Clinuvel Pharmaceuticals Ltd

🇦🇺Australia

Country: 🇦🇺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.

Clinical Trials

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

Phase 2

Completed

Conditions: Vitiligo

Interventions: Drug: Afamelanotide
Device: NB-UVB

First Posted Date: 2011-06-27

Last Posted Date: 2013-03-22

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 15

Registration Number: NCT01382589

Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)

Phase 2

Completed

Conditions: Erythropoietic Protoporphyria

Interventions: Drug: Afamelanotide
Drug: Placebo

First Posted Date: 2010-04-01

Last Posted Date: 2019-10-28

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 77

Registration Number: NCT01097044

Locations: 🇺🇸
University of Alabama, Birmingham, Alabama, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Mt. Sinai, New York, New York, United States

and more 3 locations

Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)

Phase 3

Completed

Conditions: Erythropoietic Protoporphyria

Interventions: Drug: Afamelanotide
Drug: Placebo

First Posted Date: 2009-09-18

Last Posted Date: 2021-10-12

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 74

Registration Number: NCT00979745

Locations: 🇬🇧
St Woolos Hospital, Newport, Wales, United Kingdom
🇫🇮
HUS:n Iho-ja allergiasairaala (Skin and Allergy Hospital), Helsinki, Finland
🇫🇷
Centre Français des Porphyries, Hôpital Louis Mourier, Colombes, Cedex, France

and more 5 locations

Phase II Solar Urticaria (SU) Pilot Study

Phase 2

Completed

Conditions: Solar Urticaria

First Posted Date: 2009-03-11

Last Posted Date: 2009-09-15

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 5

Registration Number: NCT00859534

Locations: 🇬🇧
Salford Royal Foundation Hospital (Hope Hospital), Manchester, United Kingdom

Phase II AK Study in Organ Transplant Patients

Phase 2

Conditions: Actinic Keratoses
Carcinoma, Squamous Cell
Organ Transplant Recipients

Interventions: Drug: Afamelanotide (CUV1647)
Drug: Placebo

First Posted Date: 2009-01-26

Last Posted Date: 2010-12-06

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 200

Registration Number: NCT00829192

Locations: 🇦🇺
The Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇧🇪
Hospital Erasme, Brussels, Belgium
🇧🇪
Gent University Hospital, Gent, Belgium

and more 9 locations

Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

Completed

Conditions: Polymorphic Light Eruption (PLE)

First Posted Date: 2007-05-14

Last Posted Date: 2011-10-05

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Target Recruit Count: 18

Registration Number: NCT00472901

Locations: 🇦🇺
St Vincents Hospital, Melbourne, Australia
🇬🇧
Hope Hospital, Manchester, United Kingdom
🇦🇹
Medical University of Vienna, Vienna, Austria

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