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Midalozam
Midalozam is a Small molecule drug developed by Istanbul University - Cerrahpasa. It is currently in Phase 1 development. Also known as: Dormicum.
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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).
| 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 | Midalozam |
|---|---|
| Also known as | Dormicum |
| Sponsor | Istanbul University - Cerrahpasa |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia (NA)
- A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) (PHASE3)
- A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects (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:
- Midalozam CI brief — competitive landscape report
- Midalozam updates RSS · CI watch RSS
- Istanbul University - Cerrahpasa portfolio CI
Frequently asked questions about Midalozam
What is Midalozam?
Who makes Midalozam?
Is Midalozam also known as anything else?
What development phase is Midalozam in?
Related
- Manufacturer: Istanbul University - Cerrahpasa — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Dormicum
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing