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In Clinical Trials Healing & Tissue Repair Evidence 3/5 · Moderate

ARA-290 (Cibinetide)

Also known as Cibinetide · pHBSP

11-amino-acid peptide derived from the helix B region of erythropoietin

Overview

An elegant piece of drug design: it takes the tissue-protective part of erythropoietin and discards the part that makes red blood cells. That separation removes the thrombotic risk that makes EPO dangerous, leaving only the repair signalling.

Investigational — not approvedInvestigational; not approved in any market.

At a glance
Regulatory statusInvestigational. Phase 2 trials in sarcoidosis-associated small fibre neuropathy. Not approved.
Drug class11-amino-acid peptide derived from the helix B region of erythropoietin
RouteSubcutaneous (investigational)
Half-life~2 minutes (tissue effects far outlast plasma levels)
Evidence rating
3/5 Moderate Evidence rating 3 out of 5: Moderate
Small or early-phase human trials, or good controlled topical human data.
Studied inPhase 2 randomized trials in sarcoidosis-associated small fibre neuropathy and in type 2 diabetes with neuropathic pain; preclinical work across neuropathy, wound and ischemia models.

How it works

Binds the innate repair receptor — a heterocomplex of the EPO receptor beta-common chain — rather than the classical homodimeric EPO receptor. This triggers anti-inflammatory and tissue-protective signalling without stimulating erythropoiesis.

Evidence base

Rated 3 of 5 — Moderate. Small or early-phase human trials, or good controlled topical human data.

  • Genuine randomized phase 2 data with an objective corneal nerve imaging endpoint — better than most compounds in this category.

Benefits & potential uses

Bars indicate how well each claim is supported: three = strong human evidence, two = moderate, one = preliminary or preclinical.

  • Improved neuropathic symptoms in phase 2 Moderate evidence

    Randomized trials in sarcoidosis-related small fibre neuropathy showed improvement in pain and autonomic symptom scores versus placebo.

  • Increased corneal nerve fibre density Moderate evidence

    An objective imaging endpoint suggesting genuine nerve regeneration, not just symptom relief.

  • No erythropoietic effect Strong evidence

    Does not raise haematocrit, avoiding the thrombosis and hypertension risks that limit EPO.

  • Good tolerability in trials Moderate evidence

    Adverse event rates comparable to placebo in phase 2.

Risks, cons & cautions

Bars indicate seriousness: three = serious or common, two = moderate, one = minor.

  • Not approved; development slow Serious

    Despite encouraging phase 2 data across several years, it has not reached approval.

  • Small trials Moderate evidence

    Phase 2 populations were modest in size, in a condition with substantial placebo response.

  • Extremely short plasma half-life Moderate evidence

    Requires assuming that brief receptor engagement produces lasting tissue effects — plausible but not fully established.

  • Injection-site reactions Minor

    The most commonly reported adverse effect.

  • Grey-market availability Serious

    Sold as a research peptide well outside the neuropathy contexts studied.

Who should avoid it

  • Use outside clinical trials
  • Pregnancy

If used under medical supervision, monitor

  • Not applicable outside trials

Investigational; not approved in any market.

Infographic

ARA-290 (Cibinetide) — benefits & risks at a glance Download SVG
Infographic summarising the benefits and risks of ARA-290 (Cibinetide), from pepteyes.com

Where to read further

We link to live literature searches rather than a frozen citation list, so you always see current results — including anything published after our last review.

neuropathyerythropoietintissue repairinvestigational

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Terms used on this page

Phase 2 Trial
A Phase 2 trial is the first test of a compound in the target patient population, sized to find a workable dose and an early efficacy signal rather than to prove clinical benefit.
Placebo and Placebo Control
A placebo is an inactive intervention matched to the real one in appearance and route, used as a control arm so that improvement caused by the drug can be separated from improvement that would occur anyway.
Adverse Event (AE)
An adverse event is any untoward medical occurrence in someone receiving a medicine, recorded whether or not the drug caused it, which is why an event table is not a harm table.

This page is educational information, not medical advice. It cannot account for your medical history, medications, or risk factors. Do not start, stop or change any treatment based on it. Speak to a qualified healthcare professional who knows your case.