Scenesse (afamelanotide)
An approved treatment for Erythropoietic Protoporphyria.
The same compound appears under different names depending on the context. Here is how to identify Afamelanotide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Afamelanotide
- Brand name
- Scenesse
- Development code
- CUV1647
- Drug class
- Melanocortin 1 receptor agonist (controlled-release implant)
- Manufacturer
- Clinuvel Pharmaceuticals
- How it's taken
- Implant placed under the skin every 2 months at an accredited EPP Specialty Center
The only FDA-approved treatment for erythropoietic protoporphyria (EPP), a small dissolving implant placed under the skin every 2 months by a trained clinician. It darkens the skin from within so adults with EPP can spend more time in sunlight before pain starts.
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Where Afamelanotide fits
The first-line prescription treatment for adults with EPP, used on top of light avoidance rather than instead of it. It is the only approved drug; dersimelagon, a daily pill with the same receptor target, is under FDA review with a decision expected by the end of February 2027, and bitopertin and PORT-77 take a different approach by lowering protoporphyrin itself.
How Afamelanotide works
In EPP, protoporphyrin builds up in the skin and reacts with visible light, setting off pain within minutes. Afamelanotide does not lower protoporphyrin. It is a laboratory-made copy of alpha-melanocyte stimulating hormone, the body's own signal for tanning, with 2 amino acids changed so it lasts longer and binds more strongly[1]. It attaches to the melanocortin 1 receptor on pigment cells and switches on production of eumelanin, the brown-black form of melanin, without any sun exposure[1].
The extra pigment absorbs some of the light before it reaches the protoporphyrin in the skin's small blood vessels, so the warning tingle starts later and people can stay outside longer. The label describes the medicine as increasing pain-free light exposure; it does not describe it as preventing phototoxic reactions, and it tells patients to keep using sun and light protection during treatment[1].
Mechanism: Synthetic 13 amino acid analog of alpha-melanocyte stimulating hormone that binds mainly the melanocortin 1 receptor (MC1-R) on pigment cells and increases eumelanin production without ultraviolet exposure
Side effects and safety
- Serious allergic reactions. Hives, angioedema and anaphylaxis have been reported since approval. A serious reaction means treatment, possible implant removal and no further Scenesse. Contraindicated after a severe hypersensitivity reaction (warning added August 2024).
- Skin darkening and moles. Generalized darkening of the skin and of existing moles and freckles is expected from the way the drug works. A full body skin exam twice a year is recommended.
- Keep sun protection. The label tells patients to keep using sun and light protection during treatment to prevent EPP phototoxic reactions.
- Removal window. The implant dissolves and may not be locatable from 10 days after insertion, so it usually cannot be removed after that.
- Observation for 30 minutes after each implant
- Dressing kept on for 24 hours, then watch the site and report any reaction
- Full body skin examination twice a year
- Contact the center if the implant is expelled
Scenesse's safety record on the label comes from 3 vehicle-controlled trials in 244 adults with EPP without significant liver involvement, of whom 125 received the drug[1]. Through month 6, the reactions reported in more than 2% of treated people, with the vehicle group in brackets, were implant site reactions 21% (10%), nausea 19% (14%), throat pain 7% (5%), cough 6% (3%), fatigue 6% (3%), skin hyperpigmentation 4% (0%), dizziness 4% (3%), a new or changed mole 4% (2%), respiratory tract infection 4% (3%), sleepiness 2% (1%), non-acute porphyria 2% (0%) and skin irritation 2% (0%)[1].
Implant site reactions include bruising, discoloration, redness, bleeding, a lump, pain, itching, swelling and an expelled implant; discoloration at the site was the most common at 10%[1].
The label carries 2 warnings. Serious allergic reactions including hives, angioedema and anaphylaxis have been reported since approval, so in August 2024 the FDA added a warning: anyone who has a serious reaction is treated, may have the implant removed, and should not receive Scenesse again, and the drug is now contraindicated after a severe hypersensitivity reaction[1][2].
The second is skin monitoring: because the drug darkens skin, existing moles and freckles can darken too, and the label recommends a full body skin examination twice a year to watch existing and new pigmented spots[1]. The implant dissolves and may not be findable from about 10 days after insertion, so removal is usually possible only in the first days[1].
