NEURACTHEL® Instant dossier filed with European regulators
CLINUVEL PHARMACEUTICALS (ASX: CUV | Nasdaq: CUVL) has filed a dossier for marketing authorisation of its second pharmaceutical product, NEURACTHEL® Instant (tetracosactide), through the European decentralised procedure (DCP). The announcement was made on 30 October 2026.
If approved, CLINUVEL will be able to commercialise NEURACTHEL® Instant as a prescription pharmaceutical in up to three initial key European Union Member States. The product would sit alongside the company’s lead SCENESSE® (afamelanotide) therapy.
NEURACTHEL® Instant is not currently approved in any country.
Dr Dennis Wright, Chief Scientific Officer
“After considerable diligence, CLINUVEL has been able to identify what we believe to be the optimal launch markets for NEURACTHEL® in Europe, based on a range of commercial and practical factors…”
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Understanding ACTH and the US$1.3 billion market
What ACTH is and why it matters
Adrenocorticotropic hormone (ACTH) is a 39-amino acid peptide hormone belonging to the family of melanocortins. Amino acids are the building blocks of peptides, which are short chains that act as signalling molecules.
NEURACTHEL® Instant is CLINUVEL’s branded generic formulation of tetracosactide, a synthetic 24-amino acid peptide analogue of the naturally occurring ACTH.
Naturally occurring and synthetic analogue ACTH products are used as follows:
- Approved as a systemic therapy in the U.S.A. for 19 conditions, including infantile spasms and acute exacerbations of multiple sclerosis.
- Administered in Europe as both a therapy and a diagnostic tool for adrenal insufficiency.
For investors, the global ACTH market is currently estimated at US$1.3 billion annually.
How the decentralised procedure works
Established under the European Parliament Directive 2001/83/EC, the DCP allows medicines to be reviewed and approved by more than one European Union Member State in parallel. A Reference Member State leads the evaluation.
Following a dossier validation period, the DCP is intended to take 300 days, excluding potential “clock stop” periods during the review. A final position is adopted at day 270.
Why three launch markets were chosen
CLINUVEL identified three key EU Member States as launch markets based on several factors:
- The use of ACTH in routine practice.
- Prescriber demand and pricing infrastructure.
- Reported shortages.
- Overlap with existing distribution of SCENESSE®, which was also considered.
The overlap allows the company to utilise existing commercial infrastructure.
Overlap with existing SCENESSE® distribution is a practical advantage, and that network has recently widened with Health Canada approval, the fourth market to authorise the therapy after Europe, the U.S.A. and Australia.
| Item | Detail |
|---|---|
| Product | NEURACTHEL® Instant |
| Active ingredient | Tetracosactide |
| Pathway | European decentralised procedure (DCP) |
| Review period | **300 days** after dossier validation, excluding clock stops |
| Approval status | Not currently approved in any country |
What happens next for CLINUVEL
The announcement points to the following steps:
- Validation and first formal feedback: Dr Wright said the company awaits validation and first formal feedback in “around four months’ time”, to be able to assess its chances of a successful outcome.
- DCP review: The review is intended to take 300 days following dossier validation, excluding potential clock stops, with a final position adopted at day 270.
- Further filings: Submissions to the UK’s medicine regulatory body (MHRA) and other EU Member States are being evaluated, with a focus on viability of commercial programs.
- U.S. FDA filing: The timeline for a filing of NEURACTHEL® to the U.S. Food and Drug Administration is now under review.
The timeline for a U.S. filing sits against a constructive FDA relationship, after the agency dropped a postmarketing cardiac study requirement for SCENESSE earlier in 2026 on the strength of accumulated long-term safety data.
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