Iongen Therapeutics Announces First Participant Dosed in Phase 1 Clinical Trial of IG001119 for the Treatment of Pain

Iongen Therapeutics Announces First Participant Dosed in Phase 1 Clinical Trial of IG001119 for the Treatment of Pain

• First-in-human Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IG001119 in healthy volunteers
• IG001119 is a highly potent and selective oral Na_V1.8 inhibitor being developed as a differentiated non-opioid therapy for acute and chronic pain
• Topline Phase 1 data expected in February 2027

Nanjing and San Diego, July 7, 2026 — Iongen Therapeutics, a biotechnology company exclusively focused on ion channel therapeutics, today announced that the first participant has been dosed in the first-in-human Phase 1 clinical trial of IG001119, the Company's lead Na_V1.8 inhibitor. The Phase 1 study consists of single ascending dose (SAD) and multiple ascending dose (MAD) cohorts and will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IG001119 in healthy adult volunteers.

IG001119 is an orally available, highly potent and selective inhibitor of Na_V1.8, a genetically and clinically validated voltage-gated sodium channel target that plays a critical role in peripheral pain signaling.IG001119 has demonstrated a compelling preclinical profile, including potent and selective Na_V1.8 inhibition, favorable ADME properties, and a broad safety margin in GLP toxicology studies. These data support its clinical evaluation as a differentiated, non-opioid analgesic candidate with the potential to offer a broad therapeutic window and convenient dosing. The advancement of IG001119 into clinical development represents an important milestone in the Company's evolution into a clinical-stage biotechnology company.

The randomized, double-blind, placebo-controlled, first-in-human Phase 1 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered IG001119 following single ascending doses (SAD) and multiple ascending doses (MAD) in healthy volunteers. The study's primary endpoints are safety and tolerability, with secondary endpoints including pharmacokinetic characterization and exploratory pharmacodynamic assessments. Approximately 64 participants are expected to be enrolled, with topline data are expected in February 2027.

About IG001119

IG001119 is a next-generation, orally available, highly potent and selective Na_V1.8 inhibitor being developed for the treatment of acute and chronic pain. Its favorable pharmacokinetic properties and broad nonclinical safety margin support its potential as a differentiated non-opioid analgesic.

About Iongen Therapeutics

Iongen Therapeutics is exclusively focused on therapies targeting ion channels and dedicated to developing next-generation pain therapeutics that address critical unmet clinical needs.

The Company's pipeline includes two Na_V1.8 inhibitor programs, one of which has entered clinical development. Complementing these programs are a dual Na_V1.7/Na_V1.8 inhibitor designed to enhance analgesic efficacy and mechanism-based combination strategies pairing Na_V1.8 inhibition with complementary pain targets to achieve superior and more durable pain relief.

Built on scientific rigor, translational pharmacology, and deep expertise in ion channel biology, Iongen Therapeutics is committed to developing breakthrough non-opioid therapies that help redefine the standard of care for patients living with pain.