By Fineline Cube 
Corxel Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 2, multicenter, randomized, double‑blind, parallel‑group, placebo‑controlled study of its oral GLP‑1 receptor agonist CX11 (VCT220) in patients with type 2 diabetes mellitus (T2DM).
Trial Design & Enrollment
| Parameter | Details |
|---|---|
| Indication | Type 2 diabetes mellitus (T2DM) |
| Population | Adults on a stable metformin regimen ± a stable SGLT2‑inhibitor for ≥ 90 days who have not achieved target glycemic control |
| Sample size | ~ 350 participants (estimated) |
| Arms | CX11 (once‑daily oral) vs. matching placebo |
| Primary endpoint | Change in HbA1c from baseline at 24 weeks |
| Key secondary endpoints | Fasting plasma glucose, body‑weight change, safety/tolerability, incidence of hypoglycemia |
| Start of enrollment | Q1 2026 (first‑quarter) |
| Sites | ≥ 30 U.S. clinical sites, geographically diverse |
Development Timeline
- April 14 2025: FDA cleared a Phase 2 obesity/overweight trial of CX11 (first IND this year). First patient dosed June 16 2025; topline results expected H1 2026.
- Nov 13 2025: FDA clears second Phase 2 IND for CX11 in T2DM. Enrollment slated to begin Q1 2026.
- 2027‑2028: Planned Phase 3 program to evaluate CX11 as a once‑daily oral alternative to injectable GLP‑1 therapies.
Strategic Rationale
- Oral GLP‑1 breakthrough: CX11 is the first oral small‑molecule GLP‑1 receptor agonist in Corxel’s pipeline, aiming to capture patients who prefer pills over injections.
- Market opportunity: The U.S. T2DM market exceeds $120 bn in drug spend; oral GLP‑1 agents could tap a ~30 % share of the injectable GLP‑1 space, valued at ≈ $12 bn.
- IP & rights: Corxel acquired global ex‑China rights to CX11 from Vincentage Pharma Co., Ltd. in December 2024, securing full development control outside China.
Financial & Share‑holder Impact
- R&D spend: CX11 program expenses are projected at $45 m for 2025‑2026, funded primarily from cash on hand and a $75 m revolving credit facility.
- Share price reaction: Corxel shares opened +3.2 % on the news, reflecting investor optimism about a differentiated oral GLP‑1 candidate.
- Future financing: Management indicated that no additional equity dilution is expected before Phase 3 initiation, pending successful Phase 2 read‑outs.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the CX11 Phase 2 trial, anticipated timelines, and market potential. Actual results may differ due to clinical outcomes, regulatory decisions, competitive dynamics, and other risks disclosed in Corxel’s most recent Form 10‑K and SEC filings.-Fineline Info & Tech