How WuXi TIDES Enabled an Innovative GLP-1 GCG Dual Peptide Program IND filing in Just 10 Months
As GLP-1 receptor agonists continue to redefine treatment for metabolic diseases, drug developers are racing to bring new and more complex therapies to the clinic. But innovation alone is not enough — speed, scalability, and execution are just as critical. That’s where WuXi TIDES delivers.
Our fully integrated CRDMO platform was built to manage complexity across the development lifecycle. From linear and cyclic peptides to chemically modified conjugates with linkers, toxins, or PEG chains, we help partners accelerate progress while solving real-world CMC challenges. One project, a dual-targeting GLP-1/GCG pegylated peptide, put this promise to the test, and proved what’s possible with the right team, platform, and partnership.
The Challenge: A Complex Cyclic Peptide, an 11-Month Clock
In 2020, Neuraly, a subsidiary of D&D Pharmatech, was preparing its lead GLP-1/GCG dual agonist program, DD01, for IND submission. The molecule, a 30-amino-acid peptide conjugated with PEG, was designed to activate both GLP-1 and glucagon receptors. In preclinical models, DD01 showed strong potential for lowering blood glucose, reducing body weight, and decreasing liver fat.
The timeline was tight. Neuraly needed:
- Non-GMP API for GLP toxicity study in 4 months
- GMP drug substance, drug product, and a complete CMC dossier for IND filing in 11 months
The original lab-scale synthesis route was not scalable. Yields were low, supply of key materials was limited, and the COVID-19 pandemic added more uncertainty.
“The timeline we were trying to target was short, and we knew the synthesis chemistry would be challenging because of the structure and conjugation. We needed not just a supplier, but an extended team who understood our science, budget, and timeframe,” said Yen-Huei Lin, then Executive Director of Biopharmaceutical Development and Manufacturing at Neuraly, now Senior Vice President of Product Development and Manufacturing.
The Challenges at a Glance
- Low-yield synthesis: The original linear route achieved only 5% purity after optimization
- Conjugation material constraints: A special building block had a lead time of up to 1 year
- Tight timeline: Two critical deadlines within 11 months, including GLP TOX study and IND submission
- COVID-19 disruption: Supply chains and logistics added complexity and risk
The Solution: Three Synthesis Paths, One Coordinated Platform
To meet the deadlines, the WuXi TIDES team launched three synthetic routes in parallel. While one team worked to optimize the original route with on-resin cyclization, another scaled up development work, and a third explored two entirely new synthetic strategies. It quickly became clear that the original approach would not scale. The team pivoted to a hybrid approach that combined fragment and linear synthesis. This new route improved the crude purity of API to 15-20%. More than 20 batches were delivered within 6 weeks to enable downstream progress to stay on schedule. To mitigate supply risk, the team screened over 25 process conditions for the conjugation step, increasing yield fourfold and reducing the need for limited starting material.
Meanwhile, analytical method development, formulation development, and CMC dossier preparation were carried out in parallel, all within the same facility. This integration eliminated delays and allowed the team to maintain speed without compromising quality.
The Result: IND Submission One Month Early
WuXi TIDES delivered non-GMP material for GLP studies in 4 months. GMP API, drug product formulation, validated methods, and the full CMC package were completed within 10 months, one month ahead of Neuraly’s internal goal.
“WuXi (TIDES) had the capacity and resources to ensure timeline commitment and to troubleshoot any issues along the process,” said Lin. “We wouldn’t have been able to file and clear DD01 IND within 10 months otherwise.”
Since then, the program has continued to advance. D&D Pharmatech / Neuraly DD01 has been granted Fast Track designation by the U.S. FDA for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) (BusinessWire, 2024). The primary endpoint of the Phase II clinical trial showed exceptional degree of liver fat reduction, with 75.8% patients achieving at least a 30% reduction and almost 50% patients reaching liver fat normalization (<5% by MRI-PDFF) within just 12 weeks of treatment (BusinessWire, 2025).
Your Complex Challenges, Our Precise Solutions
WuXi TIDES delivered what many thought was impossible: an IND-ready conjugated cyclic peptide program in just 10 months. From route design and conjugation to formulation and CMC writing, every step was executed under one roof, helping our partner meet milestones with speed and confidence.
Neuraly’s success is not an isolated case. According to a 2024 report from the J.P. Morgan Healthcare Conference, WuXi TIDES now supports more than 20 clinical-stage GLP-1 programs, including both peptides and small molecules. Whether you’re advancing a dual-acting peptide or a novel GLP-1 conjugate, our integrated CRDMO platform is purpose-built to turn complexity into results, helping you overcome roadblocks and reach the clinic faster.
Let’s move your peptide program forward, faster and smarter.
