Is GB-115 (Ranquilon) approved as a medicine, and where?

The regulatory review of GB-115 (Ranquilon) is incomplete. See the article's sources for product- and country-specific findings and remaining uncertainties. Review status means neither worldwide approval nor worldwide absence of approval.

What is GB-115 (Ranquilon) studied for?

GB-115 (Ranquilon) is most often discussed in the context of cognition, mood & sleep. Being studied for an area does not mean it is proven or approved for it.

Does GB-115 (Ranquilon) have human clinical trials?

The evidence review of GB-115 (Ranquilon) is in progress. The article's study appraisal identifies any human studies located and their limitations. An ongoing review does not itself mean that human studies are absent.

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Nootropic & Neuropeptides

GB-115 (Ranquilon)

GB115; ГБ-115; Ranquilon; Ранквилон

4 min read · Updated September 9, 2026 · 12 references

Curated by PeptideInfo Wikilast reviewed September 9, 2026how we verify

Explored forCognition, mood & sleep

GB-115, also known as Ranquilon, has been studied in humans, but the trials examined different patient groups. Reporting inconsistencies and conflicting molecular identity descriptions in preclinical and clinical sources limit interpretation. Editorial review pending.

Body & signals →

No receptor relationship mapped here yet. This does not mean the molecule has no biological effects.

Review pending

Contents5

Section 1 of 5What is GB-115 / Ranquilon?

What is GB-115 / Ranquilon?

GB-115 (ГБ-115), also known as Ranquilon (Ранквилон), is linked in the clinical sources to N-(6-phenylhexanoyl)glycyl-L-tryptophan amide. Evidence for the studied tablets does not establish the identity or equivalence of products sold under the same name. C01 (opens in a new tab)

Investigators describe a mechanism involving cholecystokinin (CCK). This review has not established receptor-subtype selectivity; a plausible mechanism is not clinical proof. C11 (opens in a new tab)

Section 2 of 5Why is the molecular identity uncertain?

Why is the molecular identity uncertain?

An unresolved identity discrepancy limits interpretation: the 2013 report prints D-Trp in its GB-115 structure, whereas the clinical sources specify an L-tryptophan derivative. This may be a typographical error, but that has not been established. We therefore do not transfer its affinity constants to the clinical product or present receptor selectivity as settled. The methods of a 2011 paper also print D-Trp. S14 (opens in a new tab) C15 (opens in a new tab)

A 2007 study in mice and rats described GB-115 as a CCK2 antagonist. Naloxone, an opioid-receptor blocker, did not block its effect on anxiety-like behavior. That experiment examines a behavioral response; it does not itself measure receptor-subtype binding or establish how the clinical product acts in humans. C13 (opens in a new tab)

A 2013 conference report screened 109 recombinant human and rat receptors in CHO and HEK-293 cells. It reported low-affinity interactions with CCK1, BRS3 and kappa-opioid receptors, with functional CCK1/BRS3 antagonism and rat kappa-opioid agonism; no CCK2 affinity was demonstrated in that screen. These are preclinical results, not proof that those targets are engaged at clinical exposure levels in humans. C14 (opens in a new tab)

Section 3 of 5Which patients were studied, and what were the results?

Which patients were studied, and what were the results?

What did the uncontrolled pilot show?

The 2019 pilot included 31 patients with generalized anxiety disorder (GAD), treated for 21 days without a placebo (placebo: a comparison treatment without the active substance being tested) control. Improvement in this design cannot establish that the drug caused the change. C02 (opens in a new tab)

What did the food-effect study examine?

A 2023 phase I report describes a food-effect crossover study in 26 healthy volunteers. It addresses pharmacokinetics (how a substance is absorbed, distributed, broken down and removed by the body), not anxiety relief. C03 (opens in a new tab)

Which dose differed from placebo?

The 2023 phase II publication reports 168 randomized participants in four groups over 28 days. Its primary endpoint was clinician-rated improvement (CGI-i). Only the middle dose significantly exceeded placebo on that endpoint; more drug did not produce a demonstrated, steadily increasing benefit. See this study and its limitations. C04 (opens in a new tab)

What did the larger controlled trial show?

The 2024 phase III publication reports 220 randomized participants and 28 days of treatment. Response meant at least a 50% reduction in HARS anxiety score at day 29: 77/110 responded on Ranquilon versus 27/110 on placebo. Crucially, this study concerned neurasthenia or adjustment disorders and excluded GAD; it is not controlled confirmation of the GAD pilot. See this study and its limitations. C05 (opens in a new tab)

Why is the reported effect estimate uncertain?

The phase III paper contains an inconsistency in the label/value of its reported effect measure. The raw response counts above are retained, but its disputed odds ratio and confidence interval are not presented as reliable estimates. C12 (opens in a new tab)

How far can these results be generalized?

