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Ketoconazole Pill
Ketoconazole Pill is a Small molecule drug developed by Peter y. Liu. It is currently in Phase 2 development. Also known as: Nizoral.
Ketoconazole is a small molecule that inhibits the enzyme Cytochrome P450 11B1, which is located in the mitochondria. It has been studied in clinical trials for various conditions, including Insulin Resistance, Prostate Cancer, Sleep Restriction, Chronic Myeloid Leukemia, and Chronic Phase.
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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 | Ketoconazole Pill |
|---|---|
| Also known as | Nizoral |
| Sponsor | Peter y. Liu |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas (EARLY_PHASE1)
- Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (EARLY_PHASE1)
- Hormonal Mechanisms of Sleep Restriction - Axis Study (PHASE1)
- Hormonal Mechanisms of Sleep Restriction (EARLY_PHASE1)
- Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia (PHASE2)
- Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (PHASE2)
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:
- Ketoconazole Pill CI brief — competitive landscape report
- Ketoconazole Pill updates RSS · CI watch RSS
- Peter y. Liu portfolio CI
Frequently asked questions about Ketoconazole Pill
What is Ketoconazole Pill?
Who makes Ketoconazole Pill?
Is Ketoconazole Pill also known as anything else?
What development phase is Ketoconazole Pill in?
Related
- Manufacturer: Peter y. Liu — full pipeline
- Also known as: Nizoral
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing