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Research & literature

This section catalogues the primary literature, safety advisories, and regulatory updates underpinning peptide articles on PeptideSciences101. Each peptide page also lists its own references; this index aggregates across all peptides. Entries record sourced facts only — no dosage guidance.
42 entries

2026

Semaglutide, Tirzepatide · studies · 2026-08-31
›Summary
A peer-reviewed retrospective electronic-health-record study compared patients with sustained prescriptions at the lowest marketed initiation doses of semaglutide (0.25 mg) and tirzepatide (2.5 mg). Using a federated EHR system covering 29 million patients, the authors identified 814 semaglutide-treated and 1,016 tirzepatide-treated patients meeting a stringent sustained low-dose prescription criterion. In matched analyses, mean 12-month weight change was -2.2% with semaglutide and -5.5% with tirzepatide. The paper also reported several higher observed adverse-event rates in the tirzepatide cohort, including constipation and acute kidney injury. Critically, the authors state that this prescribing pattern may overlap with, but does not establish, intentional microdosing. This is observational, hypothesis-generating evidence rather than a randomized test of a microdosing protocol; it does not establish causality, long-term safety, or an optimized low-dose regimen.
Tirzepatide · regulatory · 2026-08-28
›Summary
FDA approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events (MACE) — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes who are at high risk for these events, based on the SURPASS-CVOT trial (13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries). SURPASS-CVOT compared Mounjaro against Trulicity (dulaglutide), an active comparator with its own established cardiovascular benefit, and was designed as a non-inferiority trial: the hazard ratio for time to first MACE was 0.92 (95.3% CI 0.83-1.01), described by the sponsor as "non-inferiority to dulaglutide" with "an 8% lower rate" of the composite endpoint. The sponsor's release explicitly states superiority to dulaglutide was not established — the confidence interval crosses 1.00. The indication is specific to adults with type 2 diabetes at high cardiovascular risk, not a general cardiovascular-protection claim.
Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, Ipamorelin · regulatory · 2026-08-24
›Summary
FDA issued a warning letter to Royal Peptides LLC after reviewing its website in July 2026. FDA identified products marketed as tirzepatide, semaglutide, retatrutide, SS-31 (elamipretide), PT-141, tesamorelin and a tesamorelin/ipamorelin blend (BIMORELIN) as unapproved new drugs based on evidence of intended drug use in the company's labeling and website claims. In a footnote, FDA specifically stated that despite labeling the products “for research use only” and “not for human or animal consumption,” evidence from the website established that the products were intended as drugs for human use. FDA further stated that the company marketed bacteriostatic water alongside a peptide guide and peptide calculator, resources that collectively provided the means to prepare an injectable drug for human administration. The warning letter concerns the specific products and marketing FDA reviewed; it is not a finding that legitimate scientific peptide research is unlawful. FDA warning letters describe the agency's position at the time issued and may be followed by subsequent interactions with the recipient.
Semaglutide, Tirzepatide, Liraglutide, Teriparatide, Calcitonin · regulatory · 2026-07-28
›Summary
FDA Drug Alert dated 7/28/2026. FDA published 17 revised draft product-specific guidances (PSGs) for peptide products. The listed products include calcitonin salmon (CALCIMAR NDA 017769; MIACALCIN NDA 017808), dasiglucagon hydrochloride (ZEGALOGUE NDA 214231), glucagon (BAQSIMI NDA 210134; GLUCAGON NDA 020928; GVOKE NDA 212097), liraglutide (VICTOZA NDA 022341; SAXENDA NDA 206321), pegcetacoplan (SYFOVRE NDA 217171; EMPAVELI NDA 215014), semaglutide (OZEMPIC NDA 209637; WEGOVY NDA 215256), teriparatide (FORTEO NDA 021318; TERIPARATIDE NDA 218771), tirzepatide (MOUNJARO NDA 215866; ZEPBOUND NDA 217806) and vosoritide (VOXZOGO NDA 214938). Per FDA, the revised draft PSGs provide updated recommendations across five areas: submission of recombinantly, synthetically, or semi-synthetically produced peptides as ANDAs; innate immune response testing; impurity thresholds; higher order structure assessment; and biological activity assessment. FDA states that PSGs are published to facilitate generic drug development and streamline abbreviated new drug application (ANDA) assessment, and that when finalized these PSGs will describe the agency's current thinking on developing generic products therapeutically equivalent to these peptide products. On the same date FDA withdrew the May 2021 guidance for industry "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin", stating it no longer reflects FDA's current scientific thinking, and noted a plan to revise it this year. These are draft guidances open to public comment; they are not approvals and do not change the approval status of any listed product.
