FDA Peptide Tracker

MK-677 (Ibutamoren): live FDA regulatory status

GH secretagogue · oral · Category 2

The two signals

Plain-English verdict: red.

Regulatory status: Category 2 (interim 503A policy) · may present significant safety risks.

These two never collapse into one. Removal from a list is not the same as legal-to-compound, and neither is the same as available.

Availability at Peptós.LIFE

Education only

What happens next

No scheduled FDA review

Regulatory timeline

MK-677 (Ibutamoren): common questions

Is MK-677 legal in 2026?
No. Ibutamoren mesylate is named on FDA’s current Category 2 list — bulk drug substances FDA has identified as potentially presenting significant safety risks in compounding. A 503A pharmacy cannot lawfully compound from it. FDA also recommended against adding it to the 503A Bulks Regulation at the October 29, 2024 advisory meeting.
Can I get MK-677 right now?
No. MK-677 is education-only at Peptós.LIFE. We do not offer it and we will not put it on a waitlist we do not expect to be able to fill.
Why is MK-677 listed if it is not available?
Because people search for it and deserve a straight answer with a source on it. Tracking a molecule is not the same as offering it. This row exists because the two substances actually in Category 2 were the two the tracker did not cover.
What happens next for MK-677?
Nothing is scheduled. No FDA review is on the calendar for it, and we will update this page the day the FDA does anything that changes that.

PCAC is advisory: its Jul 2026 recommendation leads to rulemaking, not instant availability. A favorable advisory vote is a recommendation, not FDA approval or authorization to compound. Realistic earliest legitimate access is late 2026 into 2027. Reclassification is not the same as FDA approval. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality, where that applies, we say so, plainly.

Primary source: FDA source record

See the full status board or this molecule's knowledge-base monograph.

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Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.