{"id":"afamelanotide","rwe":[{"pmid":"41885813","year":"2026","title":"New and currently investigated pharmacotherapies for the erythropoietic protoporphyrias: spotlight on dersimelagon and bitopertin.","finding":"","journal":"Expert opinion on pharmacotherapy","studyType":"Clinical Study"},{"pmid":"41793078","year":"2026","title":"Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients.","finding":"","journal":"Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG","studyType":"Clinical Study"},{"pmid":"41766687","year":"2026","title":"Adjunctive use of Polypodium leucotomos extract in patients with erythropoietic protoporphyria: An exploratory study.","finding":"","journal":"Photochemistry and photobiology","studyType":"Clinical Study"},{"pmid":"41718315","year":"2026","title":"Congenital Erythropoietic Porphyria with Persistent Severe Biochemical Abnormalities and a Non-Mutilating Clinical Course: A Case Report.","finding":"","journal":"Reports (MDPI)","studyType":"Clinical Study"},{"pmid":"41547183","year":"2026","title":"Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide.","finding":"","journal":"Journal of pharmaceutical and biomedical analysis","studyType":"Clinical Study"}],"_fda":{"id":"49d76bf9-3f17-9ff5-e063-6394a90a54d1","set_id":"94f53286-11dd-7fbb-e053-2a95a90a7c48","openfda":{"upc":["0373372011616"],"unii":["QW68W3J66U"],"route":["SUBCUTANEOUS"],"rxcui":["2262254","2262259"],"spl_id":["49d76bf9-3f17-9ff5-e063-6394a90a54d1"],"brand_name":["SCENESSE"],"spl_set_id":["94f53286-11dd-7fbb-e053-2a95a90a7c48"],"package_ndc":["73372-0116-1"],"product_ndc":["73372-0116"],"generic_name":["AFAMELANOTIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["AFAMELANOTIDE"],"manufacturer_name":["CLINUVEL INC."],"application_number":["NDA210797"],"is_original_packager":[true]},"version":"10","description":["Descripton SCENESSE (afamelanotide) implant is a controlled-release dosage form for subcutaneous administration. Afamelanotide is a melanocortin 1 receptor (MC1-R) agonist. The active ingredient afamelanotide acetate is a synthetic peptide containing 13 amino acids with molecular formula C 78 H 111 N 21 O 19 •xC 2 H 4 O 2 (3 ≤ x ≤ 4). The molecular weight of afamelanotide is 1646.85 (anhydrous free base). Afamelanotide acetate has the following structure: Ac-Ser-Tyr-Ser-Nle-Glu-His-(D)Phe-Arg-Trp-Gly-Lys-Pro-Val-NH 2 • xCH 3 COOH. Afamelanotide is a white to off-white powder, freely soluble in water. Each SCENESSE implant contains 16 mg of afamelanotide (equivalent to 18 mg of afamelanotide acetate), and 15.3-19.5 mg of poly (DL-lactide-co-glycolide). SCENESSE implant is a single, solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. The implant core comprises of the drug substance admixed with a poly (DL-lactide-co-glycolide) bioresorbable copolymer."],"how_supplied":["SCENESSE (afamelanotide) implant, 16 mg, for subcutaneous administration (NDC 73372-0116-1) is supplied in a Type I amber glass vial sealed with a PTFE coated rubber stopper. Each vial contains one afamelanotide implant and is packaged individually in a cardboard box. SCENESSE implant is a solid white to off-white, bioresorbable and sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Store in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [ see Dosage and Administration ]."],"effective_time":"20260202","clinical_studies":["Three vehicle-controlled, parallel-group clinical trials of SCENESSE were conducted in subjects with EPP. Of these trials, two trials (Study CUV039, NCT 01605136, and Study CUV029, NCT 00979745) were designed to assess exposure to direct sunlight on days with no phototoxic pain. The two trials differed in the number of days of follow-up, the time windows within a day in which time spent outdoors was recorded, and how the amount of time spent in direct sunlight on each day was characterized. The subjects enrolled in these trials were primarily Caucasian (98%), the mean age was 40 years (range 18 to 74 years), and 53% of subjects were male and 47% were female. Study CUV039 enrolled 93 subjects, of whom 48 received SCENESSE (16 mg of afamelanotide administered subcutaneously every 2 months), 45 received vehicle. Subjects received three implants and were followed for 180 days. On each study day, subjects recorded the number of hours spent in direct sunlight between 10 am and 6 pm, the number of hours spent in shade between 10 am and 6 pm, and whether they experienced any phototoxic pain that day. The primary endpoint was the total number of hours over 180 days spent in direct sunlight between 10 am and 6 pm on days with no pain. The median total number of hours over 180 days spent in direct sunlight between 10 am and 6 pm on days with no pain was 64.1 hours for subjects receiving SCENESSE and 40.5 hours for subjects receiving vehicle. Study CUV029 enrolled 74 subjects, of whom 38 received SCENESSE (16 mg of afamelanotide administered subcutaneously every 2 months), 36 received vehicle. Subjects received five implants and were followed for 270 days. On each study day, subjects recorded the number of hours spent outdoors between 10 am and 3 pm, whether “most of the day” was spent in direct sunlight, shade, or a combination of both, and whether they experienced any phototoxic pain that day. The primary endpoint was the total number of hours over 270 days spent outdoors between 10 am and 3 pm on days with no pain for which “most of the day” was spent in direct sunlight. This analysis does not include sun exposure on days for which subjects reported spending time in a combination