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We 're taking a break from the usual corrections-focused talks for a broader look at emerging gray market peptide therapies. While GLP-1s have enjoyed a celebrity and social media-fueled blockbuster status with their demonstrated effects on weight loss and diabetes, their unapproved peptide cousins with nebulous names like BPC-157, TB-500, and MOTS-c are growing in popularity thanks in part to wellness influencers touting them as biohacks for injury recovery, muscle growth, and more.
Chris looks at the science behind peptides as a whole and their amazing history in the annals of medicine, before focusing in on the history of some gray market agents and where the research stands on their use and supposed effectiveness. He also digs into some recent regulatory controversies related to the compounding of peptide therapies and what it all means for consumers.
Before that, we review some key clinical updates:
The First mRNA Flu Vaccine
Mounjaro’s New Cardiovascular Indication
A New Single Tablet HIV Switch Option
Levetiracetam Updates
And in our Trivia Capsule segment, we look back at the development of insulin, one the most consequential peptide therapies of all time.
Sponsor Links:
Music in this Episode:
The Retro Synth by Art Haiz
Vitals & Headlines (Suno AI)
Breezy Thoughts (Suno AI)
Trivia Time Ticker (Suno AI)
References/Further Reading:
Into the Clinic:
General
OPTICS Clinical Watch – August 2026. Office of Pharmacy Therapeutics and Integrated Clinical Services, Diamond Pharmacy Services; 2026.
mFLUSIVA (mRNA-1010)
mFLUSIVA. FDA approval letter and clinical review. U.S. Food and Drug Administration. August 5, 2026.
FDAapproves mFlusiva, the first mRNA-based influenza vaccine. Pharmacy Times.August 2026.
mFLUSIVA receives FDA approval for influenza in adults 50 and older. HCPLive. August2026.
Centers for Disease Control and Prevention. 2024–2025 influenza season summary: severity, disease burden, and burden prevented. CDC; 2025.
Mounjaro (tirzepatide) — Cardiovascular Indication
FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. Eli Lilly and Company. August 28, 2026.
FDA expands tirzepatide label for cardiovascular risk reduction in type 2 diabetes. Patient Care Online. August 28, 2026.
Lilly joins Novo in cardiovascular space after FDA nod for GLP-1/GIP agonist Mounjaro. BioSpace. August 28, 2026.
Nicholls SJ, Pavo I, Bhatt DL, et al. Cardiovascular outcomes with tirzepatide versus dulaglutide in type 2 diabetes. N Engl J Med. 2025.
Bixlenvo (bictegravir/lenacapavir)
U.S. FDA approves Gilead’s Bixlenvo, a new once-daily single tablet option forvirologically suppressed adults with HIV, including those on complex regimens.Gilead Sciences, Inc. August 27, 2026.
FDA approves Gilead HIV pill Bixlenvo designed to simplify treatment. CNBC. August 27, 2026.
FDA approves Gilead’s new single tablet HIV regimen. Benzinga. August 31, 2026.
Levetiracetam–DOAC Interaction
Schubert KM, et al. Safety of antiseizure medications during direct oral anticoagulanttherapy in epilepsy. JAMA Neurol. Published online August 17, 2026.
Antiseizure med linked to a twofold increased thromboembolic risk with DOACs. Medscape Medical News. August 24, 2026.
Peptides Discussion
Peptide Basics and History (Q1–Q2)
Definition of the term “biological product.” Final rule. Fed Regist. 2020;85(35):10057-10068.
Knudsen LB, Lau J. The discovery and development of liraglutide and semaglutide. Front Endocrinol (Lausanne). 2019;10:155.
du Vigneaud V, Ressler C, Swan JM, Roberts CW, Katsoyannis PG, Gordon S. The synthesis of an octapeptide amide with the hormonal activity of oxytocin. J Am Chem Soc. 1953;75(19):4879-4880.
Merrifield RB. Solid phase peptide synthesis. I. The synthesis of a tetrapeptide. J Am Chem Soc. 1963;85(14):2149-2154.
Eng J, Kleinman WA, Singh L, Singh G, Raufman JP. Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. J Biol Chem. 1992;267(11):7402-7405.
Lau JL, Dunn MK. Therapeutic peptides: historical perspectives, current development trends, and future directions. Bioorg Med Chem. 2018;26(10):2700-2707.
Wang L, Wang N, Zhang W, et al. Therapeutic peptides: current applications and future directions. Signal Transduct Target Ther. 2022;7(1):48.
Gray-Market Peptides: Profiles, Evidence, and Safety (Q3–Q4)
Vasireddi N, Hahamyan H, Salata MJ, et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. HSS J. 2025;21(4). doi:10.1177/15563316251355551
Józwiak M, Bauer M, Kamysz W, Kleczkowska P. Multifunctionality and possible medical application of the BPC 157 peptide—literature and patent review. Pharmaceuticals (Basel). 2025;18(2):185.
Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443-454.
Mendias CL, Awan TM. Safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance. Sports Med. 2026.
U.S. Food and Drug Administration. July 23–24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — meeting materials and FDA briefing documents (BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax, Epitalon). 2026.
Damon A. Investigation underway after two women fell ill at RAADFest, a Las Vegas anti-aging conference. ProPublica. 2025.
Nevada regulators fine peptide providers at anti-aging festival where two women became critically ill. MM+M. March 2026.
World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026 (S0 Non-Approved Substances; S2.3 Growth Factors — thymosin-β4 and derivatives, e.g., TB-500). 2026.
Compounding and Regulatory Landscape (Q5)
U.S. Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A of the FD&C Act (interim categories). Updated 2026.
Snow CD, Palmer KL. FDA’s pep(tide) rally! What compounders and industry need to know (post 1 of 2). FDA Law Blog (Hyman, Phelps & McNamara). April 21, 2026.
Ault A. FDA expert panel backs compounding of six peptides. Medscape. July 28, 2026.
FDA panel supports broadening access to peptides. NPR. July 23, 2026.
FDA peptide review could lead to new compounding boom. Axios. July 23, 2026.
FDA’s advisory committee votes on peptides: what it does and doesn’t do. Mintz. July 2026.
Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. McDermott Will & Schulte. July 28, 2026.
FDA on peptides: a new landscape for compounders. Latham & Watkins LLP. August 2026.
Looking Ahead (Q7)
FDA approves Foundayo, an oral GLP-1, for adults with obesity. Healio. April 1, 2026.
Retatrutide delivers up to 22.6% weight loss in two new phase III trials. PharmExec. August 2026.
Lilly’s retatrutide displays positive topline results in successful phase III trial (TRIUMPH-4). PharmExec. 2025.
Jastreboff AM, Kaplan LM, Frías JP, et al. Triple-hormone-receptor agonist retatrutide for obesity — a phase 2 trial. N Engl J Med. 2023.
Bajaj HS, Welch M, Shah P, et al. Efficacy and safety of retatrutide in people with type 2 diabetes and inadequate glycaemic control with diet and exercise. Lancet. 2026.
Trivia Capsule - The History of Insulin
Bliss M. The Discovery of Insulin. 25th anniversary ed. University of Chicago Press; 2007.
Banting FG, Best CH, Collip JB, Campbell WR, Fletcher AA. Pancreatic extracts in the treatment of diabetes mellitus. Can Med Assoc J. 1922;12(3):141-146.
The Nobel Prize in Physiology or Medicine 1923. NobelPrize.org. Nobel Prize Outreach.
The Nobel Prize in Chemistry 1958 (Frederick Sanger). NobelPrize.org. Nobel Prize Outreach.
Johnson IS. Human insulin from recombinant DNA technology. Science. 1983;219(4585):632-637.
Definition of the term “biological product.” Final rule. Fed Regist. 2020;85(35):10057-10068.
