HPPD (HPP8668)

October 7, 2026: vTv Therapeutics (NASDAQ: VTVT) said the FDA granted Orphan Drug Designation to HPPD (HPP8668), an investigational oral Nrf2/Bach1 modulator for sickle cell disease. The designation is the catalyst event.

For HPPD, the company cited preclinical Townes sickle cell disease mouse-model data from Augusta University showing the drug was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling; vTv also said HbF induction was time- and dose-dependent and comparable to or better than hydroxyurea in those studies. HPPD remains investigational, with safety and efficacy not established.

The release also notes vTv’s separate lead program cadisegliatin (TTP399), an oral glucokinase activator for type 1 diabetes, has FDA Breakthrough Therapy designation and is being studied in a U.S. Phase 3 trial as a potential adjunctive treatment. No new cadisegliatin data were reported in this announcement.