CLINUVEL, a Melbourne- and Singapore-based biopharmaceutical company, has completed development of a proprietary single-use device designed to administer controlled-release drug formulations under the skin.
The device, named ZEROKIN, is intended to deliver subcutaneous and intradermal formulations that emerge from CLINUVEL's Vallaurix research centre in Singapore. The facility is developing a suite of controlled-release approaches for peptides, starting with melanocortins, the family that includes afamelanotide, the active ingredient in CLINUVEL's approved therapy Scenesse.
CLINUVEL said the market for devices of this kind is underdeveloped. Few products are currently registered for subcutaneous or intradermal use, and the company set out to build something adaptable enough to suit a range of formulations rather than a single drug. Zerokin was designed for both hospital administration and self-administration, with the intended setting varying by medication.
Global demand for self-administered injection devices is projected to rise from US$27.1 billion in 2026 to US$40.5 billion by 2030, with North America accounting for 42.4 per cent of revenue in 2024. CLINUVEL points to the growing prevalence of chronic disease and the expansion of new peptide-based therapeutics, a category expected to be worth US$133.2 billion by 2030, as the forces driving that growth.
An intellectual property application for the device has been submitted, and CLINUVEL says it will now move to appoint a commercial manufacturer. Regulatory work lies ahead as well. Zerokin is being pursued as a Class II device, which in the United States means clearance will be sought through the Food and Drug Administration's 510(k) pathway, alongside a parallel application for CE marking under the European Union's Medical Device Regulations.
Dr Dennis Wright, Clinuvel's Chief Scientific Officer, said the device grew out of years of clinical feedback on Scenesse and the company's other peptide products. He described ZEROKIN as the outcome of an effort by the company's scientific teams to anticipate how such treatments could better serve patients and physicians, and said the company would now move quickly toward finished manufacture and regulatory filing.
