Module 2.2 — Introduction
| Field | Value |
|---|---|
| Document ID | M22 |
| Version | 2.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard | ICH M4 §2.2 |
| Confidentiality | Confidential — portfolio use |
Change History
| Version | Date | Author | Summary of Change |
|---|---|---|---|
| 1.0 | 2026-06-29 | Regulatory | Initial introduction |
| 2.0 | 2026-07-05 | Regulatory | Expanded to full §2.2 scope (development/regulatory context, designations, application basis) |
Introduction
This marketing application concerns GLPI-103, a first-in-class synthetic peptide dual agonist of the GLP-1 and Apelin (APJ) receptors, developed by Virtual Biopharma Inc.
- Proprietary/established name: GLPI-103 (INN pending)
[MOCK]. - Pharmacological class / ATC: GLP-1 receptor agonist with additional APJ-receptor agonism; blood-glucose-lowering drug excluding insulins (ATC A10B, class placeholder)
[MOCK]. - Proposed indication: As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on metformin.
- Dosage forms and routes of administration: solution for injection (intravenous, once weekly) and immediate-release tablet (oral, once daily); both administered with dose titration.
- Proposed posology: conservative 8-week titration to maintenance (IV 4 mg once weekly; oral 8 mg once daily), consistent with the pivotal study (PROT-301 §6).
Development and Regulatory Context
GLPI-103 was developed to combine the established glycaemic and weight benefits of GLP-1 receptor agonism with APJ-mediated improvements in insulin sensitivity, endothelial and myocardial function, and inflammation, differentiating it on cardiometabolic positioning versus GLP-1-only therapies. The program comprises a nonclinical package (Modules 2.4/2.6/4), a clinical-pharmacology program (Phase 1 SAD/MAD and Phase 2 dose-finding; Modules 2.7.1/2.7.2/5.3), and a pivotal Phase 3 confirmatory study (GLPI103-301) demonstrating superiority over oral semaglutide on HbA1c change from baseline at Week 52, with a class-consistent, manageable safety profile (Modules 2.5/2.7.3/2.7.4/5.3.5). Interactions with health authorities (Pre-IND, End-of-Phase-2, and Pre-NDA/Pre-submission meetings) and any expedited-program considerations are summarized in Module 1 (regional).
Basis and Organization of the Application
The application seeks marketing authorization on the basis of the demonstrated benefit–risk in the target population (Module 2.5.6). The dossier follows the ICH Common Technical Document format, with Module 2 summaries and overviews, Module 3 quality, Module 4 nonclinical study reports, and Module 5 clinical study reports and data, and region-specific Module 1 content prepared for the FDA, EMA, and MFDS. The nonclinical and CMC content is deep-knowledge mock ([MOCK]), while the clinical thread is anchored to one simulated Phase 3 dataset that is reconciled across the dossier.