AFAMELANOTIDE ( DrugBank: Afamelanotide )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 159 | Xeroderma pigmentosum | 6 |
| 254 | Porphyria | 11 |
159. Xeroderma pigmentosum
Clinical trials : 11 / Drugs : 17 - (DrugBank : 5) / Drug target genes : 5 - Drug target pathways : 15
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05370235 (ClinicalTrials.gov) | March 28, 2022 | 21/4/2022 | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (XPC and XPV) | Xeroderma Pigmentosum | Drug: Afamelanotide | Clinuvel Europe Limited | NULL | Recruiting | 18 Years | 75 Years | All | 6 | Phase 2 | Belgium;Spain |
| 2 | EUCTR2021-001419-10-ES (EUCTR) | 31/01/2022 | 17/11/2021 | Study to evaluate the safety and the efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV) - Phase IIa XPC and XPV Study | Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: Afamelanotide (16 mg implant) | CLINUVEL EUROPE LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Belgium;Spain | ||
| 3 | NCT05159752 (ClinicalTrials.gov) | October 19, 2021 | 9/11/2021 | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) | Xeroderma Pigmentosum | Drug: Afamelanotide | Clinuvel Europe Limited | NULL | Recruiting | 18 Years | 75 Years | All | 6 | Phase 2 | Germany |
| 4 | EUCTR2021-003642-20-DE (EUCTR) | 27/09/2021 | 09/07/2021 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP) | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study | xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE INN or Proposed INN: Afamelanotide | CLINUVEL EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 5 | EUCTR2019-000597-34-DE (EUCTR) | 01/06/2021 | 11/01/2021 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients withXeroderma Pigmentosum (XP) | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study | xeroderma pigmentosum;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: SCENESSE INN or Proposed INN: AFAMELANOTIDE | CLINUVEL EUROPE LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Germany | ||
| 6 | EUCTR2021-001419-10-BE (EUCTR) | 16/11/2021 | Study to evaluate the safety and efficacy of the photoprotective drug, afamelanotide in patients with Xeroderma Pigmentosum C and V | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients with Xeroderma Pigmentosum C and V (XPC and XPV) - Phase IIa XPC and XPV Study | Patients with Xeroderma Pigmentosum C and V;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SCENESSE Product Name: Afamelanotide (16 mg implant) | CLINUVEL EUROPE LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Spain;Belgium |
254. Porphyria
Clinical trials : 72 / Drugs : 53 - (DrugBank : 16) / Drug target genes : 19 - Drug target pathways : 35
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-004164-60-NL (EUCTR) | 19/05/2022 | 21/02/2022 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease. - Phase IIa VP Study | Variegate Porphyria (VP)-related skin disease;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SCENESSE | CLINUVEL (UK) LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | Netherlands;Switzerland | ||
| 2 | NCT01605136 (ClinicalTrials.gov) | May 2012 | 22/5/2012 | Phase III Confirmatory Study in Erythropoietic Protoporphyria | A Phase III, Multicentre, Double-Blind, Randomized, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | N/A | All | 93 | Phase 3 | United States |
| 3 | NCT04578496 (ClinicalTrials.gov) | July 11, 2011 | 5/10/2020 | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 3 | NULL |
| 4 | NCT01097044 (ClinicalTrials.gov) | April 2010 | 30/3/2010 | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) | A Phase II, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States |
| 5 | EUCTR2009-011018-51-IE (EUCTR) | 09/03/2010 | 20/01/2010 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP). MedDRA version: 12.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 INN or Proposed INN: Afamelanotide | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 6 | NCT00979745 (ClinicalTrials.gov) | September 2009 | 17/9/2009 | Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 70 Years | Both | 70 | Phase 3 | Finland;France;Germany;Ireland;Netherlands;United Kingdom |
| 7 | EUCTR2009-011018-51-FI (EUCTR) | 18/08/2009 | 20/04/2009 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 8 | EUCTR2009-011018-51-NL (EUCTR) | 06/08/2009 | 03/04/2009 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2 | Erythropoietic Protoporphyria (EPP) MedDRA version: 9.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: afamelanotide Product Code: CUV1647 | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 9 | EUCTR2009-011018-51-GB (EUCTR) | 15/06/2009 | 27/04/2009 | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | A Phase III, Safety Extension Study in Patients withErythropoietic Protoporphyria (EPP) - Phase III EPP Safety Extension Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 13.1;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Afamelanotide Product Code: CUV1647 INN or Proposed INN: afamelanotide Other descriptive name: Trade Name: SCENESSE | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 3 | Finland;United Kingdom;Netherlands;Ireland | ||
| 10 | NCT04053270 (ClinicalTrials.gov) | May 2007 | 8/8/2019 | Multicentre Phase III Erythropoietic Protoporphyria Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutanenous Bioresorbable CUV1647 Implants in Patients With Erythropoietic Protoporphyria (EPP) | Erythropoietic Protoporphyria | Drug: Afamelanotide;Drug: Placebo | Clinuvel Pharmaceuticals Limited | NULL | Completed | 18 Years | 70 Years | All | 100 | Phase 3 | NULL |
| 11 | EUCTR2007-000636-13-DE (EUCTR) | 12/11/2008 | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP) - Multicentre Phase III EPP Study | Erythropoietic Protoporphyria (EPP) MedDRA version: 12.0;Level: LLT;Classification code 10015289;Term: Erythropoietic protoporphyria | Product Name: Afamelanotide Implant Product Code: CUV1647 INN or Proposed INN: afamelanotide Other descriptive name: [Nle4,D-Phe7]-a-melanocyte stimulating hormone or NDP-a-MSH | Clinuvel Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United Kingdom;Germany;Netherlands;France;Italy;Sweden |