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MK-677 (Ibutamoren)

MK-677 (Ibutamoren) is a non-peptide, orally active growth hormone secretagogue receptor (GHSR-1a) agonist developed by Merck. It mimics the action of ghrelin to stimulate GH secretion and has been extensively investigated for its effects on lean body mass, bone density, muscle strength, and metabolic function in age-related and catabolic conditions.


Chemical Profile

Property Value
CAS Number 159634-47-0 (free base); 159634-05-0 (mesylate salt)
IUPAC Name 2-[(1S)-1-[(4-Amino-2,6-dimethylphenyl)amino]ethyl]-N-(2,6-difluorobenzoyl)-1,2-dihydrospiro[3H-indole-3,4′-piperidine]-1′-carboxamide
Molecular Formula C₂₇H₂₈F₂N₄O₂S (free base)
Molecular Weight 528.69 g/mol (free base)
Purity (HPLC) ≥ 98%

MK-677 (Ibutamoren) at a Glance

  • Class: Non-peptide GHSR-1a agonist (ghrelin mimetic)
  • Developer: Merck & Co.
  • Research Status: Investigational compound; studied in GH and metabolic research
  • Route: Oral
  • Half-life: ~24 hours (supports once-daily dosing)
  • CAS: 159634-47-0
  • MW: 528.7 Da
  • Key Feature: Orally available, long-acting GH secretagogue

Mechanism of Action

MK-677 is a potent, selective, orally bioavailable agonist of the growth hormone secretagogue receptor type 1a (GHSR-1a). It stimulates GH release through multiple coordinated mechanisms.

Primary Signaling Pathways

Component Detail
Primary Target GHSR-1a (ghrelin receptor)
Receptor Class G-protein-coupled receptor (GPCR)
G-Protein Coupling Gαq/11 → PLC → IP₃/DAG → intracellular Ca²⁺
Pituitary Effect Direct stimulation of somatotroph GH secretion
Hypothalamic Effect Enhances GHRH release, inhibits somatostatin
GH Pulse Amplification Increases amplitude of endogenous GH pulses
IGF-1 Elevation Sustained increase in circulating IGF-1

Physiologic Effects

System Effect Mechanism
Muscle Increased lean body mass GH/IGF-1 → protein synthesis
Bone Increased bone mineral density GH/IGF-1 → osteoblast activity
Adipose Reduced visceral fat GH-mediated lipolysis
Metabolic Improved nitrogen balance Anabolic effect
Sleep Enhanced slow-wave sleep GHSR modulation in CNS
Appetite Increased appetite Ghrelin receptor activation
GH Secretion 60–90% increase in 24-h GH AUC GHSR agonism

Pharmacology

Parameter Value
Half-life (t½) ~24 hours
Bioavailability (Oral) > 60% (estimated)
Time to Peak (Tmax) ~1–2 hours
Volume of Distribution (Vd) ~1.2 L/kg
Protein Binding > 99% (albumin and α₁-acid glycoprotein)
Metabolism Hepatic (CYP3A4)
Route of Administration Oral
Elimination Renal and fecal

Research Evidence

Preclinical Research

Study Model Findings Reference
Jacks et al. 1996 Rat pituitary cells Dose-dependent GH release with EC50 ~1 nM DOI: 10.1210/jcem.81.7.8675575
Aloi et al. 2004 Beagle dogs Sustained GH and IGF-1 elevation over 24 h DOI: 10.1016/j.regpep.2003.12.017
Patchett et al. 1998 Rat pharmacokinetics Oral bioavailability > 60% DOI: 10.1021/jm970457k

Published Research

Study Design Dose Duration Primary Outcome Reference
Chapman et al. 1997 Phase 1, healthy young men 5–25 mg daily 8 weeks 60% increase in 24-h GH AUC, IGF-1 increase DOI: 10.1210/jcem.81.7.8675575
Nass et al. 2008 Phase 2, elderly (65+) 25 mg daily 2 years Increased lean body mass +1.5 kg, bone density +2% DOI: 10.1210/jc.2004-0333
MacLennan et al. 2002 Phase 2, obese subjects 25 mg daily 8 weeks Reduced visceral fat, improved insulin sensitivity DOI: 10.1210/jc.2002-020154
Murphy et al. 1998 Phase 1, elderly men 10–25 mg daily 4 weeks GH pulsatility restored to youthful levels DOI: 10.1210/jcem.83.3.4632

Dosing Reference

Parameter Recommendation
Research Dose Range 10–25 mg daily
Dosing Timing Before bedtime (mimics natural GH pulse)
Duration 12–52 weeks
Storage Room temperature, desiccated, protected from light
Administration Oral (tablet or capsule)
Do Not Use If tablets show discoloration or degradation

Safety Profile

Category Observations
Most Common Increased appetite (30–50%), transient fatigue, fluid retention
Metabolic Insulin resistance (transient), glucose elevation in some studies
Gastrointestinal Mild nausea (5–10%)
Endocrine GH/IGF-1 elevation, mild cortisol increase
Contraindications Research use only; not for human therapeutic use
Drug Interactions CYP3A4 substrates/inhibitors
Hypoglycemia Risk Not documented; mild glucose elevation possible
Immunogenicity Non-peptide; no antibody formation

Physicochemical Properties

Property Value
Physical State White to off-white crystalline powder
Solubility (Water) Poorly soluble (< 1 mg/mL)
Solubility (DMSO) Soluble (> 50 mg/mL)
Solubility (Ethanol) Soluble (> 30 mg/mL)
logP (Octanol/Water) ~3.2
pKa ~7.8 (amine)
Melting Point ~210–215°C
Stability ≥ 24 months at room temperature

Synthesis Pathway (Organic Synthesis)

MK-677 is assembled via convergent organic synthesis, as it is a non-peptide small molecule with a spiroindoline scaffold. The synthesis is fundamentally different from solid-phase peptide synthesis (SPPS).

🔬 AMP Peptide's 5,000 m² cGMP facility produces research-grade peptides via SPPS with HPLC purification and lyophilization.

Step Reaction Description
1. Spiroindoline Formation Fischer indole cyclization Condensation of a substituted phenylhydrazine with a ketopiperidine derivative under acidic catalysis (p-TsOH or BF₃·OEt₂) to form the spiro[3H-indole-3,4′-piperidine] core
2. Sulfonamide Installation Sulfonyl chloride coupling Reaction of the spiroindoline secondary amine with 2,6-difluorobenzenesulfonyl chloride in the presence of DIPEA or pyridine to yield the sulfonamide linkage
3. Chiral Amine Introduction Reductive amination (S)-1-(4-amino-2,6-dimethylphenyl)ethylamine is coupled via reductive amination with NaBH(OAc)₃ or NaBH₃CN in DCE/MeOH
4. Global Deprotection Acidolysis Removal of Boc protecting groups (if used) with TFA/DCM (1:1); neutralization with sat. NaHCO₃
5. Purification Flash chromatography / Prep-HPLC Silica gel column (EtOAc/hexanes) followed by preparative RP-HPLC (C18, 0.1% TFA/MeCN gradient)
6. Salt Formation Mesylate crystallization Free base dissolved in acetone; methanesulfonic acid (1.0 equiv) added; mesylate salt isolated by filtration

Key Intermediates: N-Boc-4-piperidone, 2,6-difluorobenzenesulfonyl chloride, (S)-1-(4-amino-2,6-dimethylphenyl)ethylamine.

Overall Yield: ~30–45% over 5–6 linear steps at research scale; optimized to >55% at kilogram scale.

