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metyrapone & oxazepam
metyrapone & oxazepam is a Small molecule drug developed by Embera NeuroTherapeutics, Inc.. It is currently in Phase 1 development. Also known as: Cohort 1, Cohort 2, Cohort 3.
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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 | metyrapone & oxazepam |
|---|---|
| Also known as | Cohort 1, Cohort 2, Cohort 3 |
| Sponsor | Embera NeuroTherapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study of EMB-001 as a Potential Smoking Cessation Treatment (PHASE1, PHASE2)
- A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder (PHASE2)
- Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment (PHASE2, PHASE3)
- Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations (PHASE1)
- A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine (PHASE1)
- Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001) (PHASE1)
- A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction (NA)
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:
- metyrapone & oxazepam CI brief — competitive landscape report
- metyrapone & oxazepam updates RSS · CI watch RSS
- Embera NeuroTherapeutics, Inc. portfolio CI
Frequently asked questions about metyrapone & oxazepam
What is metyrapone & oxazepam?
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Is metyrapone & oxazepam also known as anything else?
What development phase is metyrapone & oxazepam in?
Related
- Manufacturer: Embera NeuroTherapeutics, Inc. — full pipeline
- Also known as: Cohort 1, Cohort 2, Cohort 3
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing