16 tracked items, each linked to its source. Informational only.
Melanotan II remains subject to standing safety warnings from the TGA, US FDA and UK MHRA, particularly regarding changes to moles and skin-cancer surveillance risk, alongside its unapproved status in all three jurisdictions.
TGA / FDA / MHRA (standing advisories) ↗The FDA maintains a list of bulk drug substances nominated for use in compounding under section 503A. Peptide nominations and their Category 1/2 placement determine whether compounding pharmacies may legally prepare a given peptide; this list is the central US regulatory lever for research-peptide access.
U.S. FDA ↗Sport Integrity Australia maintains education noting that many peptides (GH secretagogues/releasing peptides, GHRH analogues, thymosin beta-4/TB-500, IGF-1 analogues, HCG in males) are prohibited in sport at all times under the WADA framework, independent of TGA scheduling.
Sport Integrity Australia ↗Clinical development of ACE-031 (soluble ACVR2B-Fc myostatin trap) for muscular dystrophy was discontinued, with reported off-target vascular/bleeding effects (epistaxis, telangiectasia) contributing — a cautionary data point frequently cited in myostatin-inhibition discussion.
clinical-development literature ↗The FDA's Pharmacy Compounding Advisory Committee scheduled a July 23-24, 2026 meeting to discuss bulk drug substances being considered for the 503A Bulks List, including BPC-157-related, KPV-related, TB-500-related and MOTS-c-related substances.
U.S. FDA Advisory Committee Calendar ↗HHS Secretary Robert F. Kennedy Jr. announced a regulatory reversal under which approximately 14 of the 19 peptides previously placed on the FDA Category 2 'do not compound' list would be moved back toward Category 1, allowing licensed 503A compounding pharmacies to prepare them again for patients with valid prescriptions. BPC-157 is among those expected to regain compounding eligibility. The FDA had not yet published its formal updated list at time of reporting; reclassification was still pending.
BioPharma Dive / AgeMD / PeptideJournal (timeline) ↗Industry/community reporting described tightened practical scrutiny of peptide imports into Australia in 2026 (border interception of mislabelled/code-only products). This reflects the TGA's stated enforcement posture rather than a change to the underlying Personal Importation Scheme rules. Treated as secondary reporting, not a primary regulatory instrument.
PeptideRundown (secondary reporting; corroborate with TGA primary sources) ↗Eli Lilly announced retatrutide (triple GIP/GLP-1/glucagon agonist) delivered up to ~23.7% average body-weight reduction (all participants) and ~28.7% (treatment-adherent) at 68 weeks in its first successful Phase 3 trial, and reduced knee osteoarthritis pain by up to ~62.6%. Lilly indicated FDA submission depends on completion of the Phase 3 program (expected early 2026); potential approval cited around 2027.
CNBC / Eli Lilly press release / Clinical Trials Arena ↗As of mid-2025, with the semaglutide shortage resolved, 503A community pharmacies relying on the shortage-list exemption can no longer compound 'essentially a copy' semaglutide. Pharmacies still advertising compounded semaglutide without patient-specific clinical documentation of a significant difference from the branded product face compliance risk.
Holt Law / Meto regulatory analysis ↗Eli Lilly's tirzepatide-based Zepbound generated approximately $3.6 billion in Q3 2025 sales per reporting, underscoring rapid growth of the GLP-1/GIP obesity-drug market; analysts have projected the obesity/diabetes segment could approach ~$100bn by the 2030s.
Clinical Trials Arena / industry reporting ↗The TGA published guidance expressing concern about the rise in import, supply, compounding and advertising of unapproved peptide products. It reiterated that advertising prescription-only/unapproved therapeutic goods to the public is prohibited, that practitioners must meet Commonwealth/state and Ahpra obligations, and that it continues compliance and enforcement (including infringement notices).
Therapeutic Goods Administration (TGA) ↗The TGA warned consumers that unapproved peptide products — particularly injectables, and those labelled only by codes or lacking clear active ingredient/strength/dosage — pose significant safety risks including contamination, infection and local tissue damage. The Personal Importation Scheme does not assess product safety, quality or efficacy.
Therapeutic Goods Administration (TGA) ↗The TGA reported issuing further infringement notices to a Victorian individual for allegedly importing unapproved therapeutic goods, illustrating active enforcement against unlawful import/supply.
Therapeutic Goods Administration (TGA) ↗Novo Nordisk's CagriSema combination (amylin analogue cagrilintide plus semaglutide) reported Phase 3 obesity results in the 2024-2025 window, positioning it within the competitive next-generation incretin/amylin obesity pipeline alongside tirzepatide and retatrutide.
industry pipeline reporting ↗The FDA issued a MedWatch safety alert following reports of serious adverse events associated with compounded injectable semaglutide, including nausea, vomiting, acute pancreatitis, dehydration, gallstones and hospitalisations — frequently linked to dosing errors with non-standardised compounded vials.
U.S. FDA (via regulatory summaries) ↗The Phase 2 randomised trial of retatrutide for obesity was published in the New England Journal of Medicine, reporting substantial dose-dependent weight reduction and establishing the triple-agonist mechanism's clinical signal.
New England Journal of Medicine ↗