ARA-290
Also sold as: Cibinetide, ARA 290, ARA290, ARA290 Acetate, pHSBP, pHBSP, pyroglutamate helix B surface peptide
ARA-290 (cibinetide) is not an FDA-approved drug for any indication — it has no record in Drugs@FDA — and it may not lawfully be used in pharmacy compounding under section 503A, because FDA places 'Cibinetide (ARA-290)' in Category 3 of its bulk drug substances list, the category for substances nominated without adequate support, rather than on the 503A bulks list itself. Unlike most peptides sold in this market, ARA-290 has genuinely been administered to humans: a randomised, quadruple-masked, placebo-controlled phase 2b trial of 64 subjects with sarcoidosis-associated small nerve fiber loss, sponsored by Araim Pharmaceuticals (NCT02039687), completed in February 2015 and posted results. That trial's primary endpoint was a surrogate — corneal nerve fiber area — and the placebo-corrected change reached statistical significance in only one of its three ARA 290 arms, with the confidence intervals for the other two crossing zero. No phase 3 trial of ARA-290 has been registered, ClinicalTrials.gov lists no active or recruiting study of it, and the most recently registered trial — a nine-patient phase 2 study in diabetic macular oedema — is recorded as terminated for the stated reason 'Expiry of study drug - no replacement available.'
Which molecule this is. An 11-amino-acid peptide derived from the B-helix of erythropoietin. The NCT06626971 registration gives the full chemical name as 'L-Pyroglutamyl-L-glutamyl-L-glutaminyl-L-leucyl-L-glutamyl-L-arginyl-L-alanyl-L-leucyl-L-asparaginyl-L-seryl-L-serine' — eleven residues, beginning with pyroglutamate. The NCT02039687 registration lists 'pHSBP, Cibinetide' as other names for it; the literature more often writes pHBSP, for pyroglutamate helix B surface peptide, and both spellings are aliased above so a reader searching either lands here. SALT FORM IS A LIVE DISAMBIGUATION, as it is for BPC-157. FDA's National Drug Code directory carries this substance under two different generic names — 'ARA290' and 'ARA290 Acetate' — with the same active-ingredient name, CIBINETIDE. A vial labelled 'ARA-290' does not by itself say which was in it.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, in any country this record could identify, and not in active development toward approval. THE QUERY WAS RUN THE WAY THIS PROJECT LEARNED TO RUN IT. Drugs@FDA was searched five ways — products.active_ingredients.name:"CIBINETIDE", openfda.generic_name:"cibinetide", openfda.substance_name:"CIBINETIDE", and bare free-text for both 'cibinetide' and 'ARA-290'. All five returned NOT_FOUND. Because an empty openfda block can manufacture a false negative, a positive control was run in the same request shape on the same field: products.active_ingredients.name:"SEMAGLUTIDE" returns six applications. The field works. The substance is absent. WHY NOT 'investigational', WHICH IS WHAT THE PUBLICATION RECORD SUPERFICIALLY SUGGESTS. The bar in this vocabulary is active development by an identifiable sponsor with registered trials, and the registry does not meet it. ClinicalTrials.gov returns three interventional studies of this molecule and nothing else. None is recruiting or active. The only one sponsored by Araim Pharmaceuticals (NCT02039687) has an actual completion date of February 2015. A Karolinska-led study in prediabetes and type 2 diabetes (NCT01933529) sits at status UNKNOWN with its last update posted in September 2015. And the most recently registered one (NCT06626971) was posted in October 2024 for a trial that had already run in 2016-2017, and is recorded as TERMINATED with the stated reason 'Expiry of study drug - no replacement available.' Read that last point carefully, because a pipeline sorting by 'last updated' will read 2024 as recent activity. It is not new work. It is a retrospective registration of an old trial whose drug supply ran out.
“{ "error": { "code": "NOT_FOUND", "message": "No matches found!" } }”Checked against the source on .
503A compounding
Nominated for compounding, but the nomination lacked adequate supporting information.
Verified by downloading fda.gov/media/94155/download with a browser user-agent and text-extracting it locally on 2026-08-02. The document is headed 'Updated May 14, 2026'. 'Cibinetide (ARA-290)' occurs exactly once in it, on its own bullet under the Category 3 heading, alphabetically between 'Chromium glycinate' and 'Coenzyme Q50'. It is not in Category 1 and not in Category 2 — Category 2 holds exactly six substances, and this is not one of them. WHAT CATEGORY 3 DOES AND DOES NOT MEAN. FDA's own heading defines it: nominated without adequate support. It is a finding about the NOMINATION, not about the molecule — it does not say ARA-290 is dangerous and it does not say ARA-290 is ineffective. What it does mean, operationally, is unchanged by the category: ARA-290 is not on the 503A bulks list, so a bulk drug substance that is neither the subject of a USP monograph nor a component of an approved drug may not be used in 503A compounding. Category 3 is inside the document; the bulks list is the document's subject. Being listed in a category is not being on the list.
“503A Category 3: Bulk Drug Substances Nominated Without Adequate Support … • Cibinetide (ARA-290)”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
ADMINISTRATION CHECK RUN, NOT ASSUMED — and it passes, which on this site is the less common outcome. The full NCT02039687 record was opened on 2026-08-02 and read down to the results section. Intervention type DRUG, name 'ARA 290', other names 'pHSBP, Cibinetide'; three experimental arms administered subcutaneously versus a placebo comparator described as 'Formulation buffer'; allocation RANDOMIZED, quadruple masking (participant, care provider, investigator, outcomes assessor); enrolment 64 ACTUAL; lead sponsor Araim Pharmaceuticals, Inc.; status COMPLETED with actual primary completion 2015-01 and actual completion 2015-02; results first posted 2017-01-18; hasResults true, with a participant flow table, a baseline table, outcome measures and an adverse-event table all populated. ARA-290 was GIVEN to these people. It was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. FOUR MORE HUMAN ADMINISTRATION STUDIES were checked at abstract level on 2026-08-02 and each states administration explicitly. PMIDs are given so each is independently locatable: Heij et al. 2012, PMID 23168581 (22 sarcoidosis patients with small fiber neuropathy symptoms, randomised double-blind, intravenous, ARA 290 n=12 vs placebo n=10); Dahan et al. 2013, PMID 24136731 (blinded placebo-controlled, 28 days of subcutaneous administration in patients with documented small nerve fiber loss and damage); Brines et al. 2015, PMID 25387363 (phase 2 in type 2 diabetes with painful neuropathy, self-administered subcutaneously over 28 days versus placebo); Lois et al. 2020, PMID 32674280 (phase 2 in diabetic macular oedema, nine patients recruited, self-administered subcutaneously over 12 weeks). A healthy-volunteer study also administered it: Cerit et al. 2015, PMID 26431906, N=36, double-blind randomised parallel-group versus placebo. State the limit honestly — for these five the abstract was read, not the full text; only NCT02039687 was read at record level. WHY THE TIER IS NOT HIGHER. 'Promising-but-unproven' is the tier this vocabulary reserves for a real human signal that is not established, explicitly including programmes that were tested and stopped. Three things keep it here. (1) The phase 2b primary endpoint was a SURROGATE — corneal nerve fiber area, which the authors themselves frame as a surrogate endpoint for disease modification, not as a clinical outcome. (2) It separated from placebo in only one of the three active arms: per Culver et al. 2017 the placebo-corrected 95% confidence intervals for the other two both cross zero. (3) There is no phase 3. No registered phase 3 trial of this molecule exists, and the pain endpoint the indication would actually turn on did not reach significance against placebo in that trial's own reporting (P = 0.157 in the arm the authors highlight). SCOPE. This tier attaches to sarcoidosis-associated small fiber neuropathy and the adjacent neuropathy endpoints that were actually studied. It does not travel to tissue repair, injury recovery, longevity or any other use ARA-290 is marketed for; the literature since 2018 on those questions is overwhelmingly rodent and in-vitro.
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA lists 'Cibinetide (ARA-290)' in Category 3 of the 503A bulk drug substances list — bulk drug substances nominated without adequate support — in the version updated 14 May 2026. It is not in Category 1 and not in Category 2, and it is not on the 503A bulks list itself.
The single most surprising fact on this record, and it inverts the site's usual assumption for a peptide of this profile. ARA-290 is normally described in the consumer market as having no regulatory footprint at all. It has one: somebody nominated it for pharmacy compounding, and FDA's disposition was to place it among the nominations made without adequate supporting information. Note what that does NOT license in either direction — Category 3 is not a safety finding against the molecule, and it is not a step toward availability. The substance is not on the bulks list, which is the only list that permits 503A compounding.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“503A Category 3: Bulk Drug Substances Nominated Without Adequate Support … • Cibinetide (ARA-290)”
Checked against the source on .Cibinetide does not appear in Drugs@FDA. Queries against the product active-ingredient name, the openFDA generic name, the openFDA substance name, and bare free text for both 'cibinetide' and 'ARA-290' all return no matches.
