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    67 articles
    Peptide Regulation FDA Staff Reviewers Say ‘No’ to 7 Compounded Peptides Ahead of July PCAC Vote FDA staff reviewers urged against adding seven popular peptides to the 503A bulks list ahead of the ... Jul 6, 2026 · 9 min read
    Regulation FDA reviewers urge ‘no’ on BPC-157, TB-500, MOTS-c ahead of July 2026 compounding vote FDA reviewers’ June 29 briefings recommend against listing seven popular peptides for 503A compoundi... Jul 3, 2026 · 9 min read
    Regulation Medicare Starts Paying for Obesity Drugs Today — Bridge Program Opens $50 Access for Millions Medicare's new $50 Bridge program covering Wegovy, Zepbound, Foundayo, and oral Wegovy for obesity l... Jul 2, 2026 · 10 min read
    Regulation FDA staff urges caution on compounded peptides ahead of July advisory meeting Ahead of the July 23–24 Pharmacy Compounding Advisory Committee meeting, FDA staff briefings recomme... Jul 1, 2026 · 10 min read
    Regulation FDA Accepts Sandoz's Two ANDAs for Generic Tirzepatide — First Generic Path for Mounjaro and Zepbound FDA accepts Sandoz's two abbreviated new drug applications for a generic version of tirzepatide, ope... Jun 30, 2026 · 10 min read
    Regulation FDA Import Alert 66-80 Puts GLP-1 Peptide APIs on DWPE Detention Track FDA’s Import Alert 66-80 authorizes DWPE detention of GLP-1 peptide APIs at U.S. ports, creating a g... Jun 29, 2026 · 9 min read
    Regulation FDA Import Alert 66-80 Targets GLP-1 Bulk Substances: What It Means for Compounding and the Peptide Supply Chain FDA published Import Alert 66-80 for GLP-1 receptor agonist bulk drug substances. Here’s how DWPE ca... Jun 28, 2026 · 9 min read
    Industry Lexaria Begins Dosing GLP-1-H26-7: Oral DehydraTECH-Semaglutide Goes Head-to-Head With Wegovy Tablets Lexaria's GLP-1-H26-7 trial began dosing on June 14: DehydraTECH-semaglutide tablet and capsule agai... Jun 27, 2026 · 9 min read
    Research Wisconsin Group Shows Class B1 GPCR Peptides Can Drop the Helix — and Pick Their Pathway Wisconsin chemists put D-amino acids into glucagon and PTH(1-34), broke the alpha-helix that textboo... Jun 25, 2026 · 10 min read
    Regulation Inside the Peptide Gray Market: Influencers, Telehealth, and the FDA Advisory Panel Kennedy Just Reshuffled AP and WSJ this week describe a real policy reversal in motion: Kennedy is firing FDA compounding ad... Jun 24, 2026 · 11 min read
    Clinical Trials Ascletis ASC35 Clears FDA For Phase 1: A Once-Monthly GLP-1/GIP Peptide With A Lipid Depot Ascletis ASC35, a once-monthly GLP-1/GIP peptide using a self-assembling lipid depot, cleared FDA IN... Jun 23, 2026 · 11 min read
    Regulatory FDA flags unapproved GLP-1 compounding risks: telehealth claims, cold-chain failures, dosing errors FDA highlights unapproved GLP-1 risks—fraudulent labels, warm shipments, and dosing errors—while war... Jun 17, 2026 · 9 min read
    weight-loss-metabolic AstraZeneca's Elecoglipron Pill Hits 11.8% Weight Loss At 36 Weeks, Heads To Phase 3 AstraZeneca's elecoglipron oral GLP-1 hit 11.8% weight loss at 36 weeks in VISTA and 1.9% HbA1c drop... Jun 16, 2026 · 12 min read
    Clinical Trials Enicepatide (CT-388): Roche's biased GLP-1/GIP peptide drops Phase 2 detail at ADA 2026 Roche's enicepatide (CT-388) hit 22.5% placebo-adjusted weight loss at 48 weeks in Phase 2 with no p... Jun 14, 2026 · 8 min read
    Clinical Trials Canvuparatide one-year data: once-weekly PTH peptide prodrug stays on track for Phase 3 MBX Biosciences reported one-year open-label data for once-weekly canvuparatide in chronic hypoparat... Jun 13, 2026 · 8 min read
    Regulation State pharmacy boards escalate peptide enforcement: what April–May 2026 actions signal April–May 2026 actions in TX, FL, CA, and OH show state boards targeting peptide and compounded GLP-... Jun 11, 2026 · 10 min read
    FDA & Compliance Peptide Import Inspections Are the New Front Line for Compounding Enforcement (Q1 2026) New Q1 2026 import data suggests selective border enforcement for unapproved peptides and helps expl... Jun 10, 2026 · 9 min read
