Prepared by: Research Desk. Sources are linked for verification.
\\nKlowSignal follows new primary records on research peptides and reports what they say, with a link to the source. Records fall into three groups:
\\nCompounds covered include BPC-157, TB-500, MOTS-c, SS-31 (elamipretide), Semax and DSIP (emideltide). For several of these, including BPC-157, TB-500 and MOTS-c, the published evidence is mainly preclinical. SS-31 is an exception: it has been studied in clinical trials and, as elamipretide, received an FDA accelerated approval for one rare disease.
\\nEvery item links to a primary record: a journal abstract, a registry entry or a regulator\\'s own page. Updates that cannot be traced to such a record are left out. Each item shows the date of the record itself and the date its status was last checked, because regulatory status can change.
\\nA new record is not new evidence of an effect: an advisory committee agenda is a scheduled discussion, not a decision, and a listing on a safety-risk page reflects FDA\\'s review of a nomination rather than a finding about outcomes in people. Our guide on how to read a research signal explains study types and regulatory terms. For who runs the site and how corrections work, see About.
\\nPurita is a store that sells peptides for laboratory research use only, and its product pages label items for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nKlowSignal tracks new studies and regulatory updates on research peptides. An independent editorial Research Desk runs the site. Each page reports what a primary record says and links to it. Some linked records describe animal studies, human trials or regulatory approvals. Nothing here is medical advice. Nothing here recommends, promotes or gives instructions for the use of any compound in people or animals.
\\nA signal is a new or changed entry in a primary record:
\\nNews coverage, forums and marketing copy are not signals. Claims that cannot be traced to a primary record are left out. The guide How to read a research signal explains the approach in more detail. Examples of signal reports include the July 2026 FDA compounding committee and the elamipretide accelerated approval.
\\nEach article gives the date of the record it reports and the date its sources were last checked. When a source changes, a dated update note is added to the article. Statements that something has not been found, such as the absence of a marketing authorisation, always carry an \"as of\" date.
\\nWhere wording on a page differs from a linked primary source, the primary source takes precedence. This also applies to any translated version of a page: the original English text and the linked primary records are the reference versions.
\\nErrors can be reported through the contact address below. Please include the page address and the primary source that shows the problem. Confirmed errors are corrected, and the change is dated on the page.
\\nSome pages carry paid links to Purita, a research-use-only supplier. KlowSignal is paid when readers follow these links. They are not an endorsement and do not influence which records are reported or how they are described. Research-use-only material is not an approved medicine and has not been evaluated by regulators for use in people. Full details are in the affiliate disclosure.
\\nQuestions, corrections and source suggestions can be sent to the Research Desk at info@zvezdaff.com. This is the Research Desk\\'s contact inbox for KlowSignal.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nKlowSignal reports new studies and regulatory updates on research peptides. A mouse study, a company announcement and an FDA meeting notice can all mention the same compound and still say very different things. This guide explains how we read each type of record. More about the site is on the about page.
\\nA primary endpoint is the main outcome a trial is designed to test. Missing it means the trial did not show what it set out to measure.
\\nA research-use-only (RUO) label means a material is sold as a laboratory reagent for non-clinical research. It is not a medicine, has not been evaluated or approved by FDA, and is not intended for human or animal use. The label says nothing about whether a compound works. For laboratories the key questions are identity and purity, and batch-level certificates of analysis are the minimum documentation to expect.
\\n| Signal | \\nCan show | \\nCannot show | \\nQuestions we ask | \\n
|---|---|---|---|
| Cell study | \\nA possible mechanism | \\nEffects in organisms or people | \\nWhich cells? Material characterised? Replicated? | \\n
| Animal study | \\nEffects in that species | \\nEffects in people | \\nWhich model? How many animals? Independent group? | \\n
| Observational study | \\nAssociations | \\nCause and effect | \\nConfounders? How was it measured? | \\n
| Phase 1–3 trial | \\nSafety data; at phase 3, confirmation or failure | \\nResults beyond the population tested | \\nRandomised? Placebo-controlled? Primary endpoint met? | \\n
| Press release | \\nThat a result is announced | \\nFull data or independent assessment | \\nIs there a paper or registry record? | \\n
| Registry entry | \\nPlanned design and outcomes | \\nThat results exist | \\nDo published outcomes match the plan? | \\n
| FDA approval | \\nOne product, one labelled use | \\nStatus of research-grade material | \\nStandard or accelerated? Confirmatory trial? | \\n
| Category 2 or withdrawn | \\nFDA\\'s named risks | \\nSafety or effectiveness | \\nWhich risks, section and date? | \\n
| PCAC meeting | \\nSubstances and uses discussed | \\nFDA\\'s final decision | \\nWhat was advised, and what did FDA do? | \\n
| RUO label | \\nIntended laboratory use | \\nAny effect or approval | \\nBatch-level certificate of analysis? | \\n
Purita is a store that sells peptides for laboratory research use only, and its product pages label items for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 21 October 2026
\\nThe US Food and Drug Administration (FDA) has published a meeting page for a two-day meeting of its Pharmacy Compounding Advisory Committee on 23 and 24 July 2026. According to that page, the committee will discuss seven peptide-related bulk drug substances \"being considered for inclusion on the 503A Bulks List\".
\\nThis article summarises the agenda, the uses FDA states it reviewed, the docket details and the context of FDA\\'s category 2 list.
\\nThis page does not report the committee\\'s votes or FDA\\'s final decisions. Any outcome, and any later regulatory action, should be checked directly on the FDA meeting page and related FDA records.
\\nThe agenda lists four substance groups for the first day, each named in a free base and an acetate form. The meeting page includes a chart that, in FDA\\'s words, \"identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed\".
\\n| Bulk drug substance | \\nUses evaluated (as listed by FDA) | \\n
|---|---|
| BPC-157 (free base), BPC-157 acetate | \\nUlcerative colitis (UC) | \\n
| KPV (free base), KPV acetate | \\nWound healing and inflammatory conditions | \\n
| TB-500 (free base), TB-500 acetate | \\nWound healing | \\n
| MOTs-C (free base), MOTs-C acetate | \\nObesity and osteoporosis | \\n
These entries record the scope of FDA\\'s review of each nomination. They are not a statement that any substance has been shown to work for the conditions listed.
\\nThree substance groups are listed for the second day, again each in free base and acetate forms. FDA notes that emideltide is \"also referred to as delta sleeping inducing peptide (DSIP)\".
\\n| Bulk drug substance | \\nUses evaluated (as listed by FDA) | \\n
|---|---|
| Emideltide (free base), emideltide acetate | \\nOpioid withdrawal, chronic insomnia, and narcolepsy | \\n
| Semax (free base), Semax acetate | \\nCerebral ischemia, migraine, and trigeminal neuralgia | \\n
| Epitalon (free base), Epitalon acetate | \\nInsomnia | \\n
For both days, the page states that \"the nominators of these substances will be invited to make a short presentation supporting the nomination\".
\\nFDA says it intends to post background material and a link to the live webcast \"no later than two (2) business days before the meeting\" in the Event Materials section of the page. If that is not possible, the material will be made available at the meeting location and on FDA\\'s website at the time of the meeting. The background documents, once posted, are where FDA\\'s own assessment of each substance will appear. This article does not summarise them.
\\nAccording to the meeting page, FDA has established a docket for public comment:
\\nThe page states that interested persons may present data, information or views, orally or in writing, on issues pending before the committee. It also notes that late or untimely comments are handled differently; the exact terms are on the FDA page.
\\nSeparately, FDA maintains a page on bulk drug substances used in compounding that may present significant safety risks. FDA explains there that it identified potential significant safety risks when reviewing nominations for the 503A or 503B bulks lists, and that such substances \"have been placed in category 2 under the interim policies\".
\\nThat page also lists substances previously in category 2 whose nominations were withdrawn by the nominators. BPC-157 appears in that section. FDA\\'s stated concerns were that compounded drugs containing it \"may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization\", and that the agency \"lacks sufficient information to know whether the drug would cause harm when administered to humans\". The same withdrawn section lists thymosin beta-4 fragment (LKKTETQ), also known as TB-500.
