Afamelanotide

Mechanism-of-action class: Hormone Receptor Agonists.

• SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

• 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 .contraindicated

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.

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 .

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).

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).

• Oct 8, 2019NDANDA210797Clivunel Inc

1. 1Anaphylactic Reaction421%
2. 2Contraindication To Medical Treatment316%
3. 3Type I Hypersensitivity316%
4. 4Implant Site Hypersensitivity211%
5. 5Implant Site Pruritus211%
6. 6Implant Site Urticaria211%
7. 7Vomiting211%
8. 8Acute Kidney Injury15.3%
9. 9Acute On Chronic Liver Failure15.3%
10. 10Appendicitis15.3%
11. 11Ascites15.3%
12. 12Asthenia15.3%
13. 13Cellulitis15.3%
14. 14Death15.3%
15. 15Diarrhoea15.3%

The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Afamelanotide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
  Completed · Phase 1 · Phase 2 · Interventional · 28 enrolled · Clinuvel Europe Limited
  NCT06388642updated 2026-03-25
• 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
  Active not recruiting · Phase 3 · Interventional · 200 enrolled · Clinuvel, Inc.
  NCT06109649updated 2025-07-08
• Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
  Completed · Phase 2 · Interventional · 6 enrolled · Clinuvel Pharmaceuticals Limited
  NCT05854784updated 2025-04-27
• Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
  Completed · Phase 2 · Interventional · 21 enrolled · Clinuvel Pharmaceuticals Limited
  NCT04525157updated 2023-09-22
• A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
  Unknown · Phase 2 · Interventional · 6 enrolled · Clinuvel Europe Limited
  NCT05370235updated 2023-09-21
• A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)
  Unknown · Phase 2 · Interventional · 6 enrolled · Clinuvel Europe Limited
  NCT05159752updated 2023-06-18
• A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
  Completed · Phase 2 · Interventional · 6 enrolled · Clinuvel Pharmaceuticals Limited
  NCT04962503updated 2023-04-11
• A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
  Unknown · Phase 2 · Interventional · 6 enrolled · Clinuvel, Inc.
  NCT05210582updated 2023-02-09
• DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
  Completed · Phase 1 · Interventional · 10 enrolled · Clinuvel (UK) Ltd.
  NCT05368857updated 2023-02-09
• Afamelanotide in Patients Suffering With Acne Vulgaris
  Completed · Phase 2 · Interventional · 3 enrolled · Clinuvel Pharmaceuticals Limited
  NCT04943159updated 2021-10-26

Frequently asked questions

How does Afamelanotide work?

Mechanism-of-action class: Hormone Receptor Agonists.

What is Afamelanotide used for?

According to FDA labeling, Afamelanotide carries indications including: SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Afamelanotide?

Afamelanotide is classified as Protectives against UV-radiation for systemic use, Hormone Receptor Agonists.

What are the brand names for Afamelanotide?

Afamelanotide is marketed under brand names including Scenesse.

What are the contraindications for Afamelanotide?

Afamelanotide labeling lists contraindications including: 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 .. Always consult the full prescribing information and a clinician.