The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

Start Date07 Mar 2024

Sponsor / Collaborator

Clinuvel Europe Ltd.

CTIS2023-507311-35-00 / Recruiting

A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP). - CUV052

Start Date07 Mar 2024

Sponsor / Collaborator

Clinuvel Europe Ltd.

PACTR202405869934666 / SuspendedPhase 3

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

Start Date31 Oct 2023

Sponsor / Collaborator

Clinuvel (UK) Ltd.

100 Clinical Results associated with Afamelanotide Acetate

100 Translational Medicine associated with Afamelanotide Acetate

100 Patents (Medical) associated with Afamelanotide Acetate

160

Literatures (Medical) associated with Afamelanotide Acetate

14 Aug 2024·The British journal of dermatology

The effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria: a multicentre cohort study

Article

Author: Wagenmakers, Margreet A E M ; Nekouei Shahraki, Mitra ; Kuerten, Viola ; Homey, Bernhard ; Kluijver, Louisa G ; Langendonk, Janneke G ; Schelonke, Kathrin ; Hanssen, Bettina E

Abstract:

Background:

Patients with erythropoietic protoporphyria experience lifelong painful photosensitivity resulting in a lack of sunlight exposure. Previous studies have shown that 47–63% of patients with EPP suffer from vitamin D deficiency and a high prevalence of osteoporosis. An effective treatment for EPP has been available since 2016: the α-melanocyte stimulating hormone analogue afamelanotide. So far, studies on vitamin D levels in EPP have only investigated patients who have not been treated with afamelanotide.

Objectives:

To investigate the effects of afamelanotide treatment on vitamin D levels in EPP.

Methods:

A multicentre observational cohort study in adults with EPP from the Erasmus Medical Centre, the Netherlands, and the University Hospital Düsseldorf, Germany, was carried out. Routinely collected vitamin D levels between 2005 and 2021 were used for analysis. Patient exposure to cholecalciferol or afamelanotide was categorized into four treatment groups: untreated, cholecalciferol, afamelanotide and combined treatment. A linear mixed model for longitudinal data was applied to measure the effect of the treatment groups compared with the untreated groups on vitamin D levels.

Results:

A total of 230 patients and 1774 vitamin D measurements were included. The prevalence of vitamin D deficiency and severe deficiency remained high despite afamelanotide treatment (< 50 nmol L–1 in 71.8% of patients and < 30 nmol L–1 in 48.1%, respectively). Afamelanotide treatment alone did not lead to a significant average increase in vitamin D levels [β = 0.5, 95% confidence interval (CI) –3.2 to 4.2]. In contrast, cholecalciferol and combined therapy with afamelanotide led to a significant increase in vitamin D levels [β = 11.6 (95% CI 7.2–15.9) and β = 15.2 (95% CI 12.3–18.1), respectively].

Conclusions:

Cholecalciferol remains essential for the treatment of vitamin D deficiency in EPP, irrespective of new treatment options like afamelanotide. Afamelanotide treatment did not affect vitamin D levels. We suggest that future guidelines include continuous monitoring of vitamin D and a prescription for cholecalciferol in all patients with EPP, including those treated with afamelanotide.

14 Aug 2024·BRITISH JOURNAL OF DERMATOLOGY

Vitamin D status in patients with erythropoietic protoporphyria taking the systemic photoprotective agent afamelanotide

Letter

Author: Rhodes, Lesley E

01 Aug 2024·Chinese Clinical Oncology

AB080. High-dose methotrexate with and without intra-thecal methotrexate and whole-brain radiotherapy for primary central nervous system lymphoma: a systematic review

Review

Author: July, Julius ; Dharmaraja, Fernando ; Wijovi, Felix ; Angelica, Vanessa ; Kirana, Denny Handoyo

BACKGROUND:

Primary central nervous system lymphoma (PCNSL) requires effective & well-tolerated treatment strategies. The use of high-dose methotrexate (HD-MT) with or without intra-thecal methotrexate (IT-MT) and whole-brain radiotherapy (WBRT) has emerged as a prominent approach for PCNSL. This systematic review aims to assess the efficacy and safety of these treatment modalities.

