— ERYTHROPOIETIN HELIX B PEPTIDE · NEUROPROTECTIVE & TISSUE REPAIR

ARA-290.

ARA-290 (cibinetide) is a synthetic 11-amino acid peptide derived from the helix B surface of erythropoietin, engineered to activate the innate repair receptor and deliver tissue-protective effects without triggering red blood cell production.

Key Signals
Neuroprotection · SFN · Tissue Repair
Origin
Synthetic (helix B EPO fragment)
Investigator
Brines et al. (Araim Pharmaceuticals)
Class
EPO-derived tissue-protective undecapeptide
Status (UAE)
Research compound (off-label)
— THE RESEARCH STORY

EPO's Repair Signal, Isolated and Refined

ARA-290 is synthesised from the helix B surface of erythropoietin to activate tissue-protective receptors without stimulating red blood cell production.

Phase 2 trials in sarcoidosis-associated small fibre neuropathy show significant improvements in pain and intraepidermal nerve fibre density.

The EMA grants orphan drug designation for the sarcoidosis indication — acknowledging unmet need while the compound remains without marketing approval.

— INTRAEPIDERMAL NERVE FIBRE DENSITY
CONCEPTUAL · SKIN PUNCH BIOPSY · % CHANGE FROM BASELINE
100% 115% 130% 145% DAY 1 DAY 7 DAY 14 DAY 21 DAY 28
ARA-290 TREATED UNTREATED CONTROL
— THE MOLECULE

Eleven residues, repair without red cells.

PRIMARY STRUCTURE

Gln-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser

C₅₁H₈₇N₁₇O₂₁ · MW 1274.4 Da

1274.4MOLECULAR WEIGHT Da
11AMINO ACIDS
Ph.2CLINICAL STAGE

ARA-290 maps to the helix B surface of erythropoietin — the domain responsible for tissue-protective receptor binding — with no structural overlap with the erythropoietic sites of the parent protein.

— AN HONEST READING OF THE DATA

Rare Phase 2 data, no approved indication.

Controlled Phase 2 human trial data exists; orphan designation granted but no regulatory approval in any jurisdiction.

TIER 01 / PRECLINICAL
Consistent Animal Evidence
  • IRR activation confirmed
  • Neuroprotection in rodent models
  • Anti-inflammatory (cytokine reduction)
  • Ischaemia-reperfusion protection
  • Macrophage M2 polarisation shown
TIER 02 / HUMAN DATA
Phase 2 Clinical Signals
  • Pain scores reduced (SFN cohort)
  • IENFD increased post-treatment
  • Sarcoidosis symptoms improved
  • EU orphan designation granted
TIER 03 / SPECULATIVE
Broader Repair Applications
  • Diabetic peripheral neuropathy
  • Cardiac and renal protection
  • Generalised neuroinflammation
  • Post-COVID nerve injury (early signals)
— ARA-290 MECHANISMS & RESEARCH DOSING READY

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— REGULATORY LANDSCAPE

Orphan Designation, Not Approval

In the UAE, research-grade peptides occupy a defined regulatory category distinct from licensed medicines. Compounds sold under this classification — including those offered by Dubai Peptides — are intended exclusively for qualified research applications, not for human administration.

ARA-290 holds EMA orphan drug designation for sarcoidosis-associated small fibre neuropathy — a recognition of unmet need, not approval. No drug approval has been granted in any jurisdiction, including the UAE. Phase 2 trials in the Netherlands have been completed and published; no Phase 3 programme is currently registered. In the UAE, ARA-290 circulates as a research-grade peptide.

2000s / MOLECULAR RATIONALE

Brines and Cerami characterise helix B of EPO as the tissue-protective signalling domain, establishing the molecular rationale for ARA-290's design.

2010s / PHASE 2 TRIALS

Phase 2 trials in the Netherlands confirm significant improvements in pain and nerve fibre density in sarcoidosis-associated SFN patients.

2015 / ORPHAN DESIGNATION

The EMA grants ARA-290 orphan drug designation for sarcoidosis-associated small fibre neuropathy, acknowledging unmet medical need.