Safety in people under 18 and in pregnancy has not been established, and only 4 of the 125 treated trial participants were 65 or older[1]. Clinuvel's US patient site also advises telling the doctor about blood thinners, aspirin and NSAIDs because of bruising or bleeding at the implant site[4].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Afamelanotide
Scenesse is a single implant containing 16 mg of afamelanotide, a white rod about 1.7 cm long and 1.45 mm wide that dissolves on its own[1]. A health care professional who has completed Clinuvel's training inserts it under the skin 3 to 4 cm above the front of the hip bone (the anterior supra-iliac crest) using a special cannula, after local anesthetic if wanted; the whole visit includes 30 minutes of observation afterward and the dressing stays on for 24 hours[1].
The label's schedule is 1 implant every 2 months[1]. It does not set a number of implants per year, and it does not say to stop in winter; in Europe the EMA label has allowed up to 6 implants a year since September 2025[5]. Sun and light protection measures continue during treatment[1].
In the US the drug is given only at EPP Specialty Centers that Clinuvel has trained and accredited, not through a pharmacy, and the company supplies the implants directly to those centers; it reported 120 North American Specialty Centers established as of early 2026[5][6]. Implants are stored in a refrigerator at 2 to 8 C and protected from light[1].
Availability and cost
Only available as the brand-name product.
An orphan drug for a condition Clinuvel put at about 2,300 people in the US, given at accredited centers and billed under the medical benefit with prior authorization rather than filled at a pharmacy. Clinuvel has not published a US list price, and none is given here.
Help paying for Scenesse
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
For patients with commercial or private health insurance, the Patient Assistance Program (previously the Savings Program) can cover the out-of-pocket costs of eligible Scenesse treatment. Depending on the plan, savings may apply toward co-pay, co-insurance or deductible. There is no income requirement. Not valid for Medicare, Medicaid or other government-funded programs. Terms expire at the end of each calendar year and may change.
For: private insurance · source - Insurance and case manager help
The program also helps with understanding insurance coverage for Scenesse and with referrals to an accredited EPP Specialty Center, the only places that give the implant. Contact is through the inquiry form on scenesse.com; patients apply for financial help by logging in with their Scenesse unique ID.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Clinuvel publishes no phone number, dollar maximum or free-drug program for Scenesse on its US pages; the page says only that the program can cover out-of-pocket costs for commercially insured patients. People on Medicare or Medicaid are not eligible and should ask their EPP Specialty Center about other options. Scenesse is billed under the medical benefit with prior authorization rather than filled at a pharmacy, according to Clinuvel's 2020 US distribution update. NORD's RareCare program lists a travel and lodging assistance fund for the Disc Medicine bitopertin (DISC-1459) EPP study (203-263-9188), which is for trial participants, not for Scenesse. Status is partial because the terms behind the login could not be read.
How EPP and XLP treatments compare
Scenesse is the only FDA-approved treatment for erythropoietic protoporphyria, and it is approved for adults. Behind it are 3 oral drugs at different stages: dersimelagon is under FDA review, bitopertin received a complete response letter and finished its Phase 3 trial, and PORT-77 is recruiting for a Phase 2b/3 trial. Scenesse and dersimelagon work on skin pigment; bitopertin and PORT-77 try to lower protoporphyrin itself. None has been compared head to head.
Erythropoietic Protoporphyria has 1 FDA-approved treatment: Scenesse (afamelanotide, approved 2019). Also compared, not FDA-approved for erythropoietic protoporphyria: Dersimelagon (MT-7117) (dersimelagon, Under FDA priority review, decision by end of February 2027); Bitopertin (DISC-1459) (bitopertin, Complete response letter February 13, 2026; Phase 3 APOLLO topline due October 19, 2026); PORT-77 (PORT-77, Phase 2b/3 recruiting; not yet reviewed by the FDA). Scenesse is typically used as adults with a history of phototoxic reactions from epp.