METHODS:

A comprehensive search strategy identified relevant studies from PubMed, EMBASE, and Cochrane Library. The following search terms were used: "high-dose methotrexate", "primary central nervous system lymphoma", "intra-thecal methotrexate", and "whole-brain radiotherapy". We included randomized controlled trials (RCTs), cohort studies & case-controlled studies evaluating the use of HD-MT with or without IT-MT and whole-brain radiotherapy in the treatment of confirmed PCNSL. Data extraction & quality assessment was conducted by two independent reviewers. Primary outcomes include overall survival (OS), progression-free survival (PFS) & treatment-related adverse events (TRAEs). Secondary outcomes were neurological function and quality of life (QOL) assessments. The risk of bias in individual studies was assessed using the Cochrane Risk of Bias Tool for randomized trials and the Newcastle-Ottawa Scale for observational studies.

RESULTS:

We identified 5 studies, consisting of 1 RCT, 3 cohort studies, and 1 case-controlled study. Pooled analysis revealed that HD-MT with or without IT-MT and whole-brain radiotherapy significantly improved both OS and PFS compared to other treatment modalities but we found no significant difference between patients who received HD-MT with or without IT-MT. Combination therapy was generally well-tolerated, with manageable TRAE. Subgroup analyses stratified by age, disease stage, and other relevant factors demonstrated consistent efficacy and safety profiles across different patient populations. The risk of bias assessment indicated that the majority of the included studies had low-moderate risk of bias.

CONCLUSIONS:

There was no significant difference between patients who received HD-MT with or without IT-MT plus radiotherapy, emphasizing the comparable efficacy of these treatment modalities. Combination therapy was generally well-tolerated, with manageable TRAE. This highlights the favourable safety profile of HD-MT with fewer side effects compared with the combination of IT-MT.

News (Medical) associated with Afamelanotide Acetate

30 Oct 2024

·www.pharmaceutical-technology.com

How a patient helped shape a treatment for a rare skin disorder

Dr Jasmin Barman-Aksӧzen speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference in Zurich, Switzerland. Credit: Jenna Philpott / GlobalData. When Dr Jasmin Barman-Aksӧzen began experiencing painful, unexplained burns on her skin, she turned to Wikipedia for answers. After discovering a possible diagnosis, she proposed it to her physician who confirmed that she had erythropoietic protoporphyria (EPP). This ultra-rare genetic disorder causes a phototoxic heme precursor to build up in the red blood cells, resulting in severe burn injuries on the skin after as little as ten minutes of exposure to visible light. At the time of her diagnosis, no treatment existed to alleviate or prevent the symptoms of EPP. “There was no cure, there was no therapy for the pain, and there were no preventive possibilities for this phototoxic reaction, so the only thing we could do was avoid visible light. As you can imagine, that’s socially very isolating, and it’s not compatible with a normal life, and having to avoid light also leads to depression. We sometimes see suicidal ideations,” she explained. Around the same time, Australia-based biotech Clinuvel Pharmaceuticals was in the process of developing afamelanotide – a slow-release treatment now known as Scenesse. The drug increases skin pigmentation and has anti-inflammatory properties, offering protection against light-induced skin damage. Speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference, taking place in Zurich, Switzerland, between 29 and 30 October, Barman-Aksӧzen explained that she joined a University of Zurich research group working on Scenesse as a PhD student. The treatment was already in Phase III trials, and she provided insights on clinical trial design and quality of life (QoL) measures for patients with EPP. See Also: Matinas BioPharma mulls wind-down as antifungal therapy deal falls through Amgen earns higher revenues in Q3 2024, puts rare diseases in the spotlight The results from the pivotal trial (NCT01605136) showed that patients receiving Scenesse could spend, on average, an additional 20 minutes in sunlight daily without experiencing pain, compared to those on a placebo. Maximally, the patients can spend up to three hours a day in sunlight while using the treatment. They also experienced fewer phototoxic reactions, with symptoms that were less intense and shorter in duration, leading to an overall improvement in quality of life. Though an additional 20 minutes of sun exposure a day may sound minimal, Barman-Aksӧzen highlighted how significant this can be for patients with EPP. Recalling a trip to Berlin, she shared that, without treatment, she wouldn’t have been able to take a taxi with a sunroof without risking a severe phototoxic reaction. “Those are the moments when we are really happy to have the treatment,” she explained. Data from this clinical trial led to Scenesse receiving European approval in 2014. Notably, Barman-Aksӧzen became the first patient to present directly to the European Medicines Agency (EMA) committee before its approval vote, offering insights that clarified both the condition and the treatment’s impact. The EMA subsequently announced that Scenesse was the first drug approved through a European pilot programme that incorporated patient and physician clinical experiences in regulatory decisions – an approach now more widely adopted. In 2019, the US Food and Drug Administration (FDA) followed with its own approval of the drug. Barman-Aksӧzen continues her work advocating for EPP patients and co-founded the International Porphyria Patient Network (IPPN) alongside other patient advocates. While Scenesse brought a treatment option to EPP patients, Barman-Aksӧzen underscored its limitations; it’s a fixed-dose implant for symptomatic relief, which is not scalable and cannot be used for children. Two new candidates, Mitsubishi’s dersimelagon and Disc Medicine’s bitopertin, are being evaluated in clinical trials. These trials present ethical challenges such as the potential for phototoxic burns in control groups, and the risk of a bias in patient selection, as more severely affected patients may hesitate to participate. Barman-Aksӧzen added: “As patients, we’ve requested head-to-head studies. Besides the ethical aspects, I, as a patient, want to know how a new substance compares not only to placebo but also to the existing therapy.”

Phase 3Drug ApprovalClinical ResultOligonucleotide

30 Sep 2024

·www.globenewswire.com

CLINUVEL files Canadian New Drug Submission for SCENESSE® in EPP

Patient Special Access Program continues during Health Canada reviewMELBOURNE, Australia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- CLINUVEL has filed a New Drug Submission (NDS) to Health Canada, seeking approval for its novel photoprotective therapy SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). If approved, SCENESSE® would be the first treatment for Canadian EPP patients. Health Canada review process Health Canada’s Health Products and Food Branch (HPFB) reviews and approves medications for use in Canada, assessing the safety and efficacy of the products in the proposed indication, as well as the drug’s quality. Following a formal dossier validation period, the HPFB may complete the review of a new drug candidate within 300 days. Canadian Special Access Program ongoing In 2023 CLINUVEL announced that the first Canadian EPP patient had received treatment with SCENESSE® under Canada’s Special Access Program (SAP). The SAP allows individual physicians to facilitate access to treatment for patients who have serious or life-threatening conditions and lack therapeutic alternatives. Patient treatment under the SAP continued without interruption prior to Health Canada’s review of the NDS. All Canadian patients treated under the SAP have received insurance coverage to support their treatment access. Two Canadian Specialty Centers have been trained and accredited to treat EPP patients with SCENESSE®. Further potential Canadian treatment centres have been identified to enable prompt treatment access pending regulatory and pricing approvals. To date, CLINUVEL has trained and accredited 85 Specialty Centers across North America. EPP affects approximately 1:140,000 individuals, with an estimated 280 EPP patients in Canada. Commentary “The SAP has provided an important bridge for Canadian patients to access treatment and helped us understand the Canadian therapeutic landscape,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “A formal authorisation will enable more Canadian patients to receive SCENESSE® and is a logical next step. “The dossier submitted contains both data which led to the FDA’s approval, as well as long-term data collected during the follow up of EPP patients worldwide,” Dr Wright concluded. SCENESSE® in EPP: systemic photoprotection EPP is a rare genetic disorder which causes phototoxicity, debilitating reactions and burns following light exposure. CLINUVEL has spent nearly two decades developing SCENESSE® as the first treatment for EPP. The drug, administered as a controlled-release injectable implant every 60 days, stimulates the production of melanin in skin, protecting skin cells from visible and ultraviolet light (photoprotection) and acting as a strong antioxidant. Clinical and long-term post-marketing studies of SCENESSE® have shown that it can prevent and reduce the severity of phototoxic reactions, as well as improving patients’ quality of life. The drug has been approved for adults by the European Medicines Agency, US Food and Drug Administration (FDA), and regulatory authorities in Australia and Israel. To date, over 16,000 doses of SCENESSE® have been administered to EPP patients worldwide. References Ceresnie, M. S., et al. (2022). Association of quality of life measures with afamelanotide treatment in patients with erythropoietic protoporphyria and x-linked protoporphyria: A retrospective cohort study. Journal of the American Academy of Dermatology, S0190962222028729. Elder, G., et al. (2013). The incidence of inherited porphyrias in Europe. Journal of Inherited Metabolic Disease, 36(5), 849–857. Langendonk, J., et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine, 373(1), 48–59. Wensink, D., Wagenmakers, M. A. E. M., & Langendonk, J. G. (2021). Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria. Expert Review of Clinical Pharmacology, 14(2), 151–160. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD. Head of Investor RelationsMr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquirieshttps://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see CLINUVEL’s website for the full Forward-Looking Statements disclaimer. Contact:Tel: +61 3 9660 4900Fax: +61 3 9660 4909Email: mail@clinuvel.comAustralia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia CLINUVEL on InstagramCLINUVEL on XCLINUVEL on LinkedInCLINUVEL on FacebookCLINUVEL on YouTube

Drug ApprovalOligonucleotideClinical Study

18 Jun 2024

·www.globenewswire.com

Afamelanotide in fair-skinned Parkinson’s patients

Preclinical models show benefit of afamelanotide as MC1R therapy in Parkinson’s DiseaseMELBOURNE, Australia, June 18, 2024 (GLOBE NEWSWIRE) -- CLINUVEL today announced a novel clinical program evaluating afamelanotide as a treatment in early-stage Parkinson’s Disease (PD or Parkinson’s) in fair-skinned patients. The program objectives are to determine whether afamelanotide – through melanocortin-1 receptor (MC1R) activation – is able to lower α-synuclein (a toxin) in blood levels in PD patients, and positively affect neurons of the midbrain. MC1R is known to be a key receptor in brain and skin cells. In large studies, it was found that fair-skinned patients have a higher risk of PD associated with a malfunctioning MC1R.a, 1-2 Since afamelanotide is known to optimise the function of the MC1R, it is hypothesised that the drug treatment would have a positive effect in PD by lowering α-synuclein, as recently demonstrated in preclinical studies.²ˉ³ Afamelanotide is marketed in Europe and the USA as SCENESSE® for patients diagnosed with erythropoietic protoporphyria (EPP). Evidence for use of afamelanotide in Parkinson’s Disease Worldwide, individuals born with red hair and fair skin are found to have a loss of function of MC1Rs – expressed on skin and brain cells – and to carry an increased risk of Parkinson’s and melanoma.⁴¯⁵ In various Parkinson’s models it has been illustrated that an MC1R-binding drug – such as afamelanotide – enables cellular protection against α-synuclein, a toxic substance found in the neurons of PD patients. In preclinical models, the use of afamelanotide has been shown to improve neurodegenerative conditions.⁶ Following decades of human use, it has been well established that afamelanotide strongly binds to MC1R and optimises cellular functions (signalling) through pharmacological activation. The CUV901 study is the first human study evaluating the effect of afamelanotide in PD as a therapeutic option. Study design – CUV901 The Phase IIa CUV901 study will evaluate six fair-skinned patients with early symptoms of PD who are not yet receiving medicinal therapy. The first objectives of the open-label study are to focus on the safety of afamelanotide, while determining α-synuclein in blood, and assessing visual changes in the midbrain. Secondary endpoints are to assess cognitive functions. The study design has obtained ethics and regulatory approval.b Patients between 40 and 85 years old will receive 11 doses of 0.08 mg per kilogram body weight of afamelanotide on each day of drug administration, over a study duration of 56 days. The first patients are expected to enrol before the end of 2024. Commentary “We are immensely pleased to initiate a highly innovative study for afamelanotide,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “It marks a real breakthrough to conduct this study in Parkinson’s after lengthy regulatory discussions and preparation. “At the heart of the problem in Parkinson’s lies the loss of dopamine producing neurons in the brain due to toxicity caused by α-synuclein. There is now evidence that afamelanotide – by binding to MC1R – could maintain stability and integrity of the affected neurons and