Project Insulin: Drug Development Update

Where Drug Development Stands

In July 2026, we started drug development on our biosimilar insulin. We know this process is long, and we want to be transparent about the work we're doing, so we created this timeline to show where we are in the process.

Pre-Clinical Development Timeline

In partnership with our contract development and manufacturing organization, the pre-clinical work will go through four phases. From the first gene design work through a completed, tested drug substance ready for clinical use.

(~$500K) In Progress

Designing and testing the genetic sequence behind our insulin candidate, selecting the best-performing strain, and manufacturing a master cell bank under cGMP conditions, the biological starting material every later batch is grown from.

(~$2M) Upcoming

Building and refining the manufacturing process itself, the fermentation, purification, and testing methods used to turn the cell bank into a drug substance that meets pharmaceutical quality standards.

(~$500K) Upcoming

Running the full process at a larger, pilot scale to confirm it holds up outside the lab, and generating reference material used to benchmark every batch after it.

(~$2.5M) Upcoming

Manufacturing the first official cGMP batch of drug substance, testing and releasing it, and compiling the formal reports that document the process for regulators.

Funding So Far

$300,000

raised so far

of $5,500,000 needed to complete pre-clinical trials

Phase 1 Phase 2 Phase 3 Phase 4

Funds cover manufacturing and process development costs, salaries for the team running this program, and program overhead through completion of all four phases.

Completing pre-clinical development is a major milestone, but it's not the finish line. Once this phase is done, we'll move into clinical trials to test the drug in people, followed by the FDA approval process required before it can reach patients. Both of those stages come with their own timelines and funding needs that we'll be working toward next. During the pre-clinical work, we'll begin research and preparation for these next steps to ensure we have the smoothest process to approval.