A negative result is only worth as much as the query behind it, so the query is stated in full and a positive control was run alongside it: the identical request shape with SEMAGLUTIDE in place of CIBINETIDE returns six applications. openFDA's `meta.last_updated` for drug/drugsfda was 2026-07-31 at the time of checking. This is the check that a previous pass on a different compound in this library got wrong by querying only the openfda block, which is frequently empty.
Drugs@FDA — query for CIBINETIDE as a product active ingredient (openFDA drug/drugsfda) — FDA, 31 July 2026“{ "error": { "code": "NOT_FOUND", "message": "No matches found!" } }”
Checked against the source on .Cibinetide DOES appear in FDA's National Drug Code directory — as three BULK INGREDIENT listings from active-ingredient suppliers, none of them a finished drug product. The labelers are Qingdao Biopeptek Co., Ltd (marketing start 2022-01-03), DARMERICA, LLC (2026-01-13) and Nanjing Chengong Pharmaceutical Co., Ltd. (2026-02-25). Two of the three list the substance as 'ARA290 Acetate' and one as 'ARA290'; all three name the active ingredient CIBINETIDE.
Recorded because 'it has an FDA NDC number' is the argument this market reaches for next, and it does not mean what it is used to mean. Every one of these records carries marketing_category BULK INGREDIENT, product_type BULK INGREDIENT, and finished: false. Listing a bulk substance in the NDC directory is a registration and listing obligation for the establishment; FDA does not review a bulk-ingredient listing for safety or effectiveness and no approval attaches to it. The number identifies a barrel of powder, not a medicine. The DATES are the interesting part. Two of the three listings began in the first two months of 2026 — the API supply chain organising itself around this molecule at exactly the point the consumer peptide market discovered it, and years after the clinical programme stopped.
National Drug Code Directory — listings whose active ingredient is CIBINETIDE (openFDA drug/ndc) — FDA, 31 July 2026Checked against the source on .Cibinetide and ARA-290 do not appear anywhere on FDA's page documenting bulk drug substances that may present significant safety risks, including its table of substances 'nominated but withdrawn'.
Fetched and text-extracted 2026-08-02: zero occurrences of 'cibinetide', 'ARA-290' or 'ARA 290'. Recorded to close two misreadings at once. It means FDA has published no specific safety risk for this substance under the compounding programme — which is not the same as a finding of safety, and on the evidence of this record is better read as the silence that follows a nomination FDA judged inadequately supported. It also means ARA-290's history is NOT the BPC-157 history: it was not in Category 2 and its nomination was not withdrawn. It is in Category 3 on its own terms.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 14 May 2026“Bulk drug substances nominated but withdrawn”
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Documented safety signals
In the posted results of the 64-subject phase 2b sarcoidosis trial, 3 of the 46 subjects at risk across the three ARA 290 arms had a serious adverse event, against 0 of 16 on placebo. The serious events recorded were syncope, headache, chest tightness, shortness of breath, small bowel enteritis and suicidal ideation. Non-serious treatment-emergent events were reported at a similar rate in both, 37 of 46 on ARA 290 and 12 of 16 on placebo, and were predominantly gastrointestinal.
Counts taken from the registration's own adverse-event table on 2026-08-02, with a frequency threshold of 0 and a stated time frame of the treatment period plus follow-up. Aggregated deliberately across the three active arms: the table breaks the events out by arm, and reproducing that breakdown would publish a dose-to-outcome mapping, which this site does not do. READ THE NUMBERS FOR WHAT THEY ARE. Six serious events in three subjects, in a trial of 64 people with an inflammatory multisystem disease, is not a safety signal established against placebo — the trial is far too small to separate anything at that rate, and the registration posts no statistical comparison of adverse events. It is recorded here because 'ARA-290 has no reported adverse events' is a claim that circulates, and it is false against the sponsor's own filing. Note also the participant flow: 3 of 46 subjects in the active arms did not complete, against 0 of 16 on placebo.
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 (NCT02039687) — ClinicalTrials.gov, 18 April 2017Checked against the source on .In the phase 2 diabetic macular oedema trial, the authors reported that no serious adverse events or reactions and no anti-cibinetide antibodies were observed, and concluded that the 12-week course was safe.
Included as the counterweight, with its limits stated rather than implied. Nine patients were recruited and eight completed; there was no control arm; and the corresponding registration (NCT06626971) records the study as TERMINATED. A safety conclusion drawn from eight completers in an uncontrolled, terminated study establishes almost nothing about a population — its real value is narrower and genuinely useful: this is the only study on this record that looked for antibodies to the peptide and reported the result. Immunogenicity is the risk FDA repeatedly raises for injected peptides of this size, and here somebody actually measured it, in eight people.
A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema (J Clin Med 2020;9:2225) — PubMed, 14 July 2020“No serious adverse events/reactions or anti-cibinetide antibodies were seen. … The cibinetide 12-week course was safe.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is ARA-290 FDA-approved?
No. ARA-290, whose international nonproprietary name is cibinetide, has no record in Drugs@FDA — searches of FDA's application database for CIBINETIDE as a product active ingredient, as an openFDA generic name, as an openFDA substance name, and as bare free text for both 'cibinetide' and 'ARA-290' all return no matches, while the identical query run as a control on an approved peptide returns its applications. There is no approved indication, no prescribing information and no brand name, because there is no approved product. One thing that is easy to misread: cibinetide DOES appear in FDA's National Drug Code directory, but only as bulk-ingredient listings from active-ingredient suppliers, each flagged in FDA's own data as an unfinished BULK INGREDIENT. An NDC number for a bulk substance is a listing obligation, not an approval.
Drugs@FDA — query for CIBINETIDE as a product active ingredient (openFDA drug/drugsfda) — FDA, 31 July 2026“{ "error": { "code": "NOT_FOUND", "message": "No matches found!" } }”
Checked against the source on .- Can a compounding pharmacy legally make ARA-290?
Not under section 503A. ARA-290 is not on FDA's 503A bulk drug substances list, and a bulk drug substance that is neither the subject of a USP monograph nor a component of an FDA-approved drug must be on that list to be used in 503A compounding. What makes ARA-290 unusual among the peptides sold in this market is that it is not simply absent from FDA's document: it is named in it. The list updated 14 May 2026 carries the entry 'Cibinetide (ARA-290)' under the heading '503A Category 3: Bulk Drug Substances Nominated Without Adequate Support'. Read that precisely. Category 3 is a finding about the nomination — that it did not come with enough information for FDA to evaluate the substance — not a finding that the substance is unsafe, and not a step toward availability. Being in a category on this document is not the same as being on the bulks list, and only the bulks list permits compounding.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“503A Category 3: Bulk Drug Substances Nominated Without Adequate Support … • Cibinetide (ARA-290)”
Checked against the source on .- Is there human evidence that ARA-290 works for small fiber neuropathy?
There is real human data and it is not conclusive. The largest study is a phase 2b, 28-day randomised trial of 64 subjects with sarcoidosis-associated small nerve fiber loss and neuropathic pain, reported by Culver et al. in 2017. Its primary endpoint was a surrogate — corneal nerve fiber area — and the reported result was arm-dependent: 'The placebo-corrected mean change from baseline CNFA (μm2) at day 28 was 109 (95% confidence interval [CI], -429, 647), 697 (159, 1236; P = 0.012), and 431 (-130, 992) in the [lowest], [intermediate] and [highest] arms, respectively.' Two of those three confidence intervals cross zero. On pain, the endpoint a treatment would have to move, the authors reported that pain improved significantly in all groups including placebo, and that the placebo-corrected decrease in subjects with moderate-to-severe pain carried P = 0.157 in the arm they highlight — not a statistically significant separation. The authors' own conclusion was that 'Cibinetide significantly increased small nerve fiber abundance in the cornea and skin, consistent with a disease modifying effect', and their stated purpose was in part to support corneal nerve fiber area as a surrogate endpoint for future trials. No phase 3 trial followed. The arm strengths are replaced with bracketed descriptors above under this site's no-dosing policy; nothing in the finding depends on the figures.
Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain (Invest Ophthalmol Vis Sci 2017;58:BIO52-BIO60) — PubMed, 1 May 2017Checked against the source on .- Is ARA-290 still in clinical development in 2026?
