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ARA-290

Gray market

Checked · 21 sources · 20 corrections on this page · No vendors · No affiliates · No one buys a word of it

14.5% corneal nerve fiber area up

Phase II · 28 days · on 4 mg daily · a trial of 38 adults with sarcoidosis · Dahan 2013

Gray market · On no list that allows compounding today. FDA’s 503A nominations list, Category 3: nominated without enough information, so not under evaluation and not permitted under FDA’s interim policy. Not on the 503B list. · legal line changed 18 Oct 2026 →

Sold as a research chemical. Some clinics and pharmacies still supply it; that’s their risk, not a change in the rule.

Bottom line

Small, short, developer-backed trials with signals on corneal nerves and symptom scores; no Phase 3.

Also called
  • Cibinetide
  • pyroglutamate helix-B surface peptide (pHBSP)
  • EPO helix-B mimetic
  • Araim Pharmaceuticals
Category
Peptide — Innate Repair Receptor Agonist (EPO-derived)
Class
Non-erythropoietic tissue-protective peptide
Sequence
11 amino acids (EPO helix-B surface): pGlu-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser
Molecular Weight
1,257 Da
Receptor
Innate Repair Receptor (EPO-R / βcR / CD131)
Route (studied)
SubQ, IV (people) · IP (rats and mice)
Route (sold)
SubQ vials (research chemical)
Half-life
About 2 minutes after injection into a vein, about 20 minutes after injection under the skin (people; Dahan et al., 2016)
FDA Status
Not approved (orphan designation for neuropathic pain due to sarcoidosis)
Clinical Stage
Phase II (small-fiber nerve damage; diabetic macular edema); no Phase III
Sponsor
Araim Pharmaceuticals
WADA Status
Prohibited at all times (S2.1.5 — innate repair receptor agonists; not named)
Cost & Access
Research-only

Also for injury & recovery

The other four questions

What does it do? In 28-day trials in adults with sarcoidosis or type 2 diabetes and small-fiber nerve damage, corneal nerve fibers rose and neuropathy symptom scores improved more than on placebo, while pain intensity fell as much on placebo in three of four trials (Heij et al., 2012; Dahan et al., 2013; Brines et al., 2015; Culver et al., 2017). In rats it damped nerve inflammation (Liu et al., 2014).
Who uses it? Trial volunteers: adults with sarcoidosis or type 2 diabetes and small-fiber nerve damage (Dahan et al., 2013; Brines et al., 2015). Outside trials it is sold as a research chemical.
Does the evidence hold up? Only in part. The four placebo-controlled trials had 22 to 64 people and lasted 4 weeks; in the largest, only the middle of three doses beat placebo on its main measure (Culver et al., 2017). The developer’s officers co-authored every trial in patients (Brines et al., 2015; Lois et al., 2020).
Bottom line? Small, short, developer-backed trials with signals on corneal nerves and symptom scores; no Phase 3.

Dosing from the Literature

Published for small-fiber nerve pain: 4 mg a day under the skin for 28 days in three placebo-controlled trials (one also tested 1 and 8 mg), and 2 mg into a vein three times a week for 4 weeks in a fourth. Not published: a course longer than 28 days for nerve pain, or a Phase 3 trial.

Each row is a published study’s own dose, with the people it was given to.

Indication / ProtocolDoseRoute / ScheduleNotes
Sarcoidosis small-fiber neuropathy, pilot (Heij et al., 2012)2 mgInto a vein over 2 minutes, three times a week × 4 weeksRandomized, double-blind trial: 22 adults with sarcoidosis and small-fiber neuropathy symptoms (12 on ARA-290, 10 on placebo)
Sarcoidosis small-fiber neuropathy (Dahan et al., 2013)4 mgUnder the skin, daily × 28 daysRandomized, double-blind trial: 38 adults (21 on ARA-290, 17 on placebo); the dose was chosen from a pharmacokinetic study in 10 healthy volunteers
Type 2 diabetes with painful neuropathy (Brines et al., 2015)4 mgSelf-injected under the skin of the thigh, daily × 28 daysRandomized, double-blind trial: 49 adults enrolled, 48 analysed (24 per group)
Sarcoidosis small nerve fiber loss, phase 2b (Culver et al., 2017)1, 4 or 8 mgUnder the skin, daily × 28 daysRandomized trial: 64 adults with neuropathic pain; only 4 mg beat placebo on the main measure
Diabetic macular edema (Lois et al., 2020)4 mgSelf-injected under the skin, daily × 12 weeksOpen-label trial, no placebo: 9 adults with diabetes
Healthy volunteers (Cerit et al., 2015)2 mgOne dose into a veinRandomized, double-blind, placebo-controlled: 36 healthy adults; a study of mood and emotional processing
Dosing Disclaimer

No regulator has approved ARA-290 or set a dose for it. The figures above are for educational reference only. Always work with a licensed healthcare provider.

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What It Is

ARA-290 (cibinetide; also called pyroglutamate helix B surface peptide, pHBSP) is an 11-amino-acid peptide modeled on the outward face of helix B of erythropoietin (EPO): the face that points into the surrounding fluid when EPO binds the pair of receptors that drives red-cell production (Brines et al., 2008; Collino et al., 2015). Its sequence is pGlu-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser (European Medicines Agency, 2013). Michael Brines, Anthony Cerami and colleagues described it in 2008, when they worked for Warren Pharmaceuticals (Brines et al., 2008); Araim Pharmaceuticals, where both later served as officers, developed it (Brines et al., 2015).

The idea behind it: EPO acts through two receptors. A pair of EPO receptors drives red-cell production; a complex of the EPO receptor with the β-common receptor (CD131), the subunit shared with the receptors for GM-CSF, IL-3 and IL-5, is proposed to mediate EPO’s protection of injured tissue (Brines et al., 2008; Brines & Cerami, 2012). The developers call that complex the innate repair receptor (Collino et al., 2015).

Recombinant EPO’s use for protecting tissue is limited by rises in hematocrit, platelet activation and a high risk of thrombosis (Collino et al., 2015). ARA-290 was built to act on the repair receptor alone: in rodents, neither helix B nor the 11-amino-acid peptide raised red-cell production, while the peptide reduced injury in models of stroke and kidney ischemia (Brines et al., 2008).

Its human evidence is four randomized trials in small-fiber nerve damage, 22 to 64 people and 4 weeks each, a 12-week open-label trial in 9 people with diabetic macular edema, and a single-dose study in 36 healthy volunteers (Heij et al., 2012; Dahan et al., 2013; Brines et al., 2015; Culver et al., 2017; Lois et al., 2020; Cerit et al., 2015). Araim’s officers, who own stock in the company, co-authored all five trials in patients (Brines et al., 2015; Lois et al., 2020).

Mechanism of Action

  • Innate repair receptor — ARA-290 is described as a selective agonist of the innate repair receptor, the EPO receptor–β-common receptor (CD131) complex, that does not bind the EPO-receptor pair behind red-cell production (Dahan et al., 2016). In the developers’ review, that receptor is generally not expressed by normal tissue and is switched on by injury, inflammation and low oxygen (Brines & Cerami, 2012).
  • A disputed receptor — An independent 2018 study found no binding of ARA-290 to the outer parts of either receptor, and no association between the two receptors with or without it, in tests on purified proteins; its authors call the receptor’s existence controversial (Cheung Tung Shing et al., 2018).
  • Signaling — In the developers’ review of cell and animal work with ARA-290 and carbamylated EPO, the receptor signals through JAK-2 and then STAT3 (heart) or STAT5 (brain), PI3K-Akt and MAP kinases, pathways the review ties to blocking inflammation-driven cell death (Brines & Cerami, 2012).
  • Inflammation — In mouse cells, ARA-290 cut macrophages’ release of IL-6, IL-12 and TNF-α (Watanabe et al., 2016); in rats with autoimmune neuritis it reduced nerve inflammation and inflammatory macrophage activation (Liu et al., 2014).
  • Nerve repair — In those rats it improved nerve regeneration and remyelination, and in cell culture it promoted Schwann cell growth (Liu et al., 2014). In people, corneal nerve fibers rose over 28 days on 4 mg in two sarcoidosis trials (Dahan et al., 2013; Culver et al., 2017); fibers in skin biopsies did not change in the first (Dahan et al., 2013), while regenerating skin fibers rose on 4 mg in the second (Culver et al., 2017).
  • Pain — In rats with nerve injury, relief of allodynia came with a suppressed spinal microglia response, and ARA-290 had no effect in mice lacking the β-common receptor; the investigators attribute the relief to its anti-inflammatory action, “possibly within the central nervous system” (Swartjes et al., 2011; Swartjes et al., 2014).
  • Glucose and lipids — In the type 2 diabetes trial, HbA1c fell 0.16 points by day 28 and 0.21 by day 56 on ARA-290, against −0.01 and +0.21 on placebo, and triglycerides and the cholesterol-to-HDL ratio improved; the investigators write that the mechanism “is currently unclear” and point to mouse work on insulin resistance (Brines et al., 2015).
  • Red cells — It did not raise red-cell production in rodents (Brines et al., 2008), nor red-cell counts or hemoglobin in rats treated for 2 weeks (Liu et al., 2014).

