ARA-290 (cibinetide): research, side effects and dosage in studies

In short

ARA-290 (cibinetide) is an 11-amino-acid peptide modelled on the structure of erythropoietin that does not increase red blood cell production [4]B [10]. It has no marketing authorisation in the EU or the United States [25, 31]regulator, and the human evidence comes from six small studies of up to 12 weeks, mostly on damage to small nerve fibres [1, 3]A [2]B [4, 6]B.

• There are six human studies with about 220 participants in total. Three were placebo-controlled and randomised [1, 3, 5]A, and one placebo-controlled double-blind study does not describe randomisation [2]B. The longest treatment period lasted 12 weeks [6]B.
• In nerve damage linked to sarcoidosis, ARA-290 improved symptom questionnaire scores compared with placebo [1]A [2]B, and the corneal nerve fibre area grew significantly only in the 4 mg group; in the 1 and 8 mg groups the change was not significant [3]A.
• Weakness: pain eased almost as much in the placebo groups [1, 3]A, and most studies were done by researchers from the company developing the drug [3]A [6]B.
• EMA and the FDA have granted the substance orphan designations for sarcoidosis and pancreatic islet transplantation, but a designation is not a marketing authorisation [23, 24, 27]regulator. In sport, WADA bans innate repair receptor agonists (S2.1.5) [28]regulator.
• There is no approved dosage. All figures on this page are doses used in studies.

What is ARA-290?

ARA-290 is a synthetic 11-amino-acid peptide modelled on the three-dimensional structure of erythropoietin (EPO), on the region of its helix B [10]. Its amino acid sequence is Pyr-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser, and its official generic name is cibinetide [23]regulator. In the research literature the same substance also appears as ARA290 and pHBSP (pyroglutamate helix B surface peptide) [10].

Its molecular weight is 1,257 daltons [4]B. EPO increases red blood cell production, but ARA-290 was designed not to [4]B. In a sarcoidosis study, haemoglobin did not differ between people given ARA-290 and the placebo group [1]A.

ARA-290 is being developed by the US company Araim Pharmaceuticals, which holds the EMA and FDA orphan designations [23, 25]regulator. It is one of the substances linked to tissue repair in the Peptides A-Z list.

Evidence at a glance

Each cell gives the kind of study and its source. The letter is the evidence level, not the result.

"-" = no such study is known.

What is ARA-290 studied for?

In humans, ARA-290 has been studied mainly for small fibre neuropathy, damage to thin nerve fibres that causes pain, numbness and autonomic symptoms [1]A [2]B. None of these is an approved use.

• Nerve damage linked to sarcoidosis: three placebo-controlled studies with 22, 38 and 64 patients [1, 3]A [2]B.
• Type 2 diabetes with painful neuropathy: one placebo-controlled study, 48 patients analysed [4]B.
• Diabetic macular oedema: one open study, 9 patients [6]B.
• Emotional processing in healthy people: one randomised study testing whether the substance has antidepressant-like effects, 36 participants [5]A.

In animals it has been studied much more widely, for example for wound healing, pancreatic islet transplantation, kidney injury and heart ageing [17, 18, 20, 21]C. These are described below in their own section. Performance, muscle growth or general recovery have not been studied in humans.

How does ARA-290 work?

According to its developers, ARA-290 activates the so-called innate repair receptor, which they describe as a combination of the EPO receptor and the beta-common receptor (CD131) [9]. This receptor is thought to dampen inflammation and start tissue repair [9].

According to a review by the same group, this receptor is largely absent from healthy tissue and appears only after injury or inflammation. Ordinary EPO increases red blood cells through a different receptor, which is why ARA-290 does not affect red blood cells [10].

In a rat study, ARA-290 relieved touch and cold sensitivity after nerve injury for up to 15 weeks. In mice lacking the beta-common receptor it had no effect [15]C. The authors say this points to the effect running through that receptor [15]C.

The mechanism is disputed. An independent Australian group found no sign in laboratory experiments that the EPO receptor and the beta-common receptor associate with each other, including in the presence of ARA-290 [11]D. This is covered in more detail in "What speaks against it".

Has ARA-290 been studied in humans?

Yes, but not much. We found six published human studies with about 220 participants in total. Three were randomised and placebo-controlled [1, 3, 5]A, two were placebo-controlled without described randomisation [2, 4]B and one was an open study without a comparison group [6]B. All are phase 2 or earlier studies.

