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Brotizolam tablet
Brotizolam tablet is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development.
Brotizolam is a small molecule used to treat sleep initiation and maintenance disorders. It is available in tablet form, including under the brand name Lendormin, and has been studied for bioequivalence with other formulations.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Boehringer Ingelheim is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Brotizolam tablet |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Lendormin D® Tablet (Drug Use Result Survey)
- Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers (PHASE1)
- Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males (PHASE1)
- Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males (PHASE1)
- To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers (PHASE1)
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 |
|---|---|
| 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:
- Brotizolam tablet CI brief — competitive landscape report
- Brotizolam tablet updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI
Frequently asked questions about Brotizolam tablet
What is Brotizolam tablet?
Who makes Brotizolam tablet?
What development phase is Brotizolam tablet in?
Related
- Manufacturer: Boehringer Ingelheim — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing