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Peptency Academy · Compound

Semaglutide (GLP-1 receptor agonist peptide)

Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue: a 31 residue peptide with two amino acid substitutions compared with human GLP-1 (Aib8 and Arg34) and a fatty acid side chain attached at lysine 26. Source sentenceAbstract: "Semaglutide has two amino acid substitutions compared to human GLP-1 (Aib(8), Arg(34)) and is derivatized at lysine 26." "The fatty acid moiety and the linking chemistry to GLP-1 were the key features to secure high albumin affinity and GLP-1 receptor (GLP-1R) potency"; PubChem CID 56843331 systematic name: 31 amino acid residues, L-Histidyl-2-methylalanyl-... to ...-L-arginylglycine1 J Med Chem 20152 PubChem CID 56843331 PubChem records it under CID 56843331: formula C187H291N45O59, molecular mass about 4114 Da, CAS 910463-68-2. Source sentenceCID 56843331: Title Semaglutide; MolecularFormula C187H291N45O59; MolecularWeight 4114; MonoisotopicMass 4111.1153770; InChIKey DLSWIYLPEUIQAV-CCUURXOWSA-N; synonyms include 910463-68-2, NN9535, NNC 0113-02172 PubChem CID 56843331 EMA's safety committee describes semaglutide as a GLP-1 receptor agonist. Source sentenceSemaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines3 EMA news, safety committee conclusion on NAION, 6 June 2025 PubMed held 5,662 records with semaglutide in the title or abstract on 14 Oct 2026. Source sentenceesearch semaglutide[tiab]: count 5662 on 14 Oct 20264 PubMed search for semaglutide, 14 October 2026

Version 1Edited Evidence through 26 sources

Regulatory content shown for: United States and the Americas.

Acylated peptide analogue

  • INN, PubChem CID 56843331Semaglutide31 residuesabout 4114 DaSource sentenceCID 56843331: Title Semaglutide; MolecularFormula C187H291N45O59; MolecularWeight 4114; MonoisotopicMass 4111.1153770; InChIKey DLSWIYLPEUIQAV-CCUURXOWSA-N; synonyms include 910463-68-2, NN9535, NNC 0113-02172 PubChem CID 56843331

Known, not known, contested

Known

  • The discovery paper measured GLP-1 receptor affinity and serum albumin affinity of semaglutide against liraglutide. Source sentence"The GLP-1R affinity of semaglutide [...] compared to liraglutide, whereas the albumin affinity [...]"1 J Med Chem 2015
  • Two receptor structures with semaglutide are public: a crystal structure of its peptide backbone with the GLP-1 receptor extracellular domain (PDB 4ZGM, 2015) and a cryo-EM structure of semaglutide bound to the full receptor and Gs protein (PDB 7KI0, 2021). Source sentenceRCSB 7KI0: Semaglutide-bound Glucagon-Like Peptide-1 (GLP-1) Receptor in Complex with Gs protein, ELECTRON MICROSCOPY, released 2021-08-04. RCSB 4ZGM: Crystal structure of Semaglutide peptide backbone in complex with the GLP-1 receptor extracellular domain, X-RAY DIFFRACTION, released 2015-09-095 RCSB Protein Data Bank entry 7KI06 RCSB Protein Data Bank entry 4ZGM7 Cell Rep 2021
  • PubMed tagged 311 of its semaglutide records as randomised controlled trials and 1,673 as reviews on 14 Oct 2026. Source sentenceesearch semaglutide[tiab] AND randomized controlled trial[pt]: count 311; semaglutide[tiab] AND review[pt]: count 16738 PubMed search for randomised trials of semaglutide, 14 October 20269 PubMed search for reviews of semaglutide, 14 October 2026
  • ClinicalTrials.gov listed 781 records with semaglutide as an intervention on 14 Oct 2026, 109 of them with posted results. Source sentencequery.intr semaglutide, countTotal 781 (query.term 809); filter.overallStatus COMPLETED 352, RECRUITING 168, NOT_YET_RECRUITING 105, ACTIVE_NOT_RECRUITING 69, TERMINATED 9, WITHDRAWN 14; aggFilters results:with 109; query.lead "Novo Nordisk" 26210 ClinicalTrials.gov search, 14 October 2026

Not known

  • Products sold as research peptides were not part of the 2026 impurity study's sample set, which held follow-on and compounded medicinal products. Source sentenceMaterials: "obtained from 36 commercial suppliers across North and South America, Europe, and Asia (Table I). This included nine semaglutide DS follow-on products (S1 - S9), 13 ... semaglutide compounded products (CP: CP1 - CP13), and 11 follow-on or compounded semaglutide ... products (OP: OP1 - OP11)"11 Pharm Res 2026, impurities
  • The 2024 analysis of follow-on semaglutide products states that the clinical impact of the differences it found remains unknown. Source sentenceCONCLUSION: "The impact of these changes on efficacy and safety outcomes remains unknown and should be investigated by clinical studies."12 Pharm Res 2024
  • Before a 2026 thermal stress study, its authors state, the solid state behaviour of semaglutide was unclear, while its stability in solution had been studied extensively. Source sentenceOBJECTIVE: "Although the stability of SMG in solution has been extensively studied, its solid-state behaviour remains unclear."13 Pharm Res 2026, thermal stress

Contested

Nothing listed yet.

Chemistry: semaglutide as PubChem CID 56843331 records it

Sequence
HXEGTFTSDVSSYLEGQAAKEFIAWLVRGRG
Length
31 residues
Modifications
Aib (2-methylalanine) at position 2 (Aib8 in GLP-1 numbering), Arg at position 28 (Arg34 in GLP-1 numbering), Lys20 (Lys26 in GLP-1 numbering) N6 side chain: 17-carboxy-1-oxoheptadecyl, L-gamma-glutamyl and two aminoethoxy ethoxy acetyl units
Formula
C187H291N45O59
Monoisotopic mass
4111.1154 Da
Average mass
4114 Da
CAS
910463-68-2
PubChem CID
56843331
InChIKey
DLSWIYLPEUIQAV-CCUURXOWSA-N
Synonyms
NN9535, NNC 0113-0217, semaglutida, semaglutidum, UNII 53AXN4NNHX
Salt form
No salt form stated in the record
Checked 14 October 2026 2 PubChem CID 56843331

Chemistry: the chain and the side chain

  • PubChem's systematic name lists 31 amino acid residues, from an N-terminal histidine to a C-terminal glycine; written in one-letter code with X for Aib, the chain is HXEGTFTSDVSSYLEGQAAKEFIAWLVRGRG. Source sentenceSynonym (systematic name): L-Histidyl-2-methylalanyl-L-alpha-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alpha-aspartyl-L-valyl-L-seryl-L-seryl-L-tyrosyl-L-leucyl-L-alpha-glutamylglycyl-L-glutaminyl-L-alanyl-L-alanyl-N6-(...)-L-lysyl-L-alpha-glutamyl-L-phenylalanyl-L-isoleucyl-L-alanyl-L-tryptophyl-L-leucyl-L-valyl-L-arginylglycyl-L-arginylglycine (one-letter code written for this page)2 PubChem CID 56843331
  • Position 2 is 2-methylalanine (Aib), a non-standard amino acid: PubChem's systematic name begins "L-Histidyl-2-methylalanyl". Source sentenceSynonym (systematic name): L-Histidyl-2-methylalanyl-L-alpha-glutamylglycyl-L-threonyl-...2 PubChem CID 56843331
  • The same name places the side chain on the lysine at position 20: a 17-carboxy-1-oxoheptadecyl group joined through an L-gamma-glutamyl residue and two 2-(2-(2-aminoethoxy)ethoxy)acetyl units. Source sentenceSynonym (systematic name): ...-L-alanyl-N6-(N-(17-carboxy-1-oxoheptadecyl)-L-gamma-glutamyl-2-(2-(2-aminoethoxy)ethoxy)acetyl-2-(2-(2-aminoethoxy)ethoxy)acetyl)-L-lysyl-L-alpha-glutamyl-...2 PubChem CID 56843331
  • PubChem gives a monoisotopic mass of 4111.1154 Da and the InChIKey DLSWIYLPEUIQAV-CCUURXOWSA-N; its development codes include NN9535 and NNC 0113-0217. Source sentenceCID 56843331: Title Semaglutide; MolecularFormula C187H291N45O59; MolecularWeight 4114; MonoisotopicMass 4111.1153770; InChIKey DLSWIYLPEUIQAV-CCUURXOWSA-N; synonyms include 910463-68-2, NN9535, NNC 0113-02172 PubChem CID 56843331

Sequence

HXEGTFTSDVSSYLEGQAAKEFIAWLVRGRG

K residues 20 to 20The 31 residues of semaglutide as PubChem's systematic name spells them, with Aib (2-methylalanine) at position 2 written as X. The highlighted lysine at position 20 carries the fatty acid side chain.
  • In GLP-1 numbering, which the discovery paper uses, the three changes are Aib8, Arg34 and the derivatised lysine 26. Source sentenceAbstract: "Semaglutide has two amino acid substitutions compared to human GLP-1 (Aib(8), Arg(34)) and is derivatized at lysine 26."1 J Med Chem 2015

Which molecule does a semaglutide certificate describe?

  • Read the formula and mass on the certificate of analysis. Semaglutide is C187H291N45O59, monoisotopic mass 4111.1154 Da, about 4114 Da (PubChem CID 56843331); liraglutide, another acylated GLP-1 analogue, is C172H265N43O51, about 3751 Da (PubChem CID 16134956). Source sentenceCID 56843331: C187H291N45O59, MonoisotopicMass 4111.1153770, MolecularWeight 4114; CID 16134956 (Liraglutide): C172H265N43O51, MolecularWeight 3751; PMID 26308095: "Liraglutide is an acylated glucagon-like peptide-1 (GLP-1) analogue"2 PubChem CID 5684333114 PubChem CID 161349561 J Med Chem 2015
  • TGA laboratory testing of a product sold as retatrutide found undeclared semaglutide and no retatrutide (safety advisory published 14 Sep 2026). Source sentencePublished 14 September 2026 ... TGA laboratory testing of the product found that: the product contained undeclared semaglutide and no retatrutide.15 TGA safety advisory, 14 September 2026 (Internet Archive capture of 21 September 2026)
  • A 2026 study reported distinct impurity profiles in follow-on and compounded semaglutide samples compared with the originator; the Academy news item on that study covers its samples and methods. Source sentenceRESULTS: "The follow-on drug substance and follow-on or compounded products had distinct impurity profiles"11 Pharm Res 2026, impurities
  • A 2026 thermal stress study of solid semaglutide reported temperature dependent degradation and impurity formation by RP-HPLC and LC-HRMS. Source sentenceRESULTS: "RP-HPLC and LC-HRMS analyses showed a temperature-dependent degradation and impurity formation."13 Pharm Res 2026, thermal stress

What is semaglutide?

Semaglutide is a GLP-1 receptor agonist peptide: a 31 residue analogue of human glucagon-like peptide-1 with Aib at position 8, arginine at position 34 and a fatty acid side chain on lysine 26 (PubChem CID 56843331, CAS 910463-68-2, about 4114 Da). Source sentenceAbstract: "Semaglutide has two amino acid substitutions compared to human GLP-1 (Aib(8), Arg(34)) and is derivatized at lysine 26."; PubChem CID 56843331: Semaglutide [USAN:INN], CAS 910463-68-2, MolecularWeight 41141 J Med Chem 20152 PubChem CID 56843331

Is semaglutide a peptide?

Yes. Semaglutide is a chain of 31 amino acids, one of them the non-standard 2-methylalanine (Aib), with a fatty acid side chain on one lysine. PubChem lists the name as Semaglutide [USAN:INN]. Source sentenceSynonyms: Semaglutide [USAN:INN]; systematic name L-Histidyl-2-methylalanyl-... with N6-(N-(17-carboxy-1-oxoheptadecyl)-L-gamma-glutamyl-...)-L-lysyl2 PubChem CID 56843331

Is semaglutide a GLP-1 receptor agonist?

Yes. Semaglutide is a GLP-1 analogue studied as a GLP-1 receptor agonist: a 2021 cryo-EM study resolved it bound to the GLP-1 receptor and Gs protein (PDB 7KI0), and its discovery paper measured its GLP-1 receptor affinity and its albumin affinity. Source sentencePMID 34260945: "Multiple GLP-1R agonists [...] such as semaglutide"; "we report cryoelectron microscopy (cryo-EM) structures and cryo-EM 3D variability analysis of semaglutide- and taspoglutide-bound GLP-1R-Gs protein complexes"; PMID 26308095: "The GLP-1R affinity of semaglutide [...] compared to liraglutide, whereas the albumin affinity [...]"7 Cell Rep 20211 J Med Chem 20155 RCSB Protein Data Bank entry 7KI0

What is the molecular mass of semaglutide?

PubChem gives an average mass of about 4114 Da and a monoisotopic mass of 4111.1154 Da for C187H291N45O59 (CID 56843331). Liraglutide, a related acylated GLP-1 analogue, is about 3751 Da (CID 16134956). Source sentenceCID 56843331: MolecularWeight 4114, MonoisotopicMass 4111.1153770, MolecularFormula C187H291N45O59; CID 16134956: MolecularWeight 37512 PubChem CID 5684333114 PubChem CID 16134956

Are there registered clinical trials of semaglutide?

Yes. ClinicalTrials.gov listed 781 records with semaglutide as an intervention on 14 Oct 2026: 352 completed, 168 recruiting, 105 not yet recruiting, and 109 with posted results. Novo Nordisk is lead sponsor of 262 of them. Two completed records with posted results are listed under Registered trials. Source sentencequery.intr semaglutide, countTotal 781 (query.term 809); filter.overallStatus COMPLETED 352, RECRUITING 168, NOT_YET_RECRUITING 105, ACTIVE_NOT_RECRUITING 69, TERMINATED 9, WITHDRAWN 14; aggFilters results:with 109; query.lead "Novo Nordisk" 26210 ClinicalTrials.gov search, 14 October 202616 ClinicalTrials.gov NCT0589149617 ClinicalTrials.gov NCT06401746

Is semaglutide an FDA approved drug?

US

An approved medicine with this INN exists in the United States. The catalog item is not that medicine. Source sentenceopenFDA drugsfda, products.active_ingredients.name SEMAGLUTIDE: application records with submission_status AP (checked 14 Oct 2026)18 openFDA Drugs@FDA query for semaglutide, 14 October 2026

Evidence map: semaglutide

Primary studies of semaglutide, by model and by what was measured. Reviews are not counted. An empty cell means: not mapped yet.
ModelChemistry and analyticalPharmacokineticsReceptor binding and signallingTissue histologyBiomarkersClinical endpoint
Analytical only (no biological model)Chemistry and analytical3Not mapped yetNot mapped yetNot mapped yetNot mapped yetNot mapped yet
In vitro or ex vivoNot mapped yetNot mapped yetReceptor binding and signalling1Not mapped yetBiomarkers1Not mapped yet
RodentNot mapped yetPharmacokinetics1Not mapped yetNot mapped yetNot mapped yetNot mapped yet
Other animalNot mapped yetNot mapped yetNot mapped yetNot mapped yetNot mapped yetNot mapped yetNot mapped yet
Human, uncontrolledNot mapped yetPharmacokinetics1Not mapped yetNot mapped yetNot mapped yetNot mapped yet
Human, randomisedNot mapped yetPharmacokinetics1Not mapped yetNot mapped yetNot mapped yetNot mapped yet

7 studies countedEvidence level facet: L4. A design scale, not a measure of strength or quality.