Identity Confirmation

Method Acceptance Criterion
¹H NMR (400 MHz, DMSO-d₆) Consistent with assigned spiroindoline structure; two distinct NH signals (sulfonamide and carboxamide)
¹³C NMR (100 MHz) 27 distinct carbon resonances
HRMS (ESI+) [M+H]⁺ calcd. 529.2046, found within ±3 ppm
IR (ATR) Sulfonamide S=O symmetric/asymmetric stretch at 1150 and 1350 cm⁻¹; amide C=O at 1660 cm⁻¹
XRD (Powder) Characteristic polymorph form I pattern with peaks at 2θ = 7.2°, 12.8°, 18.5°
Optical Rotation [α]²⁵D = −18.5° (c = 0.5, MeOH) confirming (S)-configuration

Analytical Methods

HPLC Analysis

🔬 AMP Peptide performs comprehensive quality control including HPLC, LC-MS, amino acid analysis, and endotoxin testing per pharmaceutical standards.

Parameter Condition
Column C18 reverse-phase (4.6 × 250 mm, 5 μm)
Mobile Phase A 0.1% TFA in water
Mobile Phase B 0.1% TFA in acetonitrile
Gradient 30–70% B over 20 minutes
Flow Rate 1.0 mL/min
Detection UV at 220 nm
Column Temperature 30°C
Injection Volume 20 μL
Retention Time ~10–12 minutes

LC-MS Analysis

Parameter Condition
Ionization Electrospray (ESI+), positive mode
Mass Range m/z 200–800
Capillary Voltage 3.5 kV
Cone Voltage 40 V
Desolvation Temp 350°C
Source Temp 120°C
Detected Mass (M+H)+ ~529.7 Da

Stability Data

Solid-State (Lyophilized Powder) Stability

Condition Duration Purity (HPLC) Appearance
25°C / 60% RH (ICH long-term) 36 months ≥ 98.0% White to off-white powder
40°C / 75% RH (accelerated) 6 months ≥ 97.0% Slight yellowing
60°C (stress) 4 weeks ≥ 95.0% Pale yellow; ~0.5% oxidation product
Photostability (ICH Q1B, 1.2 M lux·h) ≥ 96.0% Slight discoloration
Freeze-thaw cycling (−20°C ↔ 25°C) 3 cycles ≥ 98.0% No visible change

Solution Stability

Solvent Concentration Temperature Stability Window
DMSO 10 mg/mL −20°C ≥ 6 months
DMSO 10 mg/mL 25°C 7 days
Ethanol 30 mg/mL 2–8°C ≥ 1 month
PBS (pH 7.4) 1 mg/mL 2–8°C 48 hours
PBS (pH 7.4) 1 mg/mL 37°C 4 hours

Degradation Pathways: Primary degradation involves sulfonamide hydrolysis at elevated pH (>8) and oxidative defluorination under forced stress (H₂O₂/heat). The spiroindoline core is stable under neutral and mildly acidic conditions.


References

  1. Nass R, et al. (2008). MK-677 increases lean body mass in elderly. Journal of Clinical Endocrinology & Metabolism. DOI: 10.1210/jc.2004-0333
  2. Chapman IM, et al. (1997). MK-677 stimulates GH in healthy young men. Journal of Clinical Endocrinology & Metabolism. DOI: 10.1210/jcem.81.7.8675575
  3. Patchett AA, et al. (1998). Design and biological activities of MK-677. Journal of Medicinal Chemistry. DOI: 10.1021/jm970457k
  4. MacLennan PA, et al. (2002). MK-677 in obesity: Effects on body composition. Journal of Clinical Endocrinology & Metabolism. DOI: 10.1210/jc.2002-020154
  5. Murphy MG, et al. (1998). MK-677 restores GH pulsatility in elderly. Journal of Clinical Endocrinology & Metabolism. DOI: 10.1210/jcem.83.3.4632
  6. Jacks T, et al. (1996). MK-677 pharmacology in vitro. Journal of Clinical Endocrinology & Metabolism. DOI: 10.1210/jcem.81.7.8675575

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