Reglagene, Inc.

Reglagene, Inc. is a privately held, clinical-stage biopharmaceutical company headquartered in Houston, Texas, focused on central nervous system (CNS) oncology. The company was founded in November 2016 by Richard Austin, formerly of Sanofi and GSK, together with Laurence Hurley and Vijay Gokhale of the University of Arizona. The founding premise was that cancer that spreads to the brain has almost nothing that works, largely because the blood-brain barrier keeps most cancer drugs out. Reglagene was built to get a therapy through that barrier — one that acts on the primary tumor and on the metastases, including those that reach the brain. The company is focused on a single asset: RGN6024, an oral, twice-daily small molecule that targets tubulin, a mechanism validated across many solid tumors but never successfully made to work in the brain. RGN6024 is designed to cross the blood-brain barrier by design. It has roughly half the molecular size of FDA-approved tubulin-targeting therapies, and its low molecular weight makes it easier to pass into cells and into the brain. It is also not recognized by efflux pumps, the transport proteins in the brain that remove toxins and medicines, so it stays in the brain and keeps attacking the tumor. In the BT-142 intracranial glioma model, twice-daily oral RGN6024 reduced bioluminescent tumor signal by 98% versus vehicle (p < 0.0001), with 100% survival; the work was published in Molecular Cancer Therapeutics 2025;24(8):1129-1144. Reglagene's efficacy models to date are in small cell lung cancer and glioblastoma, and the same approach is intended to apply to other solid tumors that seed the brain and are susceptible to a microtubule destabilizer. Reglagene runs lean, with a small internal team working alongside contract research organization (CRO) and academic partners. RGN6024 has completed pharmacology, tolerability studies in two species, and GMP manufacturing process development, and it holds FDA Orphan Drug Designation. According to the company, two primary things stand between RGN6024 and an Investigational New Drug (IND) application: GLP toxicology and GMP manufacture. The company expanded to a new office in Houston, Texas, in 2024 and has been active in the Texas Medical Center Innovation Factory and the Brain Tumour Research Novel Therapeutics Accelerator. In May 2025, Drug Hunter selected RGN6024 as one of its Molecules of the Month. Reglagene is led by Chief Executive Officer, President and Co-Founder Richard Austin, PhD, MBA, with Vijay Gokhale, PhD, as Co-Founder. Its board blends pharmaceutical industry professionals with track records of delivering drug development programs and operations. The company is privately held and does not disclose a parent company or owner.

Reglagene was founded in November 2016, when Richard Austin, formerly of Sanofi and GSK, sat down with Laurence Hurley and Vijay Gokhale at the University of Arizona. The founding team was motivated by a stark clinical reality: no meaningful new therapy had been approved for the deadliest brain cancers since 1999, and most cancer drugs never reach the brain at all because the blood-brain barrier keeps them out. They founded Reglagene to change that, with the goal of developing a therapy that works on the primary tumor and on the metastases, including in the brain. The company's scientific approach centers on tubulin, a mechanism validated across many solid tumors but never made to work in the brain. Reglagene's lead asset, RGN6024, is an oral, twice-daily small molecule designed to cross the blood-brain barrier by design. It is roughly half the size of FDA-approved tubulin-targeting therapies, and its low molecular weight makes it easier to pass into cells and into the brain. It is also not recognized by efflux pumps — the transport proteins in the brain that remove toxins or medicines — so it stays in the brain and keeps attacking the tumor. In the BT-142 intracranial glioma model, twice-daily oral RGN6024 reduced bioluminescent tumor signal by 98% versus vehicle (p < 0.0001), with 100% survival; the work was published in Molecular Cancer Therapeutics 2025;24(8):1129-1144. Reglagene's efficacy models to date are in small cell lung cancer and glioblastoma, and the same approach is intended to apply to other solid tumors that seed the brain and are susceptible to a microtubule destabilizer. By early 2024, Reglagene had published its first peer-reviewed article, in Biomedicines as part of the Special Issue on Glioblastoma. In June 2024, the company welcomed Ben Maurey as a commercial-focused advisor on its Advisory Board. In November 2024, Reglagene was selected to participate in the Brain Tumour Research Novel Therapeutics Accelerator in Boston. In December 2024, the company concluded the year by expanding to a new office in Houston, Texas. In May 2025, CEO Richard Austin presented on the main stage at the Texas Medical Center Innovation Factory's Lunch 'n' Launch event. In June 2025, Drug Hunter selected RGN6024 as one of its Molecules of the Month for May 2025. Reglagene runs lean, with a small internal team working alongside CRO and academic partners. RGN6024 has completed pharmacology, tolerability studies in two species, and GMP manufacturing process development, and it holds FDA Orphan Drug Designation. According to the company, two primary things stand between RGN6024 and an IND: GLP toxicology and GMP manufacture. The company is privately held and headquartered in Houston, Texas.

• Reglagene founded by Richard Austin, Laurence Hurley and Vijay Gokhale at the University of Arizona

• First peer-reviewed article published in Biomedicines, Special Issue Glioblastoma

• Ben Maurey welcomed as Commercial Advisor on the Advisory Board

• Selected to participate in the Brain Tumour Research Novel Therapeutics Accelerator in Boston

• Expanded to a new office in Houston, Texas

• CEO Richard Austin presented at the Texas Medical Center Innovation Factory Lunch 'n' Launch event

• Drug Hunter selected RGN6024 as one of its Molecules of the Month for May 2025

Clinical-stage CNS oncology company developing oral, brain-penetrant therapies for primary brain tumors and brain metastases; focused on a single tubulin-targeting asset, RGN6024.

• RGN6024

  Oral, twice-daily, brain-penetrant small molecule that targets tubulin; designed to cross the blood-brain barrier and not be removed by efflux pumps; holds FDA Orphan Drug Designation; efficacy models in small cell lung cancer and glioblastoma.

1. 1Reglagene | Brain-penetrant therapies for CNS oncologyreglagene.com
2. 2About | Reglagene — CNS oncologyreglagene.com
3. 3News | Reglagene — CNS oncologyreglagene.com
4. 4Reglagene, Inc. (United States) - Wikidatawikidata.org