CLINUVEL to advance novel pharmaceutical formulations in preclinical program
CLINUVEL (NASDAQ:CLVLY) has announced significant progress in its development of novel sustained-release liquid drug formulations, marking a milestone after 10 years of research at its Singapore-based VALLAURIX laboratories. The company is advancing to a preclinical program focused on evaluating various drug release profiles.
The innovative formulations aim to extend the duration of peptide drug release, particularly melanocortins, with biocompatible delivery systems that allow flexible dosing through adjustable injection volumes. This advancement could benefit patients across different age groups and body weights. The preclinical program for the initial formulations is expected to complete in H2 2026.
CLINUVEL (NASDAQ:CLVLY) ha annunciato progressi significativi nello sviluppo di nuove formulazioni liquide a rilascio prolungato, segnando una tappa dopo 10 anni di ricerca nei laboratori VALLAURIX a Singapore. L'azienda sta procedendo verso un programma preclinico focalizzato sulla valutazione di diverse profili di rilascio del farmaco. Le formulazioni innovative mirano ad estendere la durata del rilascio di peptidi, in particolare le melanocortine, con sistemi di somministrazione biocompatibili che consentono dosaggi flessibili tramite volumi di iniezione regolabili. Questo avanzamento potrebbe beneficiare pazienti di diverse fasce d'età e pesi corporei. Il programma preclinico per le formulazioni iniziali dovrebbe concludersi in H2 2026.
CLINUVEL (NASDAQ:CLVLY) anuncia avances significativos en el desarrollo de nuevas formulaciones líquidas de liberación sostenida, marcando un hito tras 10 años de investigación en sus laboratorios VALLAURIX en Singapur. La empresa avanza hacia un programa preclínico centrado en evaluar diversos perfiles de liberación del fármaco. Las formulaciones innovadoras buscan ampliar la duración de la liberación de fármacos peptídicos, especialmente melanocortinas, con sistemas de administración biocompatibles que permiten una dosificación flexible mediante volúmenes de inyección ajustables. Este avance podría beneficiar a pacientes de distintas edades y pesos corporales. Se espera que el programa preclínico para las formulaciones iniciales se complete en H2 2026.
CLINUVEL (NASDAQ:CLVLY)은 싱가포르 VALLAURIX 연구소에서 10년 간의 연구를 거쳐 새로운 지속 방출 리퀴드 의약품 제형 개발에서 중요한 진전을 발표했습니다. 회사는 다양한 약물 방출 프로파일을 평가하는 사전임상 프로그램으로 나아가고 있습니다. 혁신적인 제형은 특히 펩타이드 약물, 특히 멜라노코르틴의 방출 지속 시간을 늘리려는 목적이며, 생체적합한 전달 시스템을 통해 주입 부피를 조절하여 유연한 투여가 가능하게 합니다. 이 진전은 연령대와 체중이 다양한 환자들에게 이익이 될 수 있습니다. 초기 제형에 대한 사전임상 프로그램은 2026년 하반기에 완료될 것으로 예상됩니다.
CLINUVEL (NASDAQ:CLVLY) a annoncé des progrès importants dans le développement de nouvelles formulations liquides à libération prolongée, marquant une étape après 10 années de recherche dans les laboratoires VALLAURIX de Singapour. L'entreprise fait avancer un programme préclinique axé sur l'évaluation de divers profils de libération du médicament. Les formulations innovantes visent à prolonger la durée de libération des peptides, en particulier les melanocortines, avec des systèmes de délivrance biocompatibles qui permettent une posologie flexible via des volumes d'injection ajustables. Cette avancée pourrait bénéficier à des patients de tous âges et poids corporels. Le programme préclinique pour les formulations initiales devrait se conclure au second semestre 2026.
CLINUVEL (NASDAQ:CLVLY) hat bedeutende Fortschritte bei der Entwicklung neuartiger lang anhaltender flüssiger Arzneimittelformulierungen bekannt gegeben und damit nach 10 Jahren Forschung in den VALLAURIX-Labors in Singapur einen Meilenstein erreicht. Das Unternehmen schreitet zu einem präklinischen Programm voran, das die Bewertung verschiedener Wirkstofffreisetzungsprofile zum Ziel hat. Die innovativen Formulierungen zielen darauf ab, die Freisetzung von Peptidmedikamenten, insbesondere Melanocortinen, zu verlängern, mit biokompatiblen Abgabesystemen, die eine flexible Dosierung durch anpassbare Injektionsvolumina ermöglichen. Dieser Fortschritt könnte Patienten unterschiedlicher Altersgruppen und Körpergewichte zugutekommen. Das Präklinikprogramm für die ersten Formulierungen soll im zweiten Halbjahr 2026 abgeschlossen werden.