of both direct sunlight and shade. The median total number of hours over 270 days spent outdoors between 10 am and 3 pm on days with no pain for which “most of the day” was spent in direct sunlight was 6.0 hours for subjects in the SCENESSE group and 0.75 hours for subjects in the vehicle group."],"adverse_reactions":["Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoietic protoporphyria (EPP) without significant liver involvement. Subjects received subcutaneous SCENESSE implants containing 16 mg of afamelanotide every 2 months. A total of 125 subjects received SCENESSE and 119 subjects received vehicle implants. Table 1 summarizes the adverse reactions that occurred in more than 2% of subjects. Table 1: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029). Table 1: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029) Adverse Reaction SCENESSE n (%) N = 125 Vehicle n (%) N = 119 Implant site reaction 1 26 (21%) 12 (10%) Nausea 24 (19%) 17 (14%) Oropharyngeal pain 9 (7%) 6 (5%) Cough 8 (6%) 4 (3%) Fatigue 7 (6%) 3 (3%) Skin hyperpigmentation 2 5 (4%) 0 (0%) Dizziness 5 (4%) 4 (3%) Melanocytic nevus 5 (4%) 2 (2%) Respiratory tract infection 5 (4%) 3 (3%) Somnolence 3 (2%) 1 (1%) Non-acute porphyria 2 (2%) 0 (0%) Skin irritation 2 (2%) 0 (0%) 1 : Implant site reaction includes: implant site bruising, discoloration, erythema, hemorrhage, hypertrophy, irritation, nodule, pain, pruritus, swelling; injection site bruising and erythema; and expelled implant. 2 : Skin hyperpigmentation includes skin hyperpigmentation, pigmentation lip (subject also had skin hyperpigmentation), and pigmentation disorder. Specific Adverse Reactions Implant Site Reactions : Implant site reactions were more common in the SCENESSE group (21%) compared to the vehicle group (10%). In the SCENESSE group, the most common implant site reaction was implant site discoloration (10%). The most common adverse reactions (incidence > 2%) are implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation . To report SUSPECTED ADVERSE REACTIONS, contact CLINUVEL INC. at 1-888-288-2031 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See PATIENT COUNSELING INFORMATION . Postmarketing Experience The following adverse reactions have been identified during post-approval use of SCENESSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity (urticaria, angioedema, and anaphylaxis) [ see Warnings and Precautions ].","Postmarketing Experience The following adverse reactions have been identified during post-approval use of SCENESSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity (urticaria, angioedema, and anaphylaxis) [ see Warnings and Precautions ]."],"contraindications":["CONTRAINDICATIONS SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE . Known hypersensitivity to afamelanotide or to any of the excipients in SCENESSE ."],"recent_major_changes":["Dosage and Administration Instructions for Removal of SCENESSE In case a clinical necessity arises to remove the implant, follow the procedure described below: • palpate the area of implant insertion • locate the position of the implant (*Note that the implant is resorbable and the implant may not be able to be located from 10 days after insertion). • inject local anesthetic at the site of foreseen puncture • wait for the local anesthetic to take effect • puncture the dermis at the site of previous insertion • digitally locate the trajectory of the implant • put digital pressure on the dermis– at the distal end of the implant • remove the implant by digitally pushing the implant out towards the puncture site (aperture) • use a pressure compress or band aid on the aperture • observe the patient for 15 minutes after removal of the implant • instruct the patient to maintain the pressure compress for 12 hours. *Note: The implant may not be palpable due to resorption, and removal would likely not be possible. In the unlikely event of the need to surgically remove SCENESSE, it may be localized by ultrasound. Contraindications SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE [ see Warnings and Precautions ] Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SCENESSE. Warn patients of the risk of hypersensitivity reactions, including anaphylaxis. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed [ see Dosage and Administration ]. The patient should not receive any further treatment with SCENESSE [ see Contraindications ]. Dosage and Administration 08/2024 Contraindications 08/2024 Warnings and Precautions 08/2024"],"storage_and_handling":["Store in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light. SCENESSE implants are not supplied with an implantation device for subcutaneous administration [ see Dosage and Administration ]."],"clinical_pharmacology":["Mechanism of Action Afamelanotide is a synthetic tridecapeptide and a structural analog of α-melanocyte stimulating hormone (α-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to MC1-R. Pharmacodynamics Afamelanotide increases production of eumelanin in the skin independently of exposure to sunlight or artificial UV light sources. Pharmacokinetics The pharmacokinetics of afamelanotide following administration of a single subcutaneous implant of SCENESSE were evaluated in 12 healthy adults. High variability was observed in the plasma concentrations of afamelanotide and for most subjects (9 out of 12), the last measurable afamelanotide concentration was at 96 hours post-dose. The mean ± SD C max and AUC 0-inf were 3.7 ± 1.3 ng/mL and 138.9 ± 42.6 hr*ng/mL, respectively. Absorption