§ 01 Overview
Overview
Synthetic α-MSH analog that selectively activates MC1R to stimulate melanogenesis without the broad melanocortin side effects of Melanotan II. The only FDA-approved melanocortin peptide for a dermatological indication (Scenesse, 2019, for erythropoietic protoporphyria).
FDA-approved October 2019 for EPP. EMA-approved December 2014. Phase III CUV039/CUV040 showed significant increase in pain-free outdoor time. Orphan drug designation in US and EU.
§ 02 Mechanism
Mechanism of action
Linear 13-amino-acid α-MSH analog with Nle⁴, D-Phe⁷ substitutions that confer selective MC1R activation. MC1R stimulation drives eumelanin production in epidermal melanocytes. Negligible MC3R/MC4R/MC5R activity means minimal sexual, appetite, or cardiovascular side effects vs. Melanotan II.
- 01FDA-approved for erythropoietic protoporphyria (EPP)
- 02Produces photoprotective eumelanin without UV exposure
- 03Receptor-selective; cleaner side-effect profile than MT-II
- 04Reduces phototoxic reactions in EPP patients
§ 03 Dosing
Dosing protocol
Standard Protocol
- Vial
- 16 mg subcutaneous implant
- BAC Water
- N/A; implant inserted by healthcare provider
- Dose Range
- 16 mg implant every 2 months
- Starting Dose
- 16 mg implant
- Route
- Other
- Timing
- Before expected sun-exposure season
- Frequency
- Every 2 months (max 4 implants per year per label)
- Cycle
- Seasonal; typically spring through fall
Storage
Refrigerate (2–8°C).
§ 04 Evidence
Evidence & research
FDA-approved October 2019 for EPP. EMA-approved December 2014. Phase III CUV039/CUV040 showed significant increase in pain-free outdoor time. Orphan drug designation in US and EU.
FDA Status
FDA-approved (Scenesse NDA 210797, October 2019).
§ 06 News
In the news
7 articles from the last 12 months · updates hourly
SCENESSE® approved for EPP in Canada - GlobeNewswire
SCENESSE® approved for EPP in Canada GlobeNewswire
How to Set Up Afamelanotide Treatment for Patients With EPP - Dermatology Times
How to Set Up Afamelanotide Treatment for Patients With EPP Dermatology Times
Monitoring Patients on Afamelanotide for EPP: Skin Exams, Labs, and Counseling - Dermatology Times
Monitoring Patients on Afamelanotide for EPP: Skin Exams, Labs, and Counseling Dermatology Times
How Afamelanotide Reduces Phototoxic Episodes in Patients With EPP - Dermatology Times
How Afamelanotide Reduces Phototoxic Episodes in Patients With EPP Dermatology Times
Clinuvel Gets EMA Advice for Pivotal Phase III Vitiligo Study - The Clinical Trial Vanguard
Clinuvel Gets EMA Advice for Pivotal Phase III Vitiligo Study The Clinical Trial Vanguard
New EPP drug candidates hard to compare with Scenesse, analysis finds - Porphyria News
New EPP drug candidates hard to compare with Scenesse, analysis finds Porphyria News
CLINUVEL’s SCENESSE demonstrates promising results in vitiligo patients - BiotechDispatch
CLINUVEL’s SCENESSE demonstrates promising results in vitiligo patients BiotechDispatch
§ 07 Sourcing
Sourcing & supply
Regulatory status
FDA-approved
This compound has an FDA approval for at least one indication. Brand pharmacy channels exist. Compounding may or may not be available depending on shortage status.
No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.
Browse full supplier directory§ 09 Safety
Safety & side effects
Side effects
- 01Nausea
- 02Implant site reactions
- 03Oropharyngeal pain
- 04Fatigue
- 05Darkening of pre-existing nevi (requires dermatological monitoring)
Contraindications
- 01Severe hepatic impairment
- 02Pregnancy / breastfeeding
§ 10 Questions
Melanotan I FAQ
- What is Melanotan I?
- Synthetic α-MSH analog that selectively activates MC1R to stimulate melanogenesis without the broad melanocortin side effects of Melanotan II. The only FDA-approved melanocortin peptide for a dermatological indication (Scenesse, 2019, for erythropoietic protoporphyria). Linear 13-amino-acid α-MSH analog with Nle⁴, D-Phe⁷ substitutions that confer selective MC1R activation. MC1R stimulation drives eumelanin production in epidermal melanocytes. Negligible MC3R/MC4R/MC5R activity means minimal sexual, appetite, or cardiovascular side effects vs. Melanotan II.
- What is Melanotan I used for?
- Reported uses include fda-approved for erythropoietic protoporphyria (epp), produces photoprotective eumelanin without uv exposure, receptor-selective; cleaner side-effect profile than mt-ii, and reduces phototoxic reactions in epp patients. Evidence strength is rated Established — see the evidence section for detail.
- How is Melanotan I dosed?
- Commonly referenced dosing is 16 mg implant every 2 months, typically every 2 months (max 4 implants per year per label), administered Other. This is educational reference only; consult a licensed clinician before use.
- How do you reconstitute Melanotan I?
- For Melanotan I, vials commonly come in 16 mg subcutaneous implant and a common reconstitution is N/A; implant inserted by healthcare provider. Use the reconstitution calculator to convert any vial size and water volume into exact insulin-syringe units.
- What are the side effects of Melanotan I?
- Commonly reported side effects include nausea, implant site reactions, oropharyngeal pain, fatigue, and darkening of pre-existing nevi (requires dermatological monitoring). This list is not exhaustive.
- Is Melanotan I legal?
- This compound has an FDA approval for at least one indication. Brand pharmacy channels exist. Compounding may or may not be available depending on shortage status. FDA status: FDA-approved (Scenesse NDA 210797, October 2019)..
§ 11 References
Selected references
- 01
CUV039 Phase III
PMID: 25963506 (NCT01605136)
- 02
Langendonk et al. NEJM 2015
PMID: 25963506