\\nFDA\\'s category 2 page also lists emideltide (DSIP), which is on the 24 July agenda. This article does not state which part of that page the entry sits in; the current wording and status should be checked on the FDA page itself.
\\nThe meeting page does not describe how the July 2026 review relates to these earlier category 2 entries. Readers interested in that connection should consult FDA\\'s records directly rather than infer an outcome.
\\nThe meeting page establishes the dates, the seven substance groups, the salt forms named, the uses FDA reviewed, the invitation to nominators and the docket details. It does not indicate how the committee will advise FDA, what FDA will decide, or how strong the scientific evidence for any listed use is.
\\nFor several of these substances the published research base is limited. Much of the BPC-157 literature comes from rat studies by a single research group, published work on TB-500 as a distinct compound is largely analytical chemistry for doping control, and human studies of MOTs-C are mostly observational. A listed \"use evaluated\" reflects the scope of a regulatory review, not an established finding.
\\nFor a general approach to regulatory items like this one, see our guide on how to read a research signal. For a contrasting example, see our report on elamipretide\\'s accelerated approval: a peptide that received FDA accelerated approval for one rare disease, based on an intermediate endpoint and conditional on a confirmatory trial.
\\nThe authoritative source for the agenda, materials, any change of schedule and the meeting outcome is the FDA meeting page. Public comments are filed under docket FDA-2025-N-6895.
\\nPurita is a store that sells peptides for laboratory research use only, and its product pages label items for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 21 October 2026
\\nSS-31 is a synthetic peptide of four amino acids: D-arginine, 2\\',6\\'-dimethyltyrosine (Dmt), lysine and phenylalanine, with an amidated C-terminus. It belongs to the Szeto-Schiller (SS) peptides, named after Hazel Szeto and Peter Schiller, who developed the series.
\\nThe structure alternates aromatic and positively charged residues. According to the research literature, this pattern lets the peptide cross cell membranes and concentrate in the inner mitochondrial membrane.
\\nThe SS peptides were first developed in opioid receptor research. Researchers later noticed that some members of the series accumulated in mitochondria, and SS-31 became the lead compound for that work. A 2014 review by Szeto in the British Journal of Pharmacology describes the discovery and development of SS-31 as the first compound designed to interact with cardiolipin.
\\nCardiolipin is a phospholipid with four fatty-acid chains. It is found almost only in the inner mitochondrial membrane, where it shapes the folds known as cristae and helps organise the respiratory chain. The preclinical record on SS-31 centres on this lipid:
\\nThese are laboratory findings about mitochondrial structure and chemistry. Results in cell-free systems, cultured cells or animal models do not predict outcomes in other conditions or in people.
\\nSS-31 is unusual among the compounds covered on this site because it has been through formal clinical development, and that record includes a negative result.
\\nA trial that misses its primary endpoint has not shown the effect it set out to measure. That result sits alongside the later approval in a different, much narrower setting.
\\nOn 19 September 2025, FDA granted accelerated approval to Forzinity (elamipretide) for Barth syndrome, limited to people weighing at least 30 kg.
\\nTwo conditions shape how the decision should be read:
\\nThe primary records are FDA\\'s approval document, the Drug Trials Snapshot for Forzinity and the prescribing information. Readers who want the regulator\\'s own wording should go to these documents rather than to secondary summaries.
\\nAccelerated approval is an FDA pathway that allows approval on the basis of an intermediate or surrogate endpoint, on the condition that a confirmatory trial follows. Three points follow from the record:
\\nOur guide on how to read a research signal explains why intermediate endpoints and conditional approvals need careful reading.
\\nA prescription approval applies to a specific product: one manufacturer\\'s material, made to a defined specification, with a reviewed label, for a stated indication. It does not attach to the molecule in general.
\\nSS-31 sold as a laboratory reagent is not Forzinity. It has not been evaluated by FDA, it is not covered by the approval, and the approval says nothing about its identity or purity. For laboratory work, batch-level certificates of analysis are the minimum documentation a laboratory should expect, because product identity and purity affect whether results can be reproduced.