The median T max was 36 hr. Elimination The apparent half-life of afamelanotide is approximately 15 hr when administered subcutaneously in a controlled release implant. Metabolism Afamelanotide may undergo hydrolysis. However, its metabolic profile has not been fully characterized. Specific Populations The effect of renal or hepatic impairment on the pharmacokinetics of afamelanotide is unknown. Drug Interaction Studies No drug interaction studies were conducted with afamelanotide.","Pharmacodynamics Afamelanotide increases production of eumelanin in the skin independently of exposure to sunlight or artificial UV light sources.","Pharmacokinetics The pharmacokinetics of afamelanotide following administration of a single subcutaneous implant of SCENESSE were evaluated in 12 healthy adults. High variability was observed in the plasma concentrations of afamelanotide and for most subjects (9 out of 12), the last measurable afamelanotide concentration was at 96 hours post-dose. The mean ± SD C max and AUC 0-inf were 3.7 ± 1.3 ng/mL and 138.9 ± 42.6 hr*ng/mL, respectively. Absorption The median T max was 36 hr. Elimination The apparent half-life of afamelanotide is approximately 15 hr when administered subcutaneously in a controlled release implant. Metabolism Afamelanotide may undergo hydrolysis. However, its metabolic profile has not been fully characterized. Specific Populations The effect of renal or hepatic impairment on the pharmacokinetics of afamelanotide is unknown. Drug Interaction Studies No drug interaction studies were conducted with afamelanotide."],"indications_and_usage":["SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)"],"warnings_and_cautions":["Hypersensitivity Skin Monitoring Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SCENESSE. Warn patients of the risk of hypersensitivity reactions, including anaphylaxis. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed [ see Dosage and Administration ]. The patient should not receive any further treatment with SCENESSE. [ see Contraindications ]. SCENESSE may lead to generalized increased skin pigmentation and darkening of pre-existing nevi and ephelides because of its pharmacologic effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing and new skin pigmentary lesions. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed. The patient should not receive any further treatment with SCENESSE . Skin Monitoring: May induce darkening of pre-existing nevi and ephelides due to its pharmacological effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing nevi and new skin pigmentary lesions ."],"nonclinical_toxicology":["Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with SCENESSE. Afamelanotide was negative in the Ames test, in vitro mouse lymphoma assay, and in vivo mouse bone marrow micronucleus assay. No effects on male or female fertility and reproductive performance were observed in rats at subcutaneous doses up to 20 mg/kg/day afamelanotide (12 times the MRHD, based on a body surface area comparison)."],"adverse_reactions_table":["<table border=\"0\" width=\"100%\"><caption>Table 1: Adverse Reactions Occurring in More Than 2% of Subjects with EPP Through Month 6 (Studies CUV039, CUV030, and CUV029)</caption><tbody><tr><td><content styleCode=\"bold\">Adverse Reaction</content></td><td><content styleCode=\"bold\">SCENESSE   n (%)   N = 125 </content></td><td><content styleCode=\"bold\">Vehicle   n (%)   N = 119 </content></td></tr><tr><td>Implant site reaction <sup>1</sup></td><td>26 (21%)</td><td>12 (10%)</td></tr><tr><td>Nausea</td><td>24 (19%)</td><td>17 (14%)</td></tr><tr><td>Oropharyngeal pain</td><td>9 (7%)</td><td>6 (5%)</td></tr><tr><td>Cough</td><td>8 (6%)</td><td>4 (3%)</td></tr><tr><td>Fatigue</td><td>7 (6%)</td><td>3 (3%)</td></tr><tr><td>Skin hyperpigmentation <sup>2</sup></td><td>5 (4%)</td><td>0 (0%)</td></tr><tr><td>Dizziness</td><td>5 (4%)</td><td>4 (3%)</td></tr><tr><td>Melanocytic nevus</td><td>5 (4%)</td><td>2 (2%)</td></tr><tr><td>Respiratory tract infection</td><td>5 (4%)</td><td>3 (3%)</td></tr><tr><td>Somnolence</td><td>3 (2%)</td><td>1 (1%)</td></tr><tr><td>Non-acute porphyria</td><td>2 (2%)</td><td>0 (0%)</td></tr><tr><td>Skin irritation</td><td>2 (2%)</td><td>0 (0%)</td></tr></tbody></table>"],"spl_unclassified_section":["Hypersensitivity Reactions Advise patients who experience any symptoms of serious hypersensitivity reactions to seek immediate medical attention for treatment and possible removal of the SCENESSE implant [see Warnings and Precautions ]. Concomitant Measures Advise patients to maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP [ see Dosage and Administration ]. Skin Monitoring Advise patients that darkening of pre-existing nevi and ephelides may occur with use of SCENESSE. A full body skin examination is recommended twice yearly to monitor pre-existing and new skin pigmentary lesions [ see Warnings and Precautions ]. Expelled Implant Advise patients to contact their healthcare provider if the implant is expelled. Dressing removal Advise patients that the dressing can be removed after 24 hours [ see Dosage and Administration ]. Insertion Site Care and Monitoring Advise patients to monitor the insertion site after dressing removal and to report any reaction observed at the site to their healthcare provider."],"dosage_and_administration":["Important Dosage and Administration Information SCENESSE should be administered by a health care professional. All healthcare professionals should be proficient in the subcutaneous implantation procedure and have completed the training program provided by CLINUVEL prior to administration of the SCENESSE implant [ see Dosage and Administration ]. Additional information, including a video, is available at http://www.clinuvel.com/US-HCP. The additional information has not been evaluated or approved by the FDA. Insert a single SCENESSE implant subcutaneously above the anterior supra-iliac crest every 2 months. Use the SFM Implantation Cannula to implant SCENESSE. Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP. SCENESSE should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration . Insert a single implant, containing 16 mg of afamelanotide, using an Cannula . Administer SCENESSE subcutaneously every 2 months . See Full Prescribing Information for instructions for removal of SCENESSE . Instructions for Implantation of SCENESSE Insert a single SCENESSE implant (containing 16 mg of afamelanotide) subcutaneously above the anterior supra-iliac crest. Implant SCENESSE observing an aseptic technique. The following equipment is needed for the implant insertion: SCENESSE implant SFM Implantation Cannula; use of a device that has not been determined to be suitable could result in damage to the SCENESSE implant [ see Dosage and Administration ]. Sterile gloves Local anesthetic, needle and syringe Blunt forceps suitable for removing the SCENESSE implant from the glass vial and placement of the SCENESSE implant Sterile gauze, adhesive bandage, pressure bandage Step 1 Take the carton containing SCENESSE out of the refrigerator to allow the product to gradually warm up to ambient temperature. Remove the seal and stopper from the glass vial containing SCENESSE. Remove the implant from the vial using the blunt forceps under aseptic conditions and place the implant on a sterile gauze. Step 2 Put the patient in a comfortable reclined supine position. Identify the insertion site 3-4 cm above the anterior supra-iliac crest and disinfect the skin surface. Step 3 (optional) Anesthetize the area of insertion (puncture) if deemed necessary and in consultation with the patient. Step 4 While pinching the skin of the insertion site, insert the cannula with the bevel facing upwards (away from the abdomen) at a 30-45° angle into the subcutaneous layer. Advance the cannula 2 cm into the subcutaneous layer. Step 5 Remove the stylet (obturator) from the cannula maintaining aseptic precautions. Load the implant into the cannula. Using the stylet (obturator) gently push the implant down the full length of the cannula’s shaft. Step 6 Apply pressure to the site of the implant while removing the stylet (obturator) and the cannula. Verify that no implant or implant portion remains in the cannula. Step 7 Verify the correct insertion and placement of the implant by palpating the skin overlying the implant. Step 8 Apply dressing to the insertion site. Leave dressing in place for 24 hours. Step 9 Monitor the patient for 30 minutes after the implant administration. Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Instructions for Removal of SCENESSE In case a clinical necessity arises to remove the implant, follow the procedure described below: • palpate the area of implant insertion • locate the position of the implant (*Note that the implant is resorbable and may not be able to be located from 10 days after insertion) • inject local anesthetic at the site of foreseen puncture • wait for the local anesthetic to take effect • puncture the dermis at the site of previous insertion • digitally locate the trajectory of the implant • put digital pressure on the dermis– at the distal end of the implant • remove the implant by digitally pushing the implant out towards the puncture site (aperture) • use a pressure compress or band aid on the aperture • observe the patient for 15 minutes after removal of the implant • instruct the patient to maintain the pressure compress for 12 hours. *Note: The implant may not be palpable due to resorption, and removal would likely not be possible. In the unlikely event of the need to surgically remove SCENESSE, it may be localized by ultrasound.","Instructions for Implantation of SCENESSE Insert a single SCENESSE implant (containing 16 mg of afamelanotide) subcutaneously above the anterior supra-iliac crest. Implant SCENESSE observing an aseptic technique. The following equipment is needed for the implant insertion: SCENESSE implant SFM Implantation Cannula; use of a device that has not been determined to be suitable could result in damage to the SCENESSE implant [ see Dosage and Administration ]. Sterile gloves Local anesthetic, needle and syringe Blunt forceps suitable for removing the SCENESSE implant from the glass vial and placement of the SCENESSE implant Sterile gauze, adhesive bandage, pressure bandage Step 1 Take the carton containing SCENESSE out of the refrigerator to allow the product to gradually warm up to ambient temperature. Remove the seal and stopper from the glass vial containing SCENESSE. Remove the implant from the vial using the blunt forceps under aseptic conditions and place the implant on a sterile gauze. Step 2 Put the patient in a comfortable reclined supine position. Identify the insertion site 3-4 cm above the anterior supra-iliac crest and disinfect the skin surface. Step 3 (optional) Anesthetize the area of insertion (puncture) if deemed necessary and in consultation with the patient. Step 4 While pinching the skin of the insertion site, insert the cannula with the bevel facing upwards (away from the abdomen) at a 30-45° angle into the subcutaneous layer. Advance the cannula 2 cm into the subcutaneous layer. Step 5 Remove the stylet (obturator) from the cannula maintaining aseptic precautions. Load the implant into the cannula. Using the stylet (obturator) gently push the implant down the full length of the cannula’s shaft. Step 6 Apply pressure to the site of the implant while removing the stylet (obturator) and the cannula. Verify that no implant or implant portion remains in the cannula. Step 7 Verify the correct insertion and placement of the implant by palpating the skin overlying the implant. Step 8 Apply dressing to the insertion site. Leave dressing in place for 24 hours. Step 9 Monitor the patient for 30 minutes after the implant administration. Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9","Instructions for Removal of SCENESSE In case a clinical necessity arises to remove the implant, follow the procedure described below: • palpate the area of implant insertion • locate the position of the implant (*Note that the implant is resorbable and may not be able to be located from 10 days after insertion) • inject local anesthetic at the site of foreseen puncture • wait for the local anesthetic to take effect • puncture the dermis at the site of previous insertion • digitally locate the trajectory of the implant • put digital pressure on the dermis– at the distal end of the implant • remove the implant by digitally pushing the implant out towards the puncture site (aperture) • use a pressure compress or band aid on the aperture • observe the patient for 15 minutes after removal of the implant • instruct the patient to maintain the pressure compress for 12 hours. *Note: The implant may not be palpable due to resorption, and removal would likely not be possible. In the unlikely event of the need to surgically remove SCENESSE, it may be localized by ultrasound."],"spl_product_data_elements":["SCENESSE afamelanotide AFAMELANOTIDE AFAMELANOTIDE white to off-white"],"dosage_forms_and_strengths":["Implant: 16 mg of afamelanotide as a solid white to off-white, bioresorbable, sterile rod approximately 1.7 cm in length and 1.45 mm in diameter. Implant: 16 mg of afamelanotide ."],"use_in_specific_populations":["Pregnancy Risk Summary There are no data on SCENESSE use in pregnant women to evaluate for any drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. In animal reproductive and development toxicity studies, no adverse developmental effects were observed with afamelanotide administration during the period of organogenesis to pregnant rats at subcutaneous doses up to 12 times the maximum recommended human dose (MRHD) ( see Data ). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In embryofetal development studies in Sprague Dawley and Lister Hooded rats, afamelanotide was administered subcutaneously to pregnant rats at doses of 0.2, 2, or 20 mg/kg/day throughout the period of organogenesis. No adverse embryofetal developmental effects were observed at doses up to 20 mg/kg/day (12 times the MRHD, based on a body surface area comparison). In a pre- and post-natal development study in Sprague Dawley rats, afamelanotide was administered subcutaneously at doses of 0.2, 2, or 20 mg/kg/day during the period of organogenesis through lactation. No treatment-related effects were observed at doses up to 20 mg/kg/day (12 times the MRHD, based on a body surface area comparison). Lactation Risk Summary There are no data on the presence of afamelanotide or any of its metabolites in human or animal milk, the effects on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SCENESSE and any potential adverse effects on the breastfed infant from SCENESSE or from the underlying maternal condition. Pediatric Use The safety and effectiveness of SCENESSE have not been established in pediatric patients. Geriatric Use There were 10 subjects 65 years old and over in the clinical studies for EPP [ see Clinical Studies ]. Of the 125 subjects treated with SCENESSE in these studies, 4 (3%) were 65 years of age and older. Clinical studies of SCENESSE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.","Lactation Risk Summary There are no data on the presence of afamelanotide or any of its metabolites in human or animal milk, the effects on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SCENESSE and any potential adverse effects on the breastfed infant from SCENESSE or from the underlying maternal condition.","Pediatric Use The safety and effectiveness of SCENESSE have not been established in pediatric patients.","Geriatric Use There were 10 subjects 65 years old and over in the clinical studies for EPP [ see Clinical Studies ]. Of the 125 subjects treated with SCENESSE in these studies, 4 (3%) were 65 years of age and older. Clinical studies of SCENESSE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients."],"package_label_principal_display_panel":["PACKAGE LABEL PRINCIPAL DISPLAY PANEL"]},"tags":[{"label":"afamelanotide","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Melanocyte-stimulating hormone receptor","category":"target"},{"label":"MC1R","category":"gene"},{"label":"MC5R","category":"gene"},{"label":"MC3R","category":"gene"},{"label":"D02BB02","category":"atc"},{"label":"Subcutaneous","category":"route"},{"label":"Implant","category":"form"},{"label":"Active","category":"status"},{"label":"Erythropoietic protoporphyria","category":"indication"},{"label":"Clivunel Inc","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Dermatologic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"ANAPHYLACTIC REACTION","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"CONTRAINDICATION TO MEDICAL TREATMENT","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"TYPE I HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"IMPLANT SITE HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"IMPLANT SITE PRURITUS","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"IMPLANT SITE URTICARIA","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ACUTE ON CHRONIC LIVER FAILURE","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"APPENDICITIS","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ASCITES","source":"FDA FAERS","actionTaken":"1 reports"}],"commonSideEffects":[{"effect":"Implant site reaction","drugRate":"21%","_validated":true,"placeboRate":"10%"},{"effect":"Nausea","drugRate":"19%","_validated":true,"placeboRate":"14%"},{"effect":"Oropharyngeal pain","drugRate":"7%","_validated":true,"placeboRate":"5%"},{"effect":"Cough","drugRate":"6%","_validated":true,"placeboRate":"3%"},{"effect":"Fatigue","drugRate":"6%","_validated":true,"placeboRate":"3%"},{"effect":"Skin hyperpigmentation","drugRate":"4%","_validated":true,"placeboRate":"0%"},{"effect":"Dizziness","drugRate":"4%","_validated":true,"placeboRate":"3%"},{"effect":"Melanocytic nevus","drugRate":"4%","_validated":true,"placeboRate":"2%"},{"effect":"Respiratory tract infection","drugRate":"4%","_validated":true,"placeboRate":"3%"},{"effect":"Somnolence","drugRate":"2%","_validated":true,"placeboRate":"1%"},{"effect":"Non-acute porphyria","drugRate":"2%","_validated":true,"placeboRate":"0%"},{"effect":"Skin irritation","drugRate":"2%","_validated":true,"placeboRate":"0%"}],"contraindications":["SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE.","Known hypersensitivity to afamelanotide or to any of the excipients in SCENESSE."],"specialPopulations":{"Pregnancy":"There are no data on SCENESSE use in pregnant women to evaluate for any drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. In animal reproductive and development toxicity studies, no adverse developmental effects were observed with afamelanotide administration during the period of organogenesis to pregnant rats at subcutaneous doses up to 12 times the maximum recommended human dose (MRHD) see Data). All pregnancies have background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively."}},"trials":[],"aliases":[],"company":"Clivunel Inc","patents":[{"applNo":"N210797","source":"FDA Orange Book","status":"Active","expires":"Jan 20, 2033","useCode":"U-2638","territory":"US","drugProduct":false,"patentNumber":"8334265","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AFAMELANOTIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:18:42.370469+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:18:42.370011+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Afamelanotide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:18:50.088394+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:18:48.650297+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:18:42.390066+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:18:40.979677+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AFAMELANOTIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:18:49.398679+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:40.086737+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:40.086801+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:18:51.022642+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Melanocortin receptor 1 agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:50.088219+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297213/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:18:49.921853+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoieti","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:19:11.574342+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:19:16.185803+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA210797","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:18:40.086812+00:00"}},"allNames":"scenesse","offLabel":[],"synonyms":["afamelanotide","melanotan I","scenesse"],"timeline":[{"date":"2014-12-12","type":"positive","source":"DrugCentral","milestone":"EMA approval (Clinuvel UK Limited)"},{"date":"2019-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from CLIVUNEL INC to Clivunel Inc"},{"date":"2019-10-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Clivunel Inc)"},{"date":"2026-10-08","type":"negative","source":"FDA Orange Book","milestone":"ODE-270 exclusivity expires"}],"aiSummary":"Scenesse (afamelanotide) is a small molecule drug developed by Clivunel Inc, targeting the melanocyte-stimulating hormone receptor. It is FDA-approved since 2019 for the treatment of erythropoietic protoporphyria, a rare genetic disorder. Scenesse is a patented product with no generic manufacturers available. Key safety considerations include the potential for skin darkening and increased risk of melanoma. As a patented product, its commercial status is subject to ongoing patent protection.","brandName":"Scenesse","ecosystem":[{"indication":"Erythropoietic protoporphyria","otherDrugs":[],"globalPrevalence":420000}],"mechanism":{"target":"Melanocyte-stimulating hormone receptor","novelty":"Follow-on","targets":[{"gene":"MC1R","source":"DrugCentral","target":"Melanocyte-stimulating hormone receptor","protein":"Melanocyte-stimulating hormone receptor"},{"gene":"MC5R","source":"DrugCentral","target":"Melanocortin receptor 5","protein":"Melanocortin receptor 5"},{"gene":"MC3R","source":"DrugCentral","target":"Melanocortin