Epitalon received a favorable PCAC recommendation with 7 yes votes, 4 no votes, and 1 abstention.
Epitalon won a favorable recommendation at FDA's July 2026 PCAC meeting. The 7–4–1 tally is the fifth favorable peptide result across the two-day meeting.
The vote is advisory. It does not itself add Epitalon to the Section 503A Bulks List or make Epitalon an FDA-approved drug.
What is Epitalon?
Epitalon is a synthetic tetrapeptide composed of four amino acids: alanine, glutamic acid, aspartic acid, and glycine. It is also written as Epithalon in some literature.
The peptide was developed from research connected to the pineal gland, which helps explain why sleep, circadian rhythm, and longevity interest often converge around it.
What FDA reviewed for Epitalon
FDA evaluated Epitalon-related bulk drug substances for insomnia. The nomination materials included subcutaneous injection proposals at 10 mg/mL and 3,000 mcg/mL.
The committee considered the nominated Epitalon forms for the Section 503A Bulks List.
Why the Epitalon PCAC vote matters
Epitalon gives Day 2 a direct bridge between sleep and longevity. The favorable recommendation creates momentum for FDA consideration through the 503A Bulks List process.
The Epitalon PCAC tally
- Yes: 7
- No: 4
- Abstain: 1
What happens after the vote
FDA considers PCAC's advice as part of the federal rulemaking record. The Section 503A Bulks List does not change until FDA completes that process.
Watch the official FDA webcast and follow every tally on Rebody's PCAC peptide tracker.
For the complete Friday scoreboard, read PCAC Day 2 results.
Epitalon PCAC FAQ
How did PCAC vote on Epitalon?
Epitalon received 7 yes votes, 4 no votes, and 1 abstention, a favorable recommendation.
Does the vote make Epitalon FDA-approved?
No. PCAC's recommendation is advisory and is not FDA approval or a final change to the 503A Bulks List.
What use did FDA review for Epitalon?
FDA reviewed Epitalon-related bulk drug substances for insomnia.