On November 12, 2025, an important announcement was made regarding an upcoming clinical trial that aims to address treatment-resistant depression (TRD). This randomized, double-blind controlled study will evaluate NRX-101—a new pharmacological compound—in conjunction with transcranial magnetic stimulation (TMS) using the ONE-D TMS device. Sponsored by NeuroRx, Inc. and AMPA Health, Inc., this trial is expected to provide fresh insights into therapeutic approaches for patients suffering from severe depressive disorders unresponsive to conventional treatment.
In this article:
- What are the trial details?
- How do NRX-101 and ONE-D TMS work?
- Clinical regulation implications
- FAQ
- Conclusion
- Disclaimer
- Read more about the announcement
What are the trial details?
The upcoming trial focuses on the combined use of NRX-101, an investigational pharmacotherapy, and the ONE-D TMS device for adult patients diagnosed with treatment-resistant depression. TMS, a non-invasive procedure, utilizes electromagnetic induction to stimulate brain regions tied to mood regulation. NRX-101 is designed to complement this stimulation by addressing biochemical pathways associated with depression.
NeuroRx, Inc., and AMPA Health, Inc. will jointly sponsor the study, ensuring adherence to clinical trial regulations and standards. As noted on ClinicalTrials.gov, the trial is currently listed as “Not yet recruiting.”
How do NRX-101 and ONE-D TMS work?
About NRX-101
NRX-101 is a novel pharmacotherapeutic compound intended for depressive symptoms. It targets NMDA receptor modulation to regulate glutamate activity, a key neurotransmitter implicated in mood disorders. This investigational drug aims to enhance the patient outcomes when combined with other interventions.
About ONE-D TMS
ONE-D TMS represents the latest generation of transcranial magnetic stimulation devices. Unlike traditional approaches, this device promises customized treatment precision, targeting areas of the brain more effectively based on individual patient profiles.
Clinical regulation implications
The planned study complies with clinical standards governed by regulatory frameworks, such as the Medical Device Regulation (MDR) Annex XIV in Europe and FDA regulations for investigational drugs and devices in the US. Under these guidelines, safety, efficacy, and intended performance form the cornerstone of trial designs.
Manufacturers of medical devices and sponsors of pharmacological compounds must demonstrate the quality and reliability of clinical evidence. For this trial, both NeuroRx and AMPA Health must verify that NRX-101 and ONE-D TMS meet specific criteria to proceed.
FAQ
1. Is this trial recruiting participants?
No, the trial is currently listed as “Not yet recruiting” on ClinicalTrials.gov.
2. What condition does this study aim to treat?
The study is targeted at treatment-resistant depression (TRD).
3. Who sponsors the study?
NeuroRx, Inc. and AMPA Health, Inc. are jointly sponsoring the trial.
Conclusion
This trial has the potential to reshape treatment approaches for patients with severe depression who do not respond to standard therapies. Both NRX-101 and ONE-D TMS bring promising advancements that demonstrate how pharmacological and device-based solutions may work synergistically in addressing unmet clinical needs.
Disclaimer
This content is intended for information purposes only and does not constitute legal or regulatory advice. Professionals should consult appropriate legal, regulatory, or clinical resources for specific guidance.
Read more about the announcement:
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07227103?term=medical+device