HOW DOES A DRUG GET DEVELOPED?

DISCONTINUED: Stages of Development for OXIGON®

The drug development process can be thought of as a series of stages, and drugs must successfully pass through each stage to become available to patients. This treatment has been evaluated, and the program has been discontinued. Thus, it is not in the pipeline.

Link to previous study

Discontinued: Phase I

2010: Phase I studies in healthy adults were completed. The drug was found to be safe and well-tolerated, and the pharmacokinetics revealed that the drug was rapidly absorbed and distributed in the body after oral administration.

September 2013: This drug was licensed to Viropharma, who launched a second Phase 1 trial of VP20629 in adults with FA. This trial was conducted at the Children’s Hospital of Philadelphia, Emory University, Univ of CA Los Angeles, Univ. of Iowa, and University of south Florida. This is was a single and multiple dose safety study.

November 2013: Shire announced an acquisition of ViroPharma and continued the ongoing Phase I trial.

July 2015: The final cohort of the Phase 1 study was completed and enrollment closed.

October 2016: Results were posted to clinicaltrials.gov. While the drug was safe and well-tolerated there were no measures supportive of efficacy. There are no plans to continue clinical development.