LongevityNot approvedEvidence tier: Human RCT

MK-677 (Ibutamoren)

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 310 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

MK-677 (Ibutamoren) in the literature

Non-peptide ghrelin mimetic taken orally that stimulates GH release via GHSR-1a; increases GH pulse amplitude and IGF-1 without affecting cortisol.

What the literature studies

Oral GH Secretagogue

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
3/5

Regulatory record

Status not verified. Status not verified. Exact FDA substance context: Ibutamoren mesylate (MK-677): 503A & 503B Category 2. This record does not specify mesylate; other forms are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1 FDA primary source 2

associated with water retention, increased appetite, and potential insulin resistance at high.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

MK-677 (ibutamoren mesylate) is an oral ghrelin-receptor agonist that raises GH/IGF-1 in humans; it is not FDA-approved, and FDA lists it in Category 2 for compounding because a hip-fracture trial was stopped early over a congestive-heart-failure safety signal.

What it is

A non-peptide, orally active growth hormone secretagogue (ghrelin mimetic) historically coded MK-677 / MK-0677; clinical programs also used the name LUM-201 in other GH-deficiency contexts [R1][R2].

Legal / FDA status (as of Oct 27 2026)

Not FDA-approved for any indication. FDA places ibutamoren mesylate in Category 2 under both 503A and 503B interim compounding policies (503B Dec 29 2022; 503A Sep 29 2023), citing significant safety risk of congestive heart failure in certain patients and the early termination of a randomized hip-fracture recovery trial for a CHF safety signal [FDA-RISK].

Human evidence

  • Daily oral MK-677 stimulated the GH/IGF-1 axis in healthy elderly adults in a controlled study [R1].
  • Multicenter randomized placebo-controlled phase IIb hip-fracture recovery trial of MK-0677 was terminated early because of a potential congestive-heart-failure safety signal [R2][FDA-RISK].
  • No FDA-approved indication for body recomposition, anti-aging, or sleep.

Animal / lab evidence

Ghrelin-pathway pharmacology is well described in animals; animal data do not establish clinical benefit for wellness uses.

Risks and unknowns

FDA-highlighted CHF signal in a vulnerable population [FDA-RISK][R2]. Expected GH-axis effects can include edema, insulin resistance/glucose changes, and other GH-related adverse effects. Gray-market tablets/powders: identity and purity unverified.

What's coming

No pending FDA approval for wellness use identified. Interim peptide/compounding policy review may continue to affect availability of Category 2 substances [OIRA].

Sources

  1. [R1] Chapman IM et al. Stimulation of the growth hormone (GH)-insulin-like growth factor I axis by daily oral administration of a GH secretagogue (MK-677) in healthy elderly subjects. J Clin Endocrinol Metab 1996;81:4249-4257. PMID 8954023
  2. [R2] Adunsky A et al. MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study. Arch Gerontol Geriatr 2011;53:183-189. PMID 21067829
  3. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (ibutamoren mesylate). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  4. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetailsrrid=1568964

Last checked 2026-10-27

Education only. Not medical advice. No dosing guidance. peptidex.ai does not sell peptides or link to sellers.