أعلنت شركة CLINUVEL (NASDAQ:CLVLY) عن تقدم ملحوظ في تطويرها لتراكيب سائلة مطوّلة الإطلاق، مما يمثل علامة فارقة بعد عشر سنوات من البحث في مختبرات فالاتاكس VALLAURIX في سنغافورة. تتجه الشركة نحو برنامج قبل إكلينيكي يركز على تقييم ملفات إطلاق دواء مختلفة. تهدف التركيبات المبتكرة إلى تمديد مدة إطلاق أدوية ببتيدية، ولا سيما الميلانوكورتينات، باستخدام أنظمة توصيل متوافقة حيوياً تسمح بتوجيه الجرعات عبر أحجام حقن قابلة للتعديل. قد يفيد هذا التقدم مرضى من فئات عمرية وأوزان جسدية مختلفة. من المتوقع أن يكتمل البرنامج قبل السريري للتركيبات الأولية في النصف الثاني من 2026.
CLINUVEL（NASDAQ:CLVLY）宣布在开发新型持续释放的液体药物制剂方面取得重大进展，这是在其新加坡VALLAURIX实验室经历的10年研究后的里程碑。公司正在推进一个以评估多种药物释放曲线为目标的临床前项目。创新制剂旨在延长肽类药物，特别是黑色素皮质激素（Melanocortins）的释放持续时间，采用生物相容性递送系统，通过可调注射体积实现灵活给药。这一进展可能使不同年龄和体重的患者受益。初步制剂的临床前计划预计在2026年下半年完成。
- Development of flexible dosing system adaptable for infants, children, and adults
- Successful completion of 10 years of fundamental research with positive, consistent results
- Potential platform technology applicable for various peptide drugs
- Cost-effective research approach with broad drug delivery applications
- Extended timeline with preclinical program completion not expected until H2 2026
- Significant time investment (10 years) before reaching preclinical stage
- Success in human trials still uncertain despite in vitro results
Next generation sustained-release formulations for a variety of peptides
Executive summary
- first biocompatible pharmaceutical formulations progress to preclinical models
- new sustained-release drug delivery platforms for peptides, melanocortins
- aim to predict drug release kinetics from new formulations
- liquid formulation allows flexible dosing through adjusting injection volumes
- perseverance during 10 years of in-house research
MELBOURNE, Australia, Sept. 28, 2025 (GLOBE NEWSWIRE) -- CLINUVEL today announced that it is advancing new sustained-release liquid drug formulations in a preclinical program evaluating various drug release profiles. A decade of investment in fundamental research & development in CLINUVEL’s fully-owned Singaporean laboratories (VALLAURIX) has provided positive, consistent results demonstrating the potential for depot formulations to extend the duration of release of peptide drugs.
Investment in novel drug delivery systems
CLINUVEL’s formulation development has sought to lengthen the duration of time that peptides are detectable in blood levels and arrive at predictable kinetics – optimising patient exposure to active pharmaceutical ingredients while minimising dosing to achieve therapeutic effects. The advantage of the chosen biocompatible formulations under review is to facilitate flexible dosing by adjusting the injection volume for delivery of peptides to infants, children and adults according to body weight.
If the technology is confirmed in vivo, the new depot formulations would serve as a platform for the delivery of various peptides, with an initial focus on melanocortins.
The preclinical program for the first formulations is expected to complete in the second half of 2026.
Commentary
“It has been challenging to realise the journey from drug delivery concepts to effective formulations containing the right drug loading, but recent reproducible in vitro results at VALLAURIX have given us confidence to pursue the preclinical program,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.
“We have selected multiple drug product candidates for preclinical evaluation, after which decisions on manufacturing of the products for human evaluation can be made. Perseverance seems to have been justified by current results of an adaptable platform that can be tailored for different release profiles and clinical needs.
“We have progressed research in a cost-effective manner, with an approach that may provide substantial options for drug delivery in general.”
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.
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
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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:
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