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Terminus Peptides
  • Research use only — not for human or veterinary use
  • 55 compound profiles, every source cited
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Research profile · Peptide

ARA-290

Also known as Cibinetide

Early human — evidence level 3 of 4: Early human evidenceExperimental — UK regulatory status: Experimental — not authorised for human use in the UK

Overview

An erythropoietin-derived peptide with genuine phase 2 trials, no phase 3, and a discontinued development programme.

Category
Peptide
Highest evidence level identified
Early human evidence
Last scientifically reviewed
20 August 2026
Last regulatory review
20 August 2026

Mechanism under investigation

Cibinetide is an eleven-amino-acid peptide engineered from a region of the erythropoietin molecule distinct from the domain responsible for stimulating red cell production. It is proposed to act on a receptor complex described as an innate repair receptor, producing anti-inflammatory and tissue-repair signalling without erythropoietic activity. That receptor model derives largely from preclinical work and remains proposed rather than definitively established in humans.

Research areas

  • Neuropathy research
  • Tissue repair models

These are fields in which the compound has been investigated. Listing a field is not a statement that anything was demonstrated within it.

Current evidence

In-vitro evidence

Cells, tissues or biochemical systems outside a living organism.

Present and reasonably developed, including inhibition of bone-resorbing cell formation, protection of isolated human pancreatic islets under stress, and dampening of innate immune cell function.

Animal evidence

Studies in living non-human animals.

Substantial, across rodent models of neuropathic pain, impaired wound healing in diabetes, islet transplantation, colitis, lupus and bone mineral density.

Human observational evidence

Studies observing people without assigning an intervention.

Limited and largely indirect. Imaging cohorts characterise corneal nerve-fibre measures rather than the compound itself.

Clinical-trial evidence

Studies assigning an intervention to human participants.

Genuine randomised placebo-controlled trials exist, but all are phase 2, and the results are inconsistent. In a 64-participant multicentre phase 2b the primary endpoint reached significance in only one of three dose groups, with no dose-response pattern, and the placebo-corrected difference in pain was not significant — pain improved in all groups including placebo. A phase 2 study in diabetic macular oedema recruited nine participants and found no improvement in visual acuity, retinal thickness, retinal sensitivity or tear production; only a questionnaire score improved. A later trial was terminated because the study drug expired with no replacement available, which indicates sponsor discontinuation rather than a scientific result.

Study limitations

  • All trials are phase 2, short and small — the largest enrolled 64 participants — so none is powered for clinical outcomes or long-term safety.
  • Efficacy is inconsistent across dose groups. In the phase 2b the primary endpoint was significant in only one of three groups with no monotonic dose-response, which is hard to reconcile with a simple receptor-mediated mechanism.
  • Primary endpoints were surrogate measures of nerve-fibre abundance rather than outcomes that matter to patients. Pain itself improved on placebo too and was not significantly better on the drug.
  • The programme has not advanced. No phase 3 has been completed, the macular oedema study was negative on every objective endpoint, and a later trial terminated for lack of study drug.

UK regulatory context

Experimental — not authorised for human use in the UK

A compound appearing in research literature that holds no UK authorisation for human use in any indication.

Source: Cibinetide — orphan designation EU/3/13/1191 (opens ema.europa.eu in a new tab) (European Medicines Agency)

Regulatory classification is jurisdiction-specific. A compound authorised elsewhere is not thereby authorised in the UK, and a supplier’s description of a substance does not determine how it is classified in law. See safety and regulation for the framework and the authoritative sources.

Safety and interpretation

Across the published phase 2 trials investigators reported no serious adverse events attributed to the compound, and no antibodies against it were detected in the macular oedema study. Cumulative human exposure is small, on the order of a hundred participants in short studies, so uncommon or delayed effects would not have been detectable. The peptide was engineered to avoid erythropoietin’s blood-forming and clotting effects, but that separation has not been tested beyond brief study periods, and no post-marketing surveillance exists because it has never been authorised.

References