\\nElamipretide does not appear on the agenda of FDA\\'s July 2026 Pharmacy Compounding Advisory Committee meeting, which covers other peptides nominated for the 503A bulks list. We found no EU marketing authorisation for elamipretide as of 19 October 2026.
\\nPurita is a store that lists SS-31 for laboratory research use only. Its product page labels the item for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 22 October 2026
\\nRetatrutide is described in both papers as an agonist of the GIP, GLP-1 and glucagon receptors, which is why it is often called a \"triple agonist\". Its earlier phase 2 obesity trial, a 48-week study of 338 adults, was published in 2023 (Jastreboff et al., 2023, PubMed).
\\nThe two new papers are the first full peer-reviewed reports from the TRIUMPH phase 3 programme in obesity:
\\nBoth were randomised, double-blind and placebo-controlled, ran for 80 weeks and compared three retatrutide groups with placebo. ClinicalTrials.gov lists both trials as completed.
\\nTRIUMPH-1 randomised 2,339 participants. It had three primary outcomes, each tested in the two upper retatrutide groups against placebo:
\\nAccording to the abstract, mean body-weight change at 80 weeks was −17.6%, −23.7% and −25.0% across the three retatrutide groups, compared with −3.9% with placebo. The authors report that both primary comparisons were statistically significant (P<0.001). The knee pain and sleep apnoea comparisons were also reported as significant in both of the analyses the paper presents. The most common adverse events were gastrointestinal.
\\nTRIUMPH-2 randomised 1,152 participants at 92 centres in eight countries, and 965 (84%) completed the study drug. The table summarises figures stated in the abstract.
\\n| Measure (week 80) | \\nRetatrutide groups | \\nPlacebo | \\n
|---|---|---|
| Mean body-weight change, treatment-regimen estimand | \\n−11.9%, −16.8%, −18.8% | \\n−5.1% | \\n
| Diarrhoea | \\n27%, 34%, 34% | \\n13% | \\n
| Nausea | \\n14%, 21%, 28% | \\n8% | \\n
| Hypotension | \\n1%, 5%, 6% | \\nunder 1% | \\n
| Dysaesthesia (abnormal skin sensation) | \\n4%, 6%, 7% | \\n1% | \\n
The authors also report improvements in glycaemic control. Permanent discontinuation of the study drug because of adverse events or death was more frequent in the two upper retatrutide groups (12% and 8%) than in the lowest group (4%) or with placebo (5%). Seven participants died during the trial, six in the retatrutide groups and one in the placebo group, and the investigators judged all deaths unrelated to the study intervention.
\\nLarge trials have to decide how to count participants who stop the study drug or start other measures. The rule chosen is called an estimand.
\\nWhen comparing headline numbers between sources, it matters which estimand each figure uses. The papers themselves are the reference for the primary analysis.
\\nNeither paper describes an approval, and the TRIUMPH-2 authors describe retatrutide as \"currently under investigation\". A query of FDA\\'s drug approvals data through openFDA on 22 October 2026 returned no match for retatrutide. That is a database check on one date, not a statement of FDA\\'s position. For how to weigh trial papers against press releases and regulator records, see our guide on how to read a research signal.
\\nResearch-grade retatrutide sold for laboratory use is not the investigational product used in these trials, and the trial results do not describe it.
\\nPurita is a store that lists retatrutide for laboratory research use only. Its product page labels the item for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 23 October 2026
\\nAnti-doping rules do not wait for a compound to receive marketing authorisation from a medicine regulator. Instead, the WADA Prohibited List captures experimental and research-grade peptides through two overlapping categories that apply both in competition and out of competition:
\\nBecause both S0 and S2 are \"at all times\" categories, anti-doping laboratories screen for these peptides in out-of-competition urine and blood samples as well as race-day or event-day samples.
\\nShort linear peptides are cleaved rapidly by peptidases in blood and tissues, which means that the intact parent peptide may appear in urine only briefly after administration in animal or in-vitro models. Analytical chemists working in anti-doping control therefore map stable breakdown fragments (metabolites) and screen for both the intact chain and its diagnostic fragments.
\\n| Compound | \\nSequence / structure | \\nKey analytical papers | \\nMatrices studied | \\n
|---|---|---|---|
| BPC-157 | \\n15-residue linear peptide (GEPPPGKPADDAGLV) | \\nHe et al., 2022, PubMed; awan / stable-isotope study, 2023, PubMed | \\nRat and dog plasma/urine; human liver microsomes and S9 fractions | \\n
| TB-500 (thymosin beta-4 fragment) | \\nN-acetylated heptapeptide Ac-LKKTETQ (or 43-residue parent) | \\nQuantification and metabolite study, 2024, PubMed; Equine population study, 2025, PubMed | \\nIn-vitro incubations, rat biological matrices, equine plasma/urine | \\n
| Multi-peptide panels | \\nPeptidic and non-peptidic doping agents | \\nHarmonized blood workflow, 2026, PubMed | \\nDried blood spots (DBS) and liquid blood | \\n
In a 2022 preclinical pharmacokinetic study in rats and dogs (He et al., 2022, PubMed), researchers reported that intact BPC-157 had a short elimination half-life and was degraded into shorter peptide fragments and constituent amino acids. Building on that challenge, a 2023 study in Molecules (PubMed) used stable-isotope labelling combined with ultra-high-performance liquid chromatography and high-resolution mass spectrometry (UHPLC-HRMS) to characterise the in-vitro metabolic profile of BPC-157 for doping control, identifying characteristic N- and C-terminal truncation products that extend the detection window.
\\nThe name TB-500 is used in research catalogues both for the full 43-residue protein thymosin beta-4 and for its synthetic N-acetylated active-site heptapeptide fragment, Ac-Leu-Lys-Lys-Thr-Glu-Thr-Gln (Ac-LKKTETQ). A 2024 analytical paper in the Journal of Chromatography B (PubMed) validated a UHPLC-Q-Exactive Orbitrap tandem mass spectrometry method to quantify TB-500 alongside its cleavage metabolites in in-vitro assays and in rats. In 2025, a study in Drug Testing and Analysis (PubMed) reported a population baseline and detection strategy for thymosin beta-4 in equine doping control.
\\nMore recently, a July 2026 paper in The Analyst (PubMed) described a rapid, harmonized extraction and mass-spectrometry workflow that screens both peptidic and non-peptidic doping agents in dried blood spots and liquid blood matrices.
\\nA listing on the WADA Prohibited List is a sport-governance rule, not a drug-approval record or a clinical trial finding:
\\nFor how to distinguish sport rules, advisory committee agendas and peer-reviewed trials, see our guide on how to read a research or regulatory signal.
\\nPurita is a store that lists BPC-157 for laboratory research use only. Its product page labels the item for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 24 October 2026
\\nThymosin alpha-1 is a 28-residue peptide first isolated from calf thymus. Goldstein et al. (1977) reported its sequence in PNAS, describing a heat-stable, highly acidic polypeptide from the thymus extract known as thymosin fraction 5. The authors linked it to the regulation and differentiation of thymus-dependent lymphocytes (T cells).
\\nLater laboratory work, summarised in a historical overview by Garaci (2007), reported effects on MHC class I and Toll-like receptor expression and on cytokine production. Those findings framed thymosin alpha-1 as an immune-regulating peptide and led to trials in sepsis, where immune suppression after the initial inflammatory phase is a recognised research question.
\\nThe first sizeable randomised trial in sepsis was ETASS, published in Critical Care (Wu et al., 2013; NCT00711620). It randomised 361 adults with severe sepsis at six teaching hospitals in China between 2008 and 2010 to thymosin alpha-1 or a control group, alongside conventional care.
\\nThe main comparison sat at the edge of conventional statistical significance, and the authors\\' conclusion was cautious, saying thymosin alpha-1 \"may be effective\" in a targeted population. TESTS, from an overlapping group of investigators, was the larger placebo-controlled test of that idea.
\\nTESTS randomised adults with sepsis to thymosin alpha-1 or a matching placebo for up to seven days, on top of standard care. The full report, including the regimen used, is open access in PubMed Central.
