Incentives and Regulatory Clarity to Unlock Repurposed Generics

On August 5, 2026, Thomas Seoh (EVP, Kitalys Institute) gave a public comment at the Reagan-Udall Foundation's Drug Repurposing: Considerations for Selection Criteria and Prioritization meeting. His comment and accompanying slide are reproduced below.

My name is Thomas Seoh. I am CEO of Kinexum, a regulatory consulting firm, and EVP of the not-for-profit Kitalys Institute, dedicated to healthy longevity for all. Thank you for this opportunity to comment.

The largest barrier to developing promising repurposed drugs is the lack of private-sector incentives. Few sponsors will fund evidence for new uses of generic drugs if competitors can free-ride by selling their generics for the new indication.

Kitalys has proposed a draft THRIVE Act: an optional pathway, evidentiary tiers, and incentives for healthspan products, including repurposed drugs, that includes market exclusivity, priority review vouchers, and prizes as incentives.

But beyond incentives, streamlined, predictable regulatory practices help too, especially for repurposed generics with extensive safety experience.

We are involved in two repurposing projects, among others: verapamil, a generic antihypertensive, being developed for type 1 diabetes based on academic trials suggesting delayed disease progression in new-onset disease. We're also developing a fixed-dose combination of low-dose metformin, sildenafil, and leucine, with phase 2 cardiometabolic benefit signals in obesity and MASH, now being studied for hypertension.

For such products, reforms such as the following could help:

First, scale safety-exposure requirements to residual risk: hundreds of exposures, not thousands by default, where safety is well characterized.

Second, sensibly prune factorial-design expectations under the combination drug rule, especially for low-dose, mechanistically supported FDCs.

Third, allow dose or formulation optimization for new indications without automatically restarting phase 2.

Fourth, adopt fit-for-purpose endpoints and biomarkers faster, with transparent standards. Bone mineral density took about a dozen years; C-peptide for type 1 diabetes still lacks full acceptance, on and off, after more than 2 decades – such cycles need to be compressed.

Fifth, consider a dedicated, accelerated pathway—perhaps a dedicated office—for repurposed generics with substantial safety experience. Duke-Margolis recommends this.

Incentives, regulatory clarity, and evidentiary standards proportionate to known risk are keys to unlocking more repurposed generics. 

Thank you.