US Investigational New Drug (IND) Application — Summary — GLPI-103
| Field | Value |
|---|---|
| Document ID | IND-US |
| Version | 1.0 |
| Region | FDA (US) |
| Standard | 21 CFR 312 |
| Confidentiality | Confidential — portfolio use |
The IND precedes the NDA and authorizes US clinical trials.
[MOCK]administrative identifiers. Cross-references existing modules.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Regulatory (US) | Initial IND summary |
Contents (21 CFR 312.23)
- Form FDA 1571 (cover) and 1572 (investigator statement) — administrative
[MOCK]. - Introductory statement & general investigational plan: GLPI-103 (GLP-1/APJ dual agonist) for T2DM; planned Phase 1→3 program (REF-002).
- Investigator's Brochure: IB-001.
- Clinical protocol(s): initial FIH protocol (→ GLPI103-101); pivotal protocol PROT-301.
- Chemistry, Manufacturing, and Controls (CMC): per Module 3 (M3) — drug substance/product, controls, stability.
- Pharmacology/Toxicology: nonclinical summary supporting first-in-human dosing (M2.4/M2.6; M4 study reports).
- Previous human experience: none at initial IND (first-in-human).
Safety Reporting
IND safety reports (7/15-day) per 21 CFR 312.32; annual reports; aligned with the Safety Management Plan (TMF-SMP).