D-cycloserine (cycloserine) is an oral antibiotic used as a second-line component for active drug-resistant tuberculosis therapy in combination regimens. It is marketed under the trade name Seromycin and has specific neurologic safety considerations. It is prescription-only in the U.S.
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07593222 |
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07542548 |
D-Cycloserine for Serine Palmitoyltransferase Inhibition |
COMPLETED | PHASE4 |
| NCT06121284 |
iTBS+D-Cycloserine for Youth Suicide |
RECRUITING | PHASE2 |
| NCT05994703 |
Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine |
COMPLETED | PHASE2 |
| NCT05731323 |
D-Cycloserine+iTBS PK Study |
COMPLETED | PHASE1 |
| NCT05591677 |
D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05395494 |
iTBS-DCS in Fibromyalgia |
TERMINATED | PHASE2 |
| NCT05177601 |
iTBS-DCS in Obsessive Compulsive Disorder |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04762836 |
Pain, Learning, and Nocebo |
COMPLETED | NA |
| NCT04357951 |
D-cycloserine Augmented Treatment for Youth With Tic Disorders |
WITHDRAWN | EARLY_PHASE1 |