| Drug | How it works | How it’s given | How often | Where you get it | Who it is for | FDA status |
|---|---|---|---|---|---|---|
Scenesse afamelanotide You are here | MC1R agonist: a peptide that switches on eumelanin production so the skin absorbs light before it reaches protoporphyrin | Dissolving 16 mg implant placed under the skin above the hip | Every 2 months | Clinuvel-accredited EPP Specialty Center (about 120 in North America) | Adults with a history of phototoxic reactions from EPP | 2019 |
Dersimelagon (MT-7117) dersimelagon | MC1R agonist: a small molecule with the same pigment target as Scenesse | Oral tablet | Once daily (200 mg in Phase 3) | Home, if approved | Studied in people aged 12 to under 75 with EPP or XLP | Under FDA priority review, decision by end of February 2027 |
Bitopertin (DISC-1459) bitopertin | GlyT1 inhibitor: slows heme production in developing red cells so less protoporphyrin is made | Oral tablet | Once daily (60 mg in Phase 3 and expanded access) | Home; US expanded access program for ages 12 and up without satisfactory options | Studied in people aged 12 and up with EPP or XLP | Complete response letter February 13, 2026; Phase 3 APOLLO topline due October 19, 2026 |
PORT-77 PORT-77 | ABCG2 inhibitor: blocks the pump that moves protoporphyrin out of red cells into plasma | Oral tablet | Once or twice daily (dose being chosen in Phase 2b) | Clinical trial sites in the US | Recruiting people aged 12 and up with EPP or XLP for PATHWAY | Phase 2b/3 recruiting; not yet reviewed by the FDA |
Only Scenesse is FDA approved. Dersimelagon, bitopertin and PORT-77 are investigational and their results come from company announcements and trial registrations, not FDA labels; the FDA has not reviewed PORT-77 and declined bitopertin's first application. Trial results for different drugs measured different things over different periods and cannot be compared directly. Talk with a porphyria specialist about what fits your age, your liver and iron tests and your access to an accredited center.
Clinical trial results
The label rests on 2 placebo-controlled trials that measured hours of sunlight on days without pain[1]. In Study CUV039 (NCT01605136), 93 adults in the US received 3 implants of Scenesse or an inactive implant over 180 days and logged each day's hours in direct sunlight between 10 AM and 6 PM; the median total on pain-free days was 64.1 hours with Scenesse and 40.5 hours with the inactive implant[1].
In Study CUV029 (NCT00979745), 74 adults in Europe received 5 implants over 270 days and logged hours outdoors between 10 AM and 3 PM on days with most of the day in direct sunlight; the median on pain-free days was 6.0 hours with Scenesse and 0.75 hours with the inactive implant[1]. Participants were 98% Caucasian, mean age 40, and 53% male[1].
Both trials were published together in the New England Journal of Medicine in 2015[3]. A third trial, CUV030, contributed to the safety data[1].
An open-label pharmacokinetic study of the 16 mg implant in 28 people with EPP (NCT06388642) finished in 2024 and was last updated in July 2026; results are not posted[7].
Development history
Afamelanotide was developed by Clinuvel, an Australian company. The European Medicines Agency approved it for EPP in 2014, the FDA approved it on October 8, 2019 as a new molecular entity with orphan drug exclusivity, and Clinuvel's March 2020 launch update named the first 3 US treatment centers, in Detroit, Los Angeles and Aventura, Florida, with the implant billed under the medical benefit after prior authorization[2][6].
The company's post-marketing commitments to the FDA include following treated patients for at least 8 years, a global EPP disease registry and controlled distribution to trained centers[6]. The label was revised in August 2024 to add the anaphylaxis warning and contraindication[2]. Clinuvel reported plans for 2026 to engage the EMA on adolescent EPP patients and expected a Health Canada decision in 2026; it has not announced a US pediatric filing[5]. The same molecule is in a Phase 3 program for vitiligo[5].
Explore Erythropoietic Protoporphyria trials
Other Erythropoietic Protoporphyria treatments
Scenesse is the only approved EPP medicine, so for now the choice is between it and sun avoidance alone. Behind it are 3 oral drugs: dersimelagon, which also darkens skin through MC1R and is under FDA review; bitopertin, which lowers protoporphyrin production and received a complete response letter in February 2026 with Phase 3 results due in October 2026; and PORT-77, which blocks the transporter that moves protoporphyrin out of red cells and is recruiting for a Phase 2b/3 trial.
