Epitalon brings the longevity-peptide audience to the July 24 meeting, with separate free-base and acetate votes scheduled for the 503A Bulks List.
Epitalon reaches the PCAC stage on July 24 with one of the strongest longevity followings in the peptide world.
FDA scheduled separate questions for Epitalon free base and Epitalon acetate. The agency's review centers on insomnia.
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.
PCAC will vote independently on the free-base and acetate forms for the Section 503A Bulks List.
Why the Epitalon PCAC vote matters
Epitalon gives Day 2 a direct bridge between sleep and longevity. A favorable committee recommendation would create momentum for a regulated compounding route through the 503A Bulks List process.
That is the same path BPC-157, KPV, and TB-500 moved toward with favorable Day 1 results.
Watch the Epitalon vote
The July 24 PCAC meeting begins at 8 a.m. Eastern. Watch the official FDA webcast and follow the result on Rebody's PCAC peptide tracker.
Read the complete PCAC Day 2 preview.
Epitalon PCAC FAQ
When is the Epitalon PCAC vote?
Epitalon is scheduled for the July 24 PCAC meeting, which begins at 8 a.m. Eastern.
Which Epitalon forms are being reviewed?
PCAC will consider Epitalon free base and Epitalon acetate separately.
What use did FDA review for Epitalon?
FDA reviewed Epitalon-related bulk drug substances for insomnia.