BT-409 / Brenig Therap - LARVOL DELTA

Phase 1 Study of BT-409, a potent, selective, brain- penetrant, and oral small molecule inhibitor of NLRP3 in Healthy Volunteers and Adults with Parkinson’s disease (MDS Congress 2026) - No abstract available

Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease • NLRP3

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Healthy Volunteers. (ANZCTR) - P1 | N=68 | Recruiting | Sponsor: Diagenta AU PTY LTD | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026

Enrollment open • First-in-human • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

Brenig Therapeutics to Present AI-Enabled Design of a Brain-Penetrant NLRP3 Inhibitor at Keystone Symposia Neuroinflammation in Health and Disease (Streetinsider.com) - "Dr. Pushechnikov's poster...will detail how the company's Hybrid AI Platform, built together with Expert Systems, Inc., guided the design of BT-409, a brain-penetrant NLRP3 inhibitor. The platform pairs physics-based structural biology with modern machine learning to tackle problems that have long slowed central nervous system (CNS) drug discovery."

Preclinical • CNS Disorders

Brenig Therapeutics to Present Phase 1 Data for BT-267 at the American Academy of Neurology (AAN) 2026 Annual Meeting (PRNewswire) - "The poster will include updated results from Brenig's Phase 1 study evaluating BT-267 in healthy volunteers, highlighting its pharmacokinetic profile, target engagement, and safety and tolerability....BT-409 is currently being evaluated in a Phase 1 study with ongoing dose escalation, and the compound continues to be well-tolerated to date."

P1 data • Trial status • Parkinson's Disease

Brenig Therapeutics Announces Oral Presentation of Phase 1 Data for BT-267 at AD/PD 2026, and Provides Updates on BT-409, its NLRP3 Inhibitor Program (PRNewswire) - "The presentation will highlight emerging clinical data evaluating the safety, tolerability, pharmacokinetics (PK), and central nervous system (CNS) penetration of BT-267 in healthy volunteers....Brenig also announced that it has dosed healthy volunteers in its Phase 1 clinical trial of BT-409, a brain-penetrant NLRP3 inhibitor targeting neuroinflammation. BT-409 has been well tolerated to date, with no safety signals observed thus far and the study is progressing as planned."

P1 data • Trial status • Parkinson's Disease

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Adults with Parkinson’s disease. (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: Diagenta Au PTY LTD

First-in-human • New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Healthy Volunteers. (ANZCTR) - P1 | N=64 | Not yet recruiting | Sponsor: Diagenta AU PTY LTD

First-in-human • New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

BT-409: Brain-Selective NLRP3 Inhibitor Advancing to First-in-Human Evaluation (PRNewswire) - "The company has initiated a Phase 1 single ascending dose (SAD)/multiple ascending dose (MAD) study, with first dosing anticipated in early Q1 2026. The study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of BT-409 in healthy volunteers...Subject to successful completion of Phase 1, Brenig plans to advance BT-409 into proof-of-concept studies in Multiple Sclerosis and Parkinson's disease, evaluating the therapeutic potential of central inflammasome inhibition in neuroinflammation and neurodegeneration, including potential interactions with pathways involved in lysosomal and neuronal homeostasis."

First-in-human • New trial • Trial status • CNS Disorders • Multiple Sclerosis • Parkinson's Disease