Trial intelligence / Profile preview

Galunisertib and Nerandomilast in GREM2-Positive ALS

NCT07321860Phase 3

Key facts

Status
Not yet recruiting
Start
Jun 2026
Primary completion
Jun 2027
Modality
Small Molecules
Conditions
amyotrophic lateral sclerosis (ALS)
01

Overview

Phase 3, randomised, double-blind trial of galunisertib and nerandomilast in amyotrophic lateral sclerosis (ALS), sponsored by Gipfel Life Sciences. Planned start Jun 2026; status: not yet recruiting.

02

Design

Study design
RandomizedDouble-blind
03

Who it enrols

Patients aged 18-80 with GREM2-positive ALS, symptom onset within 24 months, and stable background therapy.

04

Registry description

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder characterized by loss of upper and lower motor neurons, leading to muscle weakness, respiratory decline, and eventual mortality. A growing body of translational and clinical evidence implicates neuroinflammation, reactive astrocytosis, and maladaptive TGF-β signaling as central contributors to disease progression. Elevated levels of Gremlin-2 (GREM2) have been identified as a marker of dysregulated TGF-β-linked astrocytic activity and fibrotic gene programs in some ALS patients, and preclinical data…

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