C

Tier

ARA-290 (Cibinetide)

ARA-290 (Cibinetide)

ARA-290 (Cibinetide)

Non-erythropoietic EPO-derived peptide studied for neuropathic pain and repair.

Recovery & Healing

Peptide

WADA Status:

Not listed

Human Trial Scoreboard

Completed human RCTs

3
3
3

3 Phase 2 trials

Largest Human Study

64
64
64

Culver 2017, n=64

Longest exposure

4
4
4

About 4 weeks

Most Recent Trial

2020
2020
2020

Open-label pilot

Description

ARA-290, also called cibinetide, is one of the more elegant ideas in this database. Erythropoietin, the hormone athletes dope with, has a tissue-protective effect that is entirely separate from its famous ability to raise red blood cell counts. ARA-290 was engineered to trigger only the protective half, leaving the blood-boosting half alone, by targeting what researchers call the innate repair receptor. It was developed by Araim Pharmaceuticals and reached genuine mid-stage trials, mostly in the nerve pain that accompanies sarcoidosis. At least three randomised controlled trials have been completed, the largest enrolling sixty four participants, with exposures running to about four weeks. It has never progressed to a large late-stage trial and no regulator has approved it, so it sits in the honest middle ground: real science, real trials, unfinished.

What Are The Claims

Claims made for this compound: May reduce neuropathic pain and improve small-fiber nerve function (small Phase 2); Anti-inflammatory tissue-repair signaling; Does not raise red-cell count, unlike EPO

Evidence

Among the better-studied compounds on this list, with actual randomized human data - but the trials are small, the endpoints were specific to neuropathy, and it has not advanced to approval. Being in trials is not the same as being proven.

Evidence Strength

Preliminary (small Phase 2 RCTs)

Caveats

Non-erythropoietic EPO derivative; orphan designation but NOT approved; a larger trial did not significantly reduce pain.

Safety
Alternative Measures
Legal Status

US

Not approved

UK

Not approved

EU

Not approved

AU

Not approved

WADA

Not listed

Not approved. Investigational compound that has been through small Phase 2 trials, primarily for neuropathic pain in sarcoidosis.

Citations

Dahan et al. (2013). Molecular Medicine. Phase 2 RCT (sarcoidosis neuropathy). PMID: 24136731. Brines et al. (2015). Mol Med. PMID: 25387363.

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