Onselex Completes FDA IND Package and SEND Datasets for ONX-1006, Its Safer Chemotherapy Drug for Stage IV Pancreatic Cancer

November 6, 2026

Onselex Pharmaceuticals announced today that it has completed the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application package for ONX-1006, including the complete nonclinical summaries, Investigator's Brochure, and Phase I/IIa clinical trial protocol for stage IV pancreatic cancer.

Supported by more than 30 preclinical studies, the company has also completed the FDA-required SEND (Standard for Exchange of Nonclinical Data) conversion for 15 applicable studies, comprising 199 electronic datasets, in the format required for FDA submission. All 199 electronic datasets successfully passed validation using Pinnacle 21, a data validation tool used by the U.S. FDA to assess compliance with regulatory data standards.

• Estimated U.S. Development Cost: $1 million or more to complete an FDA IND application package and SEND datasets of this scope.
• Estimated Development Time: 6–9 months of specialized regulatory preparation.

Developed over several years, Onselex's nonclinical program encompasses more than 30 studies, including toxicology, safety pharmacology, genotoxicity, efficacy, and pharmacokinetics, together with supporting in vitro studies and transmission electron microscopy (TEM) particle characterization. The complete body of supporting data and documentation exceeds 4,000 pages.

The formal core of the IND submission materials comprises 25 complete nonclinical study reports totaling 2,122 pages, 199 SEND datasets, and the complete application documents.

The only major component remaining before FDA submission is the cGMP clinical manufacturing batch. The capital the company is now raising funds that batch and the first human trial.

ONX-1006 delivers paclitaxel, a proven chemotherapy drug, in polymeric nanoparticles designed to target tumors. Onselex is preparing ONX-1006 for a Phase I/IIa trial in stage IV pancreatic cancer.

The IND has not yet been submitted. Submission will follow completion of the cGMP clinical batch.