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: *
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:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Depressive Disorder
Phase 3: Insomnia|Dementia|Tic Disorders|Psychophysiologic Disorders|Depressive Disorder|Schizophrenia
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| Drug Use Result Survey | N/A |
Completed |
Insomnia |
2006-03-01 |
2019-03-20 |
Treatments |
|
| NCT01361022 | P1 |
Completed |
Healthy Volunteers |
2011-11-01 |
2019-03-19 |
Treatments |
|
| NCT02218645 | P1 |
Completed |
Healthy Volunteers |
2000-09-01 |
2019-03-20 |
Treatments |
|
| NCT02218658 | P1 |
Completed |
Healthy Volunteers |
2000-08-01 |
2019-03-20 |
Treatments |
|
| NCT02218671 | P1 |
Completed |
Healthy Volunteers |
2000-03-01 |
2019-03-20 |
Treatments |
|
| GAP | P3 |
Terminated |
Depressive Disorder|Psychophysiologic Disorders|Schizophrenia|Tic Disorders|Dementia |
2017-06-28 |
2024-10-16 |
Primary Endpoints|Treatments |
|
| cs 001-16 | P3 |
Unknown status |
Insomnia |
2017-04-01 |
2019-03-20 |
Treatments |
|
| NCT00347295 | P3 |
Completed |
Insomnia |
2007-01-01 |
2019-03-22 |
Treatments |
|
| 2013-004936-31 | P4 |
Completed |
Depressive Disorder |
2016-05-28 |
2022-03-13 |
Treatments |