Common questions about Afamelanotide
▸What is Afamelanotide (Scenesse)?
The only FDA-approved treatment for erythropoietic protoporphyria (EPP), a small dissolving implant placed under the skin every 2 months by a trained clinician. It darkens the skin from within so adults with EPP can spend more time in sunlight before pain starts.
▸How does Afamelanotide work?
In EPP, protoporphyrin builds up in the skin and reacts with visible light, setting off pain within minutes. Afamelanotide does not lower protoporphyrin. It is a laboratory-made copy of alpha-melanocyte stimulating hormone, the body's own signal for tanning, with 2 amino acids changed so it lasts longer and binds more strongly[1]. It attaches to the melanocortin 1 receptor on pigment cells and switches on production of eumelanin, the brown-black form of melanin, without any sun exposure[1]. The extra pigment absorbs some of the light before it reaches the protoporphyrin in the skin's small blood vessels, so the warning tingle starts later and people can stay outside longer. The label describes the medicine as increasing pain-free light exposure; it does not describe it as preventing phototoxic reactions, and it tells patients to keep using sun and light protection during treatment[1].
▸What are the side effects of Afamelanotide?
Scenesse's safety record on the label comes from 3 vehicle-controlled trials in 244 adults with EPP without significant liver involvement, of whom 125 received the drug[1]. Through month 6, the reactions reported in more than 2% of treated people, with the vehicle group in brackets, were implant site reactions 21% (10%), nausea 19% (14%), throat pain 7% (5%), cough 6% (3%), fatigue 6% (3%), skin hyperpigmentation 4% (0%), dizziness 4% (3%), a new or changed mole 4% (2%), respiratory tract infection 4% (3%), sleepiness 2% (1%), non-acute porphyria 2% (0%) and skin irritation 2% (0%)[1]. Implant site reactions include bruising, discoloration, redness, bleeding, a lump, pain, itching, swelling and an expelled implant; discoloration at the site was the most common at 10%[1].
The label carries 2 warnings. Serious allergic reactions including hives, angioedema and anaphylaxis have been reported since approval, so in August 2024 the FDA added a warning: anyone who has a serious reaction is treated, may have the implant removed, and should not receive Scenesse again, and the drug is now contraindicated after a severe hypersensitivity reaction[1][2]. The second is skin monitoring: because the drug darkens skin, existing moles and freckles can darken too, and the label recommends a full body skin examination twice a year to watch existing and new pigmented spots[1]. The implant dissolves and may not be findable from about 10 days after insertion, so removal is usually possible only in the first days[1]. Safety in people under 18 and in pregnancy has not been established, and only 4 of the 125 treated trial participants were 65 or older[1]. Clinuvel's US patient site also advises telling the doctor about blood thinners, aspirin and NSAIDs because of bruising or bleeding at the implant site[4].
▸How is Afamelanotide taken?
Scenesse is a single implant containing 16 mg of afamelanotide, a white rod about 1.7 cm long and 1.45 mm wide that dissolves on its own[1]. A health care professional who has completed Clinuvel's training inserts it under the skin 3 to 4 cm above the front of the hip bone (the anterior supra-iliac crest) using a special cannula, after local anesthetic if wanted; the whole visit includes 30 minutes of observation afterward and the dressing stays on for 24 hours[1]. The label's schedule is 1 implant every 2 months[1]. It does not set a number of implants per year, and it does not say to stop in winter; in Europe the EMA label has allowed up to 6 implants a year since September 2025[5]. Sun and light protection measures continue during treatment[1].
In the US the drug is given only at EPP Specialty Centers that Clinuvel has trained and accredited, not through a pharmacy, and the company supplies the implants directly to those centers; it reported 120 North American Specialty Centers established as of early 2026[5][6]. Implants are stored in a refrigerator at 2 to 8 C and protected from light[1].
▸Is Afamelanotide FDA approved?
