FDA Finalizes Reclassification of Seven Compounded Peptides, April 2026
FDA finalized the reclassification of seven peptides previously available through 503A compounding pharmacies. BPC-157, TB-500, KPV, DSIP, Epitalon, LL-37, Selank, Semax, and Melanotan II are no longer eligible for traditional compounding. Advisory panel for remaining peptides scheduled July 2026.
Truthe take: This is the regulatory event we have been tracking since 2024. Some compounds in our protocols are affected. We have updated our formulary and our patients have been notified. The July panel will determine the next wave.
— FDA.gov
FDA-Approved Antibacterials and Echinocandins
Since 1955, a total of 12 peptide-based drugs with antimicrobial or antifungal properties have received approval from the Food and Drug Administration (FDA). Peptides present a promising opportunity to address serious infections that may be challe...
Al Musaimi O — Antibiotics (Basel, Switzerland)
Tissue-specific mRNA delivery and prime editing with peptide-ionizable lipid nanoparticles
Lipid nanoparticles for mRNA delivery and gene editing have the potential to transform the current therapeutic landscape. Nonetheless, a major bottleneck using this technology is the difficulty in achieving cell- and tissue-specific delivery and a...
Lin Y, Li M, Luo Z et al. — Nature materials
Natural Weight Loss or "Ozempic Face": Demystifying A Social Media Phenomenon
New patients turning to semaglutide (Ozempic® and Wegovy®), a glucagon-like-peptide 1 (GLP-1) agonist, for weight loss, have captivated social media platforms. Wegovy® carries a United States (US) Food and Drug Ad...
Carboni A, Woessner S, Martini O et al. — Journal of drugs in dermatology : JDD
Peptide-drug conjugates: A new paradigm for targeted cancer therapy
Peptide-drug conjugates (PDCs) are the new hope for targeted therapy after antibody-drug conjugates (ADCs). Compared with ADCs, the core advantages of PDCs are enhanced tissue penetration, easier chemical synthesis, and lower production costs. Two...
Wang M, Liu J, Xia M et al. — European journal of medicinal chemistry
Anti-Amyloid Therapies for Alzheimer's Disease and the Amyloid Cascade Hypothesis
Over the past 30 years, the majority of (pre)clinical efforts to find an effective therapy for Alzheimer's disease (AD) focused on clearing the β-amyloid peptide (Aβ) from the brain since, according to the amyloid cascade hypothesis, t...
Fedele E — International journal of molecular sciences
Peptide-drug conjugates (PDCs): a novel trend of research and development on targeted therapy, hype or hope?
Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutics drug after antibody-drug conjugates (ADCs), with the core benefits of enhanced cellular permeability and improved drug selectivity. Two drugs are now approved for mark...
Fu C, Yu L, Miao Y et al. — Acta pharmaceutica Sinica. B
Peptide-based drug discovery: Current status and recent advances
The progressive development of peptides from reaction vessels to life-saving drugs via rigorous preclinical and clinical assessments is fascinating. Peptide therapeutics have gained momentum with the evolution of techniques in peptide chemistry, s...
Sharma K, Sharma KK, Sharma A et al. — Drug discovery today
Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals
Recently, two oral-administered peptide pharmaceuticals, semaglutide and octreotide, have been developed and are considered as a breakthrough in peptide and protein drug delivery system development. In 2019, the Food and Drug Administration (FDA) ...
Kim JC, Park EJ, Na DH et al. — Pharmaceuticals (Basel, Switzerland)
Glucagon-like peptide-1 (GLP-1) receptor agonists and neuroinflammation: Implications for neurodegenerative disease treatment
Chronic, excessive neuroinflammation is a key feature of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). However, neuroinflammatory pathways have yet to be effectively targeted in clinical treatments for s...
Kopp KO, Glotfelty EJ, Li Y et al. — Pharmacological research
FDA-approved bone grafts and bone graft substitute devices in bone regeneration
To induce bone regeneration there is a complex cascade of growth factors. Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. Although, BMP shows promising results as being an alternative to a...
Gillman CE, Jayasuriya AC — Materials science & engineering. C, Materials for biological applications
Prolactin-Releasing Peptide: Physiological and Pharmacological Properties
Prolactin-releasing peptide (PrRP) belongs to the large RF-amide neuropeptide family with a conserved Arg-Phe-amide motif at the C-terminus. PrRP plays a main role in the regulation of food intake and energy expenditure. This review focuses not on...
Pražienková V, Popelová A, Kuneš J et al. — International journal of molecular sciences
Battle of GLP-1 delivery technologies
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) belong to an important therapeutic class for treatment of type 2 diabetes. Six GLP-1 RAs, each utilizing a unique drug delivery strategy, are now approved by the Food and Drug Administration (F...
Yu M, Benjamin MM, Srinivasan S et al. — Advanced drug delivery reviews