Autobahn’s elunetirom receives FDA fast track designation to treat adjunctive bipolar

Elunetirom is an oral, once daily, brain-penetrant CNS thyroid hormone receptor (CNS-TR) agonist in development for bipolar depression and major depressive disorder (MDD).

The therapy is intended as an adjunctive treatment for depressive episodes in adults with bipolar I or II disorder.

The company expects top line data from the ongoing Phase II AMPLIFY-BD trial in adjunctive bipolar depression in the second quarter of 2026.

Elunetirom’s Phase II AMPLIFY trial in MDD is expected to report top line data in the third quarter of 2026.

Elunetirom is designed to enhance neurobiological activity at CNS-TRs and reduce peripheral thyroid hormone-related risks.

It has demonstrated optimised pharmacokinetics, target engagement, and safety in both clinical and non-clinical studies.

Autobahn Therapeutics vice-president and regulatory affairs head Alida Barry said: “The receipt of fast track is an important advancement in our efforts to bring elunetirom to patients suffering from bipolar depression.

“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.”

Autobahn Therapeutics president and CEO Kevin Finney said: “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.

“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.”

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