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
29 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
29
56.9%
Completed
20
39.2%
Terminated
1
2.0%
Unknown
1
2.0%
- Health Canada has granted a Notice of Compliance to CLINUVEL's SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). - SCENESSE® becomes the only treatment for EPP to receive marketing authorization from any regulatory body worldwide, following prior approvals in Europe (2014), the U.S.A. (2019), and Australia (2020). - The drug has been administered over 21,000 times globally, with the longest-treated patients receiving up to 20 years of continuous therapy, demonstrating a proven long-term safety profile. - Five trained and accredited Specialty Centers in Canada are already positioned to treat EPP patients, having previously provided SCENESSE® under special access arrangements.
- CLINUVEL received final EMA scientific advice for its pivotal Phase III CUV107 study evaluating SCENESSE (afamelanotide) as a systemic vitiligo treatment, with the agency endorsing a "totality of evidence" regulatory approach. - The 300-patient study will compare SCENESSE plus narrowband UVB therapy versus NB-UVB monotherapy alone, using T-VASI50 as the primary endpoint and central photographic review for objective assessment. - EMA emphasized that patients with darker skin types (Fitzpatrick IV-VI) would benefit most from systemic treatment due to higher disease visibility, with patient-reported outcomes playing a crucial role in final evaluation. - The study is scheduled to commence in the second half of 2026, representing a potential breakthrough for systemic vitiligo therapy in a field currently dominated by topical treatments for limited body surface areas.
- 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. - The company is pursuing approval of SCENESSE® for vitiligo treatment in the United States and Canada, which could represent a significant shift in CLINUVEL's business model. - CLINUVEL is accelerating US market presence through targeted M&A activities, with 104 of 120 EPP treatment centers currently active and ready for potential vitiligo patient treatment. - Analysts maintain a Buy recommendation with AUD 22.00 target price, representing 126% upside potential from current share price levels.
- 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. - The 20-week randomized trial (CUV105) evaluates SCENESSE® as a systemic repigmentation therapy in combination with narrowband ultraviolet B phototherapy, with first results expected in late 2026. - Early clinical observations show promising repigmentation results, particularly in patients with darker skin types, addressing a significant unmet need in the estimated 820,000 vitiligo patients across North America.
- 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. - The proposed change aims to align European guidelines with those in the US and other regions, allowing for year-round treatment and improved patient outcomes. - Clinical and real-world evidence supports the submission, indicating no change in SCENESSE's safety profile with the increased dosage. - The EMA's decision, expected in Q1 2025, could significantly enhance treatment options for EPP patients across Europe.
• 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.
• 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.