Nerve damage linked to sarcoidosis

• Heij 2012, 22 patients. Patients received ARA-290 2 mg into a vein three times a week or placebo for four weeks. The neuropathy questionnaire (SFNSL) scores of the ARA-290 group improved significantly more than those of the placebo group (change -11.5 versus -2.9). However, pain scores (BPI) and fatigue scores improved equally in both groups, and depressive symptoms did not change [1]A.
• Dahan 2013, 38 patients. ARA-290 was given at 4 mg under the skin once a day for 28 days; 21 patients received ARA-290 and 17 placebo. Neuropathy symptoms eased, the density of small corneal nerve fibres increased, and the six-minute walk distance grew [2]B.
• Culver 2017, 64 patients. In a dose comparison, groups received 1, 4 or 8 mg ARA-290 or placebo daily for 28 days [3]A, all under the skin [7]E, not peer-reviewed. The primary measure was corneal nerve fibre area. Compared with placebo it grew significantly only in the 4 mg group (p = 0.012), not in the 1 or 8 mg groups. A marker of skin nerve fibre regrowth increased in the 4 mg group. Pain eased in all groups, including placebo [3]A.

Type 2 diabetes

The Brines 2015 study enrolled 49 people with type 2 diabetes and painful neuropathy, and 48 were analysed. They injected themselves with 4 mg ARA-290 or placebo under the skin daily for 28 days, and follow-up continued for another month [4]B. In the ARA-290 group, long-term blood sugar HbA1c fell by 0.16 percentage points in 28 days and 0.21 percentage points in 56 days, while in the placebo group it stayed the same or rose (p = 0.002). Neuropathic pain questionnaire (PainDetect) scores improved [4]B. The authors named two limitations themselves: treatment lasted only 28 days, and the participants' blood sugar control was already good [4]B.

Eye and mood

• Lois 2020, diabetic macular oedema. Nine patients injected 4 mg ARA-290 under the skin daily for 12 weeks, and eight completed the study. On average, visual acuity, central retinal thickness, retinal sensitivity and tear production did not improve. Scores on a vision-related quality of life questionnaire improved by 2.7 points [6]B.
• Cerit 2015, healthy volunteers. 36 healthy people received a single 2 mg dose of ARA-290 or placebo [5]A, into a vein [8]E, not peer-reviewed. A week later, the brains of the ARA-290 group responded less to happy faces, and more attention was paid to positive pictures. There was no effect on mood. According to the authors, the results do not clearly support an antidepressant-like effect [5]A.

The most important single finding is the increase in corneal nerve fibres, because it is a measurable change rather than only a questionnaire result [3]A [2]B. It is still a surrogate measure: it does not yet show whether pain eases or function improves in the long run.

Promising, but only in animals

These findings come from animals and have not been studied in humans. Animal study results cannot be transferred directly to humans. Two animal studies on the same molecule (pHBSP) have been retracted [12, 13]E, not peer-reviewed, so only publications that have not been retracted are listed below.

• Diabetic wounds no human studies

  In genetically diabetic mice, ARA-290 given daily under the skin corrected poor wound healing: new blood vessel formation, skin regrowth and scar strength improved [17]C.

  If it held in humans: the substance could speed the closure of poorly healing wounds in people with diabetes.

  Why it might not translate: the study used incision wounds in one mouse strain. A human diabetic foot ulcer is long-lasting and often infected, and a mouse dose cannot be converted to a human dose.

  Evidence now: one Italian mouse study whose authors include a researcher from the company developing the drug. We found no registered human study on wounds.

• Pancreatic islet transplants no human studies

  In mice, ARA-290 protected islets from damage caused by inflammatory signalling molecules and improved blood sugar after islet transplantation [21]C. In a second mouse study, islets transplanted from another mouse strain worked better when the recipients received ARA-290 for two weeks [22]C.

  If it held in humans: the substance could reduce the loss of transplanted islets in islet transplantation for type 1 diabetes.

  Why it might not translate: both studies were done in mice by the same Swedish group, whose authors include researchers from the company developing the drug. The mice had drug-induced diabetes, not an autoimmune disease.

  Evidence now: two mouse studies. EMA and the FDA have granted orphan designations for this use [24, 27]regulator, but we found no registered human study.

• Heart ageing no human studies

  In ageing rats, 15 months of ARA-290 treatment reduced heart inflammation, curbed the age-related rise in blood pressure, preserved the heart's pumping function and lowered frailty index scores at the end of life [18]C.

  If it held in humans: the substance could slow ageing changes in the heart and frailty.

  Why it might not translate: treatment over a rat's lifespan is very different from human decades, the frailty index is a rat measure, and the result has not been repeated.

  Evidence now: one US rat study (National Institute on Aging) whose authors include researchers from the company developing the drug. No registered human study.

• Kidney injury no human studies

  In pigs, ARA-290 given into a vein improved kidney filtration and reduced scar tissue formation within a week after blood flow was interrupted [20]C.

  If it held in humans: the substance could protect the kidney, for example in kidney transplantation.

  Why it might not translate: the study had only eight pigs. A rat study of the same molecule in kidney injury has been retracted because the published images did not represent the actual results [12]E, not peer-reviewed.

  Evidence now: one Dutch pig study. We found no human study.

• Animal model of MS no human studies

  In rats with induced brain and spinal cord inflammation resembling MS, ARA-290 eased symptoms, shortened their duration and reduced the build-up of inflammatory cells in the spinal cord [19]C.

  If it held in humans: the substance could curb an MS-like immune attack on the nervous system.

  Why it might not translate: this rat model does not match human MS in every respect, the substance was injected into the abdominal cavity, and the finding comes from one study.

  Evidence now: one Chinese rat study. No registered human study.

Who is researching ARA-290?

Almost all human studies were done at Leiden University Medical Center in the Netherlands together with the developer, Araim Pharmaceuticals [1]A [2]B [4]B. The dose comparison study also involved Cleveland Clinic in the United States and the University of Manchester [3]A, and the eye study was done in Belfast [6]B.

Company researchers are authors of most studies, and the eye study declared that some authors own shares in the company [6]B. This does not make the results wrong, but there are no independent replications.

Author of this page: editorial team

This page was written by the Molecular Recovery editorial team. The draft was made with the help of AI, and the claims were checked against the sources (AI policy). The page has not been medically reviewed. How we work: About us.

How long does ARA-290 stay in the body?

Only briefly. According to a review, the plasma half-life of ARA-290 is about two minutes [10]. When 4 mg was given under the skin to healthy volunteers, the concentration rose to about 3 nanograms per millilitre, and the terminal half-life was about 20 minutes [4]B.

In a comparison in ten healthy volunteers, exposure (concentration over time) after 2 mg into a vein was of the same order as after 4 mg under the skin. On this basis, 4 mg under the skin was chosen as the daily dose for the trial [2]B.

In blood samples in the laboratory, ARA-290 was cut quickly from the ends of the peptide chain, and the main breakdown product was a shorter peptide, PyrEQLERALN [14]D. According to the developers, the short half-life does not rule out long-lasting effects, because the substance triggers a cellular repair response that continues after it is gone [10].

What are the side effects of ARA-290?

In studies ARA-290 was well tolerated, but the studies were small and lasted at most 12 weeks [1]A [2]B [6]B. Rare or long-term harms cannot be detected with so little data.

Measured in humans

• Into a vein three times a week: no safety concerns in clinical or laboratory assessments, 12 patients [1]A.
• Under the skin daily for 28 days: no pain or irritation at the injection site and no serious adverse events. One person on ARA-290 lost 14 kilograms, but the weight loss had started before the study [2]B.
• People with type 2 diabetes: there were four serious adverse events in the ARA-290 group. Two were judged possibly related to the substance. In one patient, kidney insufficiency worsened after the dose of a diuretic was raised, and the substance was stopped. Another developed a severe skin infection and died of a heart attack two weeks after the last dose; the safety committee judged the death unrelated to the substance [4]B.
• Dose comparison: the registry records serious adverse events in 2/16 patients in the 1 mg group, 1/14 in the 8 mg group and none in the 4 mg and placebo groups [7]E, not peer-reviewed.
• 12 weeks of treatment: all nine had at least one adverse event, most often headache (4/9) and rises in triglycerides and blood sugar. No serious adverse events or antibodies against ARA-290 were found [6]B.

What has not been studied

There are no data on use beyond 12 weeks, pregnancy, breastfeeding, children or older people. The studies used controlled, sterile preparations; they say nothing about the content or purity of a product bought online. On peptide side effects more generally: side effects in studies.

Interactions and who has no data

There are no studies on drug interactions. In the diabetes study, one patient's kidney values worsened when the dose of their diuretic was raised at the same time [4]B; the study does not say whether ARA-290 played a part.

Some of the sarcoidosis patients used corticosteroids or other immune-suppressing drugs during the study [2]B, so there is limited experience of combined use, but it has not been studied separately. There are no data on pregnancy, breastfeeding or children.

What speaks against it and what is unknown

There are four kinds of counter-evidence: a placebo response for pain, an inconsistent dose response, a disputed mechanism and retracted animal studies.

Counter-evidence

• Pain also eased on placebo. In the first study, pain and fatigue scores improved equally in both groups [1]A. In the dose comparison, pain eased in all groups, and the difference between the 4 mg group and placebo in patients with moderate or severe pain was not statistically significant (p = 0.157) [3]A.
• A larger dose did not work better. Corneal nerve fibres increased significantly only in the 4 mg group, not in the 8 mg group [3]A.
• Skin nerves did not always regrow. According to the developers' review, 28 days of treatment started nerve fibre regrowth in the cornea but not in the skin [9]. In a later study, the skin regrowth marker increased in the 4 mg group [3]A.
• The eye study was negative. In diabetic macular oedema, visual acuity and retinal thickness did not improve [6]B.
• The mechanism is disputed. An Australian group found no biophysical evidence that the two receptors described as the repair receptor associate with each other, including with ARA-290. In mice, the beta-common receptor was not needed under anaemic stress [11]D.
• Retracted publications. A rat study in which pHBSP protected the kidney was retracted in 2026 because the publisher's checks found that some image bands did not represent the actual results [12]E, not peer-reviewed. A mouse study of pHBSP and insulin resistance was retracted in 2024 [13]E, not peer-reviewed. Neither is used as evidence on this page.

What the evidence does not support

• "ARA-290 heals tissue damage and speeds recovery": in humans nerve damage, blood sugar control in diabetes, macular oedema and mood have been studied [1, 5]A [4, 6]B; apart from nerve fibres, the healing of other tissue damage has not been studied.
• "It works like EPO without the side effects": ARA-290 does not increase red blood cells [1]A, and its tissue-protective effect has not been shown in humans in the same uses as EPO.
• "ARA-290 is an approved orphan drug": an orphan designation is not a marketing authorisation, and the FDA has not approved the substance for any use [25, 26, 27]regulator.
• "The dose is known": the published doses are study designs, not treatment instructions, and a larger dose did not work better [3]A.

What is unknown

• Whether the effect lasts with treatment beyond 12 weeks and what long-term use leads to. The longest study lasted 12 weeks [6]B.
• Whether the results hold when a group independent of the developer runs the study.
• Why 4 mg worked better than 8 mg on the corneal measure [3]A.

ARA-290 dosage in studies

ARA-290 has no approved dosage. Below are the doses used in human studies. They are not recommendations.

What the figures do not tell you. The doses are study designs whose safety was followed for at most 12 weeks. In the dose comparison, 8 mg did not work better than 4 mg [3]A, so more does not mean a better effect. Detailed table with sources: ARA-290 doses in studies. Unit converter: ARA-290 calculator.

Is ARA-290 legal in Finland?

ARA-290 has no marketing authorisation in the EU: EMA's list of centrally authorised medicines contains no medicine with cibinetide [31]regulator. Fimea's medicines list (decision 230/2025) does not name it under any name [29]regulator.

• EU orphan designation. The European Commission granted the substance orphan designations for treating sarcoidosis in 2013 and for preventing graft loss in pancreatic islet transplantation in 2016 [23, 24]regulator. A designation means development support, not permission to sell or use the substance. According to EMA, at the time of the application it was not authorised for sarcoidosis anywhere in the EU [23]regulator.
• Fimea warning. Fimea has warned against using injectable peptides bought online [30]regulator.
• The label "for research use only" is a classification label, not permission for human use.

Overview of the law: peptides and the law in Finland. On bringing them back from travel: Travelling with peptides.

This is not legal advice. Disclaimer.

Situation in the United States

The FDA has granted the substance three orphan designations: for neuropathic pain in patients with sarcoidosis in 2011, and for treating sarcoidosis and improving the function of transplanted pancreatic islets in 2016. For all three, the FDA database states that the substance is not approved for that use [25, 26, 27]regulator.

Is ARA-290 doping?

