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Darolutamide intermittent
Darolutamide intermittent is a Androgen receptor antagonist Small molecule drug developed by The First Affiliated Hospital with Nanjing Medical University. It is currently in Phase 3 development for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC). Also known as: Darolutamide.
Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting prostate cancer cell growth and survival.
Darolutamide is an androgen receptor antagonist that blocks the binding of androgens to the androgen receptor, inhibiting prostate cancer cell growth and survival. Used for Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Darolutamide intermittent |
|---|---|
| Also known as | Darolutamide |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Darolutamide competitively binds to the androgen receptor with high affinity and specificity, preventing activation by testosterone and dihydrotestosterone. This blocks the transcription of androgen-responsive genes essential for prostate cancer cell proliferation. The intermittent dosing schedule aims to reduce cumulative toxicity while maintaining therapeutic efficacy in hormone-sensitive prostate cancer.
Approved indications
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC)
Common side effects
- Fatigue
- Hot flashes
- Hypertension
- Rash
- Diarrhea
Key clinical trials
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors (PHASE3)
- Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC (PHASE3)
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:
- Darolutamide intermittent CI brief — competitive landscape report
- Darolutamide intermittent updates RSS · CI watch RSS
- The First Affiliated Hospital with Nanjing Medical University portfolio CI
Frequently asked questions about Darolutamide intermittent
What is Darolutamide intermittent?
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Related
- Drug class: All Androgen receptor antagonist drugs
- Target: All drugs targeting Androgen receptor (AR)
- Manufacturer: The First Affiliated Hospital with Nanjing Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Indication: Drugs for Metastatic hormone-sensitive prostate cancer (mHSPC)
- Also known as: Darolutamide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing