Autobahn Therapeutics, Inc., a biotechnology company developing restorative treatments for people affected by neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to elunetirom, the Company’s lead candidate, for the adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Elunetirom is an oral, once daily, brain-penetrant, CNS thyroid hormone receptor (CNS-TR) agonist that Autobahn is developing as an adjunctive treatment for bipolar depression and major depressive disorder (MDD).
“The receipt of Fast Track is an important advancement in our efforts to bring elunetirom to patients suffering from bipolar depression,” said Alida Barry, Vice President, Head of Regulatory Affairs at Autobahn Therapeutics. “Fast Track designation is granted to investigational treatments that may offer substantial benefit over what is currently available for serious conditions with unmet needs. We appreciate the recognition that elunetirom has the potential to provide a meaningful new treatment option and look forward to continuing our engagement with the FDA as we advance the development of elunetirom.”
Bipolar depression affects approximately 7 million adults in the U.S. and represents one of the most disabling indications in psychiatry, where patients lose an average of more than one month of work each year. More than half of patients do not receive adequate relief on currently available therapies, which are limited by modest efficacy and significant side effects, including weight gain, sexual dysfunction, movement disorders, and metabolic complications.
“The standard of care in bipolar depression hasn’t meaningfully changed in decades, and patients continue to have to choose between inadequate relief and unacceptable side effects,” said Kevin Finney, President and Chief Executive Officer of Autobahn Therapeutics. “We see this designation as an important step toward our broader mission of transforming how serious neuropsychiatric conditions are treated. Elunetirom represents a fundamentally new treatment approach with a differentiated profile designed to enable better care for patients. I’m proud of the team’s execution in advancing this program and believe we have the potential to meaningfully impact the lives of millions of patients living with depressive disorders.”
Autobahn is on track to report topline data from its ongoing Phase 2 AMPLIFY-BD trial (NCT06869187) in adjunctive bipolar depression in the second quarter of 2026. Autobahn is also developing elunetirom as an adjunctive treatment for MDD in its ongoing Phase 2 AMPLIFY trial (NCT06633016), with topline data from that trial expected in the third quarter of 2026.
About Fast Track
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational therapies intended to treat serious conditions and address an unmet medical need. A drug that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the development process, as well as potential Accelerated Approval, Priority Review, and Rolling Review of its marketing application, if relevant criteria are met.
About Elunetirom
Elunetirom (ABX-002) is an investigational, oral, once daily, brain-penetrant small molecule prodrug that targets CNS thyroid hormone receptors (CNS-TRs). Elunetirom is believed to uniquely boost energy and plasticity in the brain through improving mitochondrial health, increasing cellular energy production, and driving neuroplastic changes in the CNS, offering a potentially fundamentally different mechanism to treat depression and other CNS disorders. Elunetirom is designed to enhance beneficial neurobiological activity at CNS-TRs while also reducing the liabilities of peripheral thyroid hormone receptor activity from the administration of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. In nonclinical and clinical studies, elunetirom has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an acceptable safety and tolerability profile. Elunetirom is being evaluated in clinical studies as a potential adjunctive treatment for MDD and bipolar depression.
About Autobahn Therapeutics
Autobahn Therapeutics, Inc., is a biotechnology company developing a portfolio of neuropsychiatric clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company’s pipeline is led by elunetirom, a CNS thyroid hormone receptor (CNS-TR) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression, including those with atypical depression, a highly prevalent and underserved subpopulation of depression. For more information, visit www.autobahntx.com.
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