Counts only the seven exact match studies reviewed for this page on 14 October 2026, out of 5,662 PubMed records with semaglutide in the title or abstract (311 tagged as randomised controlled trials). Empty cells are not mapped yet. The 2015 discovery paper is cited on this page and not counted; reviews are never counted.

Who produced this evidence

  • Semaglutide was designed at Novo Nordisk: the authors of the 2015 discovery paper list Novo Nordisk Global Research in Måløv, Denmark. Source sentenceAffiliation: Global Research, Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Måløv, Denmark1 J Med Chem 2015
  • The two human pharmacokinetic studies counted here are tied to Novo Nordisk: the renal function study states that it was funded by Novo Nordisk A/S, and the omeprazole interaction trial lists Novo Nordisk and PAREXEL author affiliations. Source sentencePMID 28349386: "FUNDING: This study was funded by Novo Nordisk A/S." PMID 29897249 affiliations: Novo Nordisk A/S, Søborg, Denmark; PAREXEL International GmbH, Berlin, Germany20 Clin Pharmacokinet 201721 Expert Opin Drug Metab Toxicol 2018
  • Both analytical comparisons of follow-on and compounded semaglutide cited here come from Novo Nordisk authors; nine authors of the 2026 study are employees and shareholders of Novo Nordisk A/S. Source sentenceConflicts of Interest: nine authors "are employees and shareholders of Novo Nordisk A/S"; PMID 39379664 affiliations: Novo Nordisk A/S, Måløv and Bagsværd, Denmark11 Pharm Res 2026, impurities12 Pharm Res 2024
  • Other studies here come from groups that declare no competing interests (the cryo-EM study at Monash University and the thermal stress study at NIPER Hajipur, India), and from a rat study at Sungkyunkwan University with one author employed by D&D Pharmatech. Source sentencePMID 34260945: "The authors declare no competing interests", affiliation Monash Institute of Pharmaceutical Sciences; PMID 42086873: "The authors declare that they have no competing financial interests", affiliation National Institute of Pharmaceutical Education and Research, Hajipur; PMID 36989942: "Eun Ji Park reports a relationship with D&D Pharmatech that includes: employment", affiliation School of Pharmacy, Sungkyunkwan University7 Cell Rep 202113 Pharm Res 2026, thermal stress19 J Chromatogr B 2023
  • On ClinicalTrials.gov, Novo Nordisk is lead sponsor of 262 of the 781 records with semaglutide as an intervention (14 Oct 2026). Source sentencequery.intr semaglutide, countTotal 781 (query.term 809); filter.overallStatus COMPLETED 352, RECRUITING 168, NOT_YET_RECRUITING 105, ACTIVE_NOT_RECRUITING 69, TERMINATED 9, WITHDRAWN 14; aggFilters results:with 109; query.lead "Novo Nordisk" 26210 ClinicalTrials.gov search, 14 October 2026

Studies

  1. Analytical only (no biological model)Pharm Res 2026

    Secondary structure (FT-IR, circular dichroism), thermal events (DSC, hot-stage microscopy) and degradation products (RP-HPLC, LC-HRMS) of solid semaglutide under thermal stress

    Design
    Analytical stability study under thermal stress
    Population or model
    none (chemistry and analytical)
    Molecule
    semaglutide exact

    Competing interest statement: the authors declare no competing financial interests.

    PubMed 42086873DOI

  2. Analytical only (no biological model)Pharm Res 2024

    Purity and impurity patterns, trace metals, residual solvents, content against label claim, release profiles, predicted MHC-II binding and fibrillation of follow-on products

    Design
    Comparative analytical study of marketed follow-on drug substances and drug products against the originators
    Population or model
    follow-on semaglutide and liraglutide samples and their originators
    Molecule
    semaglutide exact
    Comparator
    Originator semaglutide and liraglutide

    All listed affiliations are Novo Nordisk A/S, the originator manufacturer.

    PubMed 39379664DOI

  3. Analytical only (no biological model)Pharm Res 2026

    LC-MS impurity profiles, peptide presentation on donor dendritic cells (MAPPs), photostability and fibrillation of follow-on and compounded samples

    Design
    Comparative analytical study of marketed follow-on and compounded samples against the originator, plus an in vitro peptide presentation assay
    Population or model
    Follow-on drug substances and follow-on or compounded drug products from 36 suppliers; dendritic cells from healthy donors for MAPPs
    Molecule
    semaglutide exact
    Comparator
    Originator semaglutide and liraglutide

    Nine authors are employees and shareholders of Novo Nordisk A/S; one is a shareholder and was an employee when the study was undertaken.

    PubMed 42533250DOI

  4. In vitro or ex vivoCell Rep 2021

    Structure and motions of the semaglutide-bound GLP-1 receptor and Gs protein complex (PDB 7KI0)

    Design
    Cryo-electron microscopy structures and 3D variability analysis
    Population or model
    Purified GLP-1 receptor and Gs protein complexes
    Molecule
    semaglutide exact
    Comparator
    Taspoglutide-bound complex and published GLP-1-bound structures

    Declaration of interests: the authors declare no competing interests.

    PubMed 34260945DOI

  5. RodentJ Chromatogr B Analyt Technol Biomed Life Sci 2023

    Semaglutide concentrations in rat plasma and brain regions by LC-MS/MS, plasma pharmacokinetics and brain tissue to plasma partition

    Design
    LC-MS/MS method development and validation, then a rat pharmacokinetic and brain distribution study
    Population or model
    Sprague-Dawley rats
    Molecule
    semaglutide exact
    Funding
    Korea Ministry of Trade, Industry and Energy (support to one author)

    Competing interests: one author reports employment with D&D Pharmatech; one reports financial support from the Korea Ministry of Trade, Industry and Energy.

    PubMed 36989942DOI

  6. Human, uncontrolledClin Pharmacokinet 2017

    Plasma exposure (area under the concentration curve) and maximum plasma concentration by renal function group, safety and tolerability

    Design
    Multicentre, non-randomised comparison of renal function groups
    Population or model
    adults grouped by renal function: normal, mild, moderate or severe impairment, and end-stage renal disease
    Molecule
    semaglutide exact
    n
    56
    Comparator
    participants with normal renal function
    Funding
    Novo Nordisk A/S

    Funding statement: "This study was funded by Novo Nordisk A/S." Three authors are employees of, and own shares in, Novo Nordisk A/S.

    PubMed 28349386DOI

  7. Human, randomisedExpert Opin Drug Metab Toxicol 2018

    Plasma exposure (area under the concentration curve over 24 hours) and maximum concentration of semaglutide with and without omeprazole, and gastric pH

    Design
    Single-centre, randomised, open-label, parallel-group trial
    Population or model
    healthy adults
    Molecule
    semaglutide exact
    n
    54
    Comparator
    semaglutide without omeprazole
    Blinding
    open-label

    Authors list Novo Nordisk A/S and PAREXEL International affiliations.

    PubMed 29897249DOI

Mechanisms studied

  • The discovery paper measured GLP-1 receptor affinity and serum albumin affinity of semaglutide against liraglutide. Source sentence"The GLP-1R affinity of semaglutide [...] compared to liraglutide, whereas the albumin affinity [...]"1 J Med Chem 2015
  • A 2021 cryo-EM study of semaglutide bound to the GLP-1 receptor and Gs protein (PDB 7KI0, 2.5 Å) reported peptide interactions similar to GLP-1 but different motions within the receptor and the bound peptide. Source sentenceAbstract: "These reveal similar peptide interactions to GLP-1 but different motions within the receptor and bound peptides"; RCSB 7KI0 resolution 2.57 Cell Rep 20215 RCSB Protein Data Bank entry 7KI0
  • A 2015 crystal structure (PDB 4ZGM, 1.8 Å) holds the semaglutide peptide backbone in complex with the extracellular domain of the GLP-1 receptor. Source sentenceRCSB 4ZGM: Crystal structure of Semaglutide peptide backbone in complex with the GLP-1 receptor extracellular domain; X-RAY DIFFRACTION; resolution 1.8; released 2015-09-096 RCSB Protein Data Bank entry 4ZGM
  • A 2023 rat study measured semaglutide concentrations in plasma and in brain regions by LC-MS/MS and estimated a brain tissue to plasma partition coefficient. Source sentenceAbstract: "This study aimed to develop a novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis of semaglutide in both plasma and brain to characterize the pharmacokinetics and brain distribution in rats."; "The brain tissue to plasma partition coefficient (Kp) value of semaglutide was estimated [...]"19 J Chromatogr B 2023

Status matrix

United States: FDA records

US

  • US semaglutide labels checked on 14 Oct 2026 in openFDA (five label records) and DailyMed (the two current label sets) contain no wording on non-arteritic anterior ischemic optic neuropathy (NAION). Source sentenceopenFDA label.json generic_name semaglutide: 5 records; search AND "NAION": NOT_FOUND; AND "optic neuropathy": NOT_FOUND (control term found in 5). DailyMed SPL adec4fd2-6858-4c99-91d4-531f5f2a2d79 and ee06186f-2aa3-4990-a760-757579d8f77b: 0 matches for NAION or optic neuropathy23 openFDA drug label query for semaglutide, 14 October 202624 DailyMed label sets adec4fd2 and ee06186f, 14 October 2026
  • FDA Import Alert 66-80, published date 21 Sep 2026, covers detention without physical examination of GLP-1 receptor agonist bulk drug substances, and its product list includes semaglutide. Source sentenceImport Alert # 66-80 Published Date: 09/21/2026 Type: DWPE Import Alert Name: Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances ... 61P[][]72 Semaglutide25 FDA Import Alert 66-80, published date 21 September 2026 (Internet Archive capture of 3 October 2026)
  • FDA's substance registry (GSRS, UNII 53AXN4NNHX) records semaglutide as a protein substance with one 31 residue chain and gives an estimated formula C187H294O60N45 and an estimated mass of 4100 Da, which differ from PubChem's C187H291N45O59 and about 4114 Da. Source sentence_name Semaglutide; substanceClass protein; subunit 1 sequence HAEGTFTSDVSSYLEGQAAKEFIAWLVRGRG; structural modifications at residueIndex 2 and 20; official name Semaglutide (USAN, INN); codes CAS 910463-68-2, PUBCHEM 56843331, INN 9113; properties: Molecular Formula C187H294O60N45 (type ESTIMATED); MOL_WEIGHT:NUMBER(CALCULATED) average 4100.0 Da (type ESTIMATED). PubChem CID 56843331: MolecularFormula C187H291N45O59, MolecularWeight 411426 FDA Global Substance Registration System, UNII 53AXN4NNHX2 PubChem CID 56843331

Regulator safety records

No regulator safety signal recorded.

Sport anti-doping list

International

  • The WADA 2026 Prohibited List, in effect from 1 Jan 2026, does not name semaglutide, GLP-1 or glucagon-like peptide (text search of the list on 14 Oct 2026). The 2027 list was not checked for this page. Source sentence"This List shall come into effect on 1 January 2026." No match for semaglutide, GLP or glucagon in the full text of the 2026 list22 WADA Prohibited List 2026

Registered trials

  • NCT05891496Phase 3

    Status
    Completed (primary completion 19 Aug 2024, study completion 8 Sep 2025); results posted
    Sponsor
    Novo Nordisk A/S
    Site countries
    Canada, Switzerland, Denmark, Italy, Sweden, US
    Primary endpoint
    change in gene expression in cerebrospinal fluid cells and blood cells (single-cell RNA sequencing)
    Primary endpoint met
    not reported
    Last synced
    14 October 2026

  • NCT06401746Not applicable (observational cohort)

    Status
    Completed (primary completion 13 Mar 2025, study completion 1 Jun 2025); results posted
    Sponsor
    University of Western Sydney
    Site countries
    Australia (global context)
    Primary endpoint
    change in gastric myoelectrical amplitude on body surface gastric mapping
    Primary endpoint met
    not reported
    Last synced
    14 October 2026
  • ClinicalTrials.gov on 14 Oct 2026: 781 records with semaglutide as an intervention (809 in a full text search), of which 352 completed, 168 recruiting, 105 not yet recruiting, 69 active and not recruiting, 9 terminated and 14 withdrawn; 109 have posted results. Source sentencequery.intr semaglutide, countTotal 781 (query.term 809); filter.overallStatus COMPLETED 352, RECRUITING 168, NOT_YET_RECRUITING 105, ACTIVE_NOT_RECRUITING 69, TERMINATED 9, WITHDRAWN 14; aggFilters results:with 109; query.lead "Novo Nordisk" 26210 ClinicalTrials.gov search, 14 October 2026

Timeline

  1. Discovery paper describes semaglutide's design for albumin affinity and GLP-1 receptor potency Source sentenceJ Med Chem, 24 Sep 2015: "The fatty acid moiety and the linking chemistry to GLP-1 were the key features to secure high albumin affinity and GLP-1 receptor (GLP-1R) potency"1 J Med Chem 2015
  2. Cryo-EM structure of semaglutide bound to the GLP-1 receptor and Gs protein published Source sentenceCell Rep, 13 Jul 2021: cryo-EM structures of semaglutide-bound GLP-1R-Gs protein complexes7 Cell Rep 2021
  3. Analysis of follow-on semaglutide products against the originator published Source sentencePharm Res, Oct 2024: follow-on drug substances and drug products compared with originators12 Pharm Res 2024
  4. LC-MS impurity study of follow-on and compounded samples published online Source sentencePharm Res 2026 Aug;43(8):2861-2886. Epub 2026 Jul 3011 Pharm Res 2026, impurities
  5. TGA finds undeclared semaglutide in a product sold as retatrutide Source sentencePublished 14 September 2026: "the product contained undeclared semaglutide and no retatrutide"15 TGA safety advisory, 14 September 2026 (Internet Archive capture of 21 September 2026)

Integrity notes

Chemistry and records

Semaglutide: sequence, mass, CAS and regulatory record in the research library →

Sources

  1. 1J Med Chem 2015 accessed 14 Oct 2026
  2. 2PubChem CID 56843331 accessed 14 Oct 2026
  3. 3EMA news, safety committee conclusion on NAION, 6 June 2025 accessed 14 Oct 2026
  4. 4PubMed search for semaglutide, 14 October 2026 accessed 14 Oct 2026
  5. 5RCSB Protein Data Bank entry 7KI0 accessed 14 Oct 2026
  6. 6RCSB Protein Data Bank entry 4ZGM accessed 14 Oct 2026
  7. 7Cell Rep 2021 accessed 14 Oct 2026
  8. 8PubMed search for randomised trials of semaglutide, 14 October 2026 accessed 14 Oct 2026
  9. 9PubMed search for reviews of semaglutide, 14 October 2026 accessed 14 Oct 2026
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About this page

Research-use information. This library summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.

Reviewed by the Peptency editorial process. Version 1, last edited 14 October 2026, 26 sources.

Cite this page: Peptency Academy. Semaglutide: GLP-1 analogue chemistry, studies and regulator records. Version 1./us/academy/compounds/semaglutide/