Dulaglutide

GLP-1 analogue–IgG4 Fc fusion biologic · research-use material is not Trulicity

Lot-specific, multi-attribute release package required; one aggregate percentage is insufficient · target, verify batch COACAS 923950-08-7RUO

Research statusDulaglutide is an approved active ingredient in specific finished medicines; this material is Research Use Only reference context · supplied material is RUO

Supplied formDisulfide-linked, glycosylated homodimeric GLP-1 analogue–IgG4 Fc fusion protein

Lead timeConfirmed with quote

Dulaglutide — Lot- and formulation-specific material; confirm physical form, colour and container on the released-batch COA

Dulaglutide — Lot- and formulation-specific material; confirm physical form, colour and container on the released-batch COA · Representative packaging image · verify the ordered lot

Representative packaging image · verify the ordered lot

Decision summary

Key benefits

Research relevance includes GLP-1 receptor assays, Fc-fusion design, glycoprotein characterization, FcRn-related disposition models and analytical method development
AWARD and REWIND clinical outcomes are context for the licensed finished medicine, not benefits of an RUO lot.

Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.

Qualification data

Specifications to confirm against the released lot

CAS: 923950-08-7
Formula: Not applicable — glycoprotein composition varies by glycoform and source
Molecular weight: approximately 59.7-63 kDa
Appearance: Lot- and formulation-specific material; confirm physical form, colour and container on the released-batch COA
Purity: Lot-specific, multi-attribute release package required; one aggregate percentage is insufficient · target, verify batch COA
Storage: Follow the released-lot COA, formulation-specific stability data and manufacturer instructions. For an Fc-fusion biologic, qualify shipping temperature, excursion limits, freeze–thaw exposure, agitation and light protection for the actual container and formulation. Rules for a commercial prefilled Trulicity device do not apply automatically to an RUO bulk, lyophilised or reference material.
MOQ: On request
Lead time: Confirmed with quote

Qualification matrix

Identity, purity and content are separate release questions.

Identity

Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.

Purity

Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.

Content

Net peptide content is not the same as gross lyophilized powder weight. Ask which assay supports the stated amount and whether water/counter-ion is addressed.

Stability

Define long-term storage and transit exposure separately. Cold-chain can be quoted when the buyer’s risk assessment requires it and adds cost.

Research context

What researchers study about Dulaglutide

Dulaglutide is an engineered GLP-1 analogue fused through peptide linkers to a modified human IgG4 Fc domain. FDA approval applies to specific Trulicity finished formulations, devices and manufacturing controls. A separately supplied RUO dulaglutide lot is not the approved medicine and requires its own identity, glycosylation, aggregation, potency and microbiological qualification.

GLP-1 receptor pharmacology, Fc-fusion and glycoprotein analytics, bioactivity assay development and qualified comparative research
These are research applications, not clinical indications.

Mechanism context

The question the literature is testing

The modified GLP-1 moiety activates the GLP-1 receptor, while DPP-4-resistant substitutions and Fc fusion extend exposure. Fc-fusion behavior, receptor activity and immunochemical properties depend on construct integrity, disulfide state, glycosylation, aggregates and assay system and must be verified for the released lot.

Evidence map

Research routes and exposure context

Evidence tierApproved finished-product context

Research areaMetabolic and incretin research

Routes reported in sources

No administration route applies

Dose / exposure contextProtocol-specific; verify the cited primary source

Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.

Evidence boundaries

Compatibility, limitations and decision context

Not for human or veterinary use
FDA warnings, contraindications and adverse reactions apply to the licensed finished medicine and clinical context; they do not establish the safety of this RUO material
Follow the SDS and institutional biologics controls
Analytical purity does not establish sterility, injectable suitability or clinical equivalence.

Interactions reported in the literature

Not applicable as patient advice
Experimental compatibility depends on formulation, matrix, concentration and assay design and must be validated in-protocol.

Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.

Factory batch documentation

Dulaglutide factory batch COAs

Dulaglutide 5 mg Factory batch COA protected preview

Dulaglutide5 mg · WHJLP-DUL5-260410-B

Dulaglutide 10 mg Factory batch COA protected preview

Dulaglutide10 mg · WHJLP-DUL10-260410-B

Representative records, refreshed periodically

Published COAs show representative factory batches and may not be the latest available. For a current quote or shipment, our sales team can confirm the applicable lot and provide its COA.

Independent testing, arranged on request

Third-party reports are not routinely published. If independent verification is required, we can agree the laboratory, method, acceptance criteria and remedy before testing. If the agreed specification is not met, an appropriate resolution—including a refund where applicable—can be discussed under the agreed terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Help reviewing your COA

Need help reading a factory COA or third-party report? Our sales team can clarify test items, specifications and how the results relate to the lot under discussion.

Ask for the current packet, not a generic certificate

Require exact construct and chain map, orthogonal identity, intact and subunit mass where appropriate, peptide mapping, disulfide verification, glycan and charge-variant profiles, SEC aggregate/fragment analysis, assay/content, cell-based GLP-1R potency, endotoxin and relevant host-cell impurities
Sterility and bioburden are separate specifications.

Released-batch COARP-HPLC result and method contextIdentity result appropriate to the moleculeWater / counter-ion context where relevantSDS and handling statementAdditional testing scoped on request

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack

DULA-5MG5 mg10 vials

DULA-10MG10 mg10 vials

Handling

Storage in the lab and temperature during transit are different decisions

Follow the released-lot COA, formulation-specific stability data and manufacturer instructions. For an Fc-fusion biologic, qualify shipping temperature, excursion limits, freeze–thaw exposure, agitation and light protection for the actual container and formulation. Rules for a commercial prefilled Trulicity device do not apply automatically to an RUO bulk, lyophilised or reference material.

State destination, season, acceptable transit exposure and whether your protocol requires insulated or cold-chain service. Additional temperature-control cost is quoted explicitly.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. Testing must be performed by a mutually accepted, established specialist laboratory. Fee allocation, specification, sampling, method and acceptance rule must be agreed before testing; if an agreed independent result shows nonconformance, the remedy follows the signed order terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Does HPLC purity prove peptide content?+

No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.

Is cold-chain shipping always required?+

Not always. Heat can accelerate degradation, especially during summer and long transit. Cold-chain reduces exposure but raises cost. State the destination and stability risk so the right service can be quoted.

How are payment terms handled?+

Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.

Why must the testing laboratory understand peptide chemistry?+

Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.

External qualification references

WHO good storage and distribution practices IATA Temperature Control Regulations ISO/IEC 17025 laboratory competence 21 CFR 211.84 component testing and supplier COA controls

These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.

Selected sources

Literature behind the research context

Regulatory context: the FDA Trulicity label revised May 2025 and EMA product information updated January 2026. Clinical context: REWIND, AWARD-11 and the listed AWARD sources. Trial traceability: ClinicalTrials.gov NCT01394952. Analytical context: current peer-reviewed studies of dulaglutide charge heterogeneity and PTM-specific, MS-compatible Fc–GLP-1 characterisation. These sources describe the licensed product, clinical programme or analytical principles and do not qualify an RUO lot.

01
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial
The Lancet · 2019 · peer-reviewed original research (randomized controlled trial, primary results of a Phase 3 cardiovascular outcomes trial)
Open source
02
Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program
Diabetes/Metabolism Research and Reviews · 2016 · peer-reviewed review article (comprehensive review of Phase 3 program)
Open source
03
Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11)
Diabetes Care (American Diabetes Association) · 2021 · peer-reviewed original research (randomized controlled trial)
Open source
04
Dulaglutide, a long-acting GLP-1 analog fused with an Fc antibody fragment for the potential treatment of type 2 diabetes
Current Opinion in Molecular Therapeutics · 2010 · peer-reviewed review article (early mechanism-of-action / drug-development review)
Open source
05
Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review
Scientific Reports (Nature Publishing Group) · 2016 · peer-reviewed systematic review and meta-analysis
Open source
06
Trulicity (Dulaglutide): A New GLP-1 Receptor Agonist Once-Weekly Subcutaneous Injection Approved for the Treatment of Patients with Type 2 Diabetes
American Health & Drug Benefits · 2015 · peer-reviewed drug-approval review article (payer/formulary-focused clinical review)
Open source
07
Multiple analysis based on dual-mode anion-exchange chromatography strategy reveals significant impact of charge heterogeneity on structure and function of dulaglutide
International Journal of Biological Macromolecules · 2025 · peer-reviewed original research (dual-mode anion-exchange fractionation and orthogonal characterisation)
Open source
08
Sensitive RP-LC Method Enabling PTM-Specific Quality Control and MS-Compatible Characterization of Fc-Containing GLP-1 Therapeutics
Journal of the American Society for Mass Spectrometry · 2026 · peer-reviewed original research (PTM-specific RP-LC method with intact-mass and tandem-MS characterisation)
Open source

Product FAQ

Questions buyers ask about Dulaglutide

Why is an RUO Dulaglutide lot not equivalent to Trulicity?+

FDA approval applies to specific Trulicity finished formulations, devices, manufacturing sites, controls and labelled uses. A separately supplied research-use lot has not inherited that approval. Equivalence requires much more than the same name or CAS: exact construct, glycosylation, disulfides, aggregates, charge variants, potency, formulation and microbiological attributes must be qualified.

Which quality attributes matter for this Fc-fusion biologic?+

Request the chain and construct map, intact and subunit mass, peptide mapping, disulfide confirmation, glycan and charge-variant profiles, SEC aggregate and fragment results, quantitative content, cell-based GLP-1R potency, endotoxin and relevant host-cell impurities. A single HPLC purity value or nominal molecular weight is not an adequate release package.

Why is there no simple molecular formula for full Dulaglutide?+

Dulaglutide is a disulfide-linked, glycosylated Fc-fusion biologic with product- and lot-dependent glycoforms and other post-translational variants, so a single small-molecule-style formula is not an adequate identity statement. PubChem CID 171042928 depicts only the GLP-1 moiety, not the complete Fc-fusion molecule. Confirm the full construct by sequence and chain map, intact and subunit mass, peptide mapping, disulfides and glycan profiling.

Dulaglutide

Key benefits

Specifications to confirm against the released lot

Identity, purity and content are separate release questions.

What researchers study about Dulaglutide

The question the literature is testing

Research routes and exposure context

Compatibility, limitations and decision context

Interactions reported in the literature

Dulaglutide factory batch COAs

Ask for the current packet, not a generic certificate

Quote the fill and pack configuration you need

Storage in the lab and temperature during transit are different decisions

Terms to settle before the purchase order

Literature behind the research context

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial

Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program

Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11)

Dulaglutide, a long-acting GLP-1 analog fused with an Fc antibody fragment for the potential treatment of type 2 diabetes

Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review

Trulicity (Dulaglutide): A New GLP-1 Receptor Agonist Once-Weekly Subcutaneous Injection Approved for the Treatment of Patients with Type 2 Diabetes

Multiple analysis based on dual-mode anion-exchange chromatography strategy reveals significant impact of charge heterogeneity on structure and function of dulaglutide

Sensitive RP-LC Method Enabling PTM-Specific Quality Control and MS-Compatible Characterization of Fc-Containing GLP-1 Therapeutics

Questions buyers ask about Dulaglutide

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