Product Description
Brotizolam is a new thienotriazolodiazepine derivative with a pharmacological profile similar to that of benzodiazepines. It is indicated for use as an hypnotic in the management of insomnia, although it also has anticonvulsant, antianxiety and muscle relaxant properties in animals. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/3281819/)
Mechanisms of Action: GABA Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Austria | Belgium | Chile | Colombia | Egypt | Germany | Hungary | Ireland | Israel | Italy | Luxembourg | Mexico | Netherlands | Peru | Portugal | South Africa | Spain | Taiwan | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Insomnia
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| cs 001-16 | P3 |
Unknown status |
Insomnia |
2017-04-01 |
|
| NCT01361022 | P1 |
Completed |
Healthy Volunteers |
2011-11-01 |
|
| NCT00347295 | P3 |
Completed |
Insomnia |
2007-01-01 |
|
| Drug Use Result Survey | N/A |
Completed |
Insomnia |
2006-03-01 |