Data edition of
Residue An evidence-graded reference for peptide science

Afamelanotide clinical trials

Every study registered on ClinicalTrials.gov that lists Afamelanotide as an intervention, as of the data edition — what is being tested, in whom, by whom, and how far it has got.

Registered studies
23
Active or recruiting
1
Completed
18
With posted results
12
Planned or actual enrollment
1,017participants, summed
Registered studies of Afamelanotide by phase and status
PhaseStudiesBreakdown
Phase 1 3
3 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 2 13
9 completed, 0 active or recruiting, 0 stopped, 4 other
Phase 3 6
5 completed, 1 active or recruiting, 0 stopped, 0 other
Observational 1
1 completed, 0 active or recruiting, 0 stopped, 0 other
Figure 1. 23 studies on ClinicalTrials.gov match the registry search afamelanotide OR CUV1647. Multi-phase studies are counted at their highest phase. Open the full trial feed

Conditions studied

  1. Erythropoietic Protoporphyria6
  2. Vitiligo5
  3. Xeroderma Pigmentosum2
  4. Acne Vulgaris1
  5. Patients Undergoing Photodynamic Therapy Using Porfimer Sodium1
  6. Polymorphic Light Eruption1
  7. Solar Urticaria1
  8. Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers1
  9. Arterial Ischemic Stroke1
  10. Actinic Keratoses1
  11. Carcinoma, Squamous Cell1
  12. Organ Transplant Recipients1

Lead sponsors

  1. Clinuvel Pharmaceuticals Limited17
  2. Clinuvel Europe Limited3
  3. Clinuvel, Inc.2
  4. Clinuvel (UK) Ltd.1

The registry, study by study

Registration is not evidence of benefit; many registered studies never publish. Status and dates are as reported by sponsors to ClinicalTrials.gov.

Status
Phase

23 shown

Registered studies of Afamelanotide
StudyPhaseStatusStartnSponsor
NCT06109649A 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 Phase 3 Active, not recruiting Oct 2023 200 Clinuvel, Inc.
NCT06388642Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria PatientsResults posted Phase 1/Phase 2 Completed Mar 2024 28 Clinuvel Europe Limited
NCT05854784Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)Results posted Phase 2 Completed Mar 2023 6 Clinuvel Pharmaceuticals Limited
NCT05210582A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face Phase 2 Unknown status Oct 2022 6 Clinuvel, Inc.
NCT05370235A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V Phase 2 Unknown status Mar 2022 6 Clinuvel Europe Limited
NCT05368857DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers Phase 1 Completed Jan 2022 10 Clinuvel (UK) Ltd.
NCT05159752A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) Phase 2 Unknown status Oct 2021 6 Clinuvel Europe Limited
NCT04962503A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)Results posted Phase 2 Completed Jun 2021 6 Clinuvel Pharmaceuticals Limited
NCT04525157Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)Results posted Phase 2 Completed Jun 2014 21 Clinuvel Pharmaceuticals Limited
NCT01605136Phase III Confirmatory Study in Erythropoietic ProtoporphyriaResults posted Phase 3 Completed May 2012 93 Clinuvel Pharmaceuticals Limited
NCT01382589Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Phase 2 Completed Sep 2011 15 Clinuvel Pharmaceuticals Limited
NCT04578496A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)Results posted Phase 3 Completed Jul 2011 16 Clinuvel Pharmaceuticals Limited
NCT01430195Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) Phase 1 Completed Jun 2011 56 Clinuvel Pharmaceuticals Limited
NCT04943159Afamelanotide in Patients Suffering With Acne VulgarisResults posted Phase 2 Completed Aug 2010 3 Clinuvel Pharmaceuticals Limited
NCT04704713Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)Results posted Phase 3 Completed May 2010 31 Clinuvel Pharmaceuticals Limited
NCT01097044Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)Results posted Phase 2 Completed Apr 2010 77 Clinuvel Pharmaceuticals Limited
NCT03634137Implant Pharmacokinetic and Pharmacodynamic Study Phase 1 Completed Sep 2009 24 Clinuvel Pharmaceuticals Limited
NCT00979745Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)Results posted Phase 3 Completed Sep 2009 74 Clinuvel Pharmaceuticals Limited
NCT00859534Phase II Solar Urticaria (SU) Pilot Study Phase 2 Completed Dec 2008 5 Clinuvel Pharmaceuticals Limited
NCT04425746Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer SodiumResults posted Phase 2 Completed Aug 2008 16 Clinuvel Pharmaceuticals Limited
NCT00829192Phase II AK Study in Organ Transplant Patients Phase 2 Unknown status Nov 2007 200 Clinuvel Pharmaceuticals Limited
NCT00472901Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE) Observational Completed May 2007 18 Clinuvel Pharmaceuticals Limited
NCT04053270Multicentre Phase III Erythropoietic Protoporphyria StudyResults posted Phase 3 Completed May 2007 100 Clinuvel Pharmaceuticals Limited

Run this search on ClinicalTrials.gov → Query term: afamelanotide OR CUV1647