\\n| Measure | \\nThymosin alpha-1 | \\nPlacebo | \\n
|---|---|---|
| Participants analysed (modified ITT) | \\nn = 542 | \\nn = 547 | \\n
| All-cause mortality at 28 days | \\n23.4% | \\n24.1% | \\n
| Hazard ratio (95% CI) | \\n0.99; 95% CI 0.77–1.27 | \\nreference | \\n
| P value | \\n0.93 | \\n\\n |
No secondary outcome and no safety outcome differed between the groups.
\\nTwo prespecified subgroup analyses drew attention:
\\nThe authors described these as hypothesis-generating rather than as findings, which is the standard reading of subgroup results in a trial whose primary outcome was neutral. The trial was funded in part by SciClone Pharmaceuticals, and some authors reported grants or consultancy fees from the company. The BMJ published a correction to the paper in May 2025.
\\nA meta-analysis published in September 2025 (Gu et al., Frontiers in Cellular and Infection Microbiology) pooled 11 randomised trials. Across all trials, the odds of death were lower with thymosin alpha-1 (odds ratio 0.73). When the analysis was limited to higher-quality trials (OR 0.82, P=0.09) or multicentre trials (OR 0.86, P=0.20), the difference was no longer statistically significant. A trial sequential analysis judged that the total sample was still too small to reach a firm conclusion.
\\nThis pattern is common in research: smaller and single-centre trials tend to show larger effects, and the estimate shrinks as larger, blinded trials are added. TESTS is now the largest placebo-controlled trial in this setting, and it carries much of the weight in any pooled estimate.
\\nFor how to weigh a trial result against a regulatory record, see how to read a research or regulatory signal.
\\nPurita is a store that lists thymosin alpha-1 for laboratory research use only. Its product page labels the item for research use only and not for human or animal administration.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nPublished 25 October 2026
\\nGarvey et al. (2025) reported a 68-week, double-blind, placebo-controlled trial (NCT05567796) in adults with a body-mass index of at least 30, or at least 27 with at least one weight-related condition, and without diabetes. A total of 3,417 participants were randomly assigned to CagriSema, placebo, cagrilintide alone or semaglutide alone.
\\nA post hoc analysis of the same trial, published in Hypertension (Verma et al., 2026), reported a mean change in systolic blood pressure of −10.9 mmHg with CagriSema and −2.8 mmHg with placebo. A further post hoc analysis in Diabetes, Obesity and Metabolism (Busetto et al., 2026) looked at waist and other anthropometric targets. Post hoc analyses were not the trial\\'s primary question and are best read as exploratory.
\\nDavies et al. (2025), published alongside REDEFINE 1, reported a 68-week trial (NCT05394519) in 1,206 adults in 12 countries with type 2 diabetes and a body-mass index of at least 27, randomly assigned in a 3:1 ratio to CagriSema or placebo.
\\nAs in other trials of this drug class, the weight reduction in participants with type 2 diabetes was smaller than in REDEFINE 1.
\\nYamauchi et al. (2026) reported REDEFINE 5 (NCT05813925), a double-blind trial at 21 sites in Japan and one in Taiwan that compared CagriSema directly with semaglutide alone in 331 adults with overweight or obesity.
\\nUnlike REDEFINE 1 and 2, the REDEFINE 5 paper uses the trial product estimand as its primary analysis, which assumes the product was taken as intended. That figure is not directly comparable with the primary figures from the two NEJM trials.
\\nThe newest entry in the record is a design paper rather than a result. Cavender et al. (2026), in the American Heart Journal, describe REDEFINE 3 (NCT05669755), which randomised 7,076 adults with established cardiovascular disease and a body-mass index of 25 or more, with or without type 2 diabetes, at 575 sites in 24 countries between January 2023 and December 2024. Mean age at baseline was 66 years, and 62% had a prior heart attack.
\\nKlowSignal has covered retatrutide\\'s TRIUMPH phase 3 papers, which tested a single molecule acting on three receptors. CagriSema takes a different route, pairing two separate peptides, an amylin analogue and a GLP-1 receptor agonist, in one product. Direct comparisons between the two programmes are not possible from the published record: the trials differ in duration, populations, comparators and analysis methods.
\\nRecord dates: 22 June 2025 (REDEFINE 1 and 2 online), 17 April 2026 (REDEFINE 5 online), 6 October 2026 (REDEFINE 3 design). Status last checked: 25 October 2026.
\\nPurita is a store that sells peptides for laboratory research use only. It does not list CagriSema, which is an investigational pharmaceutical product; the link below goes to the store\\'s homepage.
\\n\\nAffiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
\\nPrepared by: Research Desk. Sources are linked for verification.
\\nKlowSignal is a research-only reference site. It has one commercial relationship: an affiliate arrangement with Purita, a store that sells peptides for laboratory research use only.
\\nSome pages contain links to Purita\\'s website that carry a tracking code. If a purchase is made after following one of these links, KlowSignal may earn a commission. The price paid by the buyer is the same with or without the link.
\\nEach paid link is followed by a short \"Affiliate disclosure\" note on the page, and is marked in the page code as sponsored.
\\nStatements about Purita are limited to what can be checked on Purita\\'s own website. Its product pages carry the label \"For Research Use Only. Not for human or animal administration.\", and it publishes a certificates page with batch documentation for some products.
\\nProducts sold by research suppliers are intended for laboratory research. Nothing on this site describes or encourages human or animal use. See the research-only notice.
\\nQuestions about this disclosure: info@zvezdaff.com.
\\nLast updated: 21 October 2026.
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\\nKlowSignal summarises published research and public regulatory records about peptides studied in laboratories. All content is provided for research and educational purposes only. It is not intended for human use and it is not medical advice.
\\nMaterials labelled \"research use only\" are intended for laboratory research. They are not approved medicines. A supplier\\'s certificate of analysis describes a batch; it says nothing about suitability for any use. Where a compound also exists as a regulator-approved product, that approval covers the specific product and its labelled use only.
\\nMany findings summarised here come from cell or animal studies, which often do not carry over to people. Each page links its primary sources so that readers can check the original records.
\\nThis site does not answer individual health questions.
\\nSome pages carry paid links to a research supplier. See the affiliate disclosure.
\\nCorrections and questions: info@zvezdaff.com.
\\nLast updated: 21 October 2026.
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\\nThis policy explains what data KlowSignal handles and why.
\\nKlowSignal is published by the KlowSignal Research Desk. Contact: info@zvezdaff.com.
\\nThe site has no accounts, comment forms or newsletter signups, and it does not ask visitors for personal information. It does not use advertising cookies and does not sell personal data.
\\nThe site is hosted on Framer. Like any web host, Framer processes the technical data needed to deliver pages, such as IP address, browser type and the pages requested, and it may produce aggregated visit statistics.
\\nPages link to external sources such as PubMed and the FDA, and to Purita through paid links. A paid link carries a tracking code that Purita\\'s website can record when the link is followed. Other websites apply their own privacy policies.
\\nMessages sent to info@zvezdaff.com are used only to reply. Addresses are not added to any mailing list or shared.
\\nRequests to access, correct or delete personal data can be sent to info@zvezdaff.com.
\\nLast updated: 21 October 2026.
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Here is what the record says.\",\"key\":\"fda-compounding-committee-july-2026\",\"kind\":\"Article\"},{\"path\":\"/articles/elamipretide-accelerated-approval\",\"title\":\"Elamipretide (SS-31): the 2025 accelerated approval on the record\",\"excerpt\":\"SS-31 is a Szeto-Schiller tetrapeptide studied for its binding to cardiolipin. In September 2025 FDA granted accelerated approval to elamipretide for Barth syndrome. Here is what the record shows.\",\"key\":\"elamipretide-accelerated-approval\",\"kind\":\"Article\"},{\"path\":\"/articles/retatrutide-triumph-phase-3-published\",\"title\":\"Retatrutide phase 3: TRIUMPH-1 and TRIUMPH-2 results published\",\"excerpt\":\"On 29 September 2026 the first two TRIUMPH phase 3 trials of retatrutide, a GIP, GLP-1 and glucagon receptor agonist, appeared in NEJM and The Lancet. 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