Company involvement, selected populations and short follow-up limit interpretation. This review has not established independent replication or long-term benefit. C06 (opens in a new tab)

Section 4 of 5What do we know about safety and the remaining evidence gaps?

What do we know about safety and the remaining evidence gaps?

Phase III reported 43 adverse events in 28 treated patients versus 21 events in 16 placebo patients, with no serious events reported. A non-significant comparison does not prove equivalent safety. C07 (opens in a new tab)

A 2026 open-label phase IV publication reports 200 randomized participants against an active comparator. Only its abstract and references were reviewed. Conflicting patient totals and percentages, plus a mismatch with the older registry snapshot, remain unresolved; no combined efficacy estimate is given here. C08 (opens in a new tab)

The manufacturer's leaflet lists reversible deterioration of visual acuity with unknown frequency, as well as somnolence and dizziness. The compound should not be described as free of side effects. C09 (opens in a new tab)

Section 5 of 5What does the register entry establish?

What does the register entry establish?

The official Russian register lists Ranquilon tablets of 1 mg and 2 mg, registration ЛП-№(004206)-(РГ-RU), dated 2023-12-29, held by Valenta Pharm. The latest full product information has not been retrieved; the reviewed manufacturer's leaflet is an older document. A register listing does not extend approval to other products or jurisdictions. This candidate makes no sports-eligibility claim and provides no self-treatment regimen. C10 (opens in a new tab)

Studies at a glance

Selected studies from this article. Results apply to the populations and outcomes studied; this is not a systematic literature review.

2023 · CGI-i

Participants or model: 168 randomized participants with neurasthenia or adjustment disorders; not a GAD confirmation study.
Design: Phase II, four groups, placebo comparison, 28 days; primary endpoint CGI-i.
Reported result: Only the middle dose significantly exceeded placebo on clinician-rated improvement.
Limitation: No demonstrated steadily increasing dose-response. Company involvement and short follow-up limit interpretation.

Material reviewed: Selected full-text sections

Return to the explanation Read source

2024 · HARS

Participants or model: 220 randomized participants with neurasthenia or adjustment disorders; GAD excluded.
Design: Phase III, placebo comparison, 28 days; response at day 29 required at least a 50% HARS reduction.
Reported result: 77/110 responded on Ranquilon versus 27/110 on placebo.
Limitation: The reported effect-measure label/value is inconsistent; the disputed odds ratio and interval are withheld. Company involvement and short follow-up limit interpretation; response is not proof of safety.

Material reviewed: Selected full-text sections

Return to the explanation Read source

References12

References

1.
GB-115 rodent behavioral study (2007) — 2007. source
2.
GB-115 receptor assays — conference proceedings (2013), pp. 196–197 — 2013. source
3.
GB-115 clinical pilot (2019) — 2019. source
4.
Ranquilon phase I food-effect study (2023) — 2023. source
5.
Ranquilon phase II randomized trial (2023) — 2023. source
6.
Ranquilon phase III randomized trial (2024) — 2024. source
7.
ClinicalTrials.gov NCT05586789 source
8.
Ranquilon phase IV publication — abstract (2026) — 2026. source
9.
ClinicalTrials.gov NCT06843044 source
10.
Ranquilon manufacturer patient leaflet — older version source
11.
Official Russian EAEU product-information register — search Ранквилон source
12.
S14: Kolik (2011) source

Frequently asked questions4

Frequently asked questions

What is GB-115 (Ranquilon)?: GB-115, also known as Ranquilon, has been studied in humans, but the trials examined different patient groups. Reporting inconsistencies and conflicting molecular identity descriptions in preclinical and clinical sources limit interpretation. Editorial review pending.
Is GB-115 (Ranquilon) approved as a medicine, and where?: The regulatory review of GB-115 (Ranquilon) is incomplete. See the article's sources for product- and country-specific findings and remaining uncertainties. Review status means neither worldwide approval nor worldwide absence of approval.
What is GB-115 (Ranquilon) studied for?: GB-115 (Ranquilon) is most often discussed in the context of cognition, mood & sleep. Being studied for an area does not mean it is proven or approved for it.
Does GB-115 (Ranquilon) have human clinical trials?: The evidence review of GB-115 (Ranquilon) is in progress. The article's study appraisal identifies any human studies located and their limitations. An ongoing review does not itself mean that human studies are absent.

Educational disclaimer. This article summarizes published research for informational purposes and is not medical advice. The editorial review of GB-115 (Ranquilon) is incomplete. Source-supported findings and remaining uncertainties are stated in the article; review status does not certify approval, safety or suitability for use. Consult a qualified healthcare professional before making health decisions.