Is Saltikva approved by the FDA, and what phase is it in?

No. Saltikva, developed by Salspera, Inc., has not been approved by the FDA or any other regulator for any use. The FDA Orphan Drug Designation database lists Saltikva's active ingredient as not FDA approved for the orphan indications. The University of Minnesota-sponsored Phase 1 is completed. Results from the open-label, non-randomized Phase 2 in metastatic pancreatic cancer have been published; enrollment closed in July 2024, and ClinicalTrials.gov ↗ lists the Phase 2 as active, not recruiting, while follow-up continues. A pivotal Phase 3 in stage IV metastatic pancreatic cancer is planned following an FDA Type C meeting; it is not yet active or recruiting. A treating physician can request expanded access to Saltikva through the contact form; each request is reviewed individually, and access is not guaranteed. This page does not promise treatment without charge.