What the Research Shows

  • Sarcoidosis, intravenous pilot (Heij et al., 2012; PMID 23168581) — 22 adults with sarcoidosis and small-fiber neuropathy symptoms, 2 mg or placebo into a vein three times a week for 4 weeks. The neuropathy symptom score (SFNSL) fell 11.5 points on ARA-290 against 2.9 on placebo; pain (Brief Pain Inventory) and fatigue improved equally in both groups.
  • Sarcoidosis, 28 days under the skin (Dahan et al., 2013; PMID 24136731) — 38 adults, 4 mg or placebo daily. A week after dosing ended, the SFNSL score had fallen 12.2 points on ARA-290 and 3.8 on placebo, and pain interference 36% against 16%; pain intensity fell about 9% in both groups alike. Corneal nerve fiber area rose 14.5% from baseline on the drug, a significant change, and fell 5.3% on placebo, a change that was not; nerve fibers in skin biopsies did not change significantly.
  • Type 2 diabetes with painful neuropathy (Brines et al., 2015; PMID 25387363) — 48 adults analysed, 4 mg or placebo daily for 28 days, followed to day 56. The PainDetect symptom score improved 3.3 points against 1.1 on placebo, and HbA1c and blood lipids improved; the SFNSL score and sensory tests did not change in either group, and corneal nerve fiber density rose only in a post hoc subgroup whose counts started more than one standard deviation below normal.
  • Sarcoidosis phase 2b (Culver et al., 2017; PMID 28475703) — 64 adults with sarcoidosis-associated small nerve fiber loss and neuropathic pain, 1, 4 or 8 mg or placebo daily for 28 days. Corneal nerve fiber area, the primary endpoint, rose against placebo on 4 mg (not on 1 or 8 mg), as did regenerating nerve fibers in the skin; pain improved in every group, placebo included.
  • Diabetic macular edema (Lois et al., 2020; PMID 32674280) — An open-label trial in 9 adults, 4 mg daily for 12 weeks: vision, retinal thickness, retinal sensitivity and tear production did not improve on average; a vision questionnaire score rose 2.7 points. Its registry record says it was stopped when the study drug expired and no replacement was available (NCT06626971).
  • Healthy volunteers (Cerit et al., 2015; PMID 26431906) — 36 adults given one 2 mg dose or placebo: no effect on mood; some measures of emotional processing changed, which the authors say do not “unequivocally support an antidepressant-like profile”.
  • Neuropathic pain in rats (Swartjes et al., 2011; PMID 21873879; Swartjes et al., 2014; PMID 24529189) — After a nerve injury, five injections relieved allodynia in rats for up to 15 and 20 weeks.
  • Autoimmune neuritis in rats (Liu et al., 2014; PMID 24603865) — Daily ARA-290 improved recovery, nerve regeneration and remyelination.
  • Islet transplants in mice (Watanabe et al., 2016; PMID 26683514) — Injections around a marginal islet transplant improved blood glucose against controls and damped inflammation in the liver.
  • Corneal nerve measures — The program’s investigators propose corneal nerve fiber area as a surrogate endpoint for nerve repair (Culver et al., 2017; Brines et al., 2018).
Research Limitations

Every trial was small (9 to 64 people) and short: 4 weeks of dosing, or 12 weeks in the 9-person open-label study (Lois et al., 2020). Pain intensity fell as much on placebo as on the drug in three of the four nerve trials (Heij et al., 2012; Dahan et al., 2013; Culver et al., 2017). Araim’s officers co-authored all five trials in patients, and Leiden University, where the first three were run, received Araim’s financial support for its ARA-290 studies (Dahan et al., 2016).

Human Data

  • Five trials in patients — The intravenous sarcoidosis pilot (22 people; Heij et al., 2012), the 28-day sarcoidosis trial (38; Dahan et al., 2013), the 28-day type 2 diabetes trial (48 analysed; Brines et al., 2015), the sarcoidosis phase 2b (64; Culver et al., 2017) and the open-label diabetic macular edema trial (9; Lois et al., 2020). Their results are under What the Research Shows.
  • Where they are registered — The pilot and the 28-day sarcoidosis and diabetes trials in the Netherlands Trial Register (NTR3081, NTR3575, NTR3858; Heij et al., 2012; Dahan et al., 2013; Brines et al., 2015); the phase 2b on ClinicalTrials.gov with results posted (NCT02039687); the macular edema trial as ISRCTN16962255 and NCT06626971, terminated (Lois et al., 2020).
  • Healthy volunteers — A crossover pharmacokinetic study in 10 volunteers compared 2 mg into a vein with 2, 4 and 6 mg under the skin (Dahan et al., 2013); after 4 mg under the skin, plasma levels peaked near 3 ng/mL with a terminal half-life of about 20 minutes (Brines et al., 2015). The developer reports that single and repeated doses in volunteers raised no safety issues, citing unpublished data (Heij et al., 2012). A single 2 mg dose was also given in a 36-person study of mood (Cerit et al., 2015; NCT02070783).
  • Unpublished — A 28-day trial of 4 mg in prediabetes or untreated type 2 diabetes, phase 2, last updated in 2015, status unknown, with no results posted and none in PubMed (NCT01933529; searched October 11, 2026).
  • No Phase III — ClinicalTrials.gov lists no Phase 3 trial of ARA-290 and none that started after 2016 (searched October 11, 2026).

Reconstitution & Storage

No regulator has approved ARA-290, so no label sets storage conditions or a shelf life for it. In the type 2 diabetes trial it was supplied in sterile vials for daily self-injection of 4 mg (Brines et al., 2015). The arithmetic below is for that 4 mg dose.

Vial SizeBAC WaterConcentration4 mg Dose
4 mg1 mL4 mg/mL100 units (1 mL)
4 mg2 mL2 mg/mL200 units (2 mL)
8 mg2 mL4 mg/mL100 units (1 mL); the vial holds two 4 mg doses

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Side Effects & Risks

Important

About 110 people with sarcoidosis, diabetes or diabetic eye disease have received ARA-290 in the published trials, for 4 to 12 weeks (Heij et al., 2012; Dahan et al., 2013; Brines et al., 2015; Culver et al., 2017; Lois et al., 2020). The serious adverse events among them, one followed by a death, are listed below with the investigators’ judgments.

  • Serious adverse events, type 2 diabetes trial — Four occurred on ARA-290; the investigators judged two unlikely to be related and two possibly related. In one participant on daily furosemide whose furosemide dose had been raised, borderline kidney function worsened (creatinine 119 to 159 µmol/L) and the safety committee stopped ARA-290. A 70-year-old man developed severe leg cellulitis two weeks after his last dose and died of a heart attack; the safety committee “judged the event to be unrelated to ARA 290 treatment” (Brines et al., 2015).
  • Serious adverse events, sarcoidosis phase 2b — The registry’s posted results list serious events in 2 of 16 people on 1 mg (fainting, headache, chest tightness, shortness of breath, small-bowel enteritis), 1 of 14 on 8 mg (suicidal ideation), none of 16 on 4 mg and none of 16 on placebo (NCT02039687).
  • The other trials — No serious adverse events in the 28-day sarcoidosis trial through 12 weeks of follow-up (Dahan et al., 2013) or in the 12-week macular edema trial (Lois et al., 2020); the intravenous pilot reports no adverse events noted by staff or patients (Heij et al., 2012).
  • Headache — In 8 of 46 people on cibinetide and none of 16 on placebo in the phase 2b’s posted results (NCT02039687), and in 4 of 9 in the macular edema trial, whose investigators judged it potentially related (Lois et al., 2020).
  • Nausea and fatigue — Nausea in 5 of 46 on cibinetide and none of 16 on placebo; fatigue in 5 of 46 and 2 of 16 (NCT02039687).
  • Injection site — Injection-site pain was more common on placebo (4 of 16) than on cibinetide (3 of 46) in the phase 2b (NCT02039687); the 28-day sarcoidosis trial reports no pain or irritation at injection sites (Dahan et al., 2013).
  • Blood counts — The 4-week trials report no clinically significant change in hemoglobin, other blood counts or blood chemistry (Heij et al., 2012; Dahan et al., 2013; Brines et al., 2015), and no antibodies to ARA-290 (Dahan et al., 2013; Brines et al., 2015; Lois et al., 2020).
  • Long-term use — The longest published course is 12 weeks, in 9 people (Lois et al., 2020).
  • Pregnancy and children — The published trials enrolled adults; the 28-day sarcoidosis trial excluded anyone with a positive pregnancy test (Dahan et al., 2013).
  • Drug interactions — No drug-interaction study of ARA-290 appears in PubMed (searched October 11, 2026).

Bloodwork & Monitoring

No label, guideline or trial sets monitoring for anyone taking ARA-290 outside a study. The trials measured:

Commonly Stacked With

PubMed lists no study of ARA-290 given together with BPC-157, NAD+ precursors, thymosin alpha-1 or alpha-lipoic acid; the records that name both are reviews (searched October 11, 2026). In its trials, participants kept taking their usual medicines, including pain medicines and immune suppressants (Dahan et al., 2013; Brines et al., 2015).

Stacking this? Read the receipt →

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Legal Status

Current Status — October 2026

ARA-290 (cibinetide) is not approved in the United States or the European Union (Drugs@FDA; European Medicines Agency, 2013). The European Commission gave it orphan designation for the treatment of sarcoidosis on October 7, 2013 (EU/3/13/1191), still listed as positive, with Araim Pharmaceuticals Europe as its sponsor; EMA’s record notes that the United States had granted orphan designation for neuropathic pain due to sarcoidosis (European Medicines Agency, 2013).

Of the four ARA-290 trials on ClinicalTrials.gov, Araim Pharmaceuticals sponsors one and collaborates on two (searched October 11, 2026).

ARA-290 is not named on the WADA Prohibited List 2026, but as an innate repair receptor agonist it falls under S2.1.5 (e.g. asialo EPO; carbamylated EPO), prohibited at all times, in and out of competition (World Anti-Doping Agency, 2026). Class S2 also prohibits substances of similar chemical structure or similar biological effect that it does not name.

ARA-290 was not among the 12 peptides FDA removed from Category 2 in April 2026; FDA’s 503A categories list places it in Category 3, nominated without enough data (FDA 503A categories list, May 14, 2026).

Cost & Access

ARA-290 is not approved for human use in the United States. It is sold by research-chemical suppliers, labeled for laboratory research.

FDA’s 503A categories list places it in Category 3, nominated without adequate support (FDA 503A categories list, May 14, 2026), so it is not eligible under FDA’s interim compounding policy; it is not on FDA’s 503B list. No trial of it is recruiting (ClinicalTrials.gov, searched October 11, 2026).

Pricing and availability vary by vendor, country, and trial-participation status. Kalios does not sell compounds.

