CORXEL Receives Study May Proceed Letter from the U.S. FDA for the Phase 2 Trial of CX11 in Patients with Type 2 Diabetes Mellitus
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The multicenter Phase 2 trial aims to evaluate the efficacy and safety of CX11 in patients with T2DM in doses up to 200 mg
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The trial is expected to enroll 240 patients to receive treatment over 24 weeks
NEW JERSEY – November 13, 2025 – Corxel Pharmaceuticals Limited (CORXEL), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, today announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) for a Phase 2 trial of CX11 in patients with Type 2 diabetes mellitus (T2DM).
The Phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled trial, is designed to investigate the efficacy and safety of CX11 in participants with T2DM who failed to achieve adequate glycemic control on stable dose of metformin with or without a stable dose of SGLT2 inhibitor for at least 90 days, with enrollment expected to begin in the first quarter of 2026.
This is the second Phase 2 trial of CX11 cleared by the FDA this year. On April 14, 2025, the FDA issued clearance for a randomized, double-blind, placebo-controlled Phase 2 trial aiming to evaluate the efficacy and safety of CX11 in patients with obesity and overweight conditions in the U.S. The first patient was enrolled on June 16 and topline data from this trial is expected to be released in the first half of 2026.
CX11 (also known as VCT220), for which CORXEL acquired global ex-China rights from Vincentage Pharma Co., Ltd (Vincentage) in December 2024, is an investigational oral once-daily small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA) designed to offer a convenient alternative to injectable GLP-1 treatments.
“The FDA’s clearance of our IND for CX11 in Type 2 diabetes marks CORXEL’s strategic entry into clinical development for the large and growing diabetes treatment market, expanding the company’s metabolic focus beyond obesity to include one of the world’s most prevalent metabolic disorders.” said Dr. Bo Liang, Senior Vice President, Head of Clinical Development – Metabolic at CORXEL. “By moving beyond the inherent limitations of injectables, our goal is to reshape the treatment paradigm with an oral small molecule therapy that combines efficacy with convenience, which we believe is fundamental to long-term patient compliance and application to a broader patient group.”
Additional information
This is a Phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled trial, designed to investigate the efficacy and safety of CX11 in participants with T2DM who failed to achieve adequate glycemic control on stable dose of metformin with or without a stable dose of SGLT2 inhibitor for at least 90 days. The trial will feature six treatment arms: five active treatment groups receiving 40 mg, 80 mg, 120 mg, 160 mg, 200 mg of CX11, respectively, as well as a placebo group. Patients will receive treatment for 24 weeks and will be further monitored over a 2-week follow-up period.
CX11 is an investigational oral small molecule GLP-1 RA designed to address cardiometabolic conditions. With global ex-China rights acquired by CORXEL from Vincentage in December 2024, CX11 aims to overcome limitations of current injectable GLP-1 RAs by offering convenient, once-daily oral administration, weight reduction comparable to injectable GLP1 RAs. CX11 presents favorable tolerability results, scalability and accessibility as a small molecule product candidate. Clinical data from Vincentage’s Phase 2 trial in China demonstrated competitive weight loss with a favorable safety and tolerability profile. CX11 is currently being advanced into a U.S. Phase 2 trial by CORXEL and being evaluated in a Phase 3 registrational trial in China conducted by Vincentage, positioning it as a potential best-in-class oral therapy for management of obesity and overweight conditions.
CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL’s diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral GLP-1 RA for obesity and overweight conditions and T2DM, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke and JX09, a highly selective aldosterone synthase inhibitor for hypertension.
For further information about CORXEL, please visit www.corxelbio.com
