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Oral Peptide Delivery

IND-enabling formulation and clinical supply for oral peptide therapeutics

Defining an Oral Path for Peptides

Oral delivery remains one of the most technically demanding challenges in peptide drug development, limited by instability, low permeability, and poor systemic exposure. WuXi TIDES supports oral peptide programs from early feasibility through IND-enabling formulation and GMP clinical supply, helping teams define viable delivery strategies and advance efficiently into the clinic.

Stage-Specific Formulation Strategy

Our dedicated oral peptide formulation team has hands-on, practical project experience across peptide modalities, enabling stage-specific testing aligned to key development deliverables.

Early pre-formulation studies use minimal API to assess developability, focusing on solubility, stability in solid and GI-relevant environments, and permeability to identify oral-viable peptide leads. As programs advance, formulation development shifts to risk reduction through parallel screening of stabilizers and permeation enhancers, supported by targeted formulation and physical form studies to improve oral bioavailability (link to our bioavailability enhancement technology).

At the candidate selection stage, formulation development is finalized through comprehensive physical form, excipient compatibility, and drug product studies, delivering IND-ready oral peptide formulations with a clear path to GMP manufacturing.

Integrated Formulation Development and Clinical Supply

With lead formulations selected, our oral peptide platform is designed to advance oral peptide programs into IND-enabling drug products and clinical supply. Through integrated formulation development, manufacturing readiness, and clinical execution, we help define final drug product strategies that align with regulatory expectations and early clinical needs.

Building on data-driven formulation studies and absorption optimization experience—including the use of advanced oral formulation approaches such as solid dispersions, SMEDDS (Self-Microemulsifying Drug Delivery System), and oral solid or liquid dosage forms—our teams refine selected formulations for robustness and scalability. Experience with a broad range of permeation enhancers and carrier-based strategies further supports informed formulation decisions where additional absorption enhancement is required.

Clinical drug product development and GMP manufacturing are coordinated to support tox studies and Phase I supply, including manufacturing, packaging, labeling, and batch release.

Clinical Supply