MedPath

Clinuvel Pharmaceuticals Ltd

🇦🇺Australia
Ownership
-
Employees
16
Market Cap
$473M
Website
Introduction

Clinuvel distributes a single product, Scenesse, the only approved treatment for phototoxic reactions specifically associated with a rare genetic disease called erythropoietic protoporphyria. EPP causes extreme pain or burns from brief exposure to light, affecting a patient’s quality of life. Scenesse is a patented dissolvable implant, comparable in size with a rice grain, injected underneath the skin roughly every three months for ongoing protection. The implant controls the release of a synthetic drug which promotes the production of more melanin, thereby reducing pain and increasing tolerance for light exposure. The majority of Clinuvel’s earnings stem from Europe and the US.

A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Phase 2
Completed
Conditions
Arterial Ischemic Stroke
Interventions
First Posted Date
2021-07-15
Last Posted Date
2023-04-11
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
6
Registration Number
NCT04962503
Locations
🇦🇺

The Alfred, Melbourne, Australia

Afamelanotide in Patients Suffering With Acne Vulgaris

Phase 2
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2021-06-29
Last Posted Date
2021-10-26
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
3
Registration Number
NCT04943159

Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Phase 3
Completed
Conditions
Polymorphic Light Eruption
Interventions
Drug: Afamelanotide
Drug: Placebo
First Posted Date
2021-01-12
Last Posted Date
2021-03-19
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
31
Registration Number
NCT04704713

A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)

Phase 3
Completed
Conditions
Erythropoietic Protoporphyria
Interventions
First Posted Date
2020-10-08
Last Posted Date
2020-11-19
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
16
Registration Number
NCT04578496

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)

Phase 2
Completed
Conditions
Vitiligo
Interventions
Drug: Placebo
Drug: Afamelanotide
First Posted Date
2020-08-25
Last Posted Date
2023-09-22
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
21
Registration Number
NCT04525157

Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

Phase 2
Completed
Conditions
Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Interventions
Drug: Afamelanotide
Drug: Placebo
First Posted Date
2020-06-11
Last Posted Date
2021-10-01
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
16
Registration Number
NCT04425746

Multicentre Phase III Erythropoietic Protoporphyria Study

Phase 3
Completed
Conditions
Erythropoietic Protoporphyria
Interventions
Drug: Afamelanotide
Drug: Placebo
First Posted Date
2019-08-12
Last Posted Date
2019-10-10
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
100
Registration Number
NCT04053270

Implant Pharmacokinetic and Pharmacodynamic Study

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2018-08-16
Last Posted Date
2018-08-16
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
24
Registration Number
NCT03634137
Locations
🇺🇸

Prism Research Inc., Saint Paul, Minnesota, United States

Phase III Confirmatory Study in Erythropoietic Protoporphyria

Phase 3
Completed
Conditions
Erythropoietic Protoporphyria
Interventions
Drug: Placebo
Drug: Afamelanotide
First Posted Date
2012-05-24
Last Posted Date
2019-09-19
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
93
Registration Number
NCT01605136
Locations
🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

Mt. Sinai, New York, New York, United States

🇺🇸

University of Utah, Salt Lake City, Utah, United States

and more 4 locations

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

Phase 1
Completed
Conditions
Vitiligo
Interventions
Drug: Afamelanotide
Procedure: Narrow-Band UVB Light Treatment
First Posted Date
2011-09-08
Last Posted Date
2013-03-22
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
56
Registration Number
NCT01430195
Locations
🇺🇸

Henry Ford Medical Center, Detroit, Michigan, United States

🇺🇸

The Mount Sinai School of Medicine, New York, New York, United States

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