SP-624 / Sirtsei Pharma - LARVOL DELTA

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=456 | Recruiting | Sponsor: Sirtsei Pharmaceuticals, Inc. | Trial completion date: Jul 2025 ➔ Nov 2025 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of the Sirtuin 6 Activator SP-624 in Healthy Adults. (PubMed, Clin Pharmacol Drug Dev) - "In SP-624-101 and SP-624-102, respectively, 3 (12%) and 5 (29%) SP-624-treated participants experienced treatment-emergent adverse events. SP-624 was well tolerated and reached target concentrations in healthy adults, supporting progression of SP-624 20 mg daily into Phase 2 studies of major depressive disorder."

Journal • P1 data • PK/PD data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Sirtsei Pharmaceuticals, Inc.

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Arrivo Bio Initiates Large Phase 2b Clinical Trial in Major Depressive Disorder with Novel SIRT6 Activator (Businesswire) - "Arrivo Bio announced today a significant step forward in the fight against major depressive disorder (MDD) with the dosing of the first patient in the SP-624-202 clinical trial. This registration-quality Phase 2b study will enroll 450 subjects with MDD and evaluate the effectiveness of SP-624, a SIRT6 activator and novel mechanism of action, compared to placebo in treating adults with Major Depressive Disorder. The SP-624-202 study will assess the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) as its primary endpoint."

Trial status • Major Depressive Disorder

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=456 | Recruiting | Sponsor: Sirtsei Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=456 | Not yet recruiting | Sponsor: Sirtsei Pharmaceuticals, Inc.

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=319 | Completed | Sponsor: Sirtsei Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=319 | Active, not recruiting | Sponsor: Sirtsei Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Sirtsei Pharmaceuticals, Inc. | Phase classification: P1/2 ➔ P1

Phase classification • CNS Disorders • Psychiatry • Schizophrenia

A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Sirtsei Pharmaceuticals, Inc.; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia (clinicaltrials.gov) - P1/2; N=27; Completed; Sponsor: Sirtsei Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia (clinicaltrials.gov) - P1/2; N=27; Active, not recruiting; Sponsor: Sirtsei Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Sirtsei Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Sirtsei Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia (clinicaltrials.gov) - P1/2; N=24; Not yet recruiting; Sponsor: Sirtsei Pharmaceuticals, Inc.

Clinical • New P1/2 trial • CNS Disorders • Psychiatry • Schizophrenia