NXE0027477 / Nxera Pharma - LARVOL DELTA

Sosei Heptares Regains Full Ownership from GSK of HTL0027477, a Clinic-ready, First-in-Class Oral GPR35 Agonist for Inflammatory Bowel Disease (GlobeNewswire) - "Sosei Group Corporation...announces it has regained full ownership from GSK of HTL0027477 (formerly GSK4381406), a clinic-ready, highly selective, first-in-class, oral GPR35 agonist in development as a potential new treatment for Inflammatory Bowel Diseases (IBD)....The UK Medicines and Healthcare products Regulatory Agency ('MHRA') gave approval in mid-2023 for HTL0027477 to be investigated in first-in-human studies."

European regulatory • Licensing / partnership • Inflammatory Bowel Disease

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: GlaxoSmithKline | N=84 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Sosei Heptares to Regain Full Ownership of GSK4381406, a Clinic-ready, First-in-Class Oral GPR35 Agonist for Inflammatory Bowel Disease (BioSpace) - "Sosei Group Corporation...announces it has initiated discussions with GSK to regain full ownership of GSK4381406, a highly selective first-in-class, oral GPR35 agonist in development under a Global Collaboration and License Agreement with GSK as a potential new treatment for Inflammatory Bowel Diseases (IBD). GPR35 is an important orphan G protein-coupled receptor ('GPCR') with an established genetic association to IBD, for which there remains significant unmet need for millions of sufferers worldwide."

Licensing / partnership • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis