Melanotan I (Afamelanotide) vs PT-141
Two melanocortin drugs that genuinely won FDA approval — one for a rare light sensitivity, one for low desire — and are sold online as neither.
Short answer
Melanotan I and PT-141 are both FDA-approved drugs, but they are aimed at different problems. Melanotan I is marketed for tanning and photoprotection; PT-141 is the choice for readers interested in libido and sexual dysfunction. For PT-141, desire rose 0.35 points and distress fell 0.33 points vs placebo in the phase 3 RECONNECT trials of 1,267 women.
Melanotan I (Afamelanotide)
Scenesse
FDA-approved as the Scenesse implant for the rare disease EPP (real Phase 3 evidence) — but the injectable 'Melanotan 1' sold online for tanning is a different, unregulated product.
Full Melanotan I (Afamelanotide) evidence reviewPT-141
Bremelanotide / Vyleesi
FDA-approved as Vyleesi for HSDD in premenopausal women, with phase-3 evidence — but the off-label use in men and at higher doses goes beyond what's proven.
Full PT-141 evidence reviewMelanotan I (Afamelanotide) vs PT-141: head to head
- FDA status / approved use
Melanotan I (Afamelanotide)
FDA-approved as Scenesse only for erythropoietic protoporphyria; not approved for tanningPT-141
FDA-approved as Vyleesi for acquired, generalized HSDD in premenopausal women only- Marketed for
Melanotan I (Afamelanotide)
Tanning, photoprotectionPT-141
Libido, sexual dysfunction- Outcome areas
Melanotan I (Afamelanotide)
Skin / hairPT-141
Sexual health / libido- Evidence grade
Melanotan I (Afamelanotide)
FDA-approvedPT-141
FDA-approved- How it works
Melanotan I (Afamelanotide)
Activates the melanocortin-1 receptor on pigment cells to increase eumelaninPT-141
Activates melanocortin receptors in the brain involved in sexual desire- Route and dosing
Melanotan I (Afamelanotide)
Clinician-placed implant under the skin every two months; gray-market injections also soldPT-141
On-demand subcutaneous injection before sexual activity, not daily- Headline human result
Melanotan I (Afamelanotide)
Median 69.4 versus 40.8 hours of pain-free sunlight vs placebo over six months in a US Phase 3 EPP trialPT-141
Desire rose 0.35 points and distress fell 0.33 points vs placebo in the phase 3 RECONNECT trials of 1,267 women- Strongest evidence
Melanotan I (Afamelanotide)
Langendonk, NEJM 2015 (EPP Phase 3)Melanotan I (Afamelanotide) evidence reviewPubMed 26132941PT-141
RECONNECT phase 3, Obstet Gynecol 2019PT-141 evidence reviewPubMed 31599840- Key safety signal
Melanotan I (Afamelanotide)
Gray-market tanning use can darken and change moles, interfering with melanoma surveillancePT-141
Nausea is common; transient blood-pressure rise; possible lasting skin darkening- How it is obtained
Melanotan I (Afamelanotide)
Prescription drugPT-141
Prescribed and dispensed by compounding pharmacies; legality varies by compound
| Melanotan I (Afamelanotide) | PT-141 | |
|---|---|---|
| FDA status / approved use | FDA-approved as Scenesse only for erythropoietic protoporphyria; not approved for tanning | FDA-approved as Vyleesi for acquired, generalized HSDD in premenopausal women only |
| Marketed for | Tanning, photoprotection | Libido, sexual dysfunction |
| Outcome areas | Skin / hair | Sexual health / libido |
| Evidence grade | FDA-approved | FDA-approved |
| How it works | Activates the melanocortin-1 receptor on pigment cells to increase eumelanin | Activates melanocortin receptors in the brain involved in sexual desire |
| Route and dosing | Clinician-placed implant under the skin every two months; gray-market injections also sold | On-demand subcutaneous injection before sexual activity, not daily |
| Headline human result | Median 69.4 versus 40.8 hours of pain-free sunlight vs placebo over six months in a US Phase 3 EPP trial | Desire rose 0.35 points and distress fell 0.33 points vs placebo in the phase 3 RECONNECT trials of 1,267 women |
| Strongest evidence | Langendonk, NEJM 2015 (EPP Phase 3)Melanotan I (Afamelanotide) evidence reviewPubMed 26132941 | RECONNECT phase 3, Obstet Gynecol 2019PT-141 evidence reviewPubMed 31599840 |
| Key safety signal | Gray-market tanning use can darken and change moles, interfering with melanoma surveillance | Nausea is common; transient blood-pressure rise; possible lasting skin darkening |
| How it is obtained | Prescription drug | Prescribed and dispensed by compounding pharmacies; legality varies by compound |
marks a row where the two differ. “Not established” marks a cell the available evidence does not answer. Evidence grades come from our evidence matrix, which grades each molecule on the human data for the use it is marketed for.
- FDA-approved:
- Approved by the FDA for a defined indication, on the strength of pivotal human trials.
Our verdict
Both are real approved drugs whose online versions are not the approved product. Melanotan I is approved as the Scenesse implant for erythropoietic protoporphyria on Phase 3 evidence, while the injectable 'Melanotan 1' sold for tanning is a different, unregulated product. PT-141 is approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women, also on phase 3 evidence, but its off-label use in men and at higher doses goes beyond what has been shown. In both cases the approval is narrow and the marketing is not.
Melanotan I (Afamelanotide) fits if
You are looking at the photoprotection indication that was actually approved, under specialist care, rather than at tanning.
PT-141 fits if
Your question is desire rather than pigment, and you want to know what the approved indication does and does not cover.
Melanotan I (Afamelanotide) vs PT-141: common questions
- Are Melanotan I and PT-141 both FDA-approved?
- Yes. Melanotan I is FDA-approved as Scenesse only for erythropoietic protoporphyria; not approved for tanning. PT-141 is FDA-approved as Vyleesi for acquired, generalized HSDD in premenopausal women only.
- Which has stronger human evidence, Melanotan I or PT-141?
- Neither clearly. Both have approval-level evidence. The key source for Melanotan I is Langendonk, NEJM 2015 (EPP Phase 3); for PT-141, it is RECONNECT phase 3, Obstet Gynecol 2019.
- What are the main safety concerns with Melanotan I and PT-141?
- With Melanotan I, gray-market tanning use can darken and change moles, interfering with melanoma surveillance. With PT-141, nausea is common; transient blood-pressure rise; possible lasting skin darkening.
Key studies behind each
Melanotan I (Afamelanotide)
- Langendonk JG, Balwani M, Anderson KE, et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. PubMed 26132941
- Wensink D, Wagenmakers MAEM, Barman-Aksözen J, et al. (2020). Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatol. PubMed 32186677
- Habbema L, Halk AB, Neumann M, Bergman W. (2017). Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. Int J Dermatol. PubMed 28266027
- Langan EA, Ramlogan D, Jamieson LA, Rhodes LE. (2009). Change in moles linked to use of unlicensed "sun tan jab". BMJ. PubMed 19174439
PT-141
- Kingsberg SA, Clayton AH, Portman D, et al. (2019). Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. PubMed 31599840
- Yuan XC, Tao YX. (2022). Ligands for Melanocortin Receptors: Beyond Melanocyte-Stimulating Hormones and Adrenocorticotropin. Biomolecules. PubMed 36291616
- Simon JA, Kingsberg SA, Portman D, et al. (2019). Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. PubMed 31599847
- Spielmans GI. (2021). Re-Analyzing Phase III Bremelanotide Trials for “Hypoactive Sexual Desire Disorder” in Women. J Sex Res. PubMed 33678061
The full evidence reviews
- Melanotan I (afamelanotide): an approved rare-disease drug, not a tanning peptide
As afamelanotide (Scenesse), Melanotan I is a real FDA-approved MC1R agonist with Phase 3 evidence — but only for the rare disease EPP. The injectable “Melanotan 1” sold online for tanning is a different, unregulated, unproven thing.
Updated August 2026
- PT-141 (bremelanotide): the evidence on a peptide that is actually FDA-approved
Bremelanotide (Vyleesi) is FDA-approved for HSDD in premenopausal women, with phase-3 trial evidence. A straight read of what's proven — and where off-label use goes beyond it.
Updated August 2026
Where to get it
Where to get peptide therapy
Clinician-led telehealth services that prescribe compounded peptides. The specific peptides offered vary by provider — confirm Melanotan I (Afamelanotide) availability before ordering.
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