Yes, Afamelanotide (Scenesse) is FDA approved (2019) for the treatment of Erythropoietic Protoporphyria.
▸How often do you get the Scenesse implant?
One implant every 2 months, placed by a trained clinician.
Dose: a single 16 mg afamelanotide implant under the skin above the front of the hip bone.
Visit: about 30 minutes of observation afterward; the dressing stays on for 24 hours.
Annual number: the US label sets no yearly limit and does not say to pause in winter.
Source: Scenesse prescribing information, May 2026
▸Does Scenesse cure EPP or stop the pain completely?
No. It increases the time adults with EPP can spend in light before pain starts, and the label says to keep using sun protection.
Trial result: median 64.1 hours in direct sunlight on pain-free days over 180 days with Scenesse against 40.5 hours with an inactive implant (Study CUV039).
What it does not do: it does not lower protoporphyrin, so it does not treat the liver side of the disease.
Source: Scenesse prescribing information, Clinical Studies
▸Can children or teenagers with EPP get Scenesse?
Not under the US label, which covers adults only.
Label wording: safety and effectiveness have not been established in pediatric patients.
What is changing: Clinuvel said it plans to engage the European regulator on adolescents in 2026; no US filing has been announced. The dersimelagon and bitopertin trials included people aged 12 and up.
Source: Scenesse prescribing information; Clinuvel half year report, February 26, 2026
▸Where can I get Scenesse in the US?
Only at EPP Specialty Centers that Clinuvel has trained and accredited, not at a pharmacy.
How many: Clinuvel reported 120 North American Specialty Centers established as of early 2026.
Finding one: the EPP Centers page on scenesse.com lists them, and the Patient Assistance Program helps with referrals.
Source: Clinuvel half year report, February 26, 2026; scenesse.com
▸What are the most common side effects of Scenesse?
Implant site reactions and nausea.
Numbers: implant site reaction 21% against 10% with an inactive implant; nausea 19% against 14%; throat pain 7%; cough 6%; fatigue 6%; skin darkening 4%.
Serious: allergic reactions including anaphylaxis have been reported since approval, and a serious one means no further Scenesse.
Skin: existing moles and freckles can darken, so a full body skin exam twice a year is recommended.
Source: Scenesse prescribing information, Adverse Reactions and Warnings
▸Is there help paying for Scenesse?
Yes, for people with commercial or private insurance.
Program: the Scenesse Patient Assistance Program can cover out-of-pocket costs toward co-pay, co-insurance or deductible, with no income requirement.
Not eligible: Medicare, Medicaid or other government-funded plans.
How: log in with your Scenesse unique ID on scenesse.com or use the contact form; terms expire at the end of each calendar year.
Source: scenesse.com
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Clinuvel Inc. via openFDA · 2026-05-11. SCENESSE (afamelanotide) implant, prescribing information (set id 94f53286-11dd-7fbb-e053-2a95a90a7c48, effective May 11, 2026). https://api.fda.gov/drug/label.json?search=set_id:%2294f53286-11dd-7fbb-e053-2a95a90a7c48%22
- FDA via openFDA · 2024-08-12. NDA 210797 approval history: original approval October 8, 2019; labeling supplement S-007 approved August 12, 2024. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA210797%22
- New England Journal of Medicine · 2015-07-02. Afamelanotide for Erythropoietic Protoporphyria. https://pubmed.ncbi.nlm.nih.gov/26132941/
- Clinuvel Inc. · 2023-09-13. Scenesse Patient Assistance Program (previously the Savings Program). https://scenesse.com/public/patient-assistance-program/
- Clinuvel Pharmaceuticals · 2026-02-26. Appendix 4D half year report for the half year ended December 31, 2025. https://www.clinuvel.com/wp-content/uploads/2026/02/20260226-appendix-4d-half-year-report.pdf
- Clinuvel Pharmaceuticals · 2020-03-23. USA distribution update SCENESSE (orphan drug, innovation in photoprotection). https://www.clinuvel.com/wp-content/uploads/2020/03/20200323-US-Distribution-Update.pdf
- ClinicalTrials.gov · 2026-07-27. Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients. https://clinicaltrials.gov/study/NCT06388642