SIR9900 / Sironax - LARVOL DELTA

A study evaluating the safety and effectiveness of SIR9900 compared with placebo in adults with VEXAS syndrome (ANZCTR) - P2 | N=110 | Not yet recruiting | Sponsor: Sironax USA, Inc.

New P2 trial

Development of a highly potent, brain penetrant and allosteric RIPK1 inhibitor for the treatment of neurodegenerative diseases (Neuroscience 2025) - "SIR9900 significantly and dose dependently reduced cytokine production, protected epithelial damage on GI and reduced mortality rate in the SIRS model. SIR9900 significantly reduced neuroinflammation in the AD mouse model and significantly delayed disease onset of the EAE model. SIR9900 is a potent, selective and brain penetrant RIPK1 inhibitor that exhibited good activities in vitro and in multiple in vivo preclinical models."

Alzheimer's Disease • CNS Disorders • CASP8 • CDK7 • FADD • Plasma NfL • RIPK1 • TNFA • TNFRSF1A

Safety, Pharmacokinetics and Target Engagement of a Novel Brain Penetrant RIPK1 Inhibitor (SIR9900) in Healthy Adults and Elderly Participants. (PubMed, Clin Transl Sci) - "A robust pharmacodynamic effect was demonstrated with approximately 90% peripheral target engagement at 3 h post-dose, and sustained RIPK1 inhibition over the 10-day treatment period. The promising safety, pharmacokinetic, and pharmacodynamic profile of SIR9900 with central nervous system penetrating potential in healthy adult and elderly participants supports its further clinical development in patients with inflammatory and degenerative diseases, particularly in the central nervous system."

Clinical • Journal • PK/PD data • CNS Disorders • Immunology • Inflammation • RIPK1

A Randomised, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Elderly Volunteers. (Multiple Ascending Dose (MAD), Part 2 Cohort 5). (ANZCTR) - P1 | N=10 | Completed | Sponsor: Sironax Aus Pty Ltd | Not yet recruiting ➔ Completed

Trial completion • Inflammation • RIPK1

A Randomized, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Adult Volunteers (ANZCTR) - P1 | N=80 | Completed | Sponsor: Sironax Aus Pty Ltd | Recruiting ➔ Completed

Trial completion • Inflammation • RIPK1

A Randomized, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Adult Volunteers (ANZCTR) - P1 | N=80 | Recruiting | Sponsor: Sironax Aus Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Inflammation • RIPK1

A Randomized, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Adult Volunteers (ANZCTR) - P1 | N=88 | Not yet recruiting | Sponsor: Sironax Aus Pty Ltd

New P1 trial • Inflammation • RIPK1

A Randomised, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Elderly Volunteers. (Multiple Ascending Dose (MAD), Part 2 Cohort 5). (ANZCTR) - P1 | N=10 | Not yet recruiting | Sponsor: Sironax Aus Pty Ltd

New P1 trial • Inflammation • RIPK1