alprazolam (ZRS 101) / Miravo - LARVOL DELTA

UCB presents latest research across leading neurology portfolio at American Academy of Neurology (AAN) meeting 2025 (PRNewswire) - "24 scientific abstracts reflect UCB's ongoing commitment to improving outcomes for people living with neurological conditions, including rare epilepsies Dravet syndrome and Lennox-Gastaut syndrome, as well as generalized myasthenia gravis and thymidine kinase 2 deficiency; Research includes disease course data of untreated patients with thymidine kinase 2 deficiency from largest international dataset; Also features new data on generalized myasthenia gravis treatments RYSTIGGO (rozanolixizumab-noli) and ZILBRYSQ (zilucoplan) including an open-label extension study investigating rozanolixizumab self-administration and a phase 3 study on the effect of zilucoplan on specific outcome scores; Data on FINTEPLA (fenfluramine), BRIVIACT (brivaracetam) CV, and investigational therapy STACCATO alprazolam showcase commitment to people living with epilepsies and their unmet needs."

Clinical data • Epilepsy • Immunology • Myasthenia Gravis

FDA Approved Drugs: October 2020 - "On Sept. 1, 2020, the FDA approved Onureg® tablets, an oral formulation of the pyrimidine nucleoside analog, azacitidine. It will be used to treat adults who have acute myeloid leukemia (AML) that is in complete remission — with or without complete blood count recovery — after an initial course of intensive induction chemotherapy (chemo); but who cannot tolerate intensive curative treatment. In addition to blocking the production of DNA and RNA, it is believed to destroy aberrant cells in bone marrow. Overall survival (OS) for patients treated with Onureg in a major clinical study averaged 24.7 months versus 14.8 months for participants who took a placebo. The recommended dose is 300mg each day for the first 14 days of 28-day cycles. Because it can cause nausea and vomiting, patients should take an antinausea drug about one-half hour before each dose during the first two cycles, at least."

Online posting

Alp Ex: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 (clinicaltrials.gov) - P; N=14; Completed; Sponsor: University of Maryland; Phase classification: P=N/A ➔ P

Phase classification • Biosimilar • Diabetes

Effect of GABA A receptor activation on counterregulatory responses to subsequent exercise in individuals with type 1 diabetes. (PubMed) - Diabetes - "Endogenous glucose production, lipolysis (glycerol, NEFA) and glycogenolysis (lactate) were also reduced during day 2 exercise following day 1 GABA A activation. We conclude that activation of GABA A receptors with Alp can result in widespread neuroendocrine, autonomic nervous system and metabolic counterregulatory failure during subsequent submaximal exercise and may increase the risk of exercise associated hypoglycemia in individuals with type 1 diabetes."

Journal • Biosimilar • Diabetes • Gene Therapies

Differential modulation of the discriminative stimulus effects of methamphetamine and cocaine by alprazolam and oxazepam in male and female rats. (PubMed) - Neuropharmacology - "The results of these experiments suggest that alprazolam and oxazepam can differentially affect the subjective effects of methamphetamine and cocaine. These results also demonstrate that alprazolam can differentially affect the discriminative stimulus effects of methamphetamine and cocaine."

Journal • Biosimilar

Determination of 13 Organic Toxicants in Human Blood by Liquid-Liquid Extraction Coupling High-Performance Liquid Chromatography Tandem Mass Spectrometry. (PubMed) - Anal Sci - "The limits of quantification ranged over 6.7 - 33.3 μg/L. This method was proved to be simple and reliable, and was thus successfully applied to forensic toxicology."

Journal • Biosimilar • Depression

COMBINATION THERAPY WITH FLUOXETINE AND ALPRAZOLAM TO CONTROL ANXIETY IN A HAND-REARED SNOW LEOPARD (UNCIA UNCIA). (PubMed) - J Zoo Wildl Med - "Although a palatability issue with alprazolam initially prevented consistent dosing, anxious behavior was eliminated and successful breeding behavior was achieved for the first time. After 44 mo of therapy, there have been no anxious behaviors requiring additional medications, two additional breeding behaviors observed, and no evidence of adverse side effects with long-term use."

Journal • Biosimilar

Alp Ex: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 (clinicaltrials.gov) - P=N/A; N=14; Completed; Sponsor: University of Maryland; Active, not recruiting ➔ Completed; N=28 ➔ 14; Trial primary completion date: Dec 2016 ➔ Jun 2016

Enrollment change • Trial completion • Trial primary completion date • Biosimilar • Diabetes

Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam (clinicaltrials.gov) - P1; N=42; Completed; Sponsor: National Institute on Drug Abuse (NIDA); Recruiting ➔ Completed

Trial completion • Biosimilar

Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Pfizer; N=26 ➔ 0

Enrollment change • Biosimilar

Prescription patterns of benzodiazepines in the Lebanese adult population: a cross-sectional study. (PubMed) - Neuropsychiatr Dis Treat - "The two most commonly used BDZs were alprazolam (34.6%) and bromazepam (33.6%). In conclusion, the use of BDZs is highest among females, especially for the treatment of anxiety. Moreover, continuous use of the drugs for more than a year as well as significant potential drug interactions was identified."

Journal • Biosimilar • CNS Disorders • Depression

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 (clinicaltrials.gov) - P=N/A; N=28; Active, not recruiting; Sponsor: University of Maryland; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Chronic Kidney Disease • Diabetes • Renal Cell Carcinoma

A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products. (PubMed) - "In theory, any drug that is metabolized by CYP has potential for a pharmacokinetic drug-drug interaction with all PIs, cobicistat, and most NNRTIs. When adding a new medication to an ARV regimen, use of a drug-drug interaction software and/or consultation with a clinical pharmacist/pharmacologist or HIV specialist is recommended."

Journal • Biosimilar

Alpra: Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety. (clinicaltrials.gov) - P2; N=122; Recruiting; Sponsor: Coordinación de Investigación en Salud, Mexico

New P2 trial • Biosimilar • CNS Disorders • Mood Disorders • Psychiatry

Assessment of Effect of Rapastinel on Driving Performance (clinicaltrials.gov) - P1; N=107; Active, not recruiting; Sponsor: Naurex, Inc, an affiliate of Allergan plc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - P2; N=123; Recruiting; Sponsor: EngageTherapeutics, Inc.; Trial completion date: May 2019 ➔ Aug 2019; Trial primary completion date: May 2019 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date