New noninvasive biomarkers are advancing early detection of fibrosis. A FAP-Index blood test reduces uncertain liver fibrosis results by up to 70%, a urine-based molecular imaging test detects kidney fibrosis with 84% sensitivity and 94% specificity, and liver MRE can track Gaucher disease severity over time.
Insilico Medicine named ISM9528 as its 31st AI-driven preclinical pain candidate, published a target discovery study for a rare sinonasal cancer, and advanced partnerships with MSK and Takeda. The company is also presenting oncology programs at AACR 2026.
Researchers at MD Anderson developed an extracellular vesicle-based platform that delivers full-length DMD mRNA, restoring dystrophin production and improving muscle function in preclinical Duchenne muscular dystrophy models. The study, published in Nature Biomedical Engineering, showed reduced side effects compared with viral gene therapies.
The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
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.
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.
Insilico Medicine has formed a strategic partnership with Liquid AI to develop lightweight scientific foundation models for drug discovery and entered a drug development collaboration with China Medical System Holdings targeting CNS and autoimmune diseases.
Drug candidates designed via generative artificial intelligence are achieving a 90% success rate in Phase I safety trials in early 2026, nearly double the historical industry average of approximately 50%, while compressing development timelines from six years to under 18 months.
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 |
|---|---|---|---|
| NCT07471542 |
Copper Supplementation in Cirrhosis |
RECRUITING | NA |
| NCT07333183 |
A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD |
RECRUITING | PHASE2 |
| NCT06912763 |
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) |
RECRUITING | PHASE2 |
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Radiological Spectrum Of Fatty Liver Correlate With High Resolution Ultrasonography Of Fibrosis And Cirrhosis |
ACTIVE_NOT_RECRUITING | |
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Effectiveness of Percutaneous Electrolysis in Subacute and Early Chronic Medial Gastrocnemius Muscle Injuries |
COMPLETED | NA |
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A Study of Mosliciguat in PH-ILD |
ACTIVE_NOT_RECRUITING | PHASE2 |
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The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region |
RECRUITING | NA |
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Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE) |
RECRUITING | PHASE2 |
| NCT06383819 |
Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19 |
COMPLETED | PHASE3 |
| NCT06149260 |
Subcutaneous Semaglutide in Systemic Scleroderma |
RECRUITING | PHASE1 |
