Daily intelligence on the peptide research industry.

Research Pipeline

Emideltide (DSIP): The Nine-Amino-Acid Sleep Peptide With Five Decades of Mixed Evidence Now Facing Its First FDA Compounding Review

Delta sleep-inducing peptide — designated Emideltide in US regulatory materials — is the least-discussed substance on the FDA Pharmacy Compounding Advisory Committee's July 24 agenda. Its clinical evidence base is older and narrower than many peptides in the grey market, yet it covers two areas of genuine unmet need: treatment-resistant insomnia and opioid withdrawal. FDA staff scientists have already recommended against listing it, setting up a pointed test of how the reconstituted advisory…

25 Jul 2026

Research Pipeline

TB-500: The Thymosin Beta-4 Fragment Facing a Hostile FDA Briefing Document Four Days Before Its First Compounding Vote

TB-500, a synthetic seven-amino-acid fragment of thymosin beta-4, is scheduled for review by the FDA's Pharmacy Compounding Advisory Committee on 23 July 2026. The agency's pre-published briefing document proposes that neither the free base nor the acetate form be added to the 503A Bulk Drug Substances List, citing failures of chemical characterisation and an absence of adequate human clinical evidence for wound healing.

25 Jul 2026

Research Pipeline

Epitalon: The Telomere Tetrapeptide Heading Into Its First FDA Compounding Vote Tomorrow

Epitalon — a synthetic four-amino-acid peptide derived from pineal gland extract — faces its first formal FDA compounding review on 24 July 2026, the second day of the PCAC meeting at White Oak. With fresh independent evidence from a 2025 Biogerontology study, a negative FDA staff recommendation, and reported conflicts of interest on the panel itself, the regulatory moment is more contested than the peptide's three decades of largely preclinical research would suggest.

25 Jul 2026

Research Pipeline

Tesamorelin: The Only FDA-Approved GHRH Peptide — and What Its Regulatory Journey Tells the Research Community

Tesamorelin (Egrifta) stands apart from the peptides currently before the FDA's Pharmacy Compounding Advisory Committee: it already holds three successive FDA approvals, backed by Phase III randomised controlled trials. Understanding how it got there — and what that means for compounding access, off-label research, and the GHRH class more broadly — is increasingly relevant for procurement professionals as the July 2026 PCAC meeting unfolds.

25 Jul 2026

Research Pipeline

BPC-157: A 2026 Evidence Update on the Synthetic Pentadecapeptide Heading Into Its First Formal FDA Compounding Review

BPC-157 enters the 23–24 July 2026 FDA Pharmacy Compounding Advisory Committee meeting with a growing preclinical record, a fresh 2026 systematic review in PMC, and a newly registered Phase 2 randomised controlled trial — but still no published, independent RCT data in humans. This briefing sets out what UK research-procurement teams need to know about the peptide's mechanism, evidence base, and regulatory status on both sides of the Atlantic.

13 Jul 2026

Research Pipeline

Epitalon: The Pineal Tetrapeptide With Four Decades of Russian Research Now Facing Its First FDA Compounding Review

Epitalon — a four-amino-acid synthetic peptide derived from pineal gland extracts — is scheduled for review by the FDA's Pharmacy Compounding Advisory Committee on 24 July 2026. With a research base spanning 40 years, proposed mechanisms ranging from telomerase activation to melatonin restoration, and an unresolved carcinogenicity question, it presents one of the most scientifically nuanced cases on the PCAC's agenda.

11 Jul 2026

Research Pipeline

CJC-1295 and Ipamorelin: The Dual-Pathway GH Secretagogue Stack With a Decade of Preclinical Evidence and an Unresolved Regulatory Position

CJC-1295 and ipamorelin are among the most studied growth-hormone secretagogue peptides available for research procurement, each targeting a distinct receptor pathway. This briefing examines the pharmacology, available clinical evidence, US compounding status, MHRA position, and WADA classification that procurement teams need to understand before acquiring either compound.

09 Jul 2026

Research Pipeline

TB-500: The Thymosin Beta-4 Fragment With Deep Preclinical Roots and a Critical FDA Compounding Vote Fifteen Days Away

TB-500, a synthetic seven-amino-acid fragment of the endogenous protein thymosin beta-4, enters its most consequential regulatory moment on 23 July 2026, when the FDA's Pharmacy Compounding Advisory Committee votes on whether to recommend it for the Section 503A Bulk Drug Substances List. A June 2026 scoping review in Applied Sciences maps the evidence base: rich preclinical data, established veterinary use, and a critical absence of human RCTs for the injectable fragment itself — precisely…

08 Jul 2026

Research Pipeline

Semax: The ACTH-Derived Neuropeptide With 30 Years of Russian Clinical Use Now Facing Its First FDA Compounding Review

Semax is a synthetic heptapeptide derived from ACTH(4-10) with over three decades of approved clinical use in Russia for stroke recovery and cerebral ischaemia. The FDA's Pharmacy Compounding Advisory Committee is scheduled to review it on 24 July 2026 — and the agency's own briefing documents, published last week, propose against listing it on the 503A Bulks List, citing insufficient human safety and efficacy data for injectable routes. Here is what the evidence record and regulatory outlook…

06 Jul 2026

Research Pipeline

Emideltide (DSIP): The 50-Year-Old Sleep Neuropeptide Facing Its First US Regulatory Scrutiny at the July 2026 PCAC

Emideltide — the FDA's compounding name for delta sleep-inducing peptide (DSIP) — is scheduled for review by the Pharmacy Compounding Advisory Committee on 24 July 2026. Despite more than four decades of sporadic research into sleep regulation and opioid withdrawal, its mechanistic basis remains poorly characterised and no randomised controlled human trial data exist. This briefing examines what the evidence base actually contains, where the regulatory process stands, and what…

05 Jul 2026

Research Pipeline

MOTS-c: The Mitochondrial Peptide at the Centre of the July 2026 PCAC Review

MOTS-c, a 16-amino-acid peptide encoded by mitochondrial DNA, is one of four compounds scheduled for discussion on Day 1 of the FDA's Pharmacy Compounding Advisory Committee meeting on 23 July 2026. With the deadline for oral testimony registration falling on 30 June, UK research-procurement professionals have a narrow window to understand what the evidence base actually shows — and what a favourable committee recommendation would and would not mean.

04 Jul 2026

Research Pipeline

KPV: The Alpha-MSH Tripeptide With a 20-Year Preclinical Record Now Facing Its First Formal FDA Compounding Review

KPV (Lys-Pro-Val) is a three-amino-acid fragment of alpha-melanocyte-stimulating hormone with roughly two decades of preclinical data on gut and skin inflammation — but no completed human clinical trials. The FDA's Pharmacy Compounding Advisory Committee will review it for the 503A Bulk Drug Substances List on 23 July 2026, the most significant regulatory event in its history. Here is what the evidence shows and what the outcome may mean for research procurement in the UK and US.

01 Jul 2026