sensitivity disorder

FDA-approved for a specific condition · specialist care only
Why it’s specialist care
Stylised model of the real sequence

Overview.

Melanotan I and afamelanotide are the same molecule. As afamelanotide, it is approved under the brand Scenesse, by FDA (2019) and in the EU (2014, authorised under exceptional circumstances), as a slow-release implant placed under the skin by a trained healthcare professional to treat the rare genetic photosensitivity disorder erythropoietic protoporphyria (EPP). As 'Melanotan I,' the same peptide is also sold without approval as lyophilized 'research' vials that users reconstitute and self-inject for cosmetic tanning. That is a materially different risk profile from the approved implant, despite being the same chemical entity.

Also known as Afamelanotide · Scenesse · [Nle4,D-Phe7]-alpha-MSH · NDP-MSH

The molecule, decoded.

Sequence

Ac-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2

Length
13 residues
Molecular weight
1,646.9 g/mol
Formula
C78H111N21O19
CAS number
75921-69-6
Half-life
~15 hours (apparent, from the Scenesse implant)
Routes studied
subcutaneous controlled-release implant (approved route), subcutaneous injection (unapproved 'Melanotan I' solution, self-administered)
Modifications
N-terminal acetylation; C-terminal amidation; Nle4 (norleucine) substitution; D-Phe7 (D-amino acid) substitution relative to native alpha-MSH; marketed as the acetate salt (afamelanotide acetate)

How it works.

Afamelanotide is a melanocortin-1 receptor (MC1-R) agonist that increases eumelanin production in the skin independent of UV or sunlight exposure, unlike natural tanning. Amino-acid substitutions (norleucine at position 4, D-phenylalanine at position 7) relative to native alpha-MSH confer resistance to enzymatic degradation and prolong activity.

Evidence · FDA-approved · regulatory-grade trials

What the research shows

human RCT2013

In the Phase 3 confirmatory trial (Study CUV039, NCT01605136, 93 subjects with EPP), the median total hours over 180 days spent in direct sunlight between 10am-6pm on pain-free days was 64.1 hours for subjects receiving the SCENESSE implant versus 40.5 hours for vehicle.

93 adults with erythropoietic protoporphyria (Phase 3, vehicle-controlled)

Source
human RCT2011

In Study CUV029 (NCT00979745; 74 adults with EPP: 38 SCENESSE, 36 vehicle), the median total hours over 270 days spent outdoors between 10 am and 3 pm on pain-free days when 'most of the day' was spent in direct sunlight was 6.0 hours with SCENESSE versus 0.75 hours with vehicle. Days split between sun and shade were not counted.

74 adults with erythropoietic protoporphyria (vehicle-controlled)

Source
case report2012

A 2012 case report from Oxford, UK described melanoma in situ associated with injectable melanotropic peptides ('melanotan'; the abstract does not say whether Melanotan I or II). The authors note these unlicensed compounds are available over the internet with an unproven safety record, and that dysplastic naevi and melanoma had previously been reported with their use.

single case report, UK

Source
narrative review2026

A 2026 narrative review of unregulated 'biohacking' injectables named melanotan-II (it does not mention Melanotan I or afamelanotide) alongside BPC-157 and TB-500 as unapproved peptides without established human safety profiles, citing risks including contamination, inaccurate dosing and supraphysiological hormonal signaling, and linking MT-II to darkening moles, atypical nevi and melanoma.

narrative review of unregulated injectable peptides (discusses Melanotan II only)

Source

What to know first.

Based on: the FDA-approved label.

Reported side effects

  • Approved implant, most common (>2% incidence): implant site reaction (21% vs 10% vehicle), nausea (19% vs 14%), oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria, skin irritation (per FDA label, n=125 treated / 119 vehicle)
  • Unapproved injectable 'Melanotan I/II': case reports of melanoma in situ and dysplastic naevi associated with unlicensed melanotropic peptide injection
  • Approved implant, postmarketing: hypersensitivity reactions including urticaria, angioedema and anaphylaxis (FDA label revised 08/2024)

Cautions

  • The label recommends a full-body skin examination twice yearly, because Scenesse can cause generalized skin darkening and darken existing moles and freckles; the exams monitor existing and new pigmented lesions.
  • No carcinogenicity studies have been conducted on Scenesse per its own label
  • Contraindicated in patients with a history of severe hypersensitivity to afamelanotide or any excipient in Scenesse (label revised 08/2024). Serious hypersensitivity reactions, including anaphylaxis, have been reported since approval: treat them, remove the implant if needed, and give no further Scenesse.
  • Unapproved 'Melanotan I' products carry no quality, dosing, or contamination oversight and are frequently confused with the distinct, more potent Melanotan II
  • Scenesse does not replace photoprotection: the label tells patients to keep up sun and light protection during treatment to prevent EPP phototoxic reactions.

Checked 2026-09

Where it stands.

FDA-approved for a specific condition · specialist care only. Melanotan I / Afamelanotide is FDA-approved for a specific condition (Afamelanotide (Scenesse implant) is FDA-approved to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP), and approved in the EU to prevent phototoxicity in adults with EPP) and managed through specialist care. RiptideRx doesn’t offer it.
FDA
APPROVED: SCENESSE (afamelanotide) implant, NDA 210797, approved 2019-10-08 (new molecular entity; priority review; orphan drug), sponsor Clinuvel, Inc., indicated 'to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).' This is a full (not accelerated) approval. The label was revised on 2024-08-12 (supplement S-007) to add a contraindication for prior severe hypersensitivity and a warning for serious hypersensitivity reactions, including anaphylaxis. Unapproved 'Melanotan I' research vials sold for tanning contain the same peptide but have no FDA review, approval, or quality oversight.
Approved products
  • Scenesse (FDA, 2019): increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP) Label
  • Scenesse (EMA, 2014): prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)
Compounding
The approved Scenesse implant is manufactured by Clinuvel, not compounded. Because afamelanotide is a component of an FDA-approved drug, it can qualify as a bulk drug substance for 503A compounding (section 503A(b)(1)(A)(i)(II)), but any compounded product must still meet every other 503A condition, including a patient-specific prescription, an FDA-registered API source with a certificate of analysis, and the limits on copies of commercially available drugs such as Scenesse. 'Melanotan I' research vials are not compounded drugs and sit outside any FDA pathway. Afamelanotide/Melanotan I is not on FDA's Category 2 safety-risk list (page current as of 22 Apr 2026), is not named in FDA's 503A or 503B category lists, and was not reviewed at the July 2026 PCAC.
Sport (WADA)
Not named in the WADA 2026 Prohibited List under either 'afamelanotide' or 'melanotan'. Scenesse's FDA/EMA drug approvals would likely place it outside the S0 'non-approved substance' criterion. It is chemically distinct from Melanotan II, a different cyclic melanocortin peptide sometimes discussed in anti-doping and safety contexts.
Enforcement
  • FDA's 15 Feb 2024 warning letter to LightEyez Limited mentions 'Melanotan I & II' only because it quotes that firm's eye-drop marketing claims.
References (8)
  1. Drugs@FDA · label or approval record
  2. PubMed · PMID 22724573
  3. PubMed Central · PMC13585006
  4. ema.europa.eu · scenesse
  5. U.S. FDA · certain bulk drug substances use compounding may present signifi
  6. World Anti-Doping Agency
  7. Drugs@FDA · label or approval record
  8. Drugs@FDA · label or approval record

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