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melanocortin-1 receptor agonist

Afamelanotide updates

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2 changes for Afamelanotide in the last 12 months. Latest: 2026-07-27.

DateTypeWhat changedSource
2026-07-27ResultsResults posted: Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria PatientsTrial register ClinicalTrials.gov
2026-05-11LabelFDA label revised: SCENESSE (NDA210797)Regulator FDA drug label register
2025-04-27ResultsResults posted: Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)Trial register ClinicalTrials.gov
2024-04-29TrialNew trial registered: Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria PatientsTrial register ClinicalTrials.gov
2023-10-31TrialNew trial registered: 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 VitiligTrial register ClinicalTrials.gov
2023-05-11TrialNew trial registered: Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)Trial register ClinicalTrials.gov
2023-04-11ResultsResults posted: A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)Trial register ClinicalTrials.gov
2023-02-17Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2022-05-11TrialNew trial registered: A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and VTrial register ClinicalTrials.gov
2022-05-10TrialNew trial registered: DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy VolunteersTrial register ClinicalTrials.gov
2022-01-27TrialNew trial registered: A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the FaceTrial register ClinicalTrials.gov
2021-12-16TrialNew trial registered: A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)Trial register ClinicalTrials.gov
2021-11-04Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; SCENESSERegulator Federal Register
2021-10-26ResultsResults posted: Afamelanotide in Patients Suffering With Acne VulgarisTrial register ClinicalTrials.gov
2021-10-12ResultsResults posted: Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2021-10-01ResultsResults posted: Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer SodiumTrial register ClinicalTrials.gov
2021-07-15TrialNew trial registered: A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)Trial register ClinicalTrials.gov
2021-06-29TrialNew trial registered: Afamelanotide in Patients Suffering With Acne VulgarisTrial register ClinicalTrials.gov
2021-05-21ResultsResults posted: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)Trial register ClinicalTrials.gov
2021-03-19ResultsResults posted: Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)Trial register ClinicalTrials.gov
2021-01-12TrialNew trial registered: Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)Trial register ClinicalTrials.gov
2020-11-02ResultsResults posted: A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2020-10-08TrialNew trial registered: A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2020-08-25TrialNew trial registered: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)Trial register ClinicalTrials.gov
2020-06-11TrialNew trial registered: Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer SodiumTrial register ClinicalTrials.gov
2019-10-10ResultsResults posted: Multicentre Phase III Erythropoietic Protoporphyria StudyTrial register ClinicalTrials.gov
2019-09-17ResultsResults posted: Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2019-08-26ResultsResults posted: Phase III Confirmatory Study in Erythropoietic ProtoporphyriaTrial register ClinicalTrials.gov
2019-08-12TrialNew trial registered: Multicentre Phase III Erythropoietic Protoporphyria StudyTrial register ClinicalTrials.gov
2018-08-16TrialNew trial registered: Implant Pharmacokinetic and Pharmacodynamic StudyTrial register ClinicalTrials.gov
2012-05-24TrialNew trial registered: Phase III Confirmatory Study in Erythropoietic ProtoporphyriaTrial register ClinicalTrials.gov
2011-09-08TrialNew trial registered: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)Trial register ClinicalTrials.gov
2011-06-27TrialNew trial registered: Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental VitiligoTrial register ClinicalTrials.gov
2010-04-01TrialNew trial registered: Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2009-09-18TrialNew trial registered: Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)Trial register ClinicalTrials.gov
2009-03-11TrialNew trial registered: Phase II Solar Urticaria (SU) Pilot StudyTrial register ClinicalTrials.gov
2009-01-26TrialNew trial registered: Phase II AK Study in Organ Transplant PatientsTrial register ClinicalTrials.gov
2007-05-14TrialNew trial registered: Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)Trial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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