📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The briefing book for a Pre-IND meeting with the FDA — the questions and supporting summary a sponsor sends before that meeting.
Why it exists. Before filing the IND, sponsors meet the FDA to align on the nonclinical package, first-in-human design, and CMC. The briefing book frames the sponsor's positions and specific questions so the meeting is productive.
How it is produced here. This is a region-specific administrative document, assembled to the local filing and labeling conventions. Its operational and label content is written to stay consistent with the (simulated) clinical data.
Format & governing standard. —
| Field | Value |
|---|---|
| Document ID | MTG-PREIND |
| Version | 1.0 |
| Status | Final (portfolio) |
| Meeting type | Type B (Pre-IND) — FDA, Division of Diabetes, Lipid Disorders, and Obesity [MOCK] |
| Compound | GLPI-103 (GLP-1 / Apelin [APJ] receptor dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard(s) | 21 CFR 312.82 · FDA Formal Meetings Guidance (PDUFA VII) · ICH M3(R2) |
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| Confidentiality | Confidential |
[MOCK]Briefing document supporting a Pre-IND meeting to align on the nonclinical package, first-in-human design, and CMC adequacy to support the IND.
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-30 | Regulatory Affairs | Initial Pre-IND briefing document |
To obtain FDA agreement that (i) the nonclinical pharmacology/toxicology package supports first-in-human dosing, (ii) the proposed Phase 1 SAD/MAD design and starting dose are acceptable, and (iii) the CMC and clinical pharmacology plans are adequate for the IND.
GLPI-103 is a first-in-class synthetic peptide dual agonist of the GLP-1 and apelin (APJ) receptors for T2DM, combining established GLP-1 glycaemic/weight benefit with APJ-mediated insulin-sensitizing, vascular, and myocardial effects (M2.5; PM-007).
SAD (40 healthy volunteers, 5 cohorts) and MAD (40 T2DM/prediabetes, 4 cohorts), with sentinel dosing, stopping rules, and PK/PD (apelin, NT-proBNP, hsCRP) (PM-007 §6).
Sponsor seeks written agreement on Questions 1-5 to enable IND submission within ~60 days of the meeting.