pp-168 Capsules
Dossier type
CTD
Dossier status
Under development
Country of origin
Israel
GMP approvals
Israel
Comments
Indication: Acute radiation syndrome (ARS — hematopoietic and gastrointestinal); oncology (NSCLC, cholangiocarcinoma)
Clinical stage: Phase 2/3 (ARS — BARDA-funded); Phase 2 oncology
Modality: Small molecule
Mechanism / Target: Selective sphingosine kinase-2 (SphK2) inhibitor — reduces sphingosine-1-phosphate (S1P) production; promotes ceramide-mediated apoptosis in tumour cells and radioprotection in normal tissue
Route / form: Oral capsule (500 mg twice daily)
Differentiation: Dual oncology/radioprotection utility; BARDA support for ARS indication; selective SphK2 (vs SphK1) targets S1P pathway differently from prior approaches; oral administration
Manufacturer #39192
Specialty pharmaceutical company developing treatments for gastrointestinal and infectious diseases. Advances novel combination regimens for hard-to-treat bacterial infections and GI conditions. Wholly owned pipeline with Phase 3 assets in NTM lung disease.
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