slow down progression of the disorder. “By analysing blood and brain scans of the substantia nigra, we will learn of afamelanotide’s potential effect in Parkinson’s. The ability to do something for this group of patients results from decades of clinical research and a focus on translating inhouse knowledge,” Dr Wright concluded. About Parkinson’s Disease Parkinson’s Disease is a progressive and degenerative disorder caused by oxidative stress and neuroinflammation. Symptoms consist of progressive loss of motor functions and increased tremor, as well as dementia, depression, sleep disorders and a range of autonomic dysfunctions. Ultimately PD can result in adverse clinical outcomes, contributing to over 200,000 deaths annually. PD is characterised by the loss of dopamine producing neurons predominantly in the substantia nigra (SN) of the brain, while a high accumulation is seen of the neurotoxin α-synuclein. It is thought that treatment of patients with early symptoms provides a better prognosis. The current standard of care in PD is levodopa, monoamine oxidase B (MAO-B) inhibitors or dopamine agonists, which all aim to provide symptomatic relief but are not able to slow neurodegeneration. These medications become less effective as the disease progresses and escalating doses may be required. Notes a Epidemiological analyses from 120,000 US individuals revealed that fair skinned Parkinson’s patients have an increased risk of developing melanoma in a lifetime, both populations carrying a defective MC1R function.1 Afamelanotide is known to possess very high binding property (agonist) to MC1R and offer cellular protection by overcoming a loss-of-function of the receptor in patients with fair skin with red hair phenotype.b Alpha-synuclein (α-synuclein) – as a measure of disease progress - is used as a biomarker in blood samples of PD patients. References Gao, X., et al. (2009). Genetic determinants of hair color and Parkinson’s disease risk. Ann Neurol. 65:76–82.Chen, X., et al. (2017). The Melanoma-Linked “Redhead” MC1R Influences Dopaminergic Neuron Survival. Annals of Neurology, 81(3), 395–406.Chen, X., et al. (2017). Red hair, MC1R variants, and risk for Parkinson’s disease – a meta‐analysis. Annals of Clinical and Translational Neurology, 4(3), 212–216.Gao, X., et al. (2009). Family history of melanoma and Parkinson disease risk. Neurology 73:1286–1291.Kareus, S.A., et al. (2012). Shared Predispositions of Parkinsonism and Cancer: a Population-Based Pedigree-Linked Study. Arch Neurol. 69:1572–1577.Cai, W., et al. (2022). Melanocortin 1 receptor activation protects against alpha-synuclein pathologies in models of Parkinson’s disease. Molecular Neurodegeneration, 17(1), 16.Srivast, P., et al. (2023). Peripheral MC1R activation modulates immune responses and is neuroprotective in a mouse model of Parkinson’s disease. Research Square, rs.3.rs-3042571. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD. Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries https://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see the full statement at https://www.clinuvel.com/2024/06/afamelanotide-in-fair-skinned-parkinsons-patients-20240618/. Contact: Tel: +61 3 9660 4900 Fax: +61 3 9660 4909Email: mail@clinuvel.comAustralia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

