Delving into the Latest Updates on Elunetirom with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ABX 002, ABX-002

Target

THR-β

Action

agonists

Mechanism

THR-β agonists(Thyroid hormone receptor beta agonists)

Therapeutic Areas

Nervous System DiseasesOther DiseasesImmune System Diseases+ [2]

Active Indication

Bipolar DisorderDepressive Disorder, MajorBipolar and Related Disorders+ [2]

Inactive Indication-

Originator Organization

Autobahn Therapeutics, Inc.

Active Organization

Autobahn Therapeutics, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC19H21Cl2NO3

InChIKeyCQELSEDWYWTMDG-UHFFFAOYSA-N

CAS Registry2156649-32-8

The goal of this clinical trial is to learn if ABX-002 added to participants' existing treatment(s) can improve clinical symptoms of depression and to learn about potential effects on brain chemistry that may correlate with antidepressive effects.
This is a single treatment arm, open-label, Phase 2 study of ABX-002 in up to30 adults with bipolar depression. A subset of these participants will undergo brain imaging. Five healthy volunteer participants will also be enrolled and receive no drug treatment, undergoing 2 imaging sessions to confirm instrument and test - retest method reliability control.
For bipolar disorder participants who are experiencing an episode of depression, the study will include 4 study periods:
1. Screening Period of up to 5 weeks
2. 6-week Treatment Period
3. 2-week post dose Safety Follow-up Period.
4. 6-month postdose targeted safety follow-up period
For healthy volunteers, the study will include 2 study periods:
1. Screening Period of up to 3 weeks
2. Imaging Period of up to 3 weeks.

Start Date28 Mar 2025

Sponsor / Collaborator

Autobahn Therapeutics, Inc.

NCT06633016

/ RecruitingPhase 2

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant.
This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo).
The study will include the following stages:
1. Screening, approximately 35 days
2. 42-day Treatment Period
3. 2-week post dose Safety Follow-up Period
4. 6-month postdose targeted safety follow-up period

Start Date20 Sep 2024

Sponsor / Collaborator

Autobahn Therapeutics, Inc.

NCT05528315

/ CompletedPhase 1

A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects

The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV)

Start Date12 Oct 2022

Sponsor / Collaborator

Autobahn Therapeutics, Inc.

[+1]

100 Clinical Results associated with Elunetirom

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100 Translational Medicine associated with Elunetirom

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100 Patents (Medical) associated with Elunetirom

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29

News (Medical) associated with Elunetirom

08 Apr 2026

·www.biospace.com

Autobahn Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced that Kevin Finney, President and Chief Executive Officer, and Will Stratton, Chief Business Officer, will participate in the 25 th Annual Needham Virtual Healthcare Conference being held April 13-16, 2026. Mr. Finney and Mr. Stratton will present on Wednesday, April 15, 2026, at 11:00 a.m. ET and participate in 1x1 meetings with investors. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic 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 (ABX-002), 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. Autobahn Therapeutics is based in San Diego. For more information, visit . Contacts Investors: Alex Straus, THRUST alex@thrustsc.com

08 Jul 2025

·www.businesswire.com

Autobahn Therapeutics to Participate in Evercore’s Emerging Private Biotech Conference

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced that Will Stratton, VP, Corporate Development, Strategy, and Planning, will participate in Evercore’s Emerging Private Biotech Conference being held July 13-15, 2025, in Newport, RI. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic 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 ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.

Immunotherapy

27 May 2025

·www.businesswire.com

Autobahn Therapeutics to Participate in Jefferies Global Healthcare Conference

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced that Kevin Finney, President and Chief Executive Officer, will participate in the Jefferies Global Healthcare Conference on Tuesday, June 3, 2025, in New York. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic 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 ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com.

100 Deals associated with Elunetirom

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bipolar Disorder	Phase 2	United States	Autobahn Therapeutics, Inc.	28 Mar 2025
Depressive Disorder, Major	Phase 2	-	Autobahn Therapeutics, Inc.	16 Sep 2024
Bipolar and Related Disorders	IND Approval	United States	Autobahn Therapeutics, Inc.	22 Oct 2024
Adrenoleukodystrophy	Preclinical	United States	Autobahn Therapeutics, Inc.	03 May 2022
Multiple Sclerosis	Preclinical	United States	Autobahn Therapeutics, Inc.	03 May 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05528315 (Biospace) Manual	Phase 1	Depressive Disorder, Major Adjuvant	48	ABX-002 (SAD)	oaxzrfoqrv(iycotnhkkv) = ABX-002 demonstrated acceptable, dose proportional PK across both SAD and MAD ebqmjwizvl (dubfewbhuv ) View more	Positive	07 Nov 2023
				placebo (SAD)