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.

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.

NCT06109649

/ Active, not recruitingPhase 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

The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.

Start Date11 Oct 2023

Sponsor / Collaborator-

100 Clinical Results associated with Afamelanotide Acetate

100 Translational Medicine associated with Afamelanotide Acetate

100 Patents (Medical) associated with Afamelanotide Acetate

445

Literatures (Medical) associated with Afamelanotide Acetate

01 Jul 2026·JOURNAL OF CONTROLLED RELEASE

Heterochiral co-assembly of β-strands and hairpins affords stereocomplexed peptide hydrogels for drug delivery

Article

Author: Wang, Xiaoyi ; Schneider, Joel P ; Anderson, Caleb F

Stereocomplexation is a unique design tool capable of imparting targeted characteristics to materials. Interestingly, it has not been widely utilized in drug delivery. Herein, we report the first example of a peptide-based stereocomplexed hydrogel delivery platform that utilizes the co-assembly of β-strand and β-hairpin peptides of opposite chirality. Heterochiral mixtures of peptides co-assemble to form fibrillar hydrogel networks displaying physical properties that are consistent with the formation of rippled β-sheet secondary structure-heterochiral gels form faster and are more mechanically rigid than gels formed from homochiral mixtures of strand and hairpin peptides. Biophysical and mechanical analyses show that the exact chiral identity of the strand and hairpin are inconsequential to material formation as long as they are of opposite handedness. Importantly, the β-strand component serves as a fusion peptide for drug that is ligated through an α-methylsulfone carbamate linker having pre-determined cleavage kinetics. Strand-drug peptide conjugates are directly integrated into the underlying fibril architecture of the gel network allowing control over release kinetics. Utility of this material was demonstrated through the delivery of afamelanotide, a peptide melanocortin 1 receptor agonist. The stereocomplexed delivery system offers slow sustained release of active peptide drug over several months. The heterochiral material is designed to be versatile to allow the delivery of other classes of drug by their simple ligation to the β-strand component of the system.

01 May 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide

Article

Author: Chawathe, Ashwini ; Sharma, Nitish

Afamelanotide, also known as melanotan-1, is a synthetic 13-amino acid peptidomimetic of α-melanocyte stimulating hormone (α-MSH), and is a critical peptide orphan drug used for the management of erythropoietic protoporphyria. It contains norleucine and D-phenylalanine at positions 4 and 7, in place of methionine and L-phenylalanine, respectively as found in endogenous peptide. Therapeutic peptide stability profiling is crucial in drug development because chemical and physical degradation during storage alters structural properties, potentially reducing efficacy and compromising safety by preventing target engagement. Stability testing for synthetic peptides is performed by following the International Council for Harmonisation (ICH) guidelines Q1A(R2) and Q5C. The current work endeavours to explore afamelanotide's degradation pathways under various chemical and physical stress conditions: acidic, basic, neutral, and oxidative stress, UV light exposure, and increased temperature at 60⁰C. The study demonstrated that afamelanotide undergoes degradation under all applied stress conditions with the generation of fourteen different degradation products (DPs) which were separated by gradient reversed-phase HPLC on a Zorbax SB C18 column (300 Å, 4.6*150 mm, 3.5 µm) and the method was validated according to the ICH Q2(R1) guideline. To enable comprehensive characterization, the analysis was coupled with ultra-high-performance liquid chromatography-high resolution tandem mass spectrometry (UHPLC-HRMS/MS), where collision-induced dissociation yielded abundant and accurate fragmentation patterns, enabling the detailed structural elucidation of the products. While this work has identified several degradation pathways such as truncation, methylation, deacetylation, and oxidation, it also establishes complete stability profile of α-MSH analogue, thus offering key insights for the rational design of robust drug formulations.

04 Mar 2026·EXPERT OPINION ON PHARMACOTHERAPY

New and currently investigated pharmacotherapies for the erythropoietic protoporphyrias: spotlight on dersimelagon and bitopertin

Review

Author: Falchetto, Rocco ; Dechant, Cornelia ; Barman-Aksözen, Jasmin ; Wäscher, Sebastian ; Granata, Francesca

INTRODUCTION:

The erythropoietic protoporphyrias (EPP) are ultra-rare inborn errors of the heme biosynthesis characterized by painful and debilitating phototoxic reactions in the blood vessels upon exposure to visible light. Afamelanotide is the only approved treatment for EPP and effectively prevents pain and prolongs the time patients can spend in sunlight. However, afamelanotide does not address the underlying disease mechanism and is currently only approved for use in adult patients, leaving children and adolescents without a treatment option. The two investigational pharmacotherapies, dersimelagon and bitopertin, could offer benefits such as treatment options for children and prevention of some of the associated disease complications.

AREAS COVERED:

This narrative review (using Pubmed and trial databases) aims to provide an overview of the status of development of dersimelagon and bitopertin, with a focus on the prevention of phototoxicity.

EXPERT OPINION:

The currently available trial data on dersimelagon and bitopertin suggests treatment effects in EPP as compared to placebo control groups. However, safety and efficacy of dersimelagon and bitopertin need to be further characterized. Moreover, to ensure benefit for patients and access to therapy after regulatory approval, it also would be important to generate data on the relative safety and efficacy as compared to afamelanotide.

News (Medical) associated with Afamelanotide Acetate

23 Jul 2026

·www.globenewswire.com

CLINUVEL implements strategic reorganisation to refocus on U.S. markets

MELBOURNE, Australia and NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD (ASX: CUV | Nasdaq: CUVL) today announced a strategic reorganisation of its operations and workforce, effective 1 January 2027, concurrent with the relocation of its corporate headquarters to the United States. "We have long contemplated a U.S. listing and concluded that the Company has reached a stage of maturity sufficient to attract the attention of U.S. investors,” said Mr Lachlan Hay, CLINUVEL’s Chief Operating Officer. “Based on feedback from recent non-deal roadshows, CLINUVEL's profile is seen as distinct from many U.S. biopharmaceuticals, while many U.S. investors expressed a preference to invest in U.S.-focused and listed companies. Since our future operations will be centred in the United States, we are now positioning the business functions for these next phases.” Restructuring Highlights Headquarters Relocation: CLINUVEL’s corporate headquarters and key functions will transition to the U.S., effective 1 January 2027, to strengthen regulatory engagement and commercial partnerships.Workforce Reduction: the Company is reducing its global workforce by approximately 10%-20% and relocating select functions to the U.S. This reflects a necessary realignment of operating expenditure with current revenue generation and near-term clinical and commercial priorities.U.S. Market Focus: operational resources will be pivoted exclusively toward the U.S. pharmaceutical pipeline and commercial strategy. The U.S. represents over 40% of the global pharmaceutical market by value and is the primary ecosystem for premium pricing, regulatory advancement, and M&A activity.Capital Access: the restructuring is a prerequisite to unlocking deeper, more liquid capital pools in the U.S. Strategic Rationale Capital Markets ConditionsThe current macroeconomic environment has constrained liquidity in the Australian and broader Asia-Pacific markets. Over 66% of CLINUVEL's shareholder register is currently held by foreign investors, with the majority of new shareholders originating from North America and Europe. Valuation AlignmentU.S.-listed specialty pharmaceutical companies with comparable revenue and pipeline profiles typically trade at materially higher enterprise value-to-revenue multiples relative to their ASX-listed counterparts. This valuation differential is driven by deeper sector-specific knowhow, analyses, greater institutional participation, and a more developed ecosystem for specialty pharma financing. Pipeline CommercialisationThe Company's late-stage programs, particularly in vitiligo, are primarily targeted at the U.S. patient population, which is estimated at approximately six million affected. The U.S. market for systemic vitiligo therapeutics is projected to be sizable over the coming decade. Relocating the current base and operational headquarter to the U.S. positions the Company to access distribution, and potential partnership infrastructure, required to capture the opportunity. Additional pipeline activities are all targeted to serve U.S. pharmaceutical markets. Shareholder CompositionForeign investors have dominated CLINUVEL's register for an extended period, reflecting the global appeal of the Company's assets. The U.S. focus formalises current shareholder composition and provides a structural pathway to expand the investor base to include leading global healthcare funds and institutional investors that preferentially allocate capital to U.S.-headquartered companies. Management Commentary "The Board has initiated this transformation because it believes that a U.S. focus of our operations is the single most effective means to unlock the intrinsic value of our assets,” Mr Hay added. “This restructuring positions the Company for a future of growth and will benefit shareholders, patients, and stakeholders over the long-term." About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL is a global biopharmaceutical company focused on developing and delivering innovative therapies for patients with genetic, metabolic, and dermatological disorders. The Company's portfolio is centred around melanocortin peptides, with programs advancing in photomedicine and vitiligo. CLINUVEL is listed on the Australian Securities Exchange (ASX: CUV) and the Nasdaq Stock Market (Nasdaq: CUVL). CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, 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). For further information, visit www.clinuvel.com. Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD.Head of Investor RelationsMr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTDInvestor 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. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include but are not limited to risks relating to: our ability to develop and commercialise pharmaceutical products; pandemics, epidemics, public health emergencies, geopolitical conflicts, trade restrictions, natural disasters and other disruptions affecting global supply chains, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks including the risk factors described in the Company's Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission, together with the Company's announcements lodged with the Australian Securities Exchange. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation except as required by applicable law, the rules of the Australian Securities Exchange, the U.S. Securities and Exchange Commission, Nasdaq, or other applicable regulatory requirements, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance. 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

Drug ApprovalBiosimilar

20 Jul 2026

·www.globenewswire.com

CLINUVEL’s ADS to commence trading on Nasdaq

CUVL to trade on the highest tier – Global Select MarketMELBOURNE, Australia and NEW YORK, July 20, 2026 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD today announced that its American Depositary Share (ADS) is expected to commence trading on the Nasdaq Stock Market (Nasdaq) later today (New York time) under the ticker symbol CUVL. The announcement follows the declaration from the U.S. Securities and Exchange Commission (SEC) on 17 July that the Company’s publicly filed 20-F Registration Statement is deemed effective, and approval received from Nasdaq to list the ADS. ADR uplift to Nasdaq CLINUVEL is now in compliance with more stringent U.S. reporting requirements and its existing over-the-counter American Depositary Receipt (ADR: CLVLY) will be upgraded from Level I to Level II, as an ADS traded on the Nasdaq. Each CUVL ADS will represent one ordinary share of CLINUVEL listed on the Australian Securities Exchange (ASX: CUV). The Company does not propose to raise any capital or issue any new shares as a part of the upgraded depositary share program. Holders of CLVLY do not need to take any actions to convert their ADRs to CUVL. A copy of the 20-F is available on CLINUVEL’s website. The Nasdaq Global Select Market, on which CUVL will trade, provides greater visibility among U.S. investors and specialised analytics offered by Nasdaq. Additionally, the Nasdaq Global Select Market has its own Composite Index. Commentary “The upgrade of CUVL to the Nasdaq marks an important step for CLINUVEL’s visibility in U.S. capital markets, as well as reflecting a broader shift of our business towards North America,” said Professor Jeffrey Rosenfeld, CLINUVEL’s Chairman. “In the context of all our activities, the gradual shift to the U.S. makes much sense as the Company is maturing.” Risk statementNo final decision has been made in respect of the proposed ADR uplisting. The registration of CLINUVEL’s securities under the U.S. Securities Exchange Act of 1934 has been declared effective by the SEC. The SEC’s declaration of effectiveness does not constitute an endorsement or approval of CLINUVEL’s securities or a determination that the information contained in the registration statement is accurate or complete. The process also remains subject to SEC rules and satisfaction of Nasdaq listing requirements. There is no guarantee that the uplisting will proceed, nor that it will occur within the expected timeframe. Until trading commences, no assurance can be given that trading will begin on the anticipated date. CLINUVEL will provide further updates to the market as material developments occur.This announcement does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL is a global biopharmaceutical company focused on developing and delivering innovative therapies for patients with genetic, metabolic, and dermatological disorders. The Company's portfolio is centred around melanocortin peptides, with programs advancing in photomedicine and vitiligo. CLINUVEL is listed on the Australian Securities Exchange (ASX: CUV) with a planned listing of its American Depositary Share on the Nasdaq Stock Market (Nasdaq: CUVL). CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, 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). For further information, visit 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. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include but are not limited to risks relating to: our ability to develop and commercialise pharmaceutical products; pandemics, epidemics, public health emergencies, geopolitical conflicts, trade restrictions, natural disasters and other disruptions affecting global supply chains, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks including the risk factors described in the Company's Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission, together with the Company's announcements lodged with the Australian Securities Exchange. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation except as required by applicable law, the rules of the Australian Securities Exchange, the U.S. Securities and Exchange Commission, Nasdaq, or other applicable regulatory requirements, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance. Contact: Tel: +61 3 9660 4900 Fax: +61 3 9660 4909Email: mail@clinuvel.com Australia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

Drug Approval

15 Jul 2026

·www.globenewswire.com

SCENESSE® approved for EPP in Canada

Health Canada NOC enables treatment for porphyria, metabolic disorderMELBOURNE, Australia, July 13, 2026 (GLOBE NEWSWIRE) -- CLINUVEL’s novel drug SCENESSE® (afamelanotide) has been granted a Notice of Compliance (NOC) by Health Canada for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The NOC acknowledges the compliance of the SCENESSE® new drug submission with Section C.08.002 and C.08.005 of the Canadian Food and Drug Regulations and grants CLINUVEL the right to market SCENESSE® in Canada. Commentary “Health Canada has taken a long time to arrive at this positive outcome,” said Dr Dennis Wright, CLINUVEL’s Chief Scientific Officer. “Data from our global programs – including considerable data from postmarketing experience – were used to demonstrate the safety and clinical benefit of SCENESSE® in EPP, where the mechanism of action is well understood. The major benefit of the drug is its proven long-term and consistent safety profile. Other drugs in development for EPP lack these data. “I thank our team for this momentous outcome and their tenacity for ensuring eligible patients may get access to this therapy,” Dr Wright said. SCENESSE® for EPP: peptide therapy with demonstrated long-term safety profile SCENESSE® is the only treatment for EPP to have received marketing authorisation – recognising the drug’s clinical benefit, safety and quality – from any regulatory body worldwide. The Canadian approval follows marketing authorisations in Europe (2014), the U.S.A. (2019) and Australia (2020). CLINUVEL has built a network of Specialty Centers across North America to treat EPP patients following the drug’s approval by the U.S. Food and Drug Administration in 2019. Five Centers are already trained and accredited in Canada and have treated EPP patients with SCENESSE® under special access arrangements. EPP is a rare metabolic disorder which causes debilitating phototoxic reactions and burns following brief exposure to visible light, particularly sunlight. It is estimated to affect 5,000-10,000 individuals globally, including approximately 1 in 140,000 individuals in Canada. SCENESSE® contains 16mg of the peptide afamelanotide, an analogue of a naturally occurring hormone which stimulates the production of melanin in skin. The drug provides a photoprotective effect, preventing the penetration of light through skin as well as acting as a strong antioxidant. Over 21,000 doses of SCENESSE® have been administered to EPP patients worldwide, with the longest treated patients receiving up to 20 years of continuous therapy under expert care. About SCENESSE® (afamelanotide) SCENESSE® (afamelanotide), is approved for commercial distribution in Europe, the U.S.A., Canada, 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). The drug has been administered over 21,000 times to EPP patients across clinical trials, compassionate and special access programs, and marketing authorizations. SCENESSE® is only prescribed and administered by trained and accredited Specialty Centers (North America) and EPP Expert Centres (Europe), with the subcutaneous implantation occurring in an outpatient setting. SCENESSE® has maintained a positive safety profile for up to two decades in EPP patients. Most commonly reported adverse events in clinical trials were headaches, nausea, implant site reactions, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria and skin irritation. For more information, please see https://www.clinuvel.com. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL I: 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. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the U.S.A. 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. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2025 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance. 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

Drug ApprovalOligonucleotide

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.

to view more data

Indication	Country/Location	Organization	Date
Protoporphyria, Erythropoietic	Australia	Clinuvel Pharmaceuticals Ltd.	18 Nov 2020
Porphyria, Erythropoietic	European Union	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	Iceland	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	Liechtenstein	Clinuvel Europe Ltd.	22 Dec 2014
Porphyria, Erythropoietic	Norway	Clinuvel Europe Ltd.	22 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Actinic Prurigo	Phase 3	-	Clinuvel Pharmaceuticals Ltd.	05 May 2010
Sunburn	Phase 3	United Kingdom	Clinuvel Pharmaceuticals Ltd.	19 Jan 2010
Porphyria, Variegate	Phase 2	Netherlands	Clinuvel Pharmaceuticals Ltd.	28 Mar 2023
Vitiligo	Phase 2	United States	Clinuvel Pharmaceuticals Ltd.	11 Oct 2022
Xeroderma Pigmentosum, Complementation Group E	Phase 2	Belgium	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum, Complementation Group E	Phase 2	Spain	Clinuvel Europe Ltd.	28 Mar 2022
Xeroderma Pigmentosum	Phase 2	Germany	Clinuvel Europe Ltd.	19 Oct 2021
Xeroderma Pigmentosum, Complementation Group C	Phase 2	Germany	Clinuvel Europe Ltd.	19 Oct 2021
Androgen-Insensitivity Syndrome	Phase 2	Australia	Clinuvel Pharmaceuticals Ltd.	03 Jun 2021
Ischemic stroke	Phase 2	Australia	Clinuvel Pharmaceuticals Ltd.	03 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06388642 (CTgov)	Phase 1/2	Porphyria, Erythropoietic \| Protoporphyria, Erythropoietic	28	Afamelanotide 16mg implant	jqglztwztr(xuqpeuhjsn) = mhoazallfo azjnphuved (uukkamzsjt, nhyxrbpwah - koqacyntcm) View more	-	27 Jul 2026
NCT05854784 (CTgov)	Phase 2	Porphyria, Variegate	6	Afamelanotide 16 MG	wvnqxfsstf(rdneamtbvy) = jflxsxpitv ezegqgndbp (zvfddzzfys, gxcxdafndm - xtzvrkekjd)	-	27 Apr 2025
NCT04962503 (Pubmed \| BMC Neurol)	Phase 2	Stroke	6	Afamelanotide 16 mg	mpzuwfyzax(zmsbpemviq) = 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 uupxtjgsfv (mbobzgmnsk )	-	26 Jul 2023
NCT04962503 (CTgov)	Phase 2	Androgen-Insensitivity Syndrome \| Occlusion of artery \| Ischemic stroke ... View more	6	Afamelanotide	gsdtgyupad(srwrjoylrg) = xezorxwuld vvmddsgtvq (rkirodlikt, pszbrrnlvv - tazfmkeupp) View more	-	11 Apr 2023
NCT04943159 (CTgov)	Phase 2	Acne Vulgaris	3	Afamelanotide	vncgisspra(hrnugsqybc) = lzmjsblrlv ooltlupbyi (krikxsgbzw, 30.3) View more	-	26 Oct 2021
NCT00979745 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	74	Placebo	ookrzasrfc(lsdqhyilga) = sewnunengj vbfhgffjbp (ulwnqqfiff, qtjkbnmhcl - pgqwuihuwl) View more	-	12 Oct 2021
NCT04425746 (CTgov)	Phase 2	-	16	Afamelanotide (Afamelanotide)	qjfhukaemo(usvdpezhid) = kwuaknomch gsfrbwarta (wcjgfesgfj, acyxvehika - cuojlgcice) View more	-	01 Oct 2021
NCT04425746 (CTgov)	Phase 2	-	16	Placebo (Placebo)	qjfhukaemo(usvdpezhid) = wfpfvzrzak gsfrbwarta (wcjgfesgfj, ueeragduqa - panlrxqedw) View more	-	01 Oct 2021
NCT04525157 (CTgov)	Phase 2	Nonsegmental vitiligo	21	Afamelanotide	flnbljdbor(xuenwfzmwn) = ulcxitdzdb rodzrlnzqt (dxxhkqbkmy, eyzukferyu - jbxsvfosba) View more	-	21 May 2021
NCT04704713 (CTgov)	Phase 3	Actinic Prurigo	31	Afamelanotide (Afamelanotide)	nenjprsrxn(ksnwvanwlp) = zruusfcvbk jxjzgiajox (ftyjwkatmt, ttpkvyydpw - qxwqgyxmcr) View more	-	19 Mar 2021
NCT04704713 (CTgov)	Phase 3	Actinic Prurigo	31	Placebo (Placebo)	nenjprsrxn(ksnwvanwlp) = lpvbkrmgqq jxjzgiajox (ftyjwkatmt, rffeohdgcc - oegvpstvrv) View more	-	19 Mar 2021
NCT04578496 (CTgov)	Phase 3	Protoporphyria, Erythropoietic	16	Afamelanotide	madnyijxvm(tcwivjnhdd) = ptwjwswqih lbxbjytuqs (hcaoudhmjb, dzkxcfitni - fqlkkmyjob) View more	-	02 Nov 2020

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