Phase 2OligonucleotideDrug Approval

100 Deals associated with Afamelanotide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D10511 D11334	Afamelanotide Acetate	D02BB02	DB04931

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Protoporphyria, Erythropoietic	AU	Clinuvel Pharmaceuticals Ltd.	18 Nov 2020
Porphyria, Erythropoietic	EU	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	IS	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	LI	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	NO	Clinuvel Europe Ltd.	22 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Actinic Prurigo	Phase 3	-	Clinuvel Pharmaceuticals Ltd.	05 May 2010
Porphyria, Variegate	Phase 2	NL	Clinuvel (UK) Ltd.	28 Mar 2023
Vitiligo	Phase 2	US	Clinuvel Pharmaceuticals Ltd.	11 Oct 2022
Xeroderma Pigmentosum, Complementation Group C	Phase 2	BE	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum, Complementation Group C	Phase 2	ES	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum, Complementation Group E	Phase 2	BE	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum, Complementation Group E	Phase 2	ES	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum	Phase 2	DE	Clinuvel Europe Ltd.	19 Oct 2021
Androgen-Insensitivity Syndrome	Phase 2	AU	Clinuvel Pharmaceuticals Ltd.	03 Jun 2021
Ischemic stroke	Phase 2	AU	Clinuvel Pharmaceuticals Ltd.	03 Jun 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04962503 (Pubmed)	Phase 2	Stroke	6	Afamelanotide 16 mg	wmseugimeg(rkwmdnuwpq) = One patient (who received 2 doses), suffered a fatal recurrent stroke on D9 due to a known complete acute internal carotid artery occlusion, assessed as unrelated to the study drug lijgbgtiqc (hcofbltavy )	-	26 Jul 2023
NCT04962503 (CTgov)	Phase 2	Androgen-Insensitivity Syndrome \| Occlusion of artery \| Ischemic stroke ... View more	6	Afamelanotide	cjkxloiysq(ahfosnpqxc) = oluygheunf kqgrzwapjm (fdboeathib, bfrttrhnjp - grdfetinqy) View more	-	11 Apr 2023
NCT04943159 (CTgov)	Phase 2	Acne Vulgaris	3	Afamelanotide	kmneowkadz(cqtwkvoemz) = jkryzmohvr urgvsqrbyz (jwhethgsez, xffvaetbhk - jgcayqygku) View more	-	26 Oct 2021
NCT00979745 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	74	Placebo	rbbevcyjjg(gflgcncqxw) = ypuqtbdmzl geejqrkwpt (egfakfxcwr, quoqasorib - icpkbepfeq) View more	-	12 Oct 2021
NCT04425746 (CTgov)	Phase 2	-	16	Afamelanotide (Afamelanotide)	vqdufftoas(beiccvsvzk) = rsykstcuos lbdjxfcwpd (ajrbzsvemi, kioijmkrgu - ewfcdecrps) View more	-	01 Oct 2021
NCT04425746 (CTgov)	Phase 2	-	16	Placebo (Placebo)	vqdufftoas(beiccvsvzk) = pbevauufpj lbdjxfcwpd (ajrbzsvemi, xdmqhyiqln - unzmyztkgz) View more	-	01 Oct 2021
NCT04525157 (CTgov)	Phase 2	Nonsegmental vitiligo	21	Afamelanotide	wirwvmoalb(gcvyrzxwcv) = snantttsvz wuzmbjrmbf (cqmvbvdbft, xctkmisihk - nmbusuygki) View more	-	21 May 2021
NCT04704713 (CTgov)	Phase 3	Actinic Prurigo	31	Afamelanotide (Afamelanotide)	bptnkmmvei(msqnobifdn) = ubrkuirfms fzivpmnnrw (ensnjwwqcc, izwjmdhfdu - nrsczlrxls) View more	-	19 Mar 2021
NCT04704713 (CTgov)	Phase 3	Actinic Prurigo	31	Placebo (Placebo)	bptnkmmvei(msqnobifdn) = ayfmwckpgp fzivpmnnrw (ensnjwwqcc, mfuuyqlvdj - slluccjsfi) View more	-	19 Mar 2021
NCT04578496 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	16	Afamelanotide	kgbpbizhlj(nqtzdlqjpg) = dotxcxpvsi cxtponwjyc (kdubgljeva, hgmjgbqxjr - yhiihiuvuf) View more	-	02 Nov 2020
NCT04053270 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	100	Placebo+Afamelanotide (Group A)	efgnwavrbl(tptognfhcc) = zgyzhrbgqd cxtovyogbr (ygrcxekpzv, nfulceoupq - xmrtclrxdl) View more	-	10 Oct 2019
NCT04053270 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	100	Placebo+Afamelanotide (Group B)	efgnwavrbl(tptognfhcc) = dcyzqlbyrb cxtovyogbr (ygrcxekpzv, wvryhqhwxa - skwlvzalil) View more	-	10 Oct 2019
NCT01097044 (CTgov)	Phase 2	Protoporphyria, Erythropoietic	77	Afamelanotide (Afamelanotide)	csphvrgfwd(emairjseqb) = jdbprfnhhr uodmbvspba (qajiyzjeyt, bozjpddhab - rsyarcgtgu) View more	-	17 Sep 2019
NCT01097044 (CTgov)	Phase 2	Protoporphyria, Erythropoietic	77	Placebo (Placebo)	csphvrgfwd(emairjseqb) = daglsvloax uodmbvspba (qajiyzjeyt, chlpdzedyy - trumjfmerh) View more	-	17 Sep 2019

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