Peptide News & Research Updates
The latest on peptide regulations, FDA decisions, clinical research, and industry developments. Stay informed with evidence-based reporting from the PeptideKnow editorial team.
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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. What that process means for BPC-157—and what it doesn’t....
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 down on advertising that calls them generic versions of bra...
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 FDA's PCAC prepares a July 2026 review of seven peptides....
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 regression in 212-patient F2/F3 MASH IMPACT Phase 2b at EASL 2026....
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 liver-fat improvement in the 48 mg cohort, no plateau....
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 administering any non-FDA-approved peptide, with no consent-form excep...
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 Foundayo after high-dose injectable GLP-1 therapy. Numbers....
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 CHMP opinion signals for GLP-1 access, safety, and compounding...
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 April removal — and set a PCAC review before end of February 202...
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 cellular handle for semaglutide's weight-loss effect....
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 highest figure reported in any Phase 3 obesity trial....
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 can drug protein-protein interactions ADCs can't reach....
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 sellers can trigger enforcement when claims imply human use....
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 them to GENCODE, UniProt, and PeptideAtlas as a new annotation ...
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 breast cancers and delivers MMAE chemotherapy with preclinica...
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 central amygdala and dampen dopamine in the reward circuit....
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 for 503A compounding and what changes—and what doesn’t....
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 peptide insulin receptor agonist with a 51-hour half-life dime...
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 trials. What the press got wrong, and what to track next....
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 imminently. The first oral anabolic bone drug....
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 as falling out of love is biologically plausible....
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 glycemic control), switching rules, and boxed warning....
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 antagonist; LUCIDITY Phase 3 readout due Q3 2026 data....
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, Dihexa, Melanotan II, and PEG-MGF for the 503A list....
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 prevention label, on the strength of the SOUL trial....
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 MACE 22% versus dulaglutide in older type 2 diabetes adults....
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 June 29, 2026 comment deadline with major impacts....
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 use only' disclaimers on GLP-1 peptide sellers. What change...
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—tightening rules for large-scale compounding of GLP‑1s....
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, Epithalon) into formal 503A bulks-list review....
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 GLP-1 RAs in T1D, no DKA signal. What it means clinically....
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 actually published on BPC-157 and GHK-Cu, and what PCAC can d...
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 pipeline could reshape peptide access, pricing, and safety in 2026...
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. July 9 is the cutoff for comments to reach the committee....
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 cardiovascular events versus GLP-1 comparators in PCI, TAVR, a...
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 adds 0.506 QALYs versus semaglutide....
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 is on the agenda and what stays unchanged for 503A compound...
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-1 API (semaglutide, tirzepatide, liraglutide, exenatide, dul...
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 Diabetes dosed with SAB-142 preserved endogenous C-peptide at...
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 legal again” isn’t just the PCAC calendar — it’s whether ph...
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 don’t automatically make peptides like BPC-157 and TB-500 lega...
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, TB-500, Semax, and Epitalon — ahead of the July 23–24, 2026...
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 (PCAC) meeting, naming seven peptides—including BPC-157, TB-50...
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 discovered BRP — a naturally occurring 12-amino-acid peptide t...
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 sweeping 2023 ban that cut off patient access to compounds li...