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Clinuvel Pharmaceuticals Ltd

Clinuvel Pharmaceuticals Ltd logo
🇦🇺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.

Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)

Phase 2
Completed
Conditions
Variegate Porphyria
Interventions
First Posted Date
2023-05-11
Last Posted Date
2025-04-27
Lead Sponsor
Clinuvel Pharmaceuticals Limited
Target Recruit Count
6
Registration Number
NCT05854784
Locations
🇳🇱

CLINUVEL investigational site, Rotterdam, Netherlands

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: 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
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: 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: 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
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
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