Approval Probability
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Also known as NRX-101 Oral Capsule
NRX-101 · 4 trials · 7 indications
Montgomery Asberg Depression Rating Scale Total Score
Clinical Global Impression Suicidality Scale
Mean change from baseline to endpoint (Day 42/exit) in total MADRS score, a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale (0 Minimum, 60 maximum), where higher scores indicate a worse outcome
Mean change in Glx Area Under the Curve (AUC) measured in 15 minute increments over 2 hours at following experimental drug vs. comparator
The study will measure the difference on BISS-derived MADRS score between NRX-101 and lurasidone (comparator) groups. The Bipolar Inventory of Symptom Scale (BISS) is a validated 42-item clinician-rated scale (21 items each for the depression and mania subscales) in which each item is rated on a 0-4 severity scale where higher values indicate worse severity. BISS-derived MADRS (BDM): MADRS is a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale, where a higher number indicates worse severity. Responses to each question are equally weighted and summed. The BDM has a minimum score of 0 and a maximum of 40, where higher scores indicate a worse severity, therefore decreases in average BDM are considered a better outcome. Data are presented as mean change from baseline (end of stage 1, Day 1) using LOCF
| Arm | Type | Description |
|---|---|---|
| Transcranial Magnetic Stimulation plus NRX-101 | EXPERIMENTAL | Participants are treated with Robotic Rapid TMS plus NRX-101 175mg DCS/8.5mg Lurasidone once on day of treatment |
| Transcranial Magnetic Stimualtion | PLACEBO_COMPARATOR | Participants are treated with Robotic Rapid TMSS plus placebo once on day of treatment |
| Sham TMS + NRX-101 | EXPERIMENTAL | Participants will be treated with Sham TMS (i.e. a TMS coil that does not deliver effective energy to the brain) + NRX-101 175mg DCS/8.5mg Lurasidone once on day of treatment |
| NRX-101 | EXPERIMENTAL | Following study enrollment and randomization, subjects will receive twice daily NRX-101 |
| Lurasidone | ACTIVE_COMPARATOR | Following study enrollment, subjects will receive twice daily lurasidone |
| NRX-101 vs. Placebo | EXPERIMENTAL | Following study enrollment and randomization, subjects will undergo two treatment sessions, 3 days apart. Each treatment session will be conducted while the subject is undergoing Magnetic Resonance Spectroscopy to measure Glx in the ACC. In one treatment session the subject will receive oral placebo and in the other treatment session the subject will receive oral NRX-101. Following the second treatment session, the subject will participate in a four week open study of NRX-101, at the end of which a third session of Magnetic Resonance Spectroscopy will be conducted. |
| NRX-101 vs. lurasidone HCl | EXPERIMENTAL | Following study enrollment and randomization, subjects will undergo two treatment sessions, 3 days apart. Each treatment session will be conducted while the subject is undergoing Magnetic Resonance Spectroscopy to measure Glx in the ACC. In one treatment session the subject will receive oral lurasidone and in the other treatment session the subject will receive oral NRX-101. Following the second treatment session, the subject will participate in a four week open study of NRX-101, at the end of which a third session of Magnetic Resonance Spectroscopy will be conducted. |
| Name | Type | Description |
|---|---|---|
| Neuronavigated robotic-enabled TMS | DEVICE | One Day TMS Protocol performed with the Zeta Surgical neuronavigated robotic-enabled system and the neurocare Apollo TMS Device 30 Theta burst pulses delivered as per protocol |
| NRX-101 | DRUG | D-cycloserine 175mg + Lurasidone 8.5mg |
| Sham TMS | DEVICE | An Apollo TMS device configured not to deliver effective energy to the brain |
| Oral Placebo | DRUG | An oral placebo capsule visually identical to NRX-101 |
| Lurasidone HCl | DRUG | Lurasidone HCl will be given twice a day by mouth |
| Placebo | DRUG | Placebo oral capsule |
| NRX-101 Oral Capsule | DRUG | Prospective Randomized Factorial Design Study as per arm/group descriptions |
| Lurasidone Oral Capsule | DRUG | Prospective Randomized Factorial Design Study as per arm/group descriptions |
| Ketamine Intravenous Infusion | DRUG | Randomized administration of Ketamine or Placebo in a 3 to 1 ratio |
| Saline Solution Intravenous Infusion | DRUG | Randomized administration of Ketamine or Placebo in a 3 to 1 ratio |
18 to 65 years of age, inclusive, at Screening. 2. Participants must be initiating a new course of TMS treatment and must be TMS-naïve. 3. Able to understand and provide written and dated informed consent prior to Screening. 4. Deemed likely to comply with the study protocol, including communication...
NRX-101 is an investigational oral capsule being studied for bipolar depression and treatment resistant depression. It has also been evaluated in patients with bipolar depression who have suicidal ideation. It is a small molecule in Phase 2 clinical development and has received Breakthrough Therapy designation from the FDA.
NRX-101 targets the NMDA receptor. It is a small molecule designed to act on this glutamate receptor pathway, and it is being developed as an oral capsule for psychiatric conditions including bipolar depression and treatment resistant depression.
NRX-101 is being developed by NRX Pharmaceuticals, Inc., which trades under the ticker NRXP. The company is running Phase 2 clinical programs for the drug in bipolar depression and treatment resistant depression, including a recruiting trial combining NRX-101 with robotic transcranial magnetic stimulation.
NRX-101 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The FDA has granted NRX-101 Breakthrough Therapy designation, and the program includes completed Phase 2 studies in bipolar depression as well as an active Phase 2 trial in treatment resistant depression.
NRX-101 has been studied in several Phase 2 trials. The recruiting SPARC-TMS trial is NCT07227103 in treatment resistant depression. Completed studies include NCT03395392 in bipolar depression with subacute suicidal ideation, NCT02974010 in severe bipolar depression, and NCT03402152, a Glx biomarker validation study.
Yes, NRX-101 Oral Capsule is another name for NRX-101. Both refer to the same investigational small molecule developed by NRX Pharmaceuticals for bipolar depression and treatment resistant depression, so searches under either name point to the same Phase 2 drug program.