SUL-238 / Sulfateq, Gen Ilaç ve Saglik Ürünleri - LARVOL DELTA

GEN Announces New Positive Phase 1 Trial Data of the Investigational Drug SUL-238 for Alzheimer's and Other Neurodegenerative Diseases (ACCESS Newswire) - "SUL-238 demonstrated an excellent safety and tolerability profile after multiple doses in both cohorts, while demonstrating a favourable PK profile and a high cerebrospinal fluid (CSF) penetration....First cohort PK (2000 mg b.i.d.): SUL-238 was rapidly absorbed with a mean time to maximum plasma concentration (Tmax) reached at 1.25(±0.54) and 1.50(±0.53) hours on day 1 and day 14, respectively....Second cohort PK (1500 mg t.i.d.): SUL-238 was rapidly absorbed, with a mean time to maximum plasma concentration (Tmax) reached at 0.95(±0.16) and 1.00(±0.00) hours on day 1 and day 14, respectively."

P1 data • Alzheimer's Disease • Parkinson's Disease

A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects (clinicaltrials.gov) - P1 | N=83 | Completed | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. | Active, not recruiting ➔ Completed

First-in-human • Trial completion

A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. | Recruiting ➔ Active, not recruiting

Enrollment closed

GEN and Sulfateq BV Announce Positive Phase 1 Trial Data on Investigational Drug SUL-238 for Alzheimer’s and Other Neurodegenerative Diseases (ACCESS Newswire) - P1 | N=83 | NCT06277492 | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. | "This single oral ascending dose (SAD) Phase 1, first-in-human, randomized, double-blind, placebo-controlled study was conducted in three parts, involving a total of 53 healthy elderly adults...The trial results showed that single oral doses of 50-2000 mg of SUL-238 were safe and well-tolerated, while demonstrating a favourable PK profile and high cerebrospinal fluid (CSF) penetration....No adverse effects (AEs) limited dose escalation, AE rates were comparable between SUL-238 and placebo, and all AEs were mild or moderate. The mean terminal elimination half-life was 0.86-3.80 hours, and the time to maximum plasma concentration was 0.50-1.39 hours. Under fed conditions, maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC0-∞) decreased by 50% and 60%, respectively."

P1 data • PK/PD data • Alzheimer's Disease

A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş.

New P1 trial