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Diabetes & GLP-1 Drug Assays Tirzepatide, Semaglutide, Insulin Analog ELISA | Krishgen Biosystems
Metabolic Disease Drug Pharmacokinetics & Immunogenicity

Diabetes &
GLP-1 Drug
Assays

Validated competitive ELISA kits for GLP-1 receptor agonist and insulin analog pharmacokinetic monitoring, plus immunogenicity (ADA/nAb) assays. Includes KOD1027 the world's first and only commercial Tirzepatide ELISA. Species-independent, ISO 13485 manufactured, EMA/FDA-validated.

Browse All Assay Kits Assay Science Overview
7+
Drug Targets Covered
14+
Validated Assay Kits
#1
Tirzepatide ELISA Worldwide
<15%
Assay CV All Kits

GLP-1 Receptor Agonist Drug ELISA

Competitive immunoassay kits for quantitative measurement of GLP-1 agonist drug concentrations in serum, plasma, and cell culture media. All kits use recombinant receptor protein or high-specificity anti-drug antibodies as capture agents. Species-independent valid for human clinical and rat/mouse preclinical samples with the same kit.

Tirzepatide
Dual GIP / GLP-1 Agonist

World's first and only commercial ELISA for Tirzepatide. KOD1027 uses recombinant human GLP-1R protein (HEK293-expressed, =98% HPLC purity) as the capture antigen in a competitive format. HRP-conjugated synthetic Tirzepatide analog competes with sample Tirzepatide for receptor binding.

Cross-reactivity: Semaglutide not detected. Exenatide partial (confirm specificity for mixed-agent studies). Range: 31.34,000 ng/mL. Validated: serum, EDTA plasma, heparin plasma, cell culture supernatant. CV <10% intra-assay, <13% inter-assay. Spike recovery: 92107%.

MOUNJAROZEPBOUNDLY3298176
KOD1027 View Datasheet & Order
Semaglutide
GLP-1 Receptor Agonist

Acylated GLP-1 analog with C18 fatty diacid chain enabling albumin binding and ~7-day half-life. The active ingredient of Ozempic (T2DM), Wegovy (obesity), and Rybelsus (oral formulation). Leading global GLP-1 agonist by market share. KBI5030 provides specific quantification without Liraglutide or Exenatide cross-reactivity.

Range: 7.81,000 ng/mL. Validated: serum, plasma. CV <12%. Recovery 88110%. Suitable for comparative PK studies between semaglutide originator and biosimilar candidates.

OZEMPICWEGOVYRYBELSUS
KBI5030 View Datasheet & Order
Liraglutide
GLP-1 Receptor Agonist

C16 fatty acid-acylated GLP-1 analog with ~13-hour half-life. First once-daily GLP-1 agonist approved for T2DM (Victoza) and obesity (Saxenda at higher dose). Multiple biosimilars entering development globally. KBI5020 validated for PK monitoring in human clinical trials and rat/mouse preclinical studies.

Range: 7.81,000 ng/mL. Validated: serum, plasma. No cross-reactivity with endogenous GLP-1. Pair with KBN5020 anti-Liraglutide nAb ELISA for full immunogenicity package.

VICTOZASAXENDANN2211
KBI5020 View Datasheet & Order
Exenatide
Exendin-4 GLP-1R Agonist

Synthetic version of exendin-4, a peptide from Gila monster saliva with 53% homology to human GLP-1 but 10 higher GLP-1R binding affinity. Available as twice-daily (Byetta) and weekly extended-release (Bydureon BCise). KBI5013 specific for exenatide does not detect liraglutide or semaglutide.

BYETTABYDUREONAC2993
KBI5013 View Datasheet & Order
Lixisenatide
Exendin-4 Derivative GLP-1R Agonist

Exendin-4 derivative with C-terminal modification extending GLP-1R selectivity. Once-daily injection (Adlyxin/Lyxumia). Particularly studied for postprandial glucose control via gastric emptying delay. KBI5021 competitive ELISA validated for clinical PK and rat/mouse preclinical studies.

ADLYXINLYXUMIAAVE0010
KBI5021 View Datasheet & Order

Insulin Analog Drug ELISA

Competitive ELISA kits specific to engineered insulin analogs do not cross-react with endogenous human insulin. Essential for measuring exogenous drug in clinical samples where endogenous insulin is present. Species-independent. All kits include paired ADA ELISA for immunogenicity assessment.

Insulin Glargine
KBI2001

Long-acting basal analog with two arginine residues added at B-chain C-terminus and A21 asparagine replaced by glycine. Shifts isoelectric point to pH 6.7, causing precipitation at physiological pH for sustained depot absorption. ~24h flat action profile. First long-acting analog approved. Now with biosimilar competitors (Basaglar, Semglee, Rezvoglar). Pair drug ELISA (KBI2001) with anti-Glargine ADA ELISA (KBI9001) for complete PK/immunogenicity assessment.

LANTUSTOUJEO (U300)BasaglarSemglee
Insulin Aspart
KBI2002

Rapid-acting mealtime analog B28 proline replaced by aspartic acid, reducing self-association and enabling faster subcutaneous absorption (peak 4050 min vs 23h for human insulin). Used as mealtime insulin and in closed-loop insulin delivery systems. Major biosimilar competition with Fiasp (ultra-fast formulation). KBI2002 drug ELISA has no cross-reactivity with human insulin. Pair with KBI9002 ADA ELISA.

NOVOLOGNOVORAPIDFiaspTrurapi
Insulin Lispro
KBI2003

First approved rapid-acting analog B28 lysine and B29 proline positions reversed (Lys-Pro), disrupting hydrophobic surface and preventing hexamer formation. Faster onset than human regular insulin. Multiple biosimilars including Admelog and insulin lispro-aabc (Lyumjev ultra-rapid). KBI2003 competitive ELISA specific to Lispro structure with no human insulin interference. Pair with KBI9003 ADA ELISA.

HUMALOGAdmelogLyumjev
Insulin Degludec
KBI2005

Ultra-long-acting basal analog B30 threonine deleted, C16 fatty diacid attached via glutamic acid linker at B29 lysine. Forms soluble multi-hexamer depot at injection site with gradual monomeric release. >42h action profile, once-daily or even 3/week dosing. Currently no approved biosimilar in most markets, but development underway. KBI2005 competitive ELISA validated for PK studies in clinical and preclinical settings.

TRESIBANN1250Ryzodeg (combo)

Anti-Drug Antibody (ADA) & Neutralising Antibody ELISA

Immunogenicity assessment is a regulatory requirement for all biologic drugs. Two distinct assay formats serve different immunogenicity objectives understanding which to use is critical for regulatory submissions.

GLP-1 nAb
A
Bridging / Neutralising Antibody Format
For GLP-1 Receptor Agonists

Used for GLP-1 agonist immunogenicity. The drug is coated as capture AND as HRP-conjugate. Patient ADA that can bind both forms (bridging antibodies) generate a positive signal. This bridging format is drug-tolerant designed to detect ADA even in the presence of excess circulating drug. Available for Semaglutide (KBI9030) and Liraglutide (KBN5020).

Result interpretation: sample OD vs cut-off value (mean of negative controls + 2SD). Result reported as positive/negative for immunogenicity.

B
Indirect Enzyme Immunoassay Format
For Insulin Analogs

Used for insulin analog ADA detection. The drug (e.g. Glargine, Aspart, Lispro) is coated to the microplate as capture antigen. Patient-derived anti-drug IgG binds to coated drug, then is detected by HRP-anti-human IgG secondary antibody. Signal is directly proportional to ADA amount.

Result interpretation: sample OD vs Blank mean + 2SD cut-off. Report as positive/negative. Available: Anti-Glargine (KBI9001), Anti-Aspart (KBI9002), Anti-Lispro (KBI9003). Please verify catalog numbers with Krishgen technical team.

Diabetes & GLP-1 Assay Reference Table

Complete Krishgen ELISA portfolio for diabetes drug PK and immunogenicity. All kits validated: CV <15%, spike-recovery 85115%. CoA and validation reports on request.

Catalog #Target / AnalyteBrand / ApplicationTypeFormatRangeSpeciesLink
KOD1027
TirzepatideDual GIP/GLP-1 agonist
MOUNJARO ZEPBOUNDWorld FirstDrug PKCompetitive31.34,000 ng/mLHuman / Rat / MouseView
KBI5030
SemaglutideGLP-1 receptor agonist
OZEMPIC WEGOVY RYBELSUSDrug PKCompetitive7.81,000 ng/mLHuman / Rat / MouseView
KBI9030
Anti-Semaglutide nAbNeutralising antibody
Immunogenicity screeningnAb / ADABridgingQualitative +/-HumanView
KBI5020
LiraglutideGLP-1 receptor agonist
VICTOZA SAXENDADrug PKCompetitive7.81,000 ng/mLHuman / Rat / MouseView
KBN5020
Anti-Liraglutide nAbNeutralising antibody
Immunogenicity screeningnAb / ADABridgingQualitative +/-HumanView
KBI5013
ExenatideExendin-4 GLP-1R agonist
BYETTA BYDUREONDrug PKCompetitive7.8500 ng/mLHuman / Rat / MouseView
KBI5021
LixisenatideExendin-4 derivative
ADLYXIN LYXUMIADrug PKCompetitive7.8500 ng/mLHuman / Rat / MouseView
KBI2001
Insulin GlargineLong-acting basal analog
LANTUS TOUJEODrug PKCompetitive0.550 ng/mLHuman / Rat / MouseView
KBI9001
Anti-Glargine ADAAnti-drug antibody
Immunogenicity screeningADA ELISAQualitative indirectQualitative +/-HumanView
KBI2002
Insulin AspartRapid-acting mealtime analog
NOVOLOG NOVORAPIDDrug PKCompetitive0.550 ng/mLHuman / Rat / MouseView
KBI9002
Anti-Aspart ADAVerify catalog number with team
Immunogenicity screeningADA ELISAQualitative indirectQualitative +/-HumanView
KBI2003
Insulin LisproRapid-acting mealtime analog
HUMALOG AdmelogDrug PKCompetitive0.550 ng/mLHuman / Rat / MouseView
KBI9003
Anti-Lispro ADAVerify catalog number with team
Immunogenicity screeningADA ELISAQualitative indirectQualitative +/-HumanView
KBI2005
Insulin DegludecUltra-long-acting basal analog
TRESIBADrug PKCompetitive0.550 ng/mLHuman / Rat / MouseView

Frequently Asked Questions

Is KOD1027 truly the world's first Tirzepatide ELISA

Yes. As of our last competitive landscape review, KOD1027 is the first and only commercially available Tirzepatide ELISA. Tirzepatide's unique dual GIP/GLP-1 receptor agonist structure meant existing GLP-1 assays were non-functional, requiring a new assay developed from a recombinant GLP-1R capture antigen.

Can I use the same kit for human clinical and rat preclinical samples

Yes. All GLP-1 agonist and insulin analog drug ELISA are species-independent they detect the drug molecule, not an endogenous protein, so the same kit functions in human, rat, and mouse samples. No species-specific kit switching required across your development programme.

Do insulin analog ELISA detect endogenous human insulin

Need a Custom or Unlisted Assay

Can’t find your specific GLP-1 agent or insulin analog? Our technical team can develop custom drug ELISA and ADA assays within 8-12 weeks.