No active development is visible in the trial registry. ClinicalTrials.gov holds three interventional studies of ARA-290 and none is recruiting or active. The only one sponsored by Araim Pharmaceuticals, the phase 2b sarcoidosis trial NCT02039687, has an actual completion date of February 2015. A Karolinska-led study in prediabetes and type 2 diabetes, NCT01933529, sits at status UNKNOWN with its last update posted in September 2015. The third and most recently registered, NCT06626971, is a phase 2 trial of ARA290 in diabetic macular oedema run by the Belfast Health and Social Care Trust with Araim as a collaborator; it is recorded as TERMINATED, and the registration states the reason in its own words: 'Expiry of study drug - no replacement available.' That registration was first posted in October 2024, which can look like recent activity — but the trial itself started in April 2016 and completed in August 2017, so the 2024 date is a retrospective registration, not new work. No phase 3 trial of ARA-290 is registered.
A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema (NCT06626971) — ClinicalTrials.gov, 4 October 2024“Expiry of study drug - no replacement available.”
Checked against the source on .- Was ARA-290 ever tested in people with diabetes?
Yes, in two small studies, neither of which established anything. Brines et al. reported a phase 2 study in 2015 in which subjects with type 2 diabetes and painful neuropathy self-administered ARA 290 or placebo subcutaneously over 28 days and were followed for a further month; the authors reported improvement in HbA1c and lipid profiles and a significant improvement in neuropathic symptoms on the PainDetect questionnaire, and framed their own conclusion as a hypothesis rather than a result — ARA 290 'may benefit both metabolic control and neuropathy in subjects with type 2 diabetes and deserves continued clinical evaluation.' Separately, a phase 2 trial in diabetic macular oedema recruited nine patients, of whom eight completed, and reported no improvement in the primary or main secondary measures — best corrected visual acuity, central retinal thickness, central retinal sensitivity or tear production. A registered study in prediabetes and type 2 diabetes at the Karolinska Institutet, NCT01933529, has never reported results and its registration status is UNKNOWN.
ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes (Mol Med 2015;20:658-66) — PubMed, 13 March 2015“These observations suggest that ARA 290 may benefit both metabolic control and neuropathy in subjects with type 2 diabetes and deserves continued clinical evaluation.”
Checked against the source on .- Is ARA-290 banned in sport?
The 2026 WADA Prohibited List does not name ARA-290 or cibinetide. Downloaded and text-extracted on 2 August 2026, the document returns zero hits for 'ARA', '290' and 'cibinetide'. What it does contain is an open-ended class that an athlete would need to consider: section S2.1, 'ERYTHROPOIETINS (EPO) AND AGENTS AFFECTING ERYTHROPOIESIS', is prefaced 'Including, but not limited to:', and subsection S2.1.5 reads in full 'Innate repair receptor agonists, e.g. asialo EPO; carbamylated EPO (CEPO).' The relevance is that ARA-290's own sponsor-filed trial registration describes the drug as 'A small peptide that activates the innate repair receptor'. Whether a substance that is not named falls inside an open-ended class is a determination for anti-doping authorities and not one this record makes — an athlete subject to a WADA-compliant programme should put the question to their anti-doping organisation rather than infer an answer from the absence of a name.
World Anti-Doping Code International Standard: Prohibited List 2026 — World Anti-Doping Agency, 1 January 2026“S2.1.5 Innate repair receptor agonists, e.g. asialo EPO; carbamylated EPO (CEPO).”
Checked against the source on .- Has ARA-290 been shown to help with injury recovery or tissue repair?
Not in humans. Every trial in which ARA-290 has been administered to people studied neuropathy or an eye condition: sarcoidosis-associated small fiber neuropathy in a randomised pilot reported by Heij et al. in 2012 and again by Dahan et al. in 2013, the 64-subject phase 2b reported by Culver et al. in 2017, type 2 diabetic neuropathy in Brines et al. 2015, diabetic macular oedema in Lois et al. 2020, and emotional processing in 36 healthy volunteers in Cerit et al. 2015. None of them studied wound healing, tendon or ligament injury, muscle recovery or athletic performance. The tissue-repair framing comes from the mechanism — the earliest of those trials describes ARA 290 as 'a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing' — and from a large animal and in-vitro literature. A described mechanism is a reason to run a trial, not a result from one.
Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Mol Med 2012;18:1430-6) — PubMed, 15 November 2012“ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models.”
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