At a glance
- MK-677 (ibutamoren) is not an FDA-approved drug: Drugs@FDA has no record of it.
- FDA lists it in Category 2, bulk substances that may present significant safety risks in compounding (since December 29, 2022).
- PubMed lists 118 publications mentioning it, including 18 randomized controlled trials and 31 animal-only studies.
- ClinicalTrials.gov lists 8 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 12 reports mentioning it; 10 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Ibutamoren mesylate poses significant safety risks due to the potential for congestive heart failure in certain patients. The agency is aware of a randomized, placebo-controlled trial assessing ibutamoren mesylate for the treatment of patients recovering from hip fracture that “was terminated early due to a potential safety signal of congestive heart failure.” Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Peptides in urology and sexual medicine: clinical effectiveness, dosing, indications, and safety: a narrative review.
- Peptide Supplements and Their Therapeutic Applications in Sports Medicine.
- Striosomal ghrelin receptor activity controls reward-cost integration.
- Rapid and harmonized analytical workflow for the determination of peptidic and non-peptidic doping agents in dried and liquid blood matrices.
- Spontaneous Splenic Rupture in a Patient With Recent Use of Performance-Enhancing Compounds: A Case Report and Literature Review.
- Acute stress suppresses hunger-driven food seeking through PVN activation: Reversal by anxiolytic drug and ghrelin receptor agonist, with anxiolytic-like effects of refeeding.
- Knowing the minimal detectable dose can facilitate the interpretation of a hair test result: II. Case example with ibutamoren (MK-677), a growth hormone secretagogue.
- New directions in growth hormone treatment in children.
- Hepatotoxicity induced by MK-677.
- SARMs, Metabolic Modulators and Growth Hormone Secretagogues in Suspected Illegal Medicines, Bought as Sport Performance Enhancers: A Retro- and Prospective Study Within the GEON.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 8
- Active
- 1
- With posted results
- 2
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency | Recruiting | Phase 3 | May 20, 2026 |
| The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease | Completed | Phase 2 | August 10, 2022 |
| Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects | Withdrawn | Phase 2 | Mar 2009 |
| Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients | Completed | N/A | Aug 2006 |
| Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032) | Terminated | Phase 2 | Sep 2005 |
| Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia | Completed | Phase 2 | Jul 2005 |
| Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED) | Completed | Phase 2 | Oct 2003 |
| Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults | Completed | Phase 1, Phase 2 | Jul 1998 |
All 8 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 12
- Serious
- 10
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.