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Metyrapone Capsules
Metyrapone Capsules is a Small molecule drug developed by Istituto Auxologico Italiano. It is currently in Phase 2 development.
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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).
| 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 | Metyrapone Capsules |
|---|---|
| Sponsor | Istituto Auxologico Italiano |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effects of Metyrapone in Patients With Hypercortisolism
- Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome (PHASE4)
- Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment (PHASE2, PHASE3)
- To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones. (PHASE1)
- Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001) (PHASE1)
- Cortisol and Nutritional Sympathetic Responsiveness (PHASE4)
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 Capsules CI brief — competitive landscape report
- Metyrapone Capsules updates RSS · CI watch RSS
- Istituto Auxologico Italiano portfolio CI
Frequently asked questions about Metyrapone Capsules
What is Metyrapone Capsules?
Who makes Metyrapone Capsules?
What development phase is Metyrapone Capsules in?
Related
- Manufacturer: Istituto Auxologico Italiano — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing