GlobeNewswire·Oct 7, 2026, 4:01 PM ET

vTv Therapeutics Announces FDA Orphan Drug Designation for HPPD in Sickle Cell Disease

vTv Therapeutics Inc. received Orphan Drug Designation from the FDA for HPPD, an oral first-in-class Nrf2/Bach1 modulator being investigated for sickle cell disease.
Preclinical studies using the Townes sickle cell mouse model demonstrated that HPPD was orally active, well tolerated, increased fetal hemoglobin, & reduced oxidative stress & red blood cell sickling.
HPPD showed time- & dose-dependent HbF induction with effects comparable to or exceeding hydroxyurea, the current standard HbF-inducing therapy.
The company continues to advance cadisegliatin, a novel oral glucokinase activator, for type 1 diabetes, which holds FDA Breakthrough Therapy designation.
Paul Sekhri, Chairman, President, & CEO of vTv Therapeutics, stated that the designation strengthens the company's ability to pursue strategic partnering discussions for HPPD.
Both HPPD & cadisegliatin are under investigation, & their safety & efficacy have not been established with no guarantee of regulatory approval or commercial availability.