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Tranxene (clorazepate)
Tranxene (generic name: clorazepate) is a Benzodiazepine drug developed by Ajenat Pharms. It is currently FDA-approved (first approved 1972) for Alcohol withdrawal syndrome, Anxiety, Partial Epilepsy Treatment Adjunct.
Tranxene, also known as clorazepate, is a benzodiazepine medication with anxiolytic, anticonvulsant, sedative, hypnotic, and skeletal muscle relaxant properties. It is a small molecule that serves as a prodrug for desmethyldiazepam, an active metabolite with long-lasting effects.
At a glance
| Generic name | clorazepate |
|---|---|
| Sponsor | Ajenat Pharms |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor alpha-1/beta-2/gamma-2 |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1972 |
Approved indications
- Alcohol withdrawal syndrome
- Anxiety
- Partial Epilepsy Treatment Adjunct
Boxed warnings
- WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including clorazepate dipotassium, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clorazepate dipotassium and throughout out treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including clorazepate dipotassium, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clorazepate dipotassium after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).
Common side effects
- drowsiness
- dizziness
- gastrointestinal complaints
- nervousness
- blurred vision
- dry mouth
- headache
- mental confusion
- insomnia
- skin rashes
- fatigue
- ataxia
Drug interactions
- clozapine
- ritonavir
Key clinical trials
- Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room (PHASE3)
- Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas (PHASE4)
- Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression (PHASE4)
- Bioequivalence Study of Clorazepate Dipotassium 15mg Tablets Under Fasting Conditions (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tranxene CI brief — competitive landscape report
- Tranxene updates RSS · CI watch RSS
- Ajenat Pharms portfolio CI
Frequently asked questions about Tranxene
What is Tranxene?
Tranxene (clorazepate) is a Benzodiazepine drug developed by Ajenat Pharms, indicated for Alcohol withdrawal syndrome, Anxiety, Partial Epilepsy Treatment Adjunct.
What is Tranxene used for?
Tranxene is indicated for Alcohol withdrawal syndrome, Anxiety, Partial Epilepsy Treatment Adjunct.
Who makes Tranxene?
Tranxene is developed and marketed by Ajenat Pharms (see full Ajenat Pharms pipeline at /company/ajenat-pharms).
What is the generic name of Tranxene?
clorazepate is the generic (nonproprietary) name of Tranxene.
What drug class is Tranxene in?
Tranxene belongs to the Benzodiazepine class. See all Benzodiazepine drugs at /class/benzodiazepine.
When was Tranxene approved?
Tranxene was first approved on 1972.
What development phase is Tranxene in?
Tranxene is FDA-approved (marketed).
What are the side effects of Tranxene?
Common side effects of Tranxene include drowsiness, dizziness, gastrointestinal complaints, nervousness, blurred vision, dry mouth.
What does Tranxene target?
Tranxene targets GABA-A receptor alpha-1/beta-2/gamma-2 and is a Benzodiazepine.
Related
- Drug class: All Benzodiazepine drugs
- Target: All drugs targeting GABA-A receptor alpha-1/beta-2/gamma-2
- Manufacturer: Ajenat Pharms — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Alcohol withdrawal syndrome
- Indication: Drugs for Anxiety
- Indication: Drugs for Partial Epilepsy Treatment Adjunct
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing