Clinuvel Pharmaceuticals Ltd
- Country
- 🇦🇺Australia
- Ownership
- -
- Employees
- 16
- Market Cap
- $473M
- 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
51
Trial Phases
3 Phases
Drug Approvals
1
Drug Approvals
SCENESSE afamelanotide (as acetate) 16 mg implant vial (327947)
- Product Name
- SCENESSE afamelanotide (as acetate) 16 mg implant vial
- Approval Date
- Nov 18, 2020
Clinical Trials
Distribution across different clinical trial phases (29 trials with phase data)• Click on a phase to view related trials
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
- 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)
- 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
- 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)
- 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)
- First Posted Date
- 2020-10-08
- Last Posted Date
- 2020-11-19
- Lead Sponsor
- Clinuvel Pharmaceuticals Limited
- Target Recruit Count
- 16
- Registration Number
- NCT04578496
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News
CLINUVEL CEO Returns to Drive US Expansion with Vitiligo Treatment Approval Strategy
CEO Dr. Philippe Wolgen has returned to lead CLINUVEL Pharmaceuticals following his full recovery, positioning the company for its next growth phase in North America.
Clinuvel Advances Phase III Trial for Vitiligo Treatment with SCENESSE®, Recruiting Over 200 Patients
Clinuvel Pharmaceuticals has successfully completed recruitment of more than 200 patients across North America, Africa, and Europe for its Phase III trial of SCENESSE® in vitiligo treatment.
Clinuvel Seeks EMA Approval for Increased SCENESSE Dosage in Europe
Clinuvel is in discussions with the EMA to increase the maximum annual dosage of SCENESSE for erythropoietic protoporphyria (EPP) patients from four to six doses.
Disc Medicine's Bitopertin Poised for Potential Accelerated FDA Approval in Erythropoietic Protoporphyria
• Disc Medicine's bitopertin may receive accelerated FDA approval for erythropoietic protoporphyria (EPP) treatment based on existing clinical data. • The FDA has agreed to the design of Disc's Phase III APOLLO trial, which will serve as a confirmatory study for bitopertin. • Bitopertin aims to reduce protoporphyrin IX (PPIX) levels, potentially alleviating pain and burns from sun exposure in EPP and XLP patients. • The Phase III APOLLO trial is set to begin in mid-2025 and will assess bitopertin's safety and efficacy in patients aged 12 and older.
Patient-Researcher's Journey Leads to Breakthrough Treatment for Rare Light Sensitivity Disorder
• Dr. Jasmin Barman-Aksözen's personal experience with erythropoietic protoporphyria (EPP) led her to contribute to the development and approval of Scenesse, the first treatment for this rare genetic disorder. • Clinical trials demonstrated Scenesse allows EPP patients to spend up to 20 additional minutes in sunlight daily without pain, with some achieving three hours of sun exposure while using the treatment. • The drug's approval marked a historic milestone as the first treatment approved through EMA's patient experience pilot program, though limitations remain and new therapeutic candidates are under development.