Also known as: preservative-free ketamine
Ketamine is a cyclohexanone-derived general anesthetic with analgesic and dissociative properties used in anesthesia, pain care, and depression-related treatment settings. It is pharmacologically an NMDA receptor antagonist with broader CNS effects. Ketamine was approved for use in the United States in 1970.
The Trump administration moved to reclassify marijuana from Schedule I to Schedule III under the Controlled Substances Act. The change is expected to ease research restrictions but will not immediately legalize marijuana.
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
New Zealand police arrested 11 people and seized drugs, cash, and firearms after uncovering a dark web drug import network, while Canadian police made a separate bust seizing cocaine, fentanyl, and methamphetamine. The New Zealand operation involved international cooperation and intercepted over 200kg of drugs at borders. The busts come as New Zealand data shows record-breaking cocaine consumption nationwide.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
New research challenges the theory that ketamine's psychedelic effects drive its therapeutic benefits for alcohol use disorder. A study of 96 participants found no link between ketamine's psychoactive experiences and improved abstinence rates. The findings suggest other mechanisms, such as brain network alterations, may explain ketamine's effectiveness in treating addiction.
U.S. overdose deaths declined 19% year-over-year to 72,108 for the 12 months ending September 2025, but the drug market is evolving with dangerous polydrug cocktails like "pink cocaine" and "rhino tranq" that are harder to detect and reverse. These synthetic blends combine fentanyl with stimulants, sedatives, and veterinary tranquilizers, creating new public health challenges as naloxone becomes less effective against complex overdoses.
New research reveals how ketamine rewires brain receptors to rapidly relieve severe depression, while separate trials demonstrate success with personalized brain stimulation and targeted drug therapy for treatment-resistant cases.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07536633 |
Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery |
COMPLETED | PHASE4 |
| NCT07526454 |
Electroconvulsive Therapy Versus Intravenous Ketamine in Treatment-Resistant Major Depressive Disorder |
COMPLETED | NA |
| NCT07443254 |
Prospective IR-led Sedation Feasibility |
RECRUITING | PHASE1/PHASE2 |
| NCT07385352 |
Caudal Dexmedetomidine vs Ketamine for Postoperative Analgesia in Pediatric DDH Surgery |
NOT_YET_RECRUITING | NA |
| NCT07370181 |
Ketamine Irrigation Analgesia in Laparoscopic Cholecystectomy |
NOT_YET_RECRUITING | PHASE3 |
| NCT07369089 |
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement |
NOT_YET_RECRUITING | PHASE2 |
| NCT07340008 |
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery |
RECRUITING | NA |
| NCT07330375 |
Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia |
NOT_YET_RECRUITING | PHASE3 |
| NCT07294092 |
Ketamine and Propofol NeuroImaging |
RECRUITING | EARLY_PHASE1 |
| NCT07254936 |
Comparison of Pain Using CPOT Score With Ketamine vs. Dexmedetomidine in Post-Craniotomy ICU Patients |
COMPLETED | NA |
