Renewing Medicines. Restoring Lives.
We advance proven molecules with modern science. Our lead program brings a non-sedating CNS therapy with more than fifty years of international use to one of the largest untreated neurologic conditions in the United States.
The Devah Vision
A Focus on Therapeutic Renewal
At Devah Therapeutics, we believe innovation can come from seeing hidden potential in what already exists. Our work begins with proven molecules whose value has been overlooked — and continues with rigorous modern science that reveals new paths to improve patient lives.
Through the FDA 505(b)(2) pathway, we build on decades of existing clinical and safety evidence rather than recreating it — accelerating development, reducing risk, and bringing renewed clarity to medicines that deserve a second chance.
Our goal is simple:
restore function, restore quality of life.
Our Lead Program: DTC-001
A CNS modulating small molecule with more than fifty years of prescribing history across eighteen countries — non-sedating, never scheduled as a controlled substance in any jurisdiction, and never submitted to FDA. Devah is advancing DTC-001 through the 505(b)(2) regulatory pathway.
-
Twenty-five million US adults experience tinnitus; there is no FDA-approved drug. It is one of the largest military service-connected disabilities among US veterans, with more than $5 billion paid annually in federal disability compensation. Treatment guidelines advise against every existing drug class because each is sedating, habit-forming, or impairs the adaptation patients depend on. DTC-001’s non-sedating, non-controlled, daytime-functional profile is suited to the chronic use this condition requires.
-
The most common inherited cause of intellectual disability, with no approved therapy for its core symptoms. In a blinded 2026 preclinical study in the standard Fragile X genetic model, animals dosed with DTC-001 showed correction across multiple behavioral domains — with no behavioral effects in normal animals dosed with drug - the signature of a compound that acts on the deficit rather than sedating the patient. An FDA Orphan Drug Designation application is in preparation, and the program is structured for partnership.
-
The indication with five decades of international prescribing and a 2024 randomized controlled trial demonstrating equivalence to diazepam with adverse events comparable to placebo. Reached by supplemental application following first US approval.
Why Repurpose?
Smarter Pathways to Proven Therapies
The 505(b)(2) regulatory pathway allows Devah to build on decades of existing safety and clinical data, resulting in:
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.
The Science Behind Renewal
Mechanism Matters
DTC-001 does not act through the GABA-A receptor — the mechanism responsible for the sedation, impairment, and dependence of classical anxiolytics. Its activity derives from a distinct, non-GABAergic neurochemical signature acting on the signaling systems that govern arousal and salience — the biology increasingly understood to drive tinnitus distress and related conditions.
The clinical consequence, documented across five decades of use:
efficacy without impairment. Non-sedating. Non-controlled. Compatible with work, driving, and daily life.
About Devah Therapeutics
A Company Built on Second Chances
Devah Therapeutics was founded to unlock new value in overlooked medicines, applying contemporary science to reveal their true therapeutic potential. We operate virtually by design — capital goes to data and regulatory milestones, not overhead — and we are committed to advancing safe, effective, and accessible treatments for patients whose daily lives are disrupted by conditions with few satisfying options.
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. He is leading DTC-001 into the US market through the 505(b)(2) pathway, with tinnitus as the registration indication.
-
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 collaboration with clinicians, researchers, and organizations advancing therapies for tinnitus, Fragile X syndrome, generalized anxiety disorder and related CNS conditions.
Devah is actively advancing its lead program toward FDA Pre-IND submission and welcomes conversations with aligned investors and partners.