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Minidril
Minidril is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 1 development. Also known as: ethinyl estradiol, levonorgestrel.
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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 | Minidril |
|---|---|
| Also known as | ethinyl estradiol, levonorgestrel |
| Sponsor | Astellas Pharma Inc |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Blood sodium decreased
- Blood calcium decreased
- Blood alkaline phosphatase increased
- Haemoglobin decreased
- Blood bilirubin increased
- Amylase increased
- Blood glucose decreased
- Blood glucose increased
- Blood potassium decreased
- Aspartate aminotransferase increased
- Blood magnesium decreased
- Neutrophil count decreased
Key clinical trials
- Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis (PHASE2, PHASE3)
- A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women (PHASE2)
- A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill (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:
- Minidril CI brief — competitive landscape report
- Minidril updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Minidril
What is Minidril?
Who makes Minidril?
Is Minidril also known as anything else?
What development phase is Minidril in?
What are the side effects of Minidril?
Related
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: ethinyl estradiol, levonorgestrel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing