Product Name: Dulaglutide Peptide API
CAS No.: 923950-08-7
Molecular Formula: C2646H4044N704O836S18
Molecular Weight: ~59,671
Purity: ≥99% by HPLC
Appearance: White powder
Grade: Pharmaceutical Grade
Shelf Life: 24 months
Storage: 2-8°C, protected from light, sealed storage
GMP Compliance: Manufactured under cGMP standards
Overview
Dulaglutide (LY2189265) is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist developed by Eli Lilly and Company. It was approved by the FDA in September 2014 and is commercially available as Trulicity® for the treatment of type 2 diabetes mellitus .
Unlike traditional GLP-1 analogs, Dulaglutide is a recombinant fusion protein consisting of a GLP-1 analog (residues 7-37) covalently linked to the Fc domain of human IgG4 via a small peptide linker . This innovative design protects the molecule from DPP-4 degradation and enables once-weekly subcutaneous administration, offering superior patient convenience compared to daily GLP-1 agonists .
Our Dulaglutide API is produced under strict cGMP standards with high purity and comprehensive documentation support for research and development purposes.
Key Specifications
| Parameter | Specification |
| Appearance | White powder |
| Purity (HPLC) | ≥98% |
| CAS No. | 923950-08-7 |
| Molecular Formula | C₂₆₄₆H₄₀₄₄N₇₀₄O₈₃₆S₁₈ |
| Molecular Weight | ~59,670 g/mol |
| Storage | -20°C, dry, protected from light |
| Shelf Life | 24 months (powder); 6 months (in solvent at -80°C) |
| GMP Compliance | cGMP standards |
| DMF Status | Available upon request |
GLP-1 Analog Sequence (Active Moiety):
H-HGEGTFTSDVSSYLEEQAAKEFIAWLVKGGG-OH
Structure: GLP-1 analog – (Ser₄Gly)₃ linker – human IgG4 Fc (dimer)
Mechanism of Action
Dulaglutide is a potent and selective GLP-1 receptor agonist. GLP-1 is an incretin hormone secreted by intestinal L-cells in response to nutrient ingestion . Key pharmacological effects include:
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Glucose-dependent insulin secretion – stimulates insulin release from pancreatic β-cells only when blood glucose is elevated
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Suppressed glucagon secretion – reduces hepatic glucose output
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Delayed gastric emptying – slows postprandial glucose absorption
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Appetite regulation – acts on hypothalamic centers to reduce food intake
The IgG4 Fc fusion provides two critical advantages:
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Extended half-life (~4-5 days) – supports once-weekly dosing
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Reduced immunogenicity – IgG4 minimizes unwanted immune responses
The molecule naturally forms a covalent dimer stabilized by disulfide bridges, enhancing its stability and receptor binding affinity .
Clinical Applications
Type 2 Diabetes Mellitus
Dulaglutide is indicated for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. It is available in 0.75 mg and 1.5 mg once-weekly doses.
Key clinical outcomes from the AWARD program include:
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Significant HbA1c reduction (1.1-1.6% from baseline)
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Moderate weight loss (2-3 kg on average)
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Low risk of hypoglycemia when used as monotherapy
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Cardiovascular safety profile
Approved Doses
| Indication | Dose | Administration |
| Type 2 Diabetes (initial) | 0.75 mg | Once weekly |
| Type 2 Diabetes (escalated) | 1.5 mg | Once weekly |
Structural Advantages
Dulaglutide's unique molecular design distinguishes it from other GLP-1 agonists:
| Feature | Dulaglutide | Liraglutide | Semaglutide |
| Dosing frequency | Once weekly | Once daily | Once weekly |
| Molecular type | Fc fusion protein | Fatty acid acylated peptide | Fatty acid acylated peptide |
| Half-life | ~4-5 days | ~13 hours | ~7 days |
| Administration | Subcutaneous | Subcutaneous | Subcutaneous/oral |
The Fc fusion approach eliminates the need for chemical modification or fatty acid acylation, providing a more straightforward manufacturing process while maintaining excellent pharmacokinetic properties .
Biosimilar Development
Dulaglutide is an attractive target for biosimilar development due to:
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Expiring patents – opening markets for generic versions
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Well-characterized structure – recombinant protein with established production platforms
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Growing global demand – increasing diabetes prevalence worldwide
Recent studies have demonstrated successful production of dulaglutide analogs in apoptosis-resistant CHO cell lines, achieving product titers of 1.05 g/L with ≥95% monomer purity and bioactivity comparable to the reference drug .
Why Choose Our Dulaglutide API？
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High purity – ≥98% by HPLC with validated analytical methods
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cGMP manufacturing – compliant with international pharmaceutical standards
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Comprehensive documentation – COA, stability data, DMF available upon request
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Proven stability – 24-month shelf life under recommended storage conditions
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Regulatory support – assistance with DMF filing and regulatory submissions
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Flexible scale – from R&D quantities to commercial-scale production
Applications
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Biosimilar development – reference standard for analytical comparison
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Pharmaceutical R&D – formulation development for generic versions
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Clinical research – metabolic disorder studies
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Analytical reference standard – method development and quality control
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Preclinical studies – GLP-1 receptor pharmacology research
Regulatory & Market Highlights
| Item | Status |
| Originator | Eli Lilly and Company |
| Brand Name | Trulicity® |
| First FDA Approval | September 2014 |
| ATC Code | A10BJ05 |
| Target | GLP-1 receptor (GLP1R) |
| Administration Route | Subcutaneous |
| Dosing Frequency | Once weekly |
| Patent Status | Generic/biosimilar API for R&D use |
| DMF Status | Available upon request |
- Documentation Available
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Certificate of Analysis (COA)
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Stability study data (24 months)
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GMP statement
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DMF (available upon request)
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Regulatory filing support
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Analytical development package
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Contact Us
For pricing, DMF status, sample requests, or technical inquiries regarding Dulaglutide API or biosimilar development, please contact our sales team.
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Turkey
United States