Most likely yes. Section S2.1.5 of WADA's 2026 Prohibited List bans innate repair receptor agonists, with asialo EPO and carbamylated EPO as examples. The list does not name ARA-290, but the examples are not exhaustive [28]regulator, and ARA-290 is described in studies as an agonist of exactly this receptor [3]A. Substances in class S2 are banned at all times, in and out of competition [28]regulator.

Researchers at the Cologne doping laboratory treated ARA-290 as a peptide prohibited in sport and identified its breakdown products for doping tests [14]D.

ARA-290 product quality: how to assess it

You cannot be sure what is in an ARA-290 product without analysis. The substance used in the studies was made by a pharmaceutical manufacturer in sterile vials, and the placebo's composition was stated exactly [4]B; there is no such information for a product bought online.

On a certificate of analysis (COA), check that mass spectrometry (MS) matches the 11-amino-acid chain with a mass of about 1,257 daltons [4]B, and that the HPLC purity and the batch number match the vial. Doping laboratories identify ARA-290 and its breakdown products by mass spectrometry [14]D. How to read one: how to read a COA.

What a certificate does not tell you: sterility, endotoxin content or what happened to the product in transport. ARA-290 breaks down quickly in blood [14]D, but we found no published data on its stability as a dry powder. Handling: mixing and handling.

FAQ

Read the research yourself: sources

Every source opens the original publication or the regulator's page. The level shows what the source itself reports.