CagriSema, Cagrilintide, Semaglutide, Elecoglipron · metabolic · 2026-06-05
›Summary
The American Diabetes Association's 86th Scientific Sessions run June 5-8, 2026 in New Orleans, with GLP-1-based therapies featured in seven of eight major clinical-trial result sessions. Phase 3 REIMAGINE 1, 2 and 3 data for CagriSema (cagrilintide + semaglutide, Novo Nordisk) are scheduled to be presented for the first time on Sunday, June 7. Phase 2b data for the oral small-molecule GLP-1 agonist elecoglipron (AZD5004/ECC5004) in obesity (VISTA) and type 2 diabetes (SOLSTICE) are scheduled for June 7-8. Event/agenda noted here as scheduled; per site policy no efficacy figures are recorded until primary readouts are published. Flagged for capture in the next refresh.
Retatrutide · metabolic · 2026-05-28
›Summary
Phase 3 TRANSCEND-T2D-1 (manufacturer-reported topline; Eli Lilly press release dated May 28, 2026 ahead of the ADA 86th Scientific Sessions; full results scheduled for presentation at the ADA retatrutide symposium on June 6, 2026): in adults with type 2 diabetes, retatrutide — an investigational once-weekly GIP/GLP-1/glucagon triple receptor agonist peptide — was reported to lower A1C by up to an average of 2.0% and body weight by up to an average of 36.6 lb (16.8%) at 40 weeks [human]. This is the peptide's first dedicated Phase 3 type 2 diabetes readout, complementing the obesity result in TRIUMPH-1 (ResearchArticles id 9). The figures are manufacturer-reported topline values and have not yet been peer-reviewed; retatrutide is not FDA-approved and is legally available only to participants in Lilly clinical trials. Primary source on file: PeptideSources id 37 (investor.lilly.com TRANSCEND-T2D-1 release).
Semaglutide, Tirzepatide · safety · 2026-05-23
›Summary
Peer-reviewed pharmacovigilance study (Nature Health, 2026; DOI 10.1038/s44360-026-00108-y) applying large-scale natural-language analysis to 410,198 Reddit posts (May 2019-June 2025) mentioning semaglutide or tirzepatide. Of 67,008 users who self-reported use, 43.5% described at least one side effect. Gastrointestinal symptoms predominated: nausea (36.9%), fatigue (16.7%), vomiting (16.3%), constipation (15.3%) and diarrhoea (12.6%). The study surfaced under-recognised signals not well captured in current labelling or trials, notably reproductive symptoms (e.g., menstrual irregularities) and temperature-related complaints (e.g., chills, hot flushes). Authors conclude that large-scale social-media analysis can complement traditional pharmacovigilance for detecting emerging real-world safety signals of GLP-1 receptor agonists. Reported as observational real-world safety data; no dosing guidance recorded.
Bulevirtide · antiviral · 2026-05-22
›Summary
On May 22, 2026 the FDA granted accelerated approval to Hepcludex (bulevirtide-gmod), the first and only approved US treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Bulevirtide is an HBV/HDV entry inhibitor (NTCP receptor blocker), a 47-amino-acid lipopeptide given subcutaneously. Approval was based on HDV RNA reduction and ALT normalization in the Phase 3 MYR301 study; clinical-outcome benefit not yet established (confirmatory trial required).
Retatrutide, Tirzepatide, CagriSema · Weight Management & Metabolic · 2026-05-21
›Summary
Phase 3 TRIUMPH-1 (Eli Lilly press release May 21, 2026): Retatrutide 12 mg produced 28.3% body weight loss (70.3 lb) over 80 weeks in adults with obesity without T2D. 9 mg: 25.9% (64.4 lb). 4 mg: 19.0% (47.2 lb). All doses met primary and key secondary endpoints. 45.3% of 12 mg patients achieved ≥30% weight loss (bariatric-surgery threshold). 104-week extension (BMI ≥35): 30.3% (85.0 lb). Additional readouts: TRIUMPH-4 (knee OA, 28.7%), TRANSCEND-T2D-1 (2.0% HbA1c drop). LDL-C reduction ~20% is a unique mechanistic signal. FDA NDA submission anticipated Q3–Q4 2026. Drug is not yet approved.
Semaglutide, Tirzepatide, Retatrutide · safety · 2026-05-19
›Summary
Partnership for Safe Medicines May 2026 roundup documenting safety risks across the GLP-1 weight-loss market: counterfeit Ozempic/Mounjaro seizures (US, Canada, Australia, India, UK), illicit online sales of unregistered semaglutide, tirzepatide and "research-use-only" retatrutide from non-FDA-registered foreign suppliers, and mass-compounding by 503A pharmacies operating at manufacturer scale. Cites concrete patient-harm cases: a Kentucky patient requiring a liver transplant after four weeks of compounded tirzepatide/B12, a Texas death linked to compounded semaglutide/B12 (Empower Pharmacy litigation), and multiple hospitalizations. Also summarizes FDA actions: 88 warning letters since Sept 2025 over false/misleading compounded GLP-1 marketing, the proposal to exclude semaglutide/tirzepatide/liraglutide from the 503B bulks list (comment period ends June 30, 2026), and several 503B outsourcers (ProRx, BPI Labs, Medisource, Olympia) exiting GLP-1 compounding.
Tirzepatide · regulatory · 2026-05-18
›Summary
FDA issued a warning to a 503B compounding pharmacy for producing tirzepatide after the official shortage ended, consistent with the agency's April 30, 2026 proposal to exclude GLP-1 drugs from the 503B bulks list.
Semaglutide, Tirzepatide, Liraglutide · regulatory · 2026-04-30
›Summary
FDA proposed (Apr 30, 2026; Federal Register May 1, 2026) to leave semaglutide, tirzepatide, and liraglutide OFF the 503B Bulk Drug Substances List, finding no clinical need for outsourcing-facility bulk compounding now that shortages have ended. Comment period closes June 29, 2026. Affects bulk compounding only; the drugs remain FDA-approved.
GLP-1–GIP–lanifibranor, Semaglutide, Tirzepatide · metabolic · 2026-04-29
›Summary
Peer-reviewed preclinical study (Nature, published 29 April 2026; DOI 10.1038/s41586-026-10427-5; Helmholtz Munich with Indiana Biosciences Research Institute and the Novo Nordisk Research Center Indianapolis). Reports a unimolecular quintuple agonist, GLP-1–GIP–lanifibranor, a peptide-drug conjugate that covalently tethers the small-molecule PPARα/γ/δ triple agonist lanifibranor to a GLP-1R/GIPR dual-incretin peptide backbone, delivering PPAR action selectively into GLP-1R- and GIPR-expressing cells. In vitro it is indistinguishable from GLP-1–GIP in incretin-receptor signalling and insulin secretion from isolated mouse islets. In vivo in obese, insulin-resistant mice it outperformed GLP-1R–GIPR co-agonism and semaglutide, further reducing body weight, food intake and hyperglycaemia via synergistic incretin and PPAR activity; the effect was blunted by genetic or pharmacological inhibition of GLP-1R, GIPR or PPARδ and absent in double incretin-receptor-knockout mice. Authors conclude the molecule has substantial therapeutic potential for obesity-linked metabolic dysfunction. Preclinical (mouse) data only; no human or dosing guidance recorded. A Publisher Correction was issued 18 May 2026 (DOI 10.1038/s41586-026-10619-z).
BPC-157, TB-500, Semax, Epitalon, DSIP, GHK-Cu, KPV, PEG-MGF, Melanotan II, MOTS-C, LL-37, DiHexa · regulatory · 2026-04-16
›Summary
On April 15, 2026, FDA announced removal of 12 peptide bulk drug substances from Category 2 effective April 22, 2026, following withdrawal of nominations. No longer "significant safety risk" designation but not yet on 503A Bulks List. PCAC reviews July 23-24, 2026.
LL-37, GHK-Cu, Dihexa, Melanotan II · regulatory · 2026-04-15
›Summary
FDA early announcement page for a meeting of the Pharmacy Compounding Advisory Committee (PCAC), Center for Drug Evaluation and Research; page content current as of 04/15/2026. FDA states that it "will host an advisory committee meeting before the end of February 2027". Under Agenda the page states: "The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A bulks list:" and lists five substances — Cathelicidin (LL-37); GHK-Cu; Dihexa acetate; Melanotan II; and Mechano Growth Factor, Pegylated (PEG-MGF). FDA states the meeting time and location "will be scheduled in the coming months", and that the public will have the option to participate via an online teleconferencing and/or video conferencing platform. FDA states it intends to make meeting materials and the link to the live webcast available no later than two business days before the meeting in the Event Materials section of that webpage, and that it intends to publish a Federal Register notice and establish a docket for public comment on this meeting in the near future. FDA states that advisory committees provide independent expert advice and make non-binding recommendations to the agency. Scope: this document announces an agenda for a future meeting. It records no vote, no committee recommendation, and no change to the regulatory status of any substance named, and it does not place any of the five substances on the 503A bulks list.

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