receptor 3","protein":"Melanocortin receptor 3"},{"gene":"MC4R","source":"DrugCentral","target":"Melanocortin receptor 4","protein":"Melanocortin receptor 4"},{"gene":"ADA","source":"DrugCentral","target":"Adenosine deaminase","protein":"Adenosine deaminase"}],"modality":"Peptide","drugClass":"afamelanotide","explanation":"","oneSentence":"","technicalDetail":"Afamelanotide, the active ingredient in Scenesse, is a potent agonist of the melanocortin 1 receptor (MC1R), which plays a crucial role in regulating melanin production and skin pigmentation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Afamelanotide","title":"Afamelanotide","extract":"Afamelanotide, sold under the brand name Scenesse, is a medication used to prevent phototoxicity and to reduce pain from light exposure for people with erythropoietic protoporphyria. It is a melanocortin 1 receptor (MC1 receptor) agonist and a synthetic peptide and analogue of α-melanocyte stimulating hormone. It is administered as subcutaneous implant.","wiki_history":"==History==\nα-MSH was first isolated in the 1950s and its primary structure determined. By the 1960s, its role in promoting melanin diffusion was understood.\n\nIn the 1980s, the University of Arizona synthesised more potent analogs of a-MSH, including afamelanotide. Afamelanotide was initially named melano-tan (or melanotan-I) due to its ability to tan skin with minimal sun exposure. Later, melanotan-II was synthesised. which changed its name to Clinuvel in 2006.\n\nEarly clinical trials showed that the peptide had to be injected about ten times a day due to its short half-life, so the company collaborated with Southern Research in the US to develop a depot formulation that would be injected under the skin, and release the peptide slowly. This was done by 2004. According to ClinicalTrials.gov, Clinuvel sponsored several trials between 2007 and 2011 to explore its effects on erythropoietic protoporphyria, vitiligo, polymorphous light eruption, solar urticaria and acne vulgaris. Additionally, one trial aimed to assess its role in preventing actinic keratosis in organ transplant recipients. Further trials were pursued for the first two conditions, while results for the latter three were not published. Following the initial trials, research efforts centered on erythropoietic protoporphyria, and due to the epidemiology of the condition. Clinuvel secured orphan drug for afamelanotide in both the US and the EU by 2010.\n\nThe first approval of afamelanotide came in May 2010 from the Italian Medicines Agency (AIFA, or Agenzia Italiana del Farmaco), followed by the European Medicines Agency (EMA) in January 2015. Both approvals were for the treatment of erythropoietic protoporphyria.\n\nBetween 2022 and 2023, trials were outlined to study the effects of afamelanotide on xeroderma pigmentosum and variegate porphyria, along with two additional trials exploring its impact on vitiligo. According to the register, as of April 2025, most of these trials are currently in the recruitment ph","wiki_society_and_culture":"==Society and culture==\n===Usage in general public===\nA number of products are sold online and in gyms and beauty salons as \"melanotan\" or \"melanotan-1\" which discuss afamelanotide in their marketing.\n\nWithout a prescription, these drugs are not legally sold in many jurisdictions and are potentially dangerous.\n\nStarting in 2007, health agencies in various countries began issuing warnings against their use."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-10-08, CLIVUNEL INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4836","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AFAMELANOTIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AFAMELANOTIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Afamelanotide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T08:29:37.054370","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:19:17.308425+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"betacarotene","drugSlug":"betacarotene","fdaApproval":"","relationship":"same-class"}],"exclusivity":[{"code":"ODE-270","date":"Oct 8, 2026"}],"genericName":"afamelanotide","indications":{"approved":[{"name":"Erythropoietic protoporphyria","source":"DrugCentral","snomedId":51022005,"regulator":"FDA","eligibility":"adult patients with history of phototoxic reactions","prevalenceClass":"1-9 / 100 000","globalPrevalence":420000,"prevalenceMethod":"orphanet","prevalenceSource":"Orphanet (15652607[PMID]_ORPHANET)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Clivunel Inc","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"betacarotene","brandName":"betacarotene","genericName":"betacarotene","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06388642","phase":"PHASE1,PHASE2","title":"Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients","status":"COMPLETED","sponsor":"Clinuvel Europe Limited","startDate":"2024-03-07","conditions":["Erythropoietic Protoporphyria"],"enrollment":28,"completionDate":"2025-01-20"},{"nctId":"NCT06109649","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo","status":"ACTIVE_NOT_RECRUITING","sponsor":"Clinuvel, Inc.","startDate":"2023-10-11","conditions":["Vitiligo"],"enrollment":200,"completionDate":"2026-06"},{"nctId":"NCT05854784","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2023-03-28","conditions":["Variegate