    GLP-1 Pfizer’s berobenatide: a monthly GLP‑1 peptide heads for Phase 3 Pfizer reports Phase IIb VESPER results for berobenatide, an investigational GLP‑1 peptide aiming fo... Jun 9, 2026 · 9 min read
    Regulation FTC peptide marketing enforcement accelerates: what brands and clinics need to audit this week FTC enforcement against unsubstantiated peptide marketing claims has accelerated in Q1-Q2 2026. Here... Jun 8, 2026 · 9 min read
    Clinical Trials Pfizer’s Berobenatide: A Once-Monthly GLP-1 Peptide Moves Toward Phase 3 Pfizer shared Phase 2b VESPER data for berobenatide, a GLP-1 peptide aimed at monthly dosing, and ou... Jun 7, 2026 · 9 min read
    Research PepForge uses HELM to generate modified peptides—and flags 799 new antimicrobial candidates A new bioRxiv preprint introduces PepForge, a HELM-native generative model for modified peptides. It... Jun 4, 2026 · 11 min read
    Regulation FDA removes BPC-157, KPV, Semax from Category 2 on April 22 — but they are not legal to compound yet Removed from Category 2 on April 22, 2026 because the nominations were withdrawn — not because the F... Jun 3, 2026 · 9 min read
    Regulation FDA PCAC July 2026: What the BPC-157 peptide compounding review really means FDA’s Pharmacy Compounding Advisory Committee will review seven unapproved peptides in July 2026. Wh... Jun 2, 2026 · 9 min read
    Regulation FDA signals enforcement against unapproved compounded GLP-1 drugs: what it means for peptide medicine The FDA says it will restrict GLP-1 APIs used in mass-marketed unapproved compounded drugs and crack... Jun 1, 2026 · 8 min read
    Regulatory Sublingual compounded peptides: Quicksome claims and what the FDA’s July 2026 PCAC review could change A press release claims needle-free, sublingual delivery for popular compounded peptides—just as the ... May 30, 2026 · 10 min read
    weight-loss-metabolic Pemvidutide IMPACT 48-Week MASH Data Lands At EASL 2026 Ahead Of Phase 3 Altimmune's pemvidutide hit 32.4% ELF response, 23.7% triglyceride drop, and 54.5% qFibrosis regress... May 29, 2026 · 13 min read
    Clinical Research MetaVia's DA-1726 posts -9.1% Phase 1 weight loss and FibroScan signals at EASL Congress 2026 MetaVia's DA-1726 Phase 1 readout at EASL 2026 showed -9.1% body weight at Day 54 and directional li... May 28, 2026 · 11 min read
    Regulatory Alabama medical board bans research-grade peptide prescribing, closes consent-form workaround Alabama's medical board on May 26 prohibited physicians from prescribing, compounding, or administer... May 27, 2026 · 12 min read
    Clinical Research Lilly's SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN: weight-loss maintenance with lower-dose Zepbound or oral Foundayo Two Lilly Phase 3 trials show people can hold weight loss with lower-dose Zepbound or daily oral Fou... May 26, 2026 · 11 min read
    Regulation Oral semaglutide (Wegovy pill) gets EU CHMP backing: what it means for GLP-1 access EU regulators recommended a once-daily 25 mg oral semaglutide tablet for obesity. Here’s what the CH... May 25, 2026 · 10 min read
    Regulation FDA restores non-injectable GHK-Cu to 503A Category 1 — what it means for peptide compounding FDA restored non-injectable GHK-Cu to Category 1 of its 503A bulks list on May 14, reversing an Apri... May 23, 2026 · 10 min read
    Research NIH locates semaglutide's brain handle: cAMP in area postrema neurons, and a PDE4 inhibitor that sustains it A Nature Metabolism paper out today identifies cAMP signaling in area postrema neurons as the cellul... May 22, 2026 · 10 min read
    Clinical Trials Retatrutide hits 28.3% weight loss in TRIUMPH-1: Lilly's triple agonist clears its Phase 3 obesity trial Lilly's triple-agonist retatrutide produced 28.3% mean weight loss at 80 weeks in TRIUMPH-1, the hig... May 21, 2026 · 11 min read
    Industry Regeneron bets $125M upfront on Parabilis Helicons: antibody-peptide conjugates step out of the shadows Regeneron's $125M upfront plus $2.2B milestone deal with Parabilis bets antibody-Helicon conjugates ... May 20, 2026 · 14 min read
    Regulation FDA warning letter targets retatrutide and tirzepatide ‘research peptides’: what it means for buyers and clinics The FDA’s March 31, 2026 warning letter to Gram Peptides spotlights how ‘research use only’ peptide ... May 19, 2026 · 9 min read
    Peptide Research Peptideins: Nature's New Category of Human Molecule Adds 1,785 Entries to the Proteome Nature, May 6: the TransCODE consortium formally names 1,785 microproteins 'peptideins' and adds the... May 18, 2026 · 13 min read
    Oncology Peptides BLMP6: UTHealth's Fibulin-4-Targeting Peptide for Metastatic Breast Cancer The Kolonin lab at UTHealth Houston identified BLMP6, a peptide that targets fibulin-4 on invasive b... May 17, 2026 · 11 min read
    Neuroscience & GLP-1 Orforglipron Reaches the Central Amygdala: How Oral GLP-1s Turn Down the Dopamine Reward Circuit A new Nature paper from Ali Guler's UVA lab maps how oral GLP-1 drugs like orforglipron reach the ce... May 16, 2026 · 12 min read
    Regulation FDA’s July 2026 Peptide Compounding Meeting: What PCAC Could Change for BPC-157, TB-500, Semax, and More FDA will hold a July 23–24, 2026 PCAC meeting on seven peptide bulk substances. Here’s what it means... May 15, 2026 · 10 min read
    Drug Discovery & Platforms Suga Lab's RaPID-ExCells Finds HL4, a Macrocyclic Insulin Receptor Agonist Hiroaki Suga's lab at Tokyo published a cell-based mRNA display platform that found HL4, a cyclic pe... May 13, 2026 · 13 min read
    Mechanism & Neuroscience GEP-44: What the Syracuse Triple-Agonist Peptide Actually Is, and What the Press Got Wrong Syracuse's GEP-44 is a chimeric GLP-1/Y1/Y2 peptide with strong rodent and shrew data but no human t... May 12, 2026 · 12 min read
    Regulatory & Industry Entera Submits Phase 3 Protocol for EB613, the First Oral Anabolic Bone Tablet Entera says EB613, an oral PTH 1-34 tablet, has a Phase 3 protocol at the FDA with feedback expected... May 11, 2026 · 11 min read
    Mechanism & Neuroscience GLP-1s, Dopamine, and Falling Out of Love: What the Neuroscience Actually Says GLP-1 receptors sit in the same brain circuits that build romantic bonds. The mechanism users report... May 10, 2026 · 13 min read
    Regulatory Ozempic (Semaglutide) Tablets: What the FDA Label Actually Says (Dosing, Switching, Warnings) Ozempic tablets are here. We break down the FDA label: strengths, the 30-day start dose (not for gly... May 10, 2026 · 9 min read
    Clinical Trials & Drug Development Avexitide expanded access opens: a GLP-1 receptor antagonist heads to its Phase 3 readout Amylyx opens U.S. expanded access for up to 250 PBH patients on avexitide, the first-in-class GLP-1 ... May 9, 2026 · 10 min read
    Regulation & Policy FDA's second PCAC peptide review: the 5 substances heading to a Feb 2027 meeting FDA confirms a second PCAC meeting before end of February 2027 will review LL-37, injectable GHK-Cu,... May 8, 2026 · 11 min read
    Regulation & Market Ozempic-branded oral semaglutide hits US pharmacies with primary + secondary CV indication Novo Nordisk's oral semaglutide launches as Ozempic tablets on May 4 with a primary + secondary CV p... May 7, 2026 · 10 min read
    Clinical evidence Semaglutide beats dulaglutide on MACE in 75,243-patient Medicare comparison A 75,243-patient Medicare propensity-matched study finds once-weekly semaglutide cut three-point MAC... May 6, 2026 · 9 min read
    FDA regulation FDA proposes excluding semaglutide and tirzepatide from the 503B bulks list FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, setting a... May 5, 2026 · 10 min read
    regulation-policy FDA's April 7 Warning Letter Batch: How the Bacteriostatic-Water Trigger Is Closing the 'Research Peptides' Lane FDA's April 7 batch of seven warning letters uses bacteriostatic-water pairing to overcome 'research... May 4, 2026 · 10 min read
    Regulation FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list—tight... May 3, 2026 · 10 min read
    FDA & Policy FDA sets July 2026 PCAC review for key compounding peptides (BPC-157, MOTs-C, Semax) FDA’s July 23–24, 2026 PCAC agenda puts seven peptides (BPC-157, KPV, TB-500, MOTs-C, DSIP, Semax, E... May 2, 2026 · 9 min read
    cardiovascular GLP-1 Receptor Agonists in Type 1 Diabetes: What the New Cardiorenal Evidence Means A 174,678-patient Hopkins target trial emulation found 15% lower MACE and 19% lower ESKD risk with G... May 1, 2026 · 11 min read
    regulation-policy Pop Peptides and the Evidence Gap: What Knoepfler's STAT Essay Gets Right About BPC-157 and GHK-Cu A UC Davis scientist's STAT essay says Kennedy's peptide reversal runs ahead of trial data. What's a... Apr 30, 2026 · 11 min read
    Regulation State of Peptides 2026: What the GLP-1 Pipeline and FDA Policy Signals Mean Now FormBlends’ 2026 State of Peptides report highlights how FDA compounding policy and the GLP-1 pipeli... Apr 29, 2026 · 10 min read
    regulation-policy FDA Sets July 23-24 PCAC Vote on Seven Peptides for the 503A Bulks List: BPC-157, KPV, TB-500, MOTs-C, DSIP, Semax, Epitalon FDA's July 23-24 PCAC will vote on seven peptides for the 503A Bulks List. Two dockets are open. Jul... Apr 28, 2026 · 9 min read
    weight-loss-metabolic Tirzepatide Linked to Fewer Cardiac Events After PCI and TAVR: Three Propensity-Matched Studies at SCAI 2026 and AACE 2026 Three propensity-matched studies presented April 23-24 link tirzepatide to fewer deaths and major ca... Apr 27, 2026 · 9 min read
    Research Tirzepatide vs Semaglutide Cost-Effectiveness: SURMOUNT-5 Lifetime Model Shows $41,688 Per-Patient Savings A new lifetime simulation built on SURMOUNT-5 data finds tirzepatide saves $41,688 per patient and a... Apr 26, 2026 · 8 min read
    Regulation & Policy FDA Opens Docket FDA-2025-N-6895 for July 2026 PCAC Peptide Review FDA opened docket FDA-2025-N-6895 ahead of the July 23–24, 2026 PCAC meeting on seven peptides. What... Apr 25, 2026 · 5 min read
    Regulation & Policy FDA Import Alert 66-80: GLP-1 and Peptide Bulk API Now Detained at the Border FDA has updated Import Alert 66-80 to authorize Detention Without Physical Examination for bulk GLP-... Apr 24, 2026 · 12 min read
    Research & Discovery SAB-142 Phase 1 Data: C-Peptide Preservation in Established Type 1 Diabetes At IDS 2026 on April 22, SAB Biotherapeutics reported that all four adults with established Type 1 D... Apr 23, 2026 · 10 min read
    Regulation & Policy FDA’s Peptide ‘Rally’ Update: Supply Chain and Enforcement Are the Real Bottlenecks A fresh follow-up from the FDA Law Blog (Apr 22, 2026) argues the biggest barrier to “peptides being... Apr 22, 2026 · 11 min read
    Regulation & Policy FDA’s ‘Peptide Rally’: What Changed — and What Hasn’t (Yet) A new analysis from the FDA Law Blog explains why the FDA’s recent ‘Category 2 removal’ headlines do... Apr 21, 2026 · 9 min read
    Regulation & Policy How to Submit Public Comments on FDA Peptide Compounding (Docket FDA-2025-N-6895) The FDA has opened docket FDA-2025-N-6895 for public comments on seven peptides — including BPC-157,... Apr 20, 2026 · 8 min read
    Regulation & Policy FDA Sets July 2026 PCAC Hearing for BPC-157, TB-500, MOTS-C, Semax, and More The FDA has published the agenda for its July 23–24, 2026 Pharmacy Compounding Advisory Committee (P... Apr 18, 2026 · 10 min read
    Research & Discovery BRP: Stanford's AI-Discovered Peptide That Could Replace Ozempic Stanford researchers used an AI algorithm called Peptide Predictor to scan 20,000 human genes and di... Apr 18, 2026 · 12 min read
    Regulation & Policy FDA Peptide Reclassification 2026: Which 12 Peptides Are Being Restored Under RFK Jr. In April 2026, the FDA announced it would remove 12 peptides from its Category 2 list, reversing a s... Apr 17, 2026 · 12 min read
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Today's News FDA Staff Reviewers Say ‘No’ to 7 Compounded Peptides Ahead of July PCAC Vote Jul 6, 2026
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    Cardiovascular

    Peptides with direct cardiovascular effects including natriuretic peptides, vasodilators, and cardioprotective agents.

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    Dulaglutide

    Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist marketed by Eli Lilly under the brand name Trulicity. Approved by the FDA in Septe...

    FDA-approved 2014 for T2D, label expanded 2020 to include MACE reduction. Active

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