Tenvie Therapeutics Doses First Subject in TNV313 Phase 1 Trial

BRISBANE, Calif. — October 13, 2026

TNV313 Expands Tenvie’s CNS-Penetrant NLRP3 Portfolio

TNV313 is designed to inhibit NLRP3, a key regulator of innate immune signaling implicated in multiple inflammatory conditions. By targeting this pathway, the investigational small molecule is intended to address inflammatory processes associated with neurological and other diseases. A defining feature of TNV313 is its ability to penetrate the central nervous system, potentially enabling it to act on neuroinflammatory mechanisms within the brain. Tenvie reports that preclinical studies demonstrated full CNS penetration and a favorable safety profile, supporting progression into human testing. The company’s approach emphasizes developing molecules with substantial brain exposure at potentially low clinical doses. Tenvie also reports expertise in designing CNS-penetrant compounds that are not subject to active transporter-mediated efflux. According to the company, measurements of drug concentrations in cerebrospinal fluid (CSF) and plasma can help estimate brain exposure and inform dose selection. These characteristics are intended to support development across several indications, although their clinical relevance and the candidate’s safety and effectiveness must be established through human studies. TNV313 represents the third Tenvie drug candidate to enter clinical development in 2026, according to the company.

Phase 1 Study to Assess Safety and Pharmacological Profile

The first-in-human Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of TNV313 in healthy volunteers. Pharmacokinetic assessments will characterize how the drug is absorbed and processed by the body, while pharmacodynamic evaluations will examine its biological effects. The study will also assess CNS distribution and exploratory pharmacodynamic biomarkers to help determine whether the candidate reaches the intended biological compartment and produces measurable effects. Tenvie expects to announce preliminary results in the first half of 2027. Subject to the findings, the company intends to advance TNV313 into Phase 2 clinical studies. Tony Estrada, Ph.D., co-founder, president and chief executive officer of Tenvie Therapeutics, said the first dosing milestone reflects the company’s ability to advance multiple programs through its proprietary product engine. Chief Medical Officer Tanya Z. Fischer, M.D., Ph.D., highlighted the importance of brain exposure and the use of CSF and plasma measurements to inform dose selection. The Phase 1 study will provide the initial human data needed to evaluate whether TNV313’s preclinical characteristics translate into an appropriate clinical profile. Its results will also help guide dose selection and subsequent development planning.

Parallel Development Across Neurological and Metabolic Diseases

Tenvie plans to develop TNV313 along a distinct pathway from TNV262, its other fully CNS-penetrant NLRP3 inhibitor. The company expects to initiate Phase 2 proof-of-concept studies of TNV262 in obesity, cardiometabolic disease and multiple sclerosis during the same general period in which TNV313’s preliminary Phase 1 data are anticipated. The two NLRP3 programs may allow Tenvie to investigate different indications and development strategies in parallel. Its broader pipeline also includes TNV108, a peripherally restricted allosteric inhibitor of SARM1 being developed for peripheral neuropathies. Together, these programs reflect the company’s strategy of engineering small molecules either to penetrate the CNS or remain primarily outside it, depending on the intended therapeutic target. Tenvie is focused on neuroinflammation and cellular dysfunction as biological drivers of neurological and peripheral diseases. While the company’s preclinical findings provide a rationale for advancing TNV313, its potential applications across neurological, cardiometabolic and ophthalmic conditions remain investigational. Future clinical studies will need to establish its safety, biological activity and therapeutic benefit in specific patient populations before its role in treating these diseases can be determined.

Source::Tenvie Therapeutics, press release