FDA advisory committee backs two more peptides, rejects one for compounding list
By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked to review to the list of bulk drug substances that can be used in pharmacy compounding.
The committee voted in favor all four of the substances—BPC-157, KPV, TB 500, and MOTS-c—it considered during a session that ran hours late on Thursday. On Friday, the committee voted in support of two of the three peptides on the docket, epitalon and semax, while it rejected adding emideltide to the list. (RELATED: FDA advisory committee backs two controversial peptides, Regulatory Focus 23 July 2026)
The committee's favorable endorsement of these six peptides on Friday aligns with the views of Secretary of Health and Human Services (DHS) Robert F. Kennedy, who has advocated for their more widespread use. FDA will ultimately determine whether to approve or reject the committee’s recommendations.
The committee voted against recommending emideltide for inclusion on the 503A Bulks List in a narrow 6-7 vote with one abstention. Emideltide was proposed for treating insomnia, narcotic dependence, and opioid withdrawal. In contrast, the committee recommended epitalon for inclusion on the list to treat insomnia, with a vote of 7-5 in favor with one abstention. Semax also received the committee’s backing for treating cerebral ischemia, migraine, and trigeminal neuralgia with an 8-5 vote.
These seven peptides are not part of a USP/NGF monograph or an approved drug product. During the two-day meeting, FDA officials voiced their reservations about the nominations to place the peptides on the 503A Bulks List. Many of these peptides were restricted from compounding due to a reclassification that occurred in 2023.
Emideltide
In its briefing package, FDA said there was not enough evidence to support emideltide’s inclusion on the bulk list. FDA said that the peptide is not adequately characterized and has the potential for peptide-related impurities due to incomplete coupling reactions, truncations, or side reactions.
The briefing package further notes that there are currently available FDA-approved therapies for the treatment of insomnia, narcolepsy, and opioid withdrawal.
FDA’s Katie Park said that “there is a lack of safety and efficacy data to support using emideltide for treating insomnia, narcolepsy and opioid use disorder.”
During the open public hearing, witnesses presented mixed views on whether this compound should be approved.
John Hertig, the chair of the board of the Collaborative for Evidence-Based Medicines (CEBM), said that “there is a significant lack of evidence” with this substance. He added that “the last study on this was 30 years old. It should not be shifted to routine care. I say no.”
Yet, Ricardo Rossello, the former governor of Puerto Rico supported its inclusion on the list. He said that “there is a cost of doing nothing. I served as ten years of governor. The 2023 restrictions did not raise the standards, they abandoned them.”
During the discussion period following the vote, advisory committee member addressed their rationale for the vote.
Advisory Committee member Kevin Zacharoff, an anesthesiologist, and clinical assistant professor at the Renaissance School of School of Medicine at Stony Brook University, explained his vote against the substance. “As a clinician, it’s impossible for me not to take FDA’s recommendations to heart with respect to safety and efficacy” data, he said.
Committee member Tod Durham, senior vice president of the Foundation for Fighting Blindness, said that “I voted ‘no’ primarily for low-quality evidence around efficacy,” and noted that there are approved drugs for these uses.
Though committee member Robert Harshbarger, a Tennessee state senator said that emideltide should be available with a valid prescription.
Epitalon
As it did the previous day, the advisory committee voted to override FDA staff objections and recommended that epitalon be placed on the list with a vote of 7-5, with one member abstaining.
In its briefing package, FDA staff mentioned multiple concerns with placing this substance on the bulks drug list. FDA There are no publications that discussed efficacy of epitalon administered in patients with insomnia. Officials also cited a lack of evidence to support the effectiveness of epitalon for the proposed use of insomnia, a disorder which increases the risk for serious conditions.
Epitalon also poses a risk for immunogenicity, potentially amplified by aggregation, as well as potential peptide-related impurities.
Yet the committee overrode the objections of FDA and voted to add epitalon to the list.
Committee member David Pope, a pharmacist with XiFin Pharmacy Solutions, said that he voted for the substance because “a physician and pharmacist are key to judging the risk to determine if the peptide is right” for a patient.
Yet other members disagreed. Brian Serumaga, director of personalized medicines at the US Pharmacopeia, voted to reject epitalon due to concerns about the lack of data characterizing this substance.
Durham said that he voted no because of “poor characterization” of the compound and the “potential risk with carcinogenicity.”
William Zamboni, a pharmacologist at the University of North Carolina said that he voted no because he felt there “was a significant lack of data on the safety of the product.”
