MASH stands for metabolic dysfunction-associated steatohepatitis, a progressive inflammatory liver disease that develops from fatty liver and can progress to fibrosis, cirrhosis, and liver cancer. It was previously termed nonalcoholic steatohepatitis (NASH).
Can-Fite will present late-stage pipeline at BIO 2026; GlobalData counts over 2,000 peptides in development with $91.38bn 2025 sales; Arrowhead's RNAi pipeline has two Phase 3 programs.
Amgen shares have fallen 12.6% in three months despite relatively solid Q1 results, while Novo Nordisk maintains a 54.6% global GLP-1 market share. Both companies face pipeline competition and pricing pressures.
Madrigal expands MASH pipeline with siRNA licensing deals from Arrowhead and Ribo. Ribo deal includes $60M upfront and up to $4.4B milestones; IND submissions planned for 2026.
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
Sagimet Biosciences reported fourth quarter and full year 2025 financial results, announcing plans to initiate a Phase 2 trial of denifanstat and resmetirom combination in F4 MASH patients in the second half of 2026, with a 26-week biomarker readout expected in the first half of 2028.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
Genentech announced positive Phase II results for CT-388, a dual GLP-1/GIP receptor agonist, showing 22.5% placebo-adjusted weight loss at 48 weeks in people with obesity. The treatment was well-tolerated with low discontinuation rates.
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Can-Fite BioPharma's drug candidate namodenoson met its primary endpoint in a Phase 2a pancreatic cancer trial and demonstrated anti-obesity effects in a peer-reviewed preclinical study published in the International Journal of Obesity.
The FDA has granted Fast Track designation to PLT012, a first-in-class anti-CD36 monoclonal antibody for hepatocellular carcinoma treatment. The Phase 1 trial is currently enrolling patients in Texas.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07763015 |
Study of Resmetirom in Children and Adolescents With MASH |
NOT_YET_RECRUITING | PHASE2 |
| NCT07512427 |
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants |
RECRUITING | PHASE1/PHASE2 |
| NCT07417683 |
Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity |
NOT_YET_RECRUITING | NA |
| NCT07083557 |
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD) |
RECRUITING | |
| NCT07051863 |
Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease |
RECRUITING | |
| NCT06940375 |
Incidence of Liver Disease-Related Outcomes in People With HIV |
COMPLETED | |
| NCT06903065 |
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06692283 |
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH |
WITHDRAWN | PHASE3 |
| NCT06594523 |
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis |
WITHDRAWN | PHASE3 |
| NCT06592820 |
Endoscopic Ultrasound Shear Wave Elastography Study |
RECRUITING |
