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

SHEPHERD: A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Ethics committee in the Netherlands green lights Parkinson’s clinical trial (Parkinson's News Today) - "With this approval, the company will activate a clinical site in Groningen in the northern Netherlands with patient enrollment planned to start in April....The Phase 2 SHEPHERD trial (NCT07322887) will assess SUL-238’s effects on mitochondrial function in an estimated 45 participants with early, untreated Parkinson’s."

Trial status • Parkinson's Disease

SHEPHERD: A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Mitochondria-Targeted Antioxidants Prevent Tachypacing-Induced Contractile Dysfunction in In Vitro Cardiomyocyte and In Vivo Drosophila Models of Atrial Fibrillation. (PubMed, Antioxidants (Basel)) - "MitoOxS is thus a key driver of tachypacing-induced contractile dysfunction and arrhythmia. Mitochondria-targeted antioxidants, such as MitoTEMPO or Sul-238, represent promising therapeutic strategies for AF."

Journal • Preclinical • Atrial Fibrillation • Cardiovascular • Metabolic Disorders • SOD2

Drug Development. (PubMed, Alzheimers Dement) - P1 | "In this Phase 1, first-in-human, healthy volunteer study, 50-2000 mg single oral doses of SUL-238 were safe and well-tolerated, while demonstrating a favourable PK profile, and a high CSF penetration."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease

Phase 1, Multiple Ascending Dose Study of a Novel Orally Administered Mitochondria-Directed Drug Candidate (SUL-238) in Healthy Volunteers (CTAD 2025) - No abstract available

Clinical • P1 data

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