References

  1. Brines M, Patel NS, Villa P, Brines C, Mennini T, De Paola M, Erbayraktar Z, Erbayraktar S, Sepodes B, Thiemermann C, Ghezzi P, Yamin M, Hand CC, Xie QW, Coleman T, Cerami A. Nonerythropoietic, tissue-protective peptides derived from the tertiary structure of erythropoietin. Proc Natl Acad Sci U S A. 2008;105(31):10925-10930. PMID: 18676614. (Foundational ARA-290 / cibinetide engineering paper.)
  2. Brines M, Cerami A. The receptor that tames the innate immune response. Mol Med. 2012;18(1):486-496. PMID: 22183892. (Key mechanistic review of the Innate Repair Receptor.)
  3. Brines M, Dunne AN, van Velzen M, Proto PL, Ostenson CG, Kirk RI, Petropoulos IN, Javed S, Malik RA, Cerami A, Dahan A. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Mol Med. 2015;20:658-666. PMID: 25387363. (Human Phase II — type 2 diabetes / neuropathy.)
  4. Dahan A, Dunne A, Swartjes M, Proto PL, Heij L, Vogels O, van Velzen M, Sarton E, Niesters M, Tannemaat MR, Cerami A, Brines M. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med. 2013;19:334-345. PMID: 24136731. (Phase II — sarcoidosis-associated small-fiber neuropathy.)
  5. Brines M, Culver DA, Ferdousi M, Tannemaat MR, van Velzen M, Dahan A, Malik RA. Corneal nerve fiber size adds utility to the diagnosis and assessment of therapeutic response in patients with small fiber neuropathy. Sci Rep. 2018;8(1):4734. doi:10.1038/s41598-018-23107-w. PMID: 29549285. (Extended corneal nerve fiber data from the SFN program.)
  6. Swartjes M, Morariu A, Niesters M, Brines M, Cerami A, Aarts L, Dahan A. 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.
  7. Heij L, Niesters M, Swartjes M, Hoitsma E, Drent M, Dunne A, Grutters JC, Vogels O, Brines M, Cerami A, Dahan A. 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.
  8. Watanabe M, Lundgren T, Saito Y, Cerami A, Brines M, Östenson CG, Bränström R. A Nonhematopoietic Erythropoietin Analogue, ARA 290, Inhibits Macrophage Activation and Prevents Damage to Transplanted Islets. Transplantation. 2016;100(3):554-562. PMID: 26683514.
  9. Culver DA, Dahan A, Bajorunas D, Jeziorska M, van Velzen M, Aarts LPHJ, Tavee J, Tannemaat MR, Dunne AN, Kirk RI, Petropoulos IN, Cerami A, Malik RA, Brines M. 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.
  10. Dahan A, Brines M, Niesters M, Cerami A, van Velzen M. Targeting the Innate Repair Receptor to Treat Neuropathy. Pain Rep. 2016;1(1):e566. PMID: 29392190.
  11. Wang L, Di L, Noguchi CT. Erythropoietin, a novel versatile player regulating energy metabolism beyond the erythroid system. Int J Biol Sci. 2014;10(8):921-939. PMID: 25170305. (Broader EPO / IRR biology review.)
  12. Liu Y, Luo B, Han F, Li X, Xiong J, Jiang M, et al. Erythropoietin-Derived Nonerythropoietic Peptide Ameliorates Experimental Autoimmune Neuritis by Inflammation Suppression and Tissue Protection. PLoS One. 2014;9(3):e90942. PMID: 24603865.
  13. Collino M, Thiemermann C, Cerami A, Brines M. 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.
  14. ClinicalTrials.gov. Records NCT02039687 (sarcoidosis phase 2b; completed, results posted), NCT06626971 (diabetic macular edema; terminated: “Expiry of study drug - no replacement available”), NCT02070783 (healthy volunteers; completed) and NCT01933529 (prediabetes and type 2 diabetes; status unknown, no results posted). Search: “cibinetide”, “ARA 290”, “ARA290”, “ARA-290”. Read October 11, 2026.
  15. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
  16. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S2.1.5, Innate repair receptor agonists. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Read October 3, 2026.
  17. Swartjes M, van Velzen M, Niesters M, Aarts L, Brines M, Dunne A, Cerami A, Dahan A. ARA 290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain coupled with suppression of the spinal microglia response. Mol Pain. 2014;10:13. doi:10.1186/1744-8069-10-13. PMID: 24529189.
  18. Cerit H, Veer IM, Dahan A, Niesters M, Harmer CJ, Miskowiak KW, Rombouts SA, Van der Does W. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol. 2015;25(12):2289-2299. doi:10.1016/j.euroneuro.2015.09.005. PMID: 26431906.
  19. Lois N, Gardner E, McFarland M, Armstrong D, McNally C, Lavery NJ, Campbell C, Kirk RI, Bajorunas D, Dunne A, Cerami A, Brines M. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema. J Clin Med. 2020;9(7):2225. doi:10.3390/jcm9072225. PMID: 32674280.
  20. Cheung Tung Shing KS, Broughton SE, Nero TL, Gillinder K, Ilsley MD, Ramshaw H, Lopez AF, Griffin MDW, Parker MW, Perkins AC, Dhagat U. EPO does not promote interaction between the erythropoietin and beta-common receptors. Sci Rep. 2018;8(1):12457. doi:10.1038/s41598-018-29865-x. PMID: 30127368. (Author correction: Sci Rep. 2019;9:7851.)
  21. European Medicines Agency. EU/3/13/1191: orphan designation for the treatment of sarcoidosis (cibinetide), granted October 7, 2013; status positive. ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1191. Read October 11, 2026.

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Checked 18 Oct 2026