Renewing Medicines. Restoring Lives.
A fifty-year-old medicine. A new purpose in Fragile X. Devah Therapeutics is a rare-disease company developing DTC-001 — a non-sedating CNS medicine with more than fifty years of international use — for Fragile X syndrome, through the FDA 505(b)(2) pathway.
The Devah Vision
Proven medicines, where they are needed most
Sometimes useful medicines never reach the United States. Devah brings them forward for rare conditions where families and caregivers have waited longest, using modern science and the FDA 505(b)(2) pathway — which builds on an existing record of human use rather than starting from zero. Our first program is Fragile X syndrome. Our purpose is the same in every program: restore function, restore quality of life.
Our goal is simple:
restore function, restore quality of life.
Our Program: DTC-001 for Fragile X Syndrome
DTC-001 is a CNS small molecule with more than fifty years of prescribing history across eighteen countries — non-sedating, never scheduled as a controlled substance, and never submitted to the FDA. We are developing it for Fragile X syndrome through the 505(b)(2) pathway. An Orphan Drug Designation application was submitted to FDA in September 2026.
-
Fragile X syndrome is the most common inherited cause of intellectual disability and the leading known single-gene cause of autism. When families and caregivers were asked, through the FDA’s patient-focused drug development process, what matters most, anxiety and hyperarousal came first. No approved medicine addresses them.
-
Fifty years of human use is evidence a new chemical entity cannot buy. DTC-001 calms anxiety without sedation — the trade-off that has limited existing options in this population — and its safety record lets development move faster under 505(b)(2). A modern nonclinical and manufacturing characterization is complete, and our first Fragile X mouse study is in hand.
-
We are leveraging objective measures of anxiety and hyperarousal with leading Fragile X research centers; planning clinical studies and preparing the FDA pre-IND package as our first milestone.
Why 505(b)(2)?
Smarter Pathways to Proven Therapies
The FDA 505(b)(2) pathway lets a sponsor rely on the existing record of a medicine’s human use rather than repeating it — so a proven drug can reach new patients in years, not decades.
Faster development timelines
Reduced clinical and financial risk
Clearer mechanistic hypotheses
A higher probability of success.
Repurposing is not a shortcut — it is a strategy.
First US approval of a molecule never before approved here carries five years of new-chemical-entity exclusivity, granted by statute and independent of patents. By bringing modern tools and disciplined execution to a well-characterized molecule, we create meaningful impact where traditional discovery has struggled.
For a rare disease, orphan drug designation adds seven years of market exclusivity on approval, along with fee waivers and tax credits that make small, focused programs viable.
The Science Behind Renewal
Mechanism Matters
DTC-001 does not act through the GABA-A receptor — the mechanism behind the sedation, dependence and tolerance of classic anxiolytics. It acts instead on the brain’s arousal and salience systems, which is why five decades of use show calming without impairment. In Fragile X, anxiety and hyperarousal have measurable signatures in the autonomic nervous system — and these can be captured in the clinic. Devah’s science program is building that measurement foundation, in animal models and in patients, so that the first trials measure what families actually experience.
About Devah Therapeutics
A Company Built on Second Chances
Devah Therapeutics was founded to unlock new value in overlooked medicines for rare conditions, applying contemporary science to reveal their true therapeutic potential. We operate virtually by design — We are a rare-disease company by design: one program, one community, and capital spent on data and regulatory milestones.
Our name reflects our mission: Devah—a modern reimagining of “two,” symbolizing renewal, duality, and a second chance to make a difference.
BRIAN SPEICHER
Founder & Chief Executive Officer, Devah Therapeutics
Brian Speicher is a biotechnology executive with three decades of experience advancing CNS therapeutics, repurposed drug programs, and translational clinical strategies across emerging biotechs, global pharma, and CRO environments. At Vela he repositioned deprioritized CNS medicines through the 505(b)(2) pathway — the model Devah is built on.
-
Brian’s career has been defined by a consistent focus on unlocking therapeutic value hidden inside neglected or underdeveloped molecules. He has led or contributed to CNS repurposing and clinical development programs at Vela Pharmaceuticals, Krele Pharmaceuticals, Tonix Pharmaceuticals, Eisai Medical Research, and SCIREX — organizations where redevelopment, mechanism refinement, and pathway reconstruction were core to the work. His experience spans early-stage hypothesis generation, efficient nonclinical strategy, Phase I–III clinical execution, and 505(b)(2) regulatory navigation. Brian earned an MBA at the Sloan School of Management at MIT, an MPH at the Bloomberg School of Public Health at Johns Hopkins University, and dual BSc degrees from the Pennsylvania State University.
A former venture-studio operator, Brian also spent five years leading innovation and commercialization strategy for the Desert Research Institute and served as Director & President of Desert Research Corporation, where he built a playbook for forming and capitalizing institutional spinouts. He founded Tu Biomics, raising multimillion-dollar seed capital, negotiating IP licenses, and advancing products from lab characterization through field trials.
This ecosystem leadership experience gives Brian a strategic advantage as a biotech CEO: a deep understanding of IP development, asset evaluation, partnership design, and early-stage venture formation, all applied to a CNS therapeutic platform that benefits from disciplined capital use and rigorous translational positioning.
Brian holds an MBA from the MIT Sloan School of Management, an MPH in Epidemiology and Data Science from Johns Hopkins University, and dual BSc degrees from Penn State University.
He brings to Devah Therapeutics the combination of clinical development credibility, scientific strategy, and entrepreneurial operational leadership, with a mission to turn overlooked science into therapeutics with meaningful patient impact.
Contact / Investors
Connect With Devah
Partnerships & Scientific Collaborations
We welcome conversations with Fragile X and neurodevelopmental clinicians and researchers, patient organizations, and groups working on autonomic and wearable measurement. If you treat or study Fragile X, we would like to hear from you.
Devah is advancing DTC-001 toward an FDA pre-IND meeting for Fragile X syndrome and is open to conversations with investors and partners who know rare disease. Materials are available on request.