pp-095 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
Comments
Indication: Rheumatoid arthritis in patients with inadequate response to methotrexate; also under evaluation in other immune-mediated diseases.
Clinical stage: Phase IIa in rheumatoid arthritis; Phase I pharmacology and safety studies completed in healthy volunteers; additional Phase II work in immunological indications.
Modality: Small-molecule targeted therapy
Mechanism / Target: Irreversible covalent Bruton’s tyrosine kinase inhibitor reducing B-cell receptor signaling and innate immune activation.
Route / form: Oral
Differentiation: Highly selective BTK inhibitor with demonstrated target engagement, strong BTK occupancy, inhibition of basophil activation, and early efficacy signals in RA with good tolerability.
Manufacturer #38605
A research-driven pharma company developing therapies across oncology and other major diseases. It advances innovative medicines through global R&D and strategic alliances. The organization emphasizes high-quality manufacturing and patient impact.