1. Heij L, Niesters M, Swartjes M, et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med. 2012;18(1):1430-1436. PMID 23168581 A
2. Dahan A, Dunne A, Swartjes M, et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med. 2013;19(1):334-345. PMID 24136731 B
3. Culver DA, Dahan A, Bajorunas D, et al. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain. Invest Ophthalmol Vis Sci. 2017;58(6):BIO52-BIO60. PMID 28475703 A
4. Brines M, Dunne AN, van Velzen M, et al. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Mol Med. 2015;20(1):658-666. PMID 25387363 B
5. Cerit H, Veer IM, Dahan A, et al. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol. 2015;25(12):2289-2299. PMID 26431906 A
6. Lois N, Gardner E, McFarland M, et al. A phase 2 clinical trial on the use of cibinetide for the treatment of diabetic macular edema. J Clin Med. 2020;9(7):2225. PMID 32674280 B
7. ClinicalTrials.gov. NCT02039687: A double blind, placebo controlled phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis (sponsor Araim Pharmaceuticals, completed, 64 participants, results posted). Registry record, not peer-reviewed. ClinicalTrials.gov E, not peer-reviewed
8. ClinicalTrials.gov. NCT02070783: The effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers (sponsor Leiden University Medical Center, completed, 36 participants). Registry record, not peer-reviewed. ClinicalTrials.gov E, not peer-reviewed
9. Dahan A, Brines M, Niesters M, et al. Targeting the innate repair receptor to treat neuropathy. Pain Rep. 2016;1(1):e566. PMID 29392190 (review)
10. Collino M, Thiemermann C, Cerami A, et al. Flipping the molecular switch for innate protection and repair of tissues: long-lasting effects of a non-erythropoietic small peptide engineered from erythropoietin. Pharmacol Ther. 2015;151:32-40. PMID 25728128 (review)
11. Cheung Tung Shing KS, Broughton SE, Nero TL, et al. EPO does not promote interaction between the erythropoietin and beta-common receptors. Sci Rep. 2018;8(1):12457. PMID 30127368 D
12. Retraction note: Delayed administration of pyroglutamate helix B surface peptide (pHBSP), a novel nonerythropoietic analog of erythropoietin, attenuates acute kidney injury. Mol Med. 2026;32(1):31. Retraction notice of Mol Med. 2012;18:719-727. PMID 41749083 E, not peer-reviewed
13. Retraction: A non-erythropoietic peptide derivative of erythropoietin decreases susceptibility to diet-induced insulin resistance in mice. Br J Pharmacol. 2024;181(8):1341. Retraction notice of Br J Pharmacol. 2014;171(24):5802-5815. PMID 38433016 E, not peer-reviewed
14. Thomas A, Knoop A, Schänzer W, et al. Characterization of in vitro generated metabolites of selected peptides <2 kDa prohibited in sports. Drug Test Anal. 2017;9(11-12):1799-1803. PMID 28941172 D
15. Swartjes M, Morariu A, Niesters M, et al. ARA290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain: an experimental study in rats and β-common receptor knockout mice. Anesthesiology. 2011;115(5):1084-1092. PMID 21873879 C
16. Muller C, Yassin K, Li LS, et al. ARA290 improves insulin release and glucose tolerance in type 2 diabetic Goto-Kakizaki rats. Mol Med. 2016;21(1):969-978. PMID 26736179 C
17. Bitto A, Irrera N, Pizzino G, et al. Activation of the EPOR-β common receptor complex by cibinetide ameliorates impaired wound healing in mice with genetic diabetes. Biochim Biophys Acta Mol Basis Dis. 2018;1864(2):632-639. PMID 29223734 C
18. Winicki NM, Nanavati AP, Morrell CH, et al. A small erythropoietin derived non-hematopoietic peptide reduces cardiac inflammation, attenuates age associated declines in heart function and prolongs healthspan. Front Cardiovasc Med. 2022;9:1096887. PMID 36741836 C
19. Chen H, Luo B, Yang X, et al. Therapeutic effects of nonerythropoietic erythropoietin analog ARA290 in experimental autoimmune encephalomyelitis rat. J Neuroimmunol. 2014;268(1-2):64-70. PMID 24518674 C
20. van Rijt WG, Nieuwenhuijs-Moeke GJ, van Goor H, et al. ARA290, a non-erythropoietic EPO derivative, attenuates renal ischemia/reperfusion injury. J Transl Med. 2013;11:9. PMID 23302512 C
21. Watanabe M, Lundgren T, Saito Y, et al. A nonhematopoietic erythropoietin analogue, ARA 290, inhibits macrophage activation and prevents damage to transplanted islets. Transplantation. 2016;100(3):554-562. PMID 26683514 C
22. Yao M, Watanabe M, Sun S, et al. Improvement of islet allograft function using cibinetide, an innate repair receptor ligand. Transplantation. 2020;104(10):2048-2058. PMID 32345869 C
23. European Medicines Agency. Orphan designation EU/3/13/1191: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide) for the treatment of sarcoidosis (granted 7 Oct 2013, status positive). EMA regulator
24. European Medicines Agency. Orphan designation EU/3/16/1721: cibinetide (also known as ARA 290) for the prevention of graft loss in pancreatic islet transplantation (granted 29 Aug 2016, status positive). EMA regulator
25. US Food and Drug Administration, Orphan Drug Designations database. L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser: treatment of neuropathic pain in patients with sarcoidosis (designated 13 Sep 2011; not FDA approved for the orphan indication). FDA regulator
26. US Food and Drug Administration, Orphan Drug Designations database. Same substance: treatment of sarcoidosis (designated 13 Jun 2016; not FDA approved for the orphan indication). FDA regulator
27. US Food and Drug Administration, Orphan Drug Designations database. Same substance: treatment to increase survival and improve functioning of pancreatic islets following transplantation (designated 13 Jun 2016; not FDA approved for the orphan indication). FDA regulator
28. World Anti-Doping Agency. 2026 Prohibited List, section S2.1.5: "Innate repair receptor agonists, e.g. asialo EPO; carbamylated EPO (CEPO)". WADA regulator
29. Finland. Lääkeluettelo (Fimea medicines list), 230/2025, annexes 1, 1 A and 2: ARA-290, cibinetide and pHBSP are not named. Finlex regulator
30. Fimea. Fimea warns: do not use injectable peptides purchased online (29 Jun 2026). Fimea regulator
31. European Medicines Agency. Medicines data, all centrally authorised human medicines (status 15 Oct 2026): no medicine containing cibinetide. EMA regulator

Sources read 15 Oct 2026. Doses are from the abstracts, except the patient numbers and pharmacokinetics of Dahan 2013, the participant numbers, adverse events and half-life of Brines 2015 and the adverse events of Lois 2020, which are from the full texts in PMC. The route in Culver 2017 and Cerit 2015 is from ClinicalTrials.gov. The WADA list text is from the PDF version of the 2026 list.

Evidence levels: A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed · regulator = a regulator's assessment or decision, not research evidence. The marker official means official product information (summary of product characteristics or label); it is not research evidence. For a review, the level shows what kind of research the statement rests on. No level: statements that something has not been studied, reviews' interpretations, named hypotheses and the general rules in our certificate-of-analysis guide.

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.