Last reviewed · How we verify
CLOTIAZEPAM
CLOTIAZEPAM is a clotiazepam drug. It is currently in Phase 2 development.
Clotiazepam is thought to work by modulating the activity of neurotransmitters in the brain.
Clotiazepam is a small molecule drug in the clotiazepam class, but its target and exact mechanism of action are unknown. It is not FDA-approved for any indications. The commercial status of clotiazepam is unclear, and it may be patented or off-patent. Clotiazepam's pharmacokinetic properties, such as half-life and bioavailability, are also unknown. As a result, key safety considerations and generic manufacturers are also unclear.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | CLOTIAZEPAM |
|---|---|
| Drug class | clotiazepam |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain is a busy city with many different streets and intersections. Neurotransmitters are like the traffic signals that help different parts of the brain communicate with each other. Clotiazepam may help regulate the flow of traffic by adjusting the signals that control the flow of neurotransmitters.
Approved indications
Common side effects
- Coma
- Eczema eyelids
- Suicide attempt
- Miosis
- Analgesic drug level increased
- Inappropriate antidiuretic hormone secretion
- Cross sensitivity reaction
- Hepatic function abnormal
- Somnolence
- Toxicity to various agents
- Poisoning
Key clinical trials
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:
- CLOTIAZEPAM CI brief — competitive landscape report
- CLOTIAZEPAM updates RSS · CI watch RSS
Frequently asked questions about CLOTIAZEPAM
What is CLOTIAZEPAM?
How does CLOTIAZEPAM work?
What drug class is CLOTIAZEPAM in?
What development phase is CLOTIAZEPAM in?
What are the side effects of CLOTIAZEPAM?
Related
- Drug class: All clotiazepam drugs
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing