ოთხშაბათი, აპრილი 15, 2026
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Global Ingredient Risk Index Banned Substance

Ibutamoren (MK-677)

Ibutamoren mesylate

Also known as: MK-677, ibutamoren, L-163,191, Nutrobal

CRITICAL RISK 9.0/10 How?

This ingredient is classified as unclassified risk (GIRI score: 9.0/10).

02

Safety Profile

Known Safety Concerns

  • Unapproved investigational drug — illegal as supplement everywhere
  • FDA warning letters issued
  • Increases IGF-1 — possible cancer growth promotion
  • Insulin resistance and fluid retention documented
  • WADA-prohibited — athletes sanctioned from supplement use

Contraindications

  • Unapproved investigational drug — illegal as supplement everywhere
  • FDA warning letters issued
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03

Interactions

Information not yet available for this ingredient profile.

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04

Evidence and Scientific Findings

Overview

Ingredient Overview

Ibutamoren is an unapproved investigational growth hormone secretagogue sold illegally as a supplement. It stimulates GH and IGF-1 release. No approved human use exists anywhere. The FDA has issued warning letters. It causes insulin resistance, increased appetite, fluid retention, and may promote cancer growth via IGF-1 pathway upregulation. WADA prohibits it. It is widely sold online under the name MK-677 despite being an unapproved drug.

Classification

Biological and Chemical Classification

Scientific Name
Ibutamoren mesylate
Mechanism

Mechanism of Action

Information not yet available for this ingredient profile.

Clinical Evidence

Clinical Evidence of Effectiveness

Information not yet available for this ingredient profile.

Pharmacokinetics

Pharmacokinetics

Information not yet available for this ingredient profile.

Dosage

Recommended Dosage

Information not yet available for this ingredient profile.

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05

SETI — Scientific Evidence Transparency Index

SETI Score 58/100
Risk Level High risk
Scientific Confidence Low
Evidence Strength Limited
Key Benefit Banned Substance
Key Safety Concern Unapproved investigational drug — illegal as supplement everywhere
Evidence Reviewed 2 PubMed studies
Scientific Confidence Low
Based on study quality, consistency, and recency

Executive Summary — Ingredient Assessment

SETI Score 58/100
Risk Level High risk
Evidence Strength Limited
Main Benefit Banned Substance
Main Safety Concern Unapproved investigational drug — illegal as supplement everywhere
Ingredient Ibutamoren (MK-677)
Scientific name Ibutamoren mesylate
Scientific Evidence Overview
  • 2 studies reviewed
  • 0 high-quality studies (meta-analysis or RCT)
  • Main clinical benefit observed: Banned Substance
  • Evidence consistency: High consistency across studies (100%)
Safety Signals
  • Unapproved investigational drug — illegal as supplement everywhere
  • FDA warning letters issued
  • Increases IGF-1 — possible cancer growth promotion
  • Insulin resistance and fluid retention documented
  • WADA-prohibited — athletes sanctioned from supplement use
Evidence Strength Limited
Final Scientific Assessment

The available scientific evidence for Ibutamoren (MK-677) indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.

Ingredient Ibutamoren (MK-677)
Evidence reviewed 2 peer-reviewed studies (last 10 years)
Scientific name Ibutamoren mesylate
58 /100

Total SETI Score

High risk
Evidence quality 2/40
Evidence consistency 20/20
Safety signals 16/20
Study recency 10/10
Evidence transparency 10/10

Evidence Summary

  • 2 studies reviewed
  • 0 high-quality studies (meta-analysis or systematic review)
  • 0 studies identified benefits or no safety concern (GREEN)
  • 2 studies reported limited or advisory safety evidence (YELLOW)

Evidence Policy

Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.

Last updated: 23 მარ 2026, 15:16

Evidence Distribution

2 Other / unclassified
  1. Observational / other LOW evidence YELLOW
    Equine metabolism of the growth hormone secretagogue MK-0677 in vitro and in urine and plasma following oral administration. ↗
    Journal Drug Test Anal
    Year 2022
    Study type Observational / other
    Evidence strength LOW evidence
    Cutler C et al.. Equine metabolism of the growth hormone secretagogue MK-0677 in vitro and in urine and plasma following oral administration.. Drug Test Anal. 2022. PMID:35302297.
  2. Observational / other LOW evidence YELLOW
    The Safety and Efficacy of Growth Hormone Secretagogues. ↗
    Journal Sex Med Rev
    Year 2018
    Study type Observational / other
    Evidence strength LOW evidence
    Sigalos JT et al.. The Safety and Efficacy of Growth Hormone Secretagogues.. Sex Med Rev. 2018. PMID:28400207.
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06

Score Transparency

Q × L × D × S × 10 = 9.0 / 10

The GIRI Score is the product of four independently computed evidence components, each normalised to 0–1, then scaled to 0–10. Every component is derived exclusively from peer-reviewed references and regulatory data — no editorial judgement is applied.

Q
Evidence Quantity 0 / 10
0%

0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.

Method: Q = number of approved references ÷ 10 (capped at 1.0)

L
Evidence Quality 5 / 10
50%

Limited — mostly case reports or animal studies

Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.

D
Evidence Direction 5 / 10
Benefit
Risk
50%

Mixed or neutral — roughly equal benefit and risk signals

Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.

S
Safety Signals 5 / 10
50%

One or more monitoring-level safety signals active

Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.

0Q × 5L × 5D × 5S = 9.0 / 10

Final GIRI Score for Ibutamoren (MK-677). Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.

Full methodology & data sources

The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.

  • References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
  • Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
  • Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
  • Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
07

Risk Level Classification

CRITICAL RISK 9.0/10

Based on available regulatory signals and scientific evidence, this ingredient presents a critical safety concern. Regulatory restrictions or bans are in place in multiple jurisdictions.

LOW
0–3.0
MODERATE
3.0–5.5
HIGH
5.5–7.5
CRITICAL
7.5–10
9.0

The score pin shows exactly where this ingredient falls on the fixed risk scale.

What drove the Critical classification for Ibutamoren (MK-677)

GIRI Score 9.0 / 10

A score of 9.0 places this ingredient in the Critical band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.

Evidence Quantity (Q) 0 / 10 refs

0 approved references.

Evidence Quality (L) 50%

Limited — mostly case reports or animal studies (Level 4–5).

Evidence Direction (D) 50% toward risk

Neutral or mixed — benefit and risk signals roughly balanced.

Safety Signals (S) 0 active signals

No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.

Regulatory Status No restrictions found

No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).

How are the Low / Moderate / High / Critical thresholds defined?

The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:

LevelScoreMeaning
LOW0.0 – 2.9Sparse or predominantly beneficial evidence. No active safety alerts.
MODERATE3.0 – 5.4Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups.
HIGH5.5 – 7.4Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended.
CRITICAL7.5 – 10Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision.

Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.