vTv Therapeutics Announces FDA Orphan Drug Designation for HPPD in Sickle Cell Disease
Key Highlights
- ➤FDA grants vTv Therapeutics (VTVT) Orphan Drug Designation to HPPD for sickle cell disease
- ➤HPPD preclinical studies increased fetal hemoglobin and reduced oxidative stress and red blood cell sickling
- ➤Designation strengthens vTv’s ability to advance strategic partnering discussions for HPPD
- ➤Cadisegliatin remains in a U.S. Phase 3 study as a potential oral T1D treatment
Expert Statements
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics
“The FDA’s Orphan Drug Designation reinforces both the urgency of the unmet need in this devastating disease and the opportunity to bring forward potential new therapeutic approaches.”
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics
“Receiving this designation marks an important inflection point for this program and strengthens vTv’s ability to advance strategic partnering discussions for HPPD while continuing to develop cadisegliatin in T1D.”
HIGH POINT, N.C., Oct. 07, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to HPPD, the Company’s oral, first-in-class Nrf2/Bach1 modulator. HPPD is being investigated as a treatment for sickle cell disease.
“The FDA’s Orphan Drug Designation reinforces both the urgency of the unmet need in this devastating disease and the opportunity to bring forward potential new therapeutic approaches,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. “Receiving this designation marks an important inflection point for this program and strengthens vTv’s ability to advance strategic partnering discussions for HPPD while continuing to develop cadisegliatin in T1D.”
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