Porphyria"],"enrollment":6,"completionDate":"2023-12-28"},{"nctId":"NCT04525157","phase":"PHASE2","title":"Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2014-06-06","conditions":["Vitiligo"],"enrollment":21,"completionDate":"2016-06-06"},{"nctId":"NCT05370235","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V","status":"UNKNOWN","sponsor":"Clinuvel Europe Limited","startDate":"2022-03-28","conditions":["Xeroderma Pigmentosum"],"enrollment":6,"completionDate":"2024-12"},{"nctId":"NCT05159752","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)","status":"UNKNOWN","sponsor":"Clinuvel Europe Limited","startDate":"2021-10-19","conditions":["Xeroderma Pigmentosum"],"enrollment":6,"completionDate":"2024-10"},{"nctId":"NCT04962503","phase":"PHASE2","title":"A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2021-06-03","conditions":["Arterial Ischemic Stroke"],"enrollment":6,"completionDate":"2022-02-04"},{"nctId":"NCT05368857","phase":"PHASE1","title":"DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers","status":"COMPLETED","sponsor":"Clinuvel (UK) Ltd.","startDate":"2022-01-19","conditions":["Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers"],"enrollment":10,"completionDate":"2023-02-01"},{"nctId":"NCT05210582","phase":"PHASE2","title":"A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face","status":"UNKNOWN","sponsor":"Clinuvel, Inc.","startDate":"2022-10-11","conditions":["Vitiligo"],"enrollment":6,"completionDate":"2023-08"},{"nctId":"NCT04943159","phase":"PHASE2","title":"Afamelanotide in Patients Suffering With Acne Vulgaris","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2010-08-24","conditions":["Acne Vulgaris"],"enrollment":3,"completionDate":"2011-03-08"},{"nctId":"NCT00979745","phase":"PHASE3","title":"Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2009-09","conditions":["Erythropoietic Protoporphyria"],"enrollment":74,"completionDate":"2011-05"},{"nctId":"NCT04425746","phase":"PHASE2","title":"Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2008-08-05","conditions":["Patients Undergoing Photodynamic Therapy Using Porfimer Sodium"],"enrollment":16,"completionDate":"2009-05-28"},{"nctId":"NCT04704713","phase":"PHASE3","title":"Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2010-05-05","conditions":["Polymorphic Light Eruption"],"enrollment":31,"completionDate":""},{"nctId":"NCT04578496","phase":"PHASE3","title":"A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2011-07-11","conditions":["Erythropoietic Protoporphyria"],"enrollment":16,"completionDate":"2014-02-27"},{"nctId":"NCT01097044","phase":"PHASE2","title":"Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2010-04","conditions":["Erythropoietic Protoporphyria"],"enrollment":77,"completionDate":"2011-04"},{"nctId":"NCT04053270","phase":"PHASE3","title":"Multicentre Phase III Erythropoietic Protoporphyria Study","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2007-05","conditions":["Erythropoietic Protoporphyria"],"enrollment":100,"completionDate":"2009-12-09"},{"nctId":"NCT01605136","phase":"PHASE3","title":"Phase III Confirmatory Study in Erythropoietic Protoporphyria","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2012-05","conditions":["Erythropoietic Protoporphyria"],"enrollment":93,"completionDate":"2013-07"},{"nctId":"NCT03634137","phase":"PHASE1","title":"Implant Pharmacokinetic and Pharmacodynamic Study","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2009-09","conditions":["Healthy"],"enrollment":24,"completionDate":"2010-03"},{"nctId":"NCT01382589","phase":"PHASE2","title":"Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2011-09","conditions":["Vitiligo"],"enrollment":15,"completionDate":"2012-12"},{"nctId":"NCT01430195","phase":"PHASE1","title":"Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2011-06","conditions":["Vitiligo"],"enrollment":56,"completionDate":"2012-11"},{"nctId":"NCT00472901","phase":"","title":"Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2007-05","conditions":["Polymorphic Light Eruption (PLE)"],"enrollment":18,"completionDate":"2010-09"},{"nctId":"NCT00829192","phase":"PHASE2","title":"Phase II AK Study in Organ Transplant Patients","status":"UNKNOWN","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2007-11","conditions":["Actinic Keratoses","Carcinoma, Squamous Cell","Organ Transplant Recipients"],"enrollment":200,"completionDate":"2012-08"},{"nctId":"NCT00859534","phase":"PHASE2","title":"Phase II Solar Urticaria (SU) Pilot Study","status":"COMPLETED","sponsor":"Clinuvel Pharmaceuticals Limited","startDate":"2008-12","conditions":["Solar Urticaria"],"enrollment":5,"completionDate":"2009-07"}],"_emaApprovals":[{"date":"2014-12-12","status":"Authorised","company":"Clinuvel UK Limited"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Subcutaneous","formulation":"Implant","formulations":[{"form":"IMPLANT","route":"SUBCUTANEOUS","productName":"SCENESSE"},{"form":"IMPLANT","route":"SUBCUTANEOUS","productName":"SCENESSE"}]},"_patentsChecked":true,"crossReferences":{"MMSL":"324953","NDDF":"018187","UNII":"QW68W3J66U","CHEBI":"CHEBI:136034","VANDF":"4039222","INN_ID":"9010","RXNORM":"2262250","UMLSCUI":"C2607750","chemblId":"CHEMBL4297213","ChEMBL_ID":"CHEMBL441738","KEGG_DRUG":"D10511","DRUGBANK_ID":"DB04931","PUBCHEM_CID":"16197727","SNOMEDCT_US":"819968004","IUPHAR_LIGAND_ID":"1324","MESH_SUPPLEMENTAL_RECORD_UI":"C534526"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2019-","companyName":"Clivunel Inc","relationship":"Original Developer"},{"period":"2014","companyName":"Clinuvel UK Limited","relationship":"EMA Licensee"}],"publicationCount":102,"therapeuticAreas":["Rare 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