Pipeline Clinical Candidates
Our pipeline is focused on critical, unmet clinical needs across solid tumor oncology.
Preclinical
Phase I
Phase II
(several months – 2 yrs)
Phase III
(2 – 3 yrs)
BLA Filing
1
Saltikva®
Metastatic Pancreatic Cancer
Orphan Drug DesignationFast Track DesignationApproaching Phase 3
2
Saltikva®
Osteosarcoma
Orphan Drug DesignationPhase 2 Ready
3
Saltikva®
Metastatic Colorectal Cancer
Phase 2 Ready
Completed
Approaching Phase 3 / Next Stage
Future
* Pipeline stages are approximate and subject to regulatory review timelines. Saltikva® for pancreatic cancer is approaching Phase 3 following completion of Phase 2.
Regulatory &
Expanded Access
Saltikva® is not yet an approved pharmaceutical product. Salspera is currently planning pivotal trials for approval purposes.
FDA Orphan Drug & Fast Track Designations
Saltikva® has been awarded Orphan Drug and Fast Track Designations in pancreatic cancer by the US FDA.
Compassionate Care / Expanded Access
Salspera will consider all compassionate care requests under Expanded Access, depending on the review of patient criteria and other factors such as drug availability.
Osteosarcoma Program
Salspera Osteosarcoma Program was